Real-World Ravulizumab Dosing Patterns Among Patients with Paroxysmal Nocturnal Hemoglobinuria in a US Population

Abstract Introduction: Current management of patients diagnosed with paroxysmal nocturnal hemoglobinuria (PNH) includes C5 complement inhibitors such as ravulizumab. The ravulizumab dosage regimen varies by patient body weight and consists of a single loading dose followed by maintenance doses administered every 8 weeks via intravenous infusion (see Table for label-recommended loading and maintenance dosing regimens by patient body weight category). Given its recent 2018 FDA approval, real-world data on the dosing patterns of ravulizumab are limited. This study investigated the real-world dosing patterns of patients with PNH treated with ravulizumab in a large US population. Methods: This retrospective longitudinal cohort study was conducted using provider-based claims data from the Symphony Health Integrated Dataverse ® (IDV). Patients were ≥12 years of age and received ≥2 infusions of ravulizumab between June 21, 2019 and May 6, 2021. The index date was defined as the 1st medical claim for ravulizumab infusion with ≥6 months of continuous clinical activity prior to the index (the baseline period). Patients with ≥1 diagnosis of atypical hemolytic uremic syndrome (another indication for ravulizumab) during the baseline period or on the index date were excluded to identify those with PNH. Patient baseline demographic and clinical characteristics including PNH-related comorbidities and symptoms were described. Because Symphony IDV does not record patient weight, it was assumed that all patients had a weight ≥60 and <100 kg (ie, "medium body weight"), consistent with mean weights reported in recent clinical trials of ravulizumab (~70 kg) and in the US population (men: 91 kg; women: 77 kg). Mean and mode loading and maintenance doses as well as the proportion of patients with high, label-recommended, and low loading and mean maintenance doses were calculated. To test the weight assumptions, 2 sets of sensitivity analyses were carried out to account for alternative dosing pattern scenarios, with all patients classified as "low body weight" (≥40 and <60 kg) or "high body weight" (≥100 kg). Results: A total of 433 patients with PNH were included in the study; the mean age was 47 years and 52% were female. The mean treatment period was 11.8 months; and 54%, 40%, and 6% of patients initiated ravulizumab in 2019, 2020, and 2021, respectively. Most patients (76%) were insured through a commercial insurance plan. Aplastic anemia and myelodysplastic syndrome were present at baseline in 22% and 5% of patients, respectively. The most frequent comorbidities were coagulopathy (13%), deficiency anemias (12%), and hypertension (11%); and 40% of patients had anemia (other than aplastic anemia) at baseline. Prior to initiating ravulizumab, 42% of patients had previously received ≥1 infusion of eculizumab during the baseline period. The mean (standard deviation [SD]) and mode loading doses were 3,316 (2,932) and 3,300 mg, respectively. The proportion of patients with a high, label-recommended, and low loading dose was 59%, 28%, and 13%, respectively (Table). During the maintenance phase, the mean (SD) and mode doses were 3,404 (1,024) and 3,300 mg, respectively; the proportion of patients with a high, label-recommended, and low mean dose during this phase was 27%, 51%, and 23%, respectively (Table). The sensitivity analyses revealed similar trends: nearly half or more than half of patients received a high loading dose; the proportion with a high mean dose during the maintenance phase was substantial when it was assumed that all patients had "low body weight" and negligible when assuming "high body weight" (Table). Conclusions: Most patients with PNH treated with ravulizumab received a higher than label-recommended loading dose regardless of weight category. Additionally, the mean dose received during the maintenance phase was higher than the label-recommended dose of 3,300 mg in more than one-quarter of patients (≥60 - <100 kg). The deviations from label-recommended dosing regimens-especially dosages exceeding recommendations-suggest that in some patients, PNH is not controlled by ravulizumab. Alternative weight scenarios will be tested in future analyses to account for weight distribution in the US. Future budget impact analyses of ravulizumab in patients with PNH should consider real-world dosing patterns in order to determine cost vs benefit. Figure 1 Figure 1. Disclosures Cheng: Novartis: Other: I am an employee of Analysis Group, a consulting company that received funding from Novartis for this research study.. Fishman: Apellis: Current Employment, Current equity holder in publicly-traded company. Sarda: Apellis: Current Employment, Current equity holder in publicly-traded company. Krishnan: Apellis: Current Employment, Current equity holder in publicly-traded company. Kunzweiler: Apellis: Other: Employee of Analysis Group, Inc., Research Funding. Vu: Apellis: Other: Employee of Analysis Group, Inc., Research Funding. Yenikomshian: Apellis: Other: Employee of Analysis Group, Inc., Research Funding. Duh: Novartis: Other: I am an employee of Analysis Group, a consulting company that received funding from Novartis for this research study..

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Real-World Eculizumab Dosing Patterns Among Patients with Paroxysmal Nocturnal Hemoglobinuria in a US Population

Blood ◽

10.1182/blood-2020-141636 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 13-13

Author(s):

Wendy Y Cheng ◽

Sujata P. Sarda ◽

Nikita Mody-Patel ◽

Sangeeta Krishnan ◽

Mihran Yenikomshian ◽

...

Keyword(s):

Real World ◽

Research Funding ◽

Maintenance Phase ◽

Baseline Period ◽

Induction Phase ◽

Publicly Traded ◽

Starting Dose ◽

The Mean ◽

High Label ◽

Dosing Patterns

INTRODUCTION Current pharmacologic management of patients who are diagnosed with paroxysmal nocturnal hemoglobinuria (PNH) includes C5 complement inhibitors, such as eculizumab. The standard dosage of eculizumab, administered via intravenous infusion, is 600 mg/week for the first 4 weeks (induction phase), 900 mg for the fifth dose 1 week later, and 900 mg biweekly thereafter (maintenance phase). There is limited information describing dosing patterns of eculizumab in clinical practice. The purpose of this study was to conduct a comprehensive assessment of the real-world dosing patterns of patients with PNH treated with eculizumab in a large US population. METHODS A retrospective longitudinal cohort study using provider-based claims data from the Symphony Health Integrated Dataverse® was conducted. Patients were ≥12 years of age and received ≥2 infusions of eculizumab between October 1, 2014, and September 30, 2019. The index date was defined as the first medical claim for eculizumab infusion with ≥3 months of prior continuous clinical activity, defined as ≥1 claim of any type per quarter (ie, the baseline period). Patients with ≥1 diagnosis of another indication for eculizumab, including atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder, during the baseline period or on the index date were excluded to identify patients with PNH. Patient baseline demographic and clinical characteristics, including PNH-related comorbidities and PNH-symptoms, were described. Mean starting dose and the proportion with high (>600 mg), label-recommended (600 mg), and low (<600 mg) starting dose during the induction phase were calculated. In addition, the mean and mode dose during the induction and maintenance phases, as well as the proportion of patients with high, label-recommended, and low mean dose during the induction and maintenance phases, were described. RESULTS A total of 707 patients with PNH who had ≥2 infusions of eculizumab during the study period were included in this analysis; mean observation period was 23.9 months. Mean age was 45.4 years, 55.7% were female, and 35.9% were from the South. The majority of patients (77.1%) were insured through a commercial insurance plan. Respectively, 32.5% and 6.8% of patients had a diagnosis for aplastic anemia and myelodysplastic syndrome during baseline. The most frequent comorbidities in this sample included hypertension (26.6%), coagulopathy (26.6%), and renal failure (20.5%). In addition, 85.1% of patients experienced anemia (other than aplastic anemia) at baseline. The mean (standard deviation) starting dose during the induction phase was 862 (412) mg; the proportion of patients with high, label-recommended, and low starting dose was 64.1%, 30.6%, and 5.4%, respectively. The mean (standard deviation) and mode dose was 859 (391) mg and 900 mg during the induction phase, and 1011 (333) mg and 900 mg during the maintenance phase. Respectively, 67.9%, 25.9%, and 6.2% of patients had a high, label-recommended, and low mean dose during the induction phase, and 45.9%, 41.6%, and 12.5% had a high, label-recommended, and low mean dose during the maintenance phase. CONCLUSIONS This study demonstrates that the majority of patients with PNH treated with eculizumab were started on a dose in the induction phase that was higher than the label-recommended dose of 600 mg, and the mean dose received during the maintenance phase was higher than the label-recommended dose of 900 mg in approximately half of all patients. Future analyses that investigate budget impact of eculizumab in patients with PNH should account for real-world dosing patterns in order to comprehensively assess costs and benefits. Disclosures Cheng: Apellis: Research Funding. Sarda:Apellis: Current Employment, Current equity holder in publicly-traded company. Mody-Patel:Apellis: Current Employment, Current equity holder in publicly-traded company. Krishnan:Apellis: Current Employment, Current equity holder in publicly-traded company. Yenikomshian:Apellis: Research Funding. Scoble:Apellis: Current Employment, Current equity holder in publicly-traded company. Kunzweiler:Apellis: Research Funding. Vu:Apellis: Research Funding. Cheung:Apellis: Research Funding. Duh:Merck: Research Funding; Pharmacyclics: Research Funding; Takeda Oncology: Research Funding; GlaxoSmithKline: Research Funding; AstraZeneca: Research Funding; Blueprint Medicine: Research Funding; Novartis: Research Funding; Shire: Research Funding; Apellis: Research Funding.

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853. Real-World Persistency of Patients Receiving Tenofovir-Based Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the US

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1048 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S516-S517

Author(s):

Alan Oglesby ◽

Guillaume Germain ◽

Francois Laliberte ◽

Staci Bush ◽

Heidi Swygard ◽

...

Keyword(s):

Hiv Infection ◽

Real World ◽

Patient Characteristics ◽

Baseline Period ◽

Hiv Diagnosis ◽

Analysis Group ◽

Populations At Risk ◽

Proportion Of Days Covered ◽

Exposure Prophylaxis

Abstract Background Once-daily oral tenofovir-based combinations as pre-exposure prophylaxis (PrEP) have shown to be an effective biomedical HIV prevention strategy for populations at-risk of acquiring HIV-1. However, low adherence can lead to poor effectiveness. This study described the characteristics of commercially-insured US PrEP users. Methods This retrospective study used IQVIA™ PharMetrics Plus data (1/1/2015–3/31/2020) to identify adults newly initiated (index date) on emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF) as daily PrEP. Users had ≥6 months of continuous enrollment pre-index (baseline); those diagnosed with HIV or with antiretroviral therapy (ART) use during baseline were excluded. User characteristics were described during the baseline period. For FTC/TDF users, proportion of days covered (PDC), persistence, treatment breaks, and switching were described during the follow-up period, which spanned from index to the earliest of disenrollment or end of data. Non-persistence was defined as a >90-day gap from last day of supply, with re-initiation after this gap indicating treatment break. For PDC and persistence, follow-up was censored at HIV infection, defined by both multi-class ART initiation and HIV diagnosis. Results In total 24,232 FTC/TDF and 1,187 FTC/TAF users were identified. Overall, mean age was 35.1 years and 94.5% were male (Table 1). Mean [median] length of follow-up was longer for FTC/TDF (504 [390] days) than FTC/TDF users (77 [70] days). On average, FTC/TDF users had 9.0 dispensings with 38.3 days of supply per dispensing over follow-up; 11.1% had ≥1 treatment break (mean length, 249 days). Among those initiated on FTC/TDF, 10.8% switched to FTC/TAF. The mean PDC for FTC/TDF users at 6 and 12 months was 0.74 and 0.67, respectively, corresponding to 63.7% and 57.9% of patients with PDC ≥0.70 (Figure 1). Persistence to FTC/TDF at 6 and 12 months was 70.2% and 57.4%, respectively (Figure 2). Table 1. Baseline Demographics and Clinical Characteristics of PrEP Users by Regimen Figure 1. Proportion of Days Covered of FTC/TDF Users Figure 2. Kaplan-Meier Persistence Rates of FTC/TDF Users Conclusion Patient characteristics of PrEP users are broadly similar between regimens, though switching from FTC/TDF to FTC/TAF is common. FTC/TDF users had lower real-world PDC and persistence than in recent clinical trials (DISCOVER and HPTN 083). Disclosures Alan Oglesby, MPH, GlaxoSmithKline (GSK) (Employee, Shareholder) Guillaume Germain, MSc, ViiV Healthcare (Other Financial or Material Support, I am an employee of Groupe d’analyse, Ltée, a consulting company that provided paid consulting services to ViiV Healthcare for the conduct of the present study.) Francois Laliberte, MA, Viiv (Research Grant or Support) Staci Bush, NP, GlaxoSmithKline (GSK) (Employee, Shareholder) Heidi Swygard, MD, ViiV Healthcare (Employee) Sean MacKnight, MScPH, Analysis Group (Employee) Annalise Hilts, BA, Analysis Group, Inc. (Employee) Mei Sheng Duh, MPH, ScD, ViiV Healthcare (Grant/Research Support)

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Treatment Patterns and Economic Burden Among Elderly Patients with Acute Myeloid Leukemia Treated with Hypomethylating Agents: A SEER-Medicare Analysis

Blood ◽

10.1182/blood-2021-145593 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4975-4975

Author(s):

Andrew M. Brunner ◽

David Huggar ◽

Ronda Copher ◽

Zheng-Yi Zhou ◽

Miriam L. Zichlin ◽

...

Keyword(s):

Induction Therapy ◽

Economic Burden ◽

Research Funding ◽

Index Date ◽

Baseline Period ◽

Publicly Traded ◽

Patient Costs ◽

Analysis Group ◽

Remission Phase

Abstract Introduction: Previously, we assessed the economic burden of newly diagnosed acute myeloid leukemia (AML) among Medicare patients and found that the economic burden of relapse is high, at approximately 1.2 and 1.6 times the monthly per-patient costs associated with early and late post-remission therapy, respectively (Tabah A, et al. Blood 2020:136(suppl 1):45). A notably high proportion of patients (55%) received ≥ 1 cycle of a hypomethylating agent (HMA). Therefore, the objective of this study was to assess the economic burden of AML among a subgroup of elderly patients who received only HMA monotherapy during induction and then achieved disease remission. Healthcare resource utilization (HCRU) and costs associated with various phases (ie, induction, post-remission therapy, and post-relapse) were assessed. Methods: A retrospective analysis was conducted using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, which comprised Medicare claims (parts A, B, and D from 2007 through 2016) and the US National Cancer Institute's SEER database (cancer diagnoses from 2007 to 2015). Included patients had an AML diagnosis in the SEER registry, were ≥ 65 years of age at the AML diagnosis date, had initiated HMA (and no other active treatment) in the outpatient (OP) setting during the first induction cycle post-AML diagnosis, and had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) diagnosis code for AML remission following the initiation of induction therapy. Patients were excluded if they had another blood malignancy (including a history of myelodysplastic syndromes), had received hematopoietic stem cell transplantation, or were enrolled in a clinical trial. The induction therapy period was defined as the first initiation of HMA post diagnosis (index date) to the end of the cycle during which a patient had a code for AML remission. The 6-month period prior to the index date was defined as the baseline period. The post-remission phase ended at the earliest of relapse or end of follow-up (ie, death, end of eligibility, or end of available data [December 31, 2016]). The post-relapse phase was from the date of first AML relapse ICD-9/10 code after remission to the end of follow-up. Patient characteristics during the baseline period were summarized descriptively. HCRU and costs (adjusted to 2019 US dollars) associated with induction and post-remission therapy were assessed during days that were part of a treatment cycle. The average per-patient monthly HCRU and costs were reported for the induction, post-remission, and post-relapse phases. Results: A total of 71 patients with newly diagnosed AML (azacitidine: n = 31; decitabine: n = 40) received HMA induction therapy and achieved remission. The median age at AML diagnosis was 78.8 years, 50.7% of patients were male, and 85.9% were White. The mean ± standard deviation (median) time from index date to the end of follow-up was 16.0 ± 12.3 (14.0) months. A total of 63.4% of patients (n = 45) received post-remission therapy. Among all patients, 43.7% relapsed and 85.9% died by the end of follow-up. OP visits were the most common type of visit across all phases with 95.6% of patients having ≥ 1 OP visit during post-remission therapy and 83.9% during the post-relapse phase. Inpatient (IP) visits were highest in the post-relapse phase with 77.4% of patients having ≥ 1 IP visit. The monthly mean per-patient healthcare costs were highest for the post-relapse phase, followed by post-remission therapy, and induction (Table). Costs associated with the OP setting were the greatest contributor to the induction costs (48.9%) while costs associated with the IP setting were the drivers of the costs in the post-remission therapy (56.2%) and post-relapse (72.8%) phases. Conclusions: The economic burden of AML treated with HMA induction therapy was highest in the post-relapse phase, at approximately 1.7 and 1.6 times the monthly per-patient costs during the induction and post-remission therapy phases, respectively. In addition, IP costs made up nearly two-thirds of total monthly per-patient costs in the post-relapse phase, up from approximately 44% and 56% of the induction and post-remission therapy phases, respectively. Treatment options that extend the post-remission phase would reduce the high economic burden associated with AML relapse. Figure 1 Figure 1. Disclosures Brunner: Celgene, Forty Seven Inc, Jazz: Other: Advisory Board; Novartis, Celgene, Takeda, AstraZeneca: Research Funding. Huggar: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Copher: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Zhou: Sanofi: Research Funding; Analysis Group: Current Employment, Other: Employee of Analysis Group which received consulting fees for this project . Zichlin: Analysis Group, Inc.: Consultancy, Current Employment; GlaxoSmithKline: Research Funding. Anderson: Analysis Group, which received consultancy fees from GSK: Consultancy, Current Employment. Downes: nalysis Group (employment), Bristol Myers Squibb (consultancy): Consultancy, Current Employment. McBride: BMS: Current Employment.

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A Real-World Study of Pre-Post Annualized Bleed Rates and All Cause Costs Among Non-Inhibitor Patients with Hemophilia a Switching from FVIII Prophylaxis to Emicizumab

Blood ◽

10.1182/blood-2021-146616 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 3028-3028

Author(s):

Katharine Batt ◽

Bob G Schultz ◽

Jorge Caicedo ◽

Christopher S Hollenbeak ◽

Neha Agrawal ◽

...

Keyword(s):

Real World ◽

Bayesian Model ◽

Hemophilia A ◽

Publicly Traded ◽

Real World Data ◽

Population Mean ◽

Icd 10 ◽

Bleeding Episodes ◽

The Mean ◽

Privately Held

Abstract Background Hemophilia A (HA) is a rare genetic disease characterized by a deficiency in clotting factor VIII (FVIII). Persons with HA suffer from spontaneous and traumatic bleeds which significantly impact short- and long-term quality of life. Prophylaxis treatment with FVIII replacement or non-factor replacement (e.g. emicizumab) intends to prevent bleeding episodes. To date, clinical comparisons between FVIII and emicizumab are limited to non-interventional studies and indirect comparisons. Comparisons of costs are limited to cost-effectiveness models or observational studies that include patients with and without inhibitors. An increase in availability of real-world data since emicizumab's approval in 2018 has created opportunity for comparative outcomes research in the non-inhibitor HA population. Objective To compare billed annualized bleed rates (ABR b) and all-cause costs (ACC) among non-inhibitor HA patients switching from prophylaxis with FVIII replacement to emicizumab. Methods This retrospective, observational, pre-post study used the IQVIA PharMetrics® Plus database (2015-2020)-a large longitudinal US commercial health plan database with over 190 million lives. International Classification of Diseases codes (ICD-10), National Drug Codes, and Healthcare Common Procedure Coding System were used to identify diagnoses, therapies, and procedures. Males with ≥1 claim for emicizumab who were on prophylaxis treatment with FVIII prior to initiating emicizumab were included in the analysis. Patients who received bypassing agents, immune tolerance induction, or rituximab were assumed to have inhibitors and were excluded. Patients with ≥2 occurrences of any of the following diagnoses were excluded: von Willebrand disease, hemophilia B, acquired HA, or other coagulation disorders. Annualized bleed rate was defined as billed ABR and represents bleeding episodes that required evaluation, treatment, or procedure resulting in an ICD-10 claim. Therefore, bleeds treated at home and untreated bleeds were not captured. A clinical review of ICD-10 codes resulted in a list of 535 codes used to identify HA-related bleeding episodes (e.g. hemarthrosis). The ACC were calculated as the mean cost per patient per year in 2020 US dollars actually paid by the insurer. Descriptive statistics were used to summarize, and Bayesian models were developed to compare, ABR b and ACC in the pre- and post-switch periods. Bayesian inferences estimated the population mean difference in ABR b and ACC after switching from FVIII prophylaxis to emicizumab. Inferences were conducted by computing posterior probabilities for hypotheses and summarized with 95% credible intervals (CrI). Results A total of 121 patients were included with mean age [range] of 25.9 [2-63] years. The majority of patients were over the age of 18 (60.3%), 33.1% were ≥7-18, and 6.6% were <7. The mean (SD) years on FVIII replacement (pre-switch) and emicizumab (post-switch) were 2.5 (1.5) and 1.1 (0.4), respectively (Table 1). Descriptive In the majority of patients, ABR b remained unchanged from pre-switch to post-switch (42%) while 38% had some magnitude of improvement, and 20% experienced a worsening of ABR b. The mean observed ABR b and ACC were 0.68 and $518,151, respectively, in the pre-switch period, and 0.55 and $652,679, respectively, in the post-switch period. Bayesian Model The Bayesian model demonstrated a mean change in ABR b of -0.128 [95% CrI: -0.441 to 0.184] after switch (Table 2). The mean change in ACC was +$159,680 [95% CrI: $74,842 to $247,841] after switch. The model determined there is a 21.0% probability ABR b will worsen after switch and a 99.9% probability ACC will increase after switch. Conclusions Prophylaxis with FVIII replacement and emicizumab result in similar prevention of billed bleeds in a real-world switch population. Although the population mean ABR b is more likely to fall after switching from FVIII replacement to emicizumab, there is only a 1.02% posterior probability the population mean ABR b will fall by ≥0.5 after switching to emicizumab and a 21.0% probability the ABR b will worsen after switch. Additionaly, ACC are almost certain to substantially increase after switching to emicizumab (99.9%). As additional real-world data becomes available in the non-inhibitor HA population, further research should help to strengthen clinical and economic outcomes for different prophylaxis treatment options. Figure 1 Figure 1. Disclosures Batt: Sanofi: Current equity holder in publicly-traded company; Bayer Therapeutics: Consultancy; Sprouts Consulting: Other: CEO, Principal Consultant; Merck: Current equity holder in publicly-traded company; Forma: Consultancy, Current equity holder in publicly-traded company; Precision Health: Consultancy; Takeda Pharmaceuticals U.S.A.: Consultancy. Schultz: Takeda Pharmaceuticals U.S.A., Inc.: Current Employment, Current holder of individual stocks in a privately-held company. Caicedo: Takeda Pharmaceuticals U.S.A., Inc.: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Hollenbeak: Takeda Pharmaceuticals U.S.A., Inc.: Consultancy. Agrawal: Takeda Pharmaceuticals U.S.A., Inc.: Consultancy. Chatterjee: Takeda Pharmaceuticals U.S.A., Inc.: Consultancy. Dayma: Takeda Pharmaceuticals U.S.A., Inc.: Consultancy. Bullano: Takeda Pharmaceuticals U.S.A., Inc.: Current Employment, Current holder of individual stocks in a privately-held company.

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Early use of erenumab in US real-world practice

Cephalalgia Reports ◽

10.1177/25158163211020419 ◽

2021 ◽

Vol 4 ◽

pp. 251581632110204

Author(s):

Alina Bogdanov ◽

Victoria Chia ◽

Mark Bensink ◽

Robert Urman ◽

Lauren Fischer ◽

...

Keyword(s):

Real World ◽

The United States ◽

Baseline Period ◽

Calcitonin Gene ◽

Proportion Of Days Covered ◽

Early Use ◽

High Adherence ◽

The Mean ◽

Anxiety Depression

Background: Erenumab, a monoclonal antibody (mAb) developed to block the calcitonin gene-related peptide (CGRP) receptor, is approved for the prevention of migraine in adults. This retrospective observational study sought to describe early real-world use of erenumab. Methods: This study used the Practice Fusion ambulatory Electronic Health Record database, which represents approximately 6% of ambulatory care among primary care and specialist practices in the United States. Among migraine patients initiating erenumab, demographics, migraine type, comorbidities, and prior treatments were assessed during the 12-month baseline period. Treatment patterns including changes in acute and preventive medications, switches to other CGRP mAbs (fremanezumab and galcanezumab), and for erenumab, changes in dose and adherence were examined among patients with 6 months of follow-up. Results: Of 3,336 patients identified (85.9% female; mean age = 49.1 years), approximately 40% had documentation of chronic migraine. Common comorbidities included non-migraine headache, anxiety, depression, and hypertension. Most patients (76.3%) initiated on the 70 mg dose of erenumab. Among 1,638 patients included in the treatment pattern analysis, 53.1% used acute medications and 55.7% used other non-specific preventive migraine medications during follow-up, reductions of 9.8% and 10.2%, respectively, over the same period of time before index. Switching to fremanezumab and galcanezumab were observed in 12.2% and 13.8% of patients, respectively. The mean proportion of days covered by erenumab at 6 months was 79%. Dosage of erenumab increased (from 70 mg to 140 mg) in 13.0% and decreased (from 140 mg to 70 mg) in 24.9% of patients. Conclusion: This early real-world study showed high adherence among erenumab users. This combined with observed reductions in previously used acute and preventive medications are suggestive of erenumab’s benefit.

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SUN-LB112 Efficacy & Safety After Switchover to Remogliflozin in Indian T2DM Patients - a Real World Study

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa046.2146 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

Author(s):

Supratik Bhattacharyya ◽

Sagar Katare

Keyword(s):

Body Weight ◽

Glycaemic Control ◽

Adverse Events ◽

Real World ◽

Medical Records ◽

Tertiary Care ◽

Care Hospital ◽

The Mean ◽

Observation Period ◽

Hba1c Levels

Abstract INTRODUCTON: Remogliflozin is new SGLT2i recently approved in India, but more economical than the previously available SGLT2i. It is prudent to evaluate its effectiveness & tolerability in comparison to other SGLT2i in real world setting. METHODS: In this observational retrospective study, medical data from EMR of tertiary care hospital in Kolkata was retrieved. The records of adult Type 2 diabetes mellitus (T2DM) patients who were on a dual therapy of Metformin plus SGLT2i (Canagliflozin, Dapagliflozin or Empagliflozin) for at least 6 months with adequate glycaemic control (HbA1c to target based on age & duration of diabetes) & subsequently switched over to Remogliflozin 100 mg twice daily because of economic reasons were screened. The day of switchover was considered as index day (Day 1) The patient records whose data was unavailable, metformin dose was altered during period of next 6 months, who had evidence of active UTI on index day, were receiving injectable anti-diabetic drugs or had recorded eGFR <45 mL/min were excluded. The effectiveness was assessed in terms of maintenance of HbA1c, FBS, PPBS, body weight after 3 & 6 months of treatment. The safety was assessed by adverse events recorded in medical records in terms of abnormal symptoms, signs or laboratory reported values during the observation period of 6 months & compared to equivalent period of 6 months before index day. The data was collected & analysed using appropriate statistical techniques. RESULTS: After screening, medical records of 50 adult T2DM patients (54% male) were found to be eligible. The mean baseline characteristics on Index day in terms of Age, HbA1c levels, FBS, PPBS, weight & BMI was 51.3±12.5 years, 6.8±0.4%, 108.7±8.1 mg/dL, 144.5±21.3 mg/dL, 65.5±5.7 kg & 25.8±2.8 kg/m2 respectively. After treatment period of 6-months with Remogliflozin-based regimen, the mean HbA1c, FBS, PPBS, -Body weight & BMI was 6.7±0.8%, 110.3±10.5 mg/dL, 138.5±12.7 mg/dL, 66.3±6.5 kg & 25.9±3.2 kg/m2 Mean change from baseline in HbA1c levels, FBS, PPBS, weight & BMI were-0.1±0.19%, -1.6±7.2 mg, -6.0±8.3 mg, +0.8±0.2kg, & +0.1±0.0.7 kg/m2 respectively. These change from baseline of all above parameters were not found to be statistically significant (P>0.05) No events of hypoglycaemia, disturbance in electrolytes or any unusual adverse events were reported. Combined incidence of UTI & genital Mycotic infection was similar during 6 month observation period as compared to 6 months prior to index day. (8% vs 6%) CONCLUSION: In real world clinical practice, replacement of ongoing SGLT2i with Remogliflozin was observed to provide consistent glycaemic control without any tolerability issues. Hence, novel SGLT2i Remogliflozin can be considered as equivalent alternative for SGLT2i based regimen in management of Indian T2DM patients

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Characteristics and Treatment of Patients with Multiple Myeloma Who Received Daratumumab in a Large Claims Database in the United States

Blood ◽

10.1182/blood-2021-149001 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4031-4031

Author(s):

Snow X Feng ◽

Alex Z. Fu ◽

Vipin Khare ◽

Augustina Ogbonnaya ◽

Shuchita Kaila

Keyword(s):

Multiple Myeloma ◽

Renal Impairment ◽

Real World ◽

Index Date ◽

The United States ◽

Baseline Period ◽

Cell Transplant ◽

Claims Database ◽

The Mean ◽

Diagnosis Date

Abstract Introduction: Daratumumab (DARA) is a human IgGk monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. Since its approval for relapsed or refractory multiple myeloma (MM) in 2015 and newly diagnosed MM (NDMM) in 2018, DARA has become the foundation of treatment for MM. However, there is limited real-world evidence describing patients (pts) with MM treated with DARA-containing regimens in the US, especially for NDMM pts. Thus, using a large US claims database, we evaluated pt and treatment characteristics among MM pts who received DARA-containing regimens as first-line (1L) or second-line (2L) therapy, and separately for the subset who received DARA plus lenalidomide/dexamethasone (D-Rd) given its more recent approval in NDMM. Methods: This retrospective, observational cohort study evaluated pts aged ≥18 years at the index date (first observed treatment date with ≥1 medical or pharmacy claim for DARA) from the Optum Clinformatics Data Mart database between January 1, 2013 and December 31, 2020, with ≥1 diagnosis code for MM before the index date, and who were continuously enrolled in a medical benefit plan and pharmacy plan from ≥6 months before the initial MM diagnosis date to the index date. Pts with a hematopoietic stem cell transplant from 6 months before the observed initial MM diagnosis date to the index date were excluded. Eligible pts were categorized into 4 cohorts: pts with (1) a DARA-containing regimen as 1L (1L DARA-based cohort), (2) a DARA-containing regimen as 2L (2L DARA-based cohort), (3) D-Rd as 1L (1L D-Rd cohort), and (4) D-Rd as 2L (2L D-Rd cohort) after the observed initial MM diagnosis. Demographics were assessed on the index date; clinical characteristics, all-cause healthcare resource utilization (HCRU), and total all-cause healthcare costs (medical + pharmacy costs) were measured during the 6-month baseline period before the index date. Results: Among the 1L DARA-based cohort (n=235), 48 (20.4%) pts received D-Rd (1L D-Rd cohort). Overall, the most common 1L DARA-based regimens (with or without dexamethasone or prednisone) were D-R (28.5%), DARA plus bortezomib (V)/R (D-VR; 23.8%), D-V (18.7%), and D (14.9%). Among the 2L DARA-based cohort (n=310), 44 (14.2%) pts received D-Rd (2L D-Rd cohort). In the 1L DARA-based and 1L D-Rd cohorts, the mean (SD) age on the index date was 72.4 (9.0) and 76.1 (7.9) years, respectively. In the 2L DARA-based and 2L D-Rd cohorts, the mean (SD) age on the index date was 72.7 (9.3) and 70.5 (11.5) years, respectively. Mean baseline Quan-Charlson Comorbidity index was higher in the 2L cohorts versus 1L cohorts (1L DARA-based: 3.1; 1L D-Rd: 2.8; 2L DARA-based: 3.5; 2L D-Rd: 3.6). Hypercalcemia, renal impairment, anemia, and/or bone lesions (CRAB symptoms) were identified in about 50% of pts in all cohorts. Renal impairment was identified in 32.3%, 22.9%, 32.9%, and 34.1% of pts in the 1L DARA-based, 1L D-Rd, 2L DARA-based, and 2L D-Rd cohorts, respectively. Cardiovascular conditions (myocardial infarction, angina, peripheral vascular disease, and/or congestive heart failure) were found in 26.4% of pts in the 1L DARA-based cohort, 29.2% in the 1L D-Rd cohort, 34.5% in the 2L DARA-based cohort, and 47.7% in the 2L D-Rd cohort. The most common (>5% of pts) 1L regimens for pts in the 2L D-Rd cohort were VRd (17 [38.6%] pts), Vd (6 [13.6%]), V/cyclophosphamide (C)/d (4 [9.1%]), Rd (4 [9.1%]), and VC (3 [6.8%]). In the 1L DARA-based, 1L D-Rd, 2L DARA-based, and 2L D-Rd cohorts, 47.7%, 41.7%, 47.7%, and 54.5% of pts, respectively, had ≥1 hospitalization, and mean numbers of outpatient encounters were 26.4, 25.1, 50.6, and 52.8 within the 6-month baseline period. Mean 6-month baseline total healthcare cost (in 2020 USD) was $53,874 (medical: $51,837; pharmacy: $2,038) in the 1L DARA-based cohort, $39,695 ($35,896; $3,799) in the 1L D-Rd cohort, $131,832 ($96,737; $35,095) in the 2L DARA-based cohort, and $136,218 ($97,380; $38,838) in the 2L D-Rd cohort. Conclusions: In this real-world assessment using claims data, pts with MM receiving DARA-based therapy in 1L or 2L had median age ≥70 years, with high clinical burden as observed by their comorbidities, HCRU, and costs. Understanding the characteristics of real-world pts with MM treated with DARA-based therapy can further aid in the understanding of effective use of DARA in the real world. Disclosures Feng: Janssen: Current Employment. Fu: Janssen: Current Employment. Khare: Janssen: Current Employment. Ogbonnaya: Janssen: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment.

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Real-World Experience of Voxelotor for the Management of Complications in Sickle Cell Disease

Blood ◽

10.1182/blood-2021-153138 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 2052-2052

Author(s):

Nirmish Shah ◽

Thokozeni Lipato ◽

Ofelia A. Alvarez ◽

Thomas Delea ◽

Alexander Lonshteyn ◽

...

Keyword(s):

Policy Analysis ◽

Real World ◽

Research Funding ◽

Health Claims ◽

Transfusion Rate ◽

Cell Disease ◽

Publicly Traded ◽

Advisory Committees ◽

Management Of Complications ◽

The Mean

Abstract Background: Sickle cell disease (SCD) is an inherited systemic disorder characterized by chronic hemolytic anemia and recurrent vaso-occlusion, which can lead to acute and chronic complications, disability, and early mortality. Patients with SCD are hospitalized frequently and most commonly for vaso-occlusive crises (VOCs). Furthermore, most will require a blood transfusion for prevention or acute management of complications, with >90% of adults receiving ≥1 transfusion in their lifetime. Voxelotor (Oxbryta ®) tablets are indicated for treatment of SCD in adults and adolescents aged ≥12 years. Emerging evidence shows that voxelotor, an oral, once-daily sickle hemoglobin-polymerization inhibitor, may improve the clinical symptoms of SCD and reduce VOC rates as well as the need for transfusions. This study sought to assess the real-world impact of voxelotor treatment on the rates and management of SCD-related complications. Methods: Medical and pharmacy claims data for patients aged ≥12 years with SCD who initiated voxelotor therapy between November 2019 and March 2021 were procured from the Symphony Health claims database. Patients with ≥1 year's data before the index date (date of the first voxelotor claim for each patient) were included in the analyses. Baseline demographic and clinical characteristics were summarized using descriptive and inferential statistics. Annualized rates per patient-year (PPY) for transfusions, VOCs, VOC-related and all-cause hospitalizations, before and after voxelotor initiation were compared. Hemoglobin (Hb) responses were evaluated for a subset of patients for whom Hb lab data were available (≥1 Hb value recorded 30 days before initiating voxelotor and ≥1 Hb value recorded after the index date). Results: As of March 2021, a total of 2695 eligible patients from the Symphony Health claims database were included in the analysis (mean age: 34.6 years; 60% female); 915 patients (34%) had ≥1 VOC in the 3 months before initiating voxelotor. Among the subset of patients with pre- and post-voxelotor Hb measurements (n=63), mean (95% CI) Hb was 7.9 (7.5-8.2) g/dL at baseline, and final Hb was 8.9 (8.4-9.4) g/dL after voxelotor initiation. Most patients (38/63; 60.3%) achieved a Hb increase of >1 g/dL at any time point during follow-up. In 357 patients who received ≥1 transfusion in the year before voxelotor initiation, the mean (95% CI) transfusion rate decreased by 43%, from 3.2 (2.8-3.7) to 1.8 (1.4-2.3) PPY (P<0.001) (Table). In 40 patients receiving chronic transfusions (≥8), the mean (95% CI) transfusion rate decreased by 34%, from 9.8 (8.3-11.4) to 6.5 (4.4-8.5) PPY (P=0.007). Among patients who had ≥1 VOC in the 3 months before initiating voxelotor, the mean (95% CI) annualized VOC rate decreased by 22%, from 10.9 (10.4-11.5) to 8.5 (7.8-9.3) (P<0.001); and the mean (95% CI) rate of VOC-related hospitalizations decreased by 32%, from 7.3 (6.9-7.7) to 5.0 (4.4-5.6) (P<0.001). In 636 patients who were previously hospitalized in the 3 months before voxelotor initiation, the mean (95% CI) all-cause hospitalization rate reduced by 36%, from 7.5 (7.1-7.9) to 4.8 (4.3-5.3) (P<0.001) after treatment. Limitations of this analysis include the possibility of secular trend biases or general regression to the mean. Conclusions: In real-world practice, voxelotor increased Hb by ≥1 g/dL, consistent with the HOPE trial. Data suggest statistically significant reductions in transfusions, VOCs, all-cause and VOC-related hospitalizations after voxelotor use. This real-world evidence provides additional support for the use of voxelotor in the treatment of hemolytic anemia and the management of its associated complications. Figure 1 Figure 1. Disclosures Shah: Novartis: Research Funding, Speakers Bureau; Emmaus: Consultancy; Alexion: Speakers Bureau; GLG: Consultancy; GBT: Consultancy, Research Funding, Speakers Bureau; Guidepoint Global: Consultancy; Bluebird Bio: Consultancy; CSL Behring: Consultancy. Lipato: Global Blood Therapeutics: Speakers Bureau. Alvarez: Forma Therapeutics: Membership on an entity's Board of Directors or advisory committees; GBT: Membership on an entity's Board of Directors or advisory committees. Delea: Global Blood Therapeutics: Research Funding; Amgen: Research Funding; Bristol-Myers Squibb: Research Funding; Celgene: Research Funding; Takeda: Research Funding; Merck: Research Funding; Policy Analysis Inc.: Current Employment; AbbVie: Research Funding; Novartis: Research Funding; Regeneron: Research Funding; Sanofi: Research Funding. Lonshteyn: Policy Analysis Inc. (PAI): Current Employment; Global Blood Therapeutics: Research Funding; Novartis: Research Funding. Weycker: Policy Analysis Inc. (PAI): Current Employment, Current equity holder in publicly-traded company; Global Blood Therapeutics: Research Funding; Novartis: Research Funding. Nguyen: Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Beaubrun: Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Agodoa: Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company.

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Real-World Treatment Patterns, Healthcare Resource Utilization and Associated Costs Among Patients with Chronic Myeloid Leukemia in Later Lines of Therapy

Blood ◽

10.1182/blood-2020-136074 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 8-9

Author(s):

Ehab L. Atallah ◽

Rodrigo Maegawa ◽

Dominick Latremouille-Viau ◽

Carmine Rossi ◽

Annie Guerin ◽

...

Keyword(s):

Medical Costs ◽

Healthcare Resource Utilization ◽

Treatment Patterns ◽

Publicly Traded ◽

Pharmaceutical Corporation ◽

Analysis Group ◽

Ed Visits ◽

The Mean ◽

Line Of Therapy

Introduction: Despite advances in tyrosine kinase inhibitor (TKI) therapy for chronic myeloid leukemia (CML), there remains a sizeable proportion of patients (pts) with CML in chronic phase who are refractory or intolerant to these agents. A good understanding of the most recent real-world patterns of care in these pts is necessary in order to provide context for assessing the potential benefits of new treatments undergoing clinical development. The aim of this study was to evaluate treatment patterns in CML pts cycling through TKI therapies achieving later lines of therapy, and to estimate their healthcare resource utilization (HRU) and costs. Methods: Adult pts with CML in the United States who received at least 3 lines of TKI therapy were identified in the IBM MarketScan Commercial and Medicare Supplement databases (Q1/2001-Q2/2019). Treatment patterns were observed from CML diagnosis. Pt characteristics were measured during the 6 months prior to third line (3L) initiation (baseline period). All-cause HRU (inpatient [IP] admissions and days, days with outpatient [OP] services, and emergency department [ED] visits) and costs (medical and pharmacy) were measured 1) during the course of 3L therapy (from 3L initiation to termination) and 2) between 3L initiation and end of follow-up (stem cell transplant [SCT], or end of data availability/health plan coverage). HRU was reported using monthly incidence rates per 100 pts (IR/100pts); costs (2019 USD) were evaluated per-pt-per-month (PPPM) from a payer's perspective. Results: Of the 48,168 pts identified with CML, a total of 296 CML pts initiated 3L therapy; median age was 58.5 years (30% were aged ≥65 years) and 50% were female. The mean follow-up period from CML diagnosis was 57.8 months and from 3L initiation was 24.5 months. Most pts had their first CML diagnosis in or after 2010 (71%) and achieved 3L in or after 2014 (50%). At baseline, the mean modified Charlson Comorbidity Index score (excluding CML) was 1.6 with 24% of pts with a score ≥3, 64% of pts had a moderate or severe Darkow Disease Complexity Index, and the most prevalent comorbidities were hypertension (45%) and diabetes (25%); 21% of pts (i.e., ≥1 indicator of congestive heart failure, cirrhosis, or end-stage renal disease, or ≥75 years old). The most common sequences of TKIs from first line (1L) to 3L were imatinib → dasatinib → nilotinib (28%), imatinib → nilotinib → dasatinib (16%), imatinib → dasatinib → imatinib (9%), and dasatinib → imatinib → nilotinib (5%). The mean duration of 1L, second line (2L), and 3L therapy was 14.9, 10.4, and 15.6 months, respectively; 62% of pts were still in 3L at the end of follow-up. Only one patient received SCT after 3L. The most common TKIs received at each line were imatinib in 1L (65%), dasatinib in 2L (49%), and nilotinib in 3L (36%). The mean treatment-free period (time between line of therapy termination and next line initiation) between 1L and 2L was 1.3 months, 2.6 months between 2L and 3L, and 1.5 months between 3L and 4L. During 3L therapy, pts had a monthly IR/100pts of 3.4 IP admissions, 21.2 IP days, 248.8 OP days, and 10.2 ED visits (Figure 1A). Pharmacy costs accounted for 69% of the mean total costs of $15,192 PPPM, with medical costs accounting for the remainder (Figure 1B). In 3L therapy and later, pts had a monthly IR/100pts of 3.5 IP admissions, 28.7 IP days, 252.2 OP days, and 10.0 ED visits (Figure 1A). Pharmacy costs accounted for 49% of the mean total costs of $18,767 PPPM, with medical costs mainly driven by IP costs (Figure 1B). Conclusions: This study characterized CML pts receiving later lines of therapy, a clinical population which has not been previously well studied with important unmet treatment needs as they repetitively fail TKI therapy. Although the majority of pts were likely fit for SCT, SCT was rare. In addition, pts quickly switched to the subsequent line of therapy, both facts suggesting that an important proportion of pts were intolerant to previous TKIs. While pharmacy costs accounted for nearly half of the total cost burden during 3L, the proportion of medical costs PPPM took more importance following 3L therapy, with IP costs being the primary cost drivers for this increase. These findings support the need for better treatment options in pts with CML undergoing later lines of therapy. Disclosures Atallah: Novartis Pharmaceutical Corporation: Consultancy; Jazz: Consultancy; Pfizer: Consultancy; Takeda: Consultancy, Research Funding; Abbvie: Consultancy; Genentech: Consultancy. Maegawa:Novartis Pharmaceutical Corporation: Current Employment, Current equity holder in publicly-traded company. Latremouille-Viau:Novartis Pharmaceutical Corporation: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.; Sanofi Genzyme: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.. Rossi:Novartis Pharmaceutical Corporation: Consultancy, Other: Carmine Rossi is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Guerin:Abbvie: Consultancy, Other; Sanofi Genzyme: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Patwardhan:Novartis Pharmaceutical Corporation: Current Employment, Current equity holder in publicly-traded company.

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Real-World Clinical Effectiveness and Tolerability of Hydroxychloroquine 400 Mg in Uncontrolled Type 2 Diabetes Subjects who are not Willing to Initiate Insulin Therapy (HYQ-Real-World Study)

Current Diabetes Reviews ◽

10.2174/1573399815666190425182008 ◽

2019 ◽

Vol 15 (6) ◽

pp. 510-519 ◽

Cited By ~ 5

Author(s):

Amit Gupta

Keyword(s):

Body Weight ◽

Glycemic Control ◽

Insulin Therapy ◽

Real World ◽

Antidiabetic Drugs ◽

Hypoglycemic Agents ◽

Oral Hypoglycemic Agents ◽

Good Glycemic Control ◽

Hs Crp ◽

Change In Mean

Objective: The epidemic of T2DM is rising across the globe. Systemic inflammation plays a pivotal role in the pathogenesis and complications of T2DM. Combination of two or more oral hypoglycemic agents (OHA) is widely prescribed in patients with T2DM, however many patients have poor glycemic control despite receiving combination therapy. The new antidiabetic drugs are relatively costly or many patients have anxiety over the use of injectable insulin. The objective of this observational study was to investigate the effectiveness and tolerability of hydroxychloroquine (HCQ) in T2DM patients uncontrolled on multiple OHA and despite high sugar level not willing to initiate insulin therapy in a real-world clinical setting. Methods: A prospective, investigator-initiated, observational, single-centred study was conducted where 250 patients (18-65 years) with T2DM for more than 5 years, with uncontrolled glycemia despite on a combination of multiple OHA, HbA1c between ≥7% and <10.5%, FPG >130 mg/dL or PPG >180 mg/dL and BMI between >25 and <39 kg/m2, were prescribed hydroxychloroquine sulphate 400 mg once daily for 48 weeks. Percentage of drugs used at the baseline were as follows: metformin 2000 mg (100%), glimepiride 4 mg (100%), pioglitazone 30 mg (100%), sitagliptin 100 mg (100%), canagliflozin 300 mg (52.4%), empagliflozin 25 mg (22.8%), dapagliflozin 10 mg (17.6%) and voglibose 0.3 mg (62%). Mean change in HbA1c, blood glucose and hs-CRP at baseline, week 12, 24 and 48 were assessed using the paired t-test. Results: After 48 weeks of add-on treatment with HCQ, almost all SGLT-2 inhibitors were withdrawn; metformin dose was reduced to 1000 mg, glimepiride reduced to 1 mg and sitagliptin reduced to 50 mg OD. Patients continued to have good glycemic control. HbA1c was reduced from 8.83% to 6.44%. Reduction in FPG was 40.78% (baseline 177.30 mg/dL) and PPG was reduced by 58.95% (baseline 329.86 mg/dL). Change in mean body weight was -4.66 Kg. The reduction in glycemic parameters and mean body weight was significant (p < 0.0001). Hs-CRP was significantly reduced from 2.70±1.98 mg/L to 0.71±0.30 mg/L 9 (p < 0.0001). More reduction in glycemic parameters and body weight was observed among the patients with higher hs-CRP (> 3 mg/L) as compared to patients with baseline hs- CRP ≤ 3 mg/L. Most common adverse events reported with the drug therapy were GI irritation (3.6%) and hypoglycemia (2%). None of the patients required medical assistance for hypoglycemia. Conclusion: Add-on treatment of HCQ effectively improved glycemic control in T2DM patients uncontrolled on multiple antidiabetic drugs. By virtue of its antidiabetic and anti-inflammatory properties, it may emerge as a valuable therapeutic intervention for the patients with T2DM.

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