scholarly journals 1035. Patient-Reported Outcomes on Long-Acting Cabotegravir + Rilpivirine as Maintenance Therapy: FLAIR 96-Week Results

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S548-S548
Author(s):  
Vasiliki Chounta ◽  
Enrique Bernal ◽  
Johan Lombaard ◽  
Harold P Katner ◽  
Sharon Walmsley ◽  
...  
Keyword(s):  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Hiv Treatment ◽  
Virologic Suppression ◽  
Research Support ◽  
Treatment Groups ◽  
Patient Reported ◽  
The Difference ◽  
Long Acting ◽  
Hiv 1

Abstract Background In the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegravir (CAB) + rilpivirine (RPV) was noninferior to continued daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for the maintenance of virologic suppression over 96 weeks in adults with HIV-1. Key patient-reported outcomes (PROs) through Week 96 are presented. Methods In FLAIR, ART-naive adult participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA < 50 c/mL at 16 weeks were randomized (1:1) to continue DTG/ABC/3TC or receive monthly CAB + RPV LA injections after a 4-week lead-in with daily oral CAB + RPV through Week 96. Treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) and acceptability of injections (Perception of Injection [PIN] Questionnaire) up to Week 96 were secondary endpoints. Results A total of 566 participants were randomized (median age, 34 years; 22% female); baseline characteristics were similar between treatment groups. At Week 96, significantly greater improvement from baseline in total treatment satisfaction score was observed in the CAB + RPV LA vs DTG/ABC/3TC treatment group (adjusted mean difference, 2.3 [95% CI, 1.1-3.5]; P< 0.001), further increasing from Weeks 24 (2.1 [0.9-3.3]) and 44 (0.7 [−0.4, 1.9]). Key drivers for the difference in HIVTSQs between treatment groups were items assessing convenience, flexibility, and satisfaction to continue with LA therapy. In participants receiving CAB + RPV LA, mean score for the “Acceptability of ISRs” dimension of PIN (scale, 1-5) significantly decreased (improved) from Week 5 to Weeks 41, 48, and 96 (2.08 to 1.71, 1.66, and 1.71, respectively; P< 0.001 for all). In addition, 82% and 85% of LA participants, respectively, rated pain and local reactions due to injections as “totally” or “very acceptable” at Week 96. Conclusion At Week 96, FLAIR participants receiving LA therapy reported greater improvement in treatment satisfaction compared with participants continuing on daily oral medication as well as overall good acceptability of injections with improvement over time. Overall, these results support monthly CAB + RPV LA as an alternative to daily oral regimens for adults with HIV-1. Disclosures Vasiliki Chounta, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sharon Walmsley, FRCPC, MD, MSC, GSK (Grant/Research Support)ViiV Healthcare (Grant/Research Support) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Patient-reported outcomes for HIV: the future of long-acting injectables and antiretroviral therapy evaluations

2021 ◽  
Author(s):  
Richard Leong ◽  
Leon Owusu ◽  
Jerrica Tang ◽  
Neeraj John ◽  
Kira E Voyer ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Potential Role ◽  
Drug Regimen ◽  
Patient Reported ◽  
Immunodeficiency Virus ◽  
Long Acting ◽  
Hiv 1 ◽  
Human Immunodeficiency Virus 1

Patient-reported outcomes (PROs) are an increasingly important aspect of patient care, as they offer a perspective from the patient themselves in the treatment and management of a particular disease state. They have a potential role in helping clinicians select an appropriate drug regimen in human immunodeficiency virus-1 (HIV-1)-infected individuals, as well as those with HIV/hepatitis C (HCV) co-infection. They can also provide insight for individuals receiving long-acting (LA) injectable antiretroviral therapy (ART). Studies found from PROs that participants on an LA injectable ART regimen reported greater preference and treatment satisfaction compared with those on an oral ART regimen. Some additional studies have also used PROs to evaluate the switch to single-tablet regimens and compare different ART in treating HIV-1. Current PROs and how they can be improved for LA injectables were also discussed.

scholarly journals Analysis of Low-Frequency Mutations Associated with Drug Resistance to Raltegravir before Antiretroviral Treatment

2010 ◽  
Vol 55 (3) ◽  
pp. 1114-1119 ◽  
Author(s):  
Jia Liu ◽  
Michael D. Miller ◽  
Robert M. Danovich ◽  
Nathan Vandergrift ◽  
Fangping Cai ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Treatment Failure ◽  
Low Frequency ◽  
Hiv Treatment ◽  
Viral Population ◽  
Virologic Suppression ◽  
Resistance Mutations ◽  
The Difference ◽  
Allele Specific Sequencing ◽  
Hiv 1

ABSTRACTRaltegravir is highly efficacious in the treatment of HIV-1 infection. The prevalence and impact on virologic outcome of low-frequency resistant mutations among HIV-1-infected patients not previously treated with raltegravir have not been fully established. Samples from HIV treatment-experienced patients entering a clinical trial of raltegravir treatment were analyzed using a parallel allele-specific sequencing (PASS) assay that assessed six primary and six secondary integrase mutations. Patients who achieved and sustained virologic suppression (success patients,n= 36) and those who experienced virologic rebound (failure patients,n= 35) were compared. Patients who experienced treatment failure had twice as many raltegravir-associated resistance mutations prior to initiating treatment as those who achieved sustained virologic success, but the difference was not statistically significant. The frequency of nearly all detected resistance mutations was less than 1% of viral population, and the frequencies of mutations between the success and failure groups were similar. Expansion of pre-existing mutations (one primary and five secondary) was observed in 16 treatment failure patients in whom minority resistant mutations were detected at baseline, suggesting that they might play a role in the development of drug resistance. Two or more mutations were found in 13 patients (18.3%), but multiple mutations were not present in any single viral genome by linkage analysis. Our study demonstrates that low-frequency primary RAL-resistant mutations were uncommon, while minority secondary RAL-resistant mutations were more frequently detected in patients naïve to raltegravir. Additional studies in larger populations are warranted to fully understand the clinical implications of these mutations.

scholarly journals 2484. Patient Reported Outcomes After Switching to a 2-Drug Regimen of Dolutegravir + Rilpivirine: Week 148 Results from the Sword-1 and Sword-2 Studies

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S861-S861
Author(s):  
Alan Oglesby ◽  
Kostas Angelis ◽  
Yogesh Punekar ◽  
Vasiliki Chounta ◽  
Antonio Antela ◽  
...  
Keyword(s):  
Health Status ◽  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Symptom Burden ◽  
Drug Regimen ◽  
Virologic Suppression ◽  
Symptom Bother ◽  
Alternative Treatment Option ◽  
Maximum Utility ◽  
Patient Reported

Abstract Background The SWORD-1 and SWORD-2 studies previously demonstrated that high rates of virologic suppression were maintained for 148 weeks after switching virologically suppressed HIV-1 infected adults from their current 3- or 4-drug antiretroviral regimen (CAR) to the 2-drug regimen (2DR) of dolutegravir + rilpivirine on Day 1 (Early Switch (ES) DTG+RPV group). This abstract reports the pooled SWORD-1/2 results of patient reported outcomes (PRO) measures through Week 148. Methods HIV Treatment Satisfaction Questionnaire (HIVTSQ) and Symptom Distress Module (SDM) were secondary PRO endpoints in the SWORD trials. For HIVTSQ, high scores represent greater treatment satisfaction (range 0 to 60). SDM was assessed using the Symptom Bother Score with low values indicating less symptom bother (range 0 to 80). The EQ-5D-5L measure of general health status was assessed as an exploratory endpoint with maximum utility score of 1 to indicate perfect health. Change from Baseline in these endpoints was calculated for the ES subjects (over 148 weeks). Subjects randomized to CAR switched to DTG+RPV at Week 52 (Late Switch (LS) DTG+RPV group) and change from LS Baseline (i.e., last pre-switch assessment) was calculated (over 96 weeks). Results Low Symptom Bother (9.6 and 10.3) and high TSQ scores (54.4 and 54.3) were reported pre-switch in the ES and LS groups, respectively. ES subjects reported modest improvements from Baseline in both symptom burden and overall treatment satisfaction in all visits through Week 148 (Figures 1 and 2). Among the LS group, there was little change in symptom burden but similar improvement in treatment satisfaction. Pre-switch health status was high in ES and LS groups (EQ-5D mean utility: 0.96 and 0.94, respectively) and remained stable in both groups at all time points. Conclusion High treatment satisfaction and low symptom burden that were observed in patients under CAR were maintained long term after switching to DTG+RPV. These results corroborate DTG+RPV as a well-tolerated 2DR alternative treatment option in patients currently suppressed on other 3/4-drug regimens without previous virologic failure. Disclosures All authors: No reported disclosures.

scholarly journals 877. North American Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy, Safety, and Virologic Outcomes

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S530-S531
Author(s):  
Babafemi O Taiwo ◽  
Darrell Tan ◽  
Parul Patel ◽  
Paula Teichner ◽  
Joseph Polli ◽  
...  
Keyword(s):  
Treatment Guidelines ◽  
Virologic Failure ◽  
Descriptive Analysis ◽  
Injection Site Reaction ◽  
Treatment Preference ◽  
Virologic Suppression ◽  
Research Support ◽  
Phase 3 ◽  
Long Acting ◽  
Hiv 1

Abstract Background Cabotegravir (CAB) plus rilpivirine (RPV) is the first complete long-acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. CAB+RPV LA dosed every 4 weeks (Q4W) or every 8 weeks (Q8W) demonstrated noninferior efficacy in multinational Phase 3/3b trials. This post hoc descriptive analysis summarizes efficacy, virologic outcomes, safety, and treatment preference for US and Canadian (CAN) participants through Week (W) 48. Methods This analysis focuses on data for US/CAN participants naive to CAB+RPV (n=376) from the larger pooled population of the ATLAS, FLAIR, and ATLAS-2M Phase 3/3b studies (N=1245). Endpoints included the proportion of participants with plasma HIV-1 RNA ≥ 50 and < 50 c/mL at W48 (FDA Snapshot algorithm), incidence of confirmed virologic failure (CVF; 2 consecutive HIV-1 RNA ≥ 200 c/mL), safety, and treatment preference through W48. Results 376 US/CAN participants received CAB+RPV LA Q4W or Q8W. Median (range) age was 39y (20–74); 14.9% were female, 66.0% were White. At W48, 93.1% (350/376) maintained virologic suppression (HIV-1 RNA < 50 c/mL), 1.9% (7/376) had HIV-1 RNA ≥ 50 c/mL, and 0.8% (3/376) met the CVF criterion, consistent with the overall global pooled population (Table 1). Two of the three participants with CVF had ≥ 2 of the three baseline factors (archived RPV resistance-associated mutations [RAMs], HIV subtype A6/A1, body mass index [BMI] ≥ 30 kg/m2) previously associated with CVF. Among the US/CAN participants with a single baseline factor, none met CVF. Overall, archived RPV RAMs were observed in 3.2% (12/376), HIV subtype A6/A1 in 1.1% (4/376), and BMI ≥ 30 kg/m2 in 26.3% (99/376) of participants. Safety and injection site reaction findings were similar to the overall pooled population (Table 2). Most participants (120/134, 89.6%) preferred LA over oral dosing (7/134, 5.2%). Table 1. Snapshot outcomes following CAB+RPV LA Q4W and Q8W at Week 48 in participants naive to CAB+RPV from ATLAS, FLAIR, and ATLAS-2M (ITT-E population) Table 2. Safety summary through Week 48 following CAB+RPV LA Q4W and Q8W or comparator ART in participants naive to CAB+RPV from ATLAS, FLAIR, and ATLAS-2M Conclusion In US/CAN Phase 3/3b trial participants, CAB+RPV LA was highly effective and well tolerated, with outcomes consistent with the overall pooled population. Baseline prevalence of archived RPV RAMs and subtype A6/A1 was low and aligned with regional prevalence/surveillance data. CAB+RPV LA provides a tolerable and effective injectable LA treatment option for virologically suppressed US/CAN individuals with HIV. Disclosures Babafemi O. Taiwo, MBBS, Gilead (Consultant)Merck (Consultant)ViiV Healthcare (Consultant) Darrell Tan, MD PhD, Abbvie (Grant/Research Support)Gilead (Grant/Research Support)GlaxoSmithKline (Scientific Research Study Investigator)ViiV Healthcare (Grant/Research Support) Parul Patel, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Paula Teichner, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Joseph Polli, PhD, FAAPS, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Louise Garside, PhD, GlaxoSmithKline (Employee) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Christine L. Talarico, M.S., GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Rodica Van Solingen-Ristea, MD, Janssen Research and Development (Employee)ViiV Healthcare (Employee) Bryan Baugh, MD, Janssen, Johnson & Johnson (Employee, Shareholder) William Spreen, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Michael Aboud, MBChB, MRCP, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Matthew Bosse, DO, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

scholarly journals OP0118 EFFECT OF WITHDRAWING ETANERCEPT OR METHOTREXATE ON PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS IN REMISSION ON COMBINATION THERAPY: RESULTS FROM THE SEAM-RA TRIAL

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 66.1-66
Author(s):  
J. Curtis ◽  
E. Karis ◽  
V. Bykerk ◽  
G. Kricorian ◽  
P. Yen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Joint Pain ◽  
Patient Reported Outcomes ◽  
Sustained Remission ◽  
Research Support ◽  
Treatment Groups ◽  
Sf 36 ◽  
Patient Reported ◽  
The Mean ◽  
Domain Scores

Background:Limited studies have assessed the effect of withdrawal of either methotrexate (MTX) or etanercept (ETN) on patient-reported outcomes (PROs) in rheumatoid arthritis (RA).Objectives:To evaluate the baseline and change in PROs following withdrawal of MTX or ETN in RA patients with sustained remission receiving combination ETN+MTX.Methods:Adult patients with RA on ETN+MTX and in remission (SDAI ≤3.3) for ≥12 months (including a 24-week, open-label, run-in period) were randomized to a 48-week double-blind period to receive ETN 50 mg weekly (N=101), oral MTX 10-25 mg weekly (N=101) or continue ETN+MTX (N=51). The primary endpoint was maintenance of SDAI remission without disease worsening (DW) at week 48 between ETN and MTX groups. Patients who experienced SDAI >11 at any time after randomization, or SDAI >3.3 and ≤11 during 2 consecutive or on 3 non-consecutive visits were considered to have DW and resumed ETN+MTX. PROs assessed were patient global assessment of disease activity (PtGA, 0-100 mm), patient joint pain (PtJP, 0-100 mm), Health Assessment Questionnaire-Disability Index (HAQ-DI), and the 36-item short-form health survey (SF-36) component and domain scores. A 2-sample t-test was used to compare the treatment differences between groups. A subgroup analysis for patients with DW was also performed (DW analysis set) and compared PROs between ETN vs MTX arms (ETN+MTX not shown given the small sample size).Results:Of the 253 patients randomized, 121 (47.8%) experienced DW and were included in the DW analysis set. Baseline demographics were generally balanced between the 3 treatment groups. Most patients were women (76.3%), White (87.0%), and with a mean age of 55.6 years. The mean (SD) MTX dose was 16.3 (4.69) mg and the mean (SD) duration of RA was 10.3 (7.8) years. At week 48, a significantly greater proportion of patients on ETN vs MTX monotherapy maintained SDAI remission (49.5% vs 28.7%; P=0.004) after therapy withdrawal. In the overall population, PtGA and PtJP scores were very low at baseline (PtGA–MTX: 4.4, ETN: 4.5, ETN+MTX: 3.5; PtJP–MTX: 4.9, ETN: 5.5, ETN+MTX: 3.5) and showed some worsening over the study period in all treatment groups, with a mean change at week 48 ranging from 5.0 to 10.0 units for PtGA and 3.7 to 8.1 units for PtJP. Patients on ETN had less worsening, with a nominally significant treatment difference observed between ETN and MTX monotherapy groups for PtGA at almost all timepoints, and for PtJP at weeks 12 and 36 (Figure). Mean HAQ-DI (MTX: 0.32; ETN: 0.26; ETN+MTX: 0.28) and SF-36 scores (physical component [PCS]–MTX: 52.1, ETN: 52.7, ETN+MTX: 52.3; mental component [MCS]–MTX: 55.5, ETN: 55.8, ETN+MTX: 57.1) at baseline show that patients had low disability and excellent health-related quality of life compared with normative values for the general non-RA population. HAQ-DI scores were well maintained at weeks 24 and 48 (change from baseline at week 48–MTX: 0.14; ETN: 0.15; ETN+MTX: 0.21). The SF-36 PCS, MCS, and domain scores decreased minimally from baseline with treatment differences that were not nominally significant between groups. Among patients with DW during the study, those on ETN showed less PtGA and PtJP worsening from baseline than those on MTX at weeks 12, 36, and 48 (Figure). Other PROs (HAQ-DI [change from baseline at week 24–ETN: 0.34; MTX: 0.21; at week 48–ETN: 0.15; MTX: 0.15], SF-36 PCS, MCS, and domain scores) showed a similar degree of worsening in both the MTX and ETN arms.Conclusion:In patients with sustained SDAI remission on ETN+MTX, mental and physical health as measured by SF-36 was comparable with that of the non-RA population. Withdrawal of ETN (MTX monotherapy) resulted in a greater worsening of PtGA and PtJP than withdrawal of MTX (ETN monotherapy), and patients on ETN monotherapy restored these scores close to baseline towards the end of the treatment period. These findings demonstrate that ETN monotherapy has a greater effect on maintaining overall patient assessment of disease and joint pain compared with MTX monotherapy.Disclosure of Interests:Jeffrey Curtis Speakers bureau: AbbVie, BMS, Gilead, Lilly, Novartis, Sanofi, Scipher, Amgen, Corrona, Janssen, Myriad, and Pfizer, Consultant of: AbbVie, BMS, Gilead, Lilly, Novartis, Sanofi, Scipher, Amgen, Corrona, Janssen, Myriad, and Pfizer, Grant/research support from: AbbVie, BMS, Gilead, Lilly, Novartis, Sanofi, Scipher, Amgen, Corrona, Janssen, Myriad, and Pfizer, Elaine Karis Shareholder of: Amgen Inc., Employee of: Amgen Inc., Vivian Bykerk Speakers bureau: Amgen, BMS, Gilead, Pfizer, Sanofi-Genzyme/Regeneron, Scipher Medicine, and UCB., Consultant of: Amgen, BMS, Gilead, Pfizer, Sanofi-Genzyme/Regeneron, Scipher Medicine, and UCB., Grant/research support from: Amgen and Novartis, Greg Kricorian Shareholder of: Amgen Inc., Employee of: Amgen Inc., Priscilla Yen Shareholder of: Amgen Inc., Employee of: Amgen Inc., Paul Emery Speakers bureau: AbbVie, BMS, Celltrion, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Samsung, Sandoz, and UCB., Consultant of: AbbVie, BMS, Celltrion, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Samsung, Sandoz, and UCB., Paul Haraoui Speakers bureau: AbbVie, Celgene, Janssen, Pfizer, and UCB., Consultant of: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Merck, Pfizer, Roche, Sandoz, Sanofi-Genzyme, and UCB., Grant/research support from: Roche, AbbVie, Amgen, Merck, and Pfizer, David Collier Shareholder of: Amgen Inc., Employee of: Amgen Inc., Brad Stolshek Shareholder of: Amgen Inc., Employee of: Amgen Inc.

Effects of an Antihypertensive Combination in Japanese Hypertensive Outpatients Based on the Long-Acting Calcium Channel Blocker Benidipine on Vascular and Renal Events: A Sub-Analysis of the COPE Trial

2020 ◽  
Vol 16 ◽  
Author(s):  
Seiji Umemoto ◽  
Toshio Ogihara ◽  
Masunori Matsuzaki ◽  
Hiromi Rakugi ◽  
Kazuyuki Shimada ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Calcium Channel ◽  
Calcium Channel Blocker ◽  
Channel Blocker ◽  
Rank Test ◽  
Vascular Events ◽  
Treatment Groups ◽  
Β Blocker ◽  
The Difference ◽  
Long Acting

Background: In the trial known as COPE (Combination Therapy of Hypertension to Prevent Cardiovascular Events) three benidipine (a calcium channel blocker; CCB) regimens were compared. Hypertensive Japanese outpatients aged 40–85 years (n=3,293) who did not achieve the target blood pressure of <140/90 mmHg with benidipine 4 mg/day were treated with the diuretic thiazide (n=1,094) or a β-blocker (n=1,089) or an additional angiotensin receptor blocker (ARB; n=1,110). A significantly higher incidence of hard cardiovascular composite endpoints and of fatal or non-fatal strokes was observed in the benidipine-β-blocker group compared to the benidipine-thiazide group. Objective and Methods: We further evaluated the treatment effects of the three benidipine-based regimens on vascular and renal events in a sub-analysis of the COPE patients. Results: A total of 10 vascular events (0.8 per 1,000 person-years) including one aortic dissection (0.1 per 1,000 person-years) and nine cases of peripheral artery disease (0.8 per 1,000 person-years) were documented, as was a total of seven renal events (0.6 per 1,000 person-years). No significant differences in vascular and renal events were revealed among the three treatment groups: vascular events p=0.92 renal events p=0.16 log-rank test. Conclusions: Blood pressure-lowering therapy with benidipine combined with an ARB, β-blocker, or thiazide was similarly effective in the prevention of vascular and renal events in hypertensive outpatients, although there is no enough these events to compare the difference in the three treatment groups.

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

scholarly journals The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data?

2021 ◽  
Vol 20 ◽  
pp. 232595822110090
Author(s):  
Kimberly K. Scarsi ◽  
Susan Swindells
Keyword(s):  
Medication Adherence ◽  
Antiretroviral Therapy ◽  
Hiv Treatment ◽  
Virologic Suppression ◽  
Social Barriers ◽  
Treatment And Prevention ◽  
Undetectable Viremia ◽  
Long Acting ◽  
Available Information ◽  
Living With Hiv

As with other chronic conditions, adherence to daily medications remains a challenge for many individuals living with HIV due to structural, behavioral, and social barriers. Unfortunately, high levels of adherence to antiretroviral therapy are required to maintain virologic suppression. Alternative approaches are being explored to decrease the burden of daily pill administration, including long-acting injectable, oral, and implantable products. Phase 3 data support the efficacy of nanoformulated injectable cabotegravir and rilpivirine for HIV treatment in patients with undetectable viremia, but we have yet to learn how this strategy may benefit those with medication adherence challenges. Despite this, the affected community and HIV providers are very interested in exploring the role of long-acting therapies to address some types of barriers to medication adherence. This review summarizes available information about the potential for long-acting therapy to improve adherence for some patients and outlines associated opportunities and challenges with the implementation of long-acting therapy for the treatment and prevention of HIV.

Objective and Subjective Outcomes in Patients with Hearing Aids: A Cross-Sectional, Comparative, Associational Study

2021 ◽  
pp. 1-9
Author(s):  
Xunyi Wang ◽  
Yun Zheng ◽  
Gang Li ◽  
Jingzhe Lu ◽  
Yan Yin
Keyword(s):  
Hearing Aids ◽  
Patient Reported Outcomes ◽  
Cross Sectional ◽  
Patient Reported ◽  
Objective Tests ◽  
The Difference ◽  
Potential Factors ◽  
Positive Correlations ◽  
The Relationship ◽  
Subjective Outcomes

<b><i>Introduction:</i></b> Outcome assessment for hearing aids (HAs) is an essential part of HA fitting and validation. There is no consensus about the best or standard approach for evaluating HA outcomes. And, the relationship between objective and subjective measures is ambiguous. This study aimed to determine the outcomes after HA fitting, explore correlations between subjective benefit and acoustic gain improvement as well as objective audiologic tests, and investigate several variables that may improve patients’ perceived benefits. <b><i>Methods:</i></b> Eighty adults with bilateral symmetrical hearing loss using HAs for at least 1 month were included in this study. All subjects completed the pure tone average (PTA) threshold and word recognition score (WRS) tests in unaided and aided conditions. We also administered the Chinese version of International Outcome Inventory for Hearing Aids (IOI-HA), to measure participants’ subjective benefits. Objective HA benefit (acoustic gain improvement) was defined as the difference in thresholds or scores between aided and unaided conditions indicated with ΔPTA and ΔWRS. Thus, patients’ baseline hearing levels were taken into account. Correlations were assessed among objective audiologic tests (PTA and WRS), acoustic gain improvement (ΔPTA and ΔWRS), multiple potential factors, and IOI-HA overall scores. <b><i>Results:</i></b> PTA decreased significantly, but WRS did not increase when aided listening was compared to unaided listening. Negative correlations between PTAs and IOI-HA scores were significant but weak (<i>r</i> = −0.370 and <i>r</i> = −0.393, all <i>p</i> &#x3c; 0.05). Significant weak positive correlations were found between WRSs and IOI-HA (<i>r</i> = 0.386 and <i>r</i> = 0.309, all <i>p</i> &#x3c; 0.05). However, there was no correlation among ΔPTA, ΔWRS, and IOI-HA (<i>r</i> = 0.056 and <i>r</i> = −0.086, all <i>p</i> &#x3e; 0.05). Moreover, 2 nonaudiological factors (age and daily use time) were significantly correlated with IOI-HA (<i>r</i> = −0.269 and <i>r</i> = 0.242, all <i>p</i> &#x3c; 0.05). <b><i>Conclusions:</i></b> Correlations among objective audiologic tests, acoustic gain, and subjective patient-reported outcomes were weak or absent. Subjective questionnaires and objective tests do not reflect the same hearing capability. Therefore, it is advisable to evaluate both objective and subjective outcomes when analyzing HA benefits on a regular basis and pay equal attention to nonaudiological and audiological factors.

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