scholarly journals Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

2020 ◽  
Vol 11 ◽  
pp. 215013272095993 ◽  
Author(s):  
Andrew M. Blumenfeld ◽  
Atul T. Patel ◽  
Ira M. Turner ◽  
Kathleen B. Mullin ◽  
Aubrey Manack Adams ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Work Productivity ◽  
Preventive Treatment ◽  
Activity Impairment ◽  
Treatment Benefit ◽  
Study Results ◽  
Patient Reported ◽  
Headache Impact

Introduction/Objective: Chronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated efficacy (treatment benefit under ideal conditions) for the prevention of headaches in people with CM in clinical trials, but real-world studies suggest markedly different clinical effectiveness (treatment benefit based on a blend of efficacy and tolerability). This study sought to evaluate patient-reported outcomes (PROs) of onabotulinumtoxinA versus topiramate immediate release for people with CM. Methods: FORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ). Results: A total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate ( P < .001). Improvements in depression over time were observed via larger changes in PHQ-9 scores with onabotulinumtoxinA than topiramate ( P < .001). Work productivity assessed via WPAI:SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P = .024) and Activity Impairment ( P < .001) domains. Results from the FIMQ also revealed a larger reduction from baseline with onabotulinumtoxinA vs topiramate ( P < .0001). Conclusion: OnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM. Trial Registration: ClinicalTrials.gov: NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579

scholarly journals Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2–4 preventives were not useful: results from the LIBERTY study

2021 ◽  
pp. jnnp-2020-324396
Author(s):  
Michel Lanteri-Minet ◽  
Peter J Goadsby ◽  
Uwe Reuter ◽  
Shihua Wen ◽  
Peggy Hours-Zesiger ◽  
...  
Keyword(s):  
Functional Outcomes ◽  
Impact Test ◽  
Work Productivity ◽  
Placebo Treatment ◽  
Episodic Migraine ◽  
Activity Impairment ◽  
Everyday Activities ◽  
Point Reduction ◽  
Patient Reported ◽  
Headache Impact

ObjectiveTo evaluate the effect of erenumab on patient-reported, functional outcomes in patients with episodic migraine (EM) in whom 2–4 preventives were not useful from the Phase 3b LIBERTY study.MethodsAs previously reported, 246 patients with EM with 2–4 prior failed preventives were randomised 1:1 to subcutaneous erenumab 140 mg or placebo every 4 weeks for 12 weeks. This analysis evaluated Migraine Physical Function Impact Diary (MPFID), Headache Impact Test (HIT-6) and Work Productivity and Activity Impairment (WPAI) scores at Week 12. P values were nominal without multiplicity adjustment.ResultsErenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: −3.5 (−5.7 to –1.2) (p=0.003); MPFID-EA: −3.9 (−6.1 to –1.7)) (p<0.001) at 12 weeks. Patients on erenumab were more likely to have a ≥5-point reduction in MPFID score (OR vs placebo (95% CI) MPFID-EA: 2.1 (1.2 to 3.6); MPFID-PI: 2.5 (1.4 to 4.5)). A similar trend was observed for HIT-6 (TD: −3.0; p<0.001); significantly higher proportions of patients on erenumab reported a ≥5-point reduction (OR (95% CI): 2.4 (1.4 to 4.1)). In three out of four WPAI domains, erenumab showed improvement versus placebo.ConclusionAt 12 weeks, erenumab was efficacious on functional outcomes in patients with EM in whom 2–4 preventives were not useful.Trial registration detailsClinicalTrials.gov identifier: NCT03096834.

scholarly journals Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY

Rheumatology ◽  
2020 ◽  
Author(s):  
Vibeke Strand ◽  
Namita Tundia ◽  
Alvin Wells ◽  
Maya H Buch ◽  
Sebastiao C Radominski ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Short Form ◽  
Work Productivity ◽  
Least Square ◽  
Normative Values ◽  
Inadequate Response ◽  
Activity Impairment ◽  
Clinical Trial Registration ◽  
Patient Reported

Abstract Objective To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR). Methods PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined. Results In 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values. Conclusion Among MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone. Clinical trial registration number SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.

Understanding characteristics of patients newly initiating ixekizumab: findings from the Corrona Psoriasis Registry

2020 ◽  
Author(s):  
Jashin J Wu ◽  
Ryan W Harrison ◽  
Baojin Zhu ◽  
Orin M Goldblum ◽  
William N Malatestinic ◽  
...  
Keyword(s):  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Disease Duration ◽  
Severe Disease ◽  
Work Productivity ◽  
Real World Data ◽  
Patient Reported

Background: Real-world data on patients newly initiating ixekizumab is limited. Our study describes the characteristics of patients who initiated ixekizumab and other biologics for psoriasis treatment in North American dermatological practices. Materials & methods: Characteristics of patients ascertained at registry enrollment are described via means and frequencies. Results: Compared with other biologic initiators, ixekizumab initiators had: longer disease duration (17.1 vs 15.1 years); more were considered least severe by body surface area (33 vs 26%); moderate-to-severe by IGA (56 vs 48%); were biologic-experienced (80 vs 52%); obese (54 vs 47%); and experienced greater impact in work productivity (5.3 vs 2.9%) versus other biologic initiators. Conclusion: Psoriasis patients initiating ixekizumab had more severe disease, biologic experience, and worse patient-reported outcomes than those initiating other biologics.

scholarly journals Erenumab in chronic migraine

Neurology ◽  
2019 ◽  
Vol 92 (19) ◽  
pp. e2250-e2260 ◽  
Author(s):  
Richard B. Lipton ◽  
Stewart J. Tepper ◽  
Uwe Reuter ◽  
Stephen Silberstein ◽  
Walter F. Stewart ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Role Function ◽  
Patient Reported ◽  
Headache Impact

ObjectiveTo determine the effect of erenumab, a human monoclonal antibody targeting the calcitonin gene-related peptide receptor, on health-related quality of life (HRQoL), headache impact, and disability in patients with chronic migraine (CM).MethodsIn this double-blind, placebo-controlled study, 667 adults with CM were randomized (3:2:2) to placebo or erenumab (70 or 140 mg monthly). Exploratory endpoints included migraine-specific HRQoL (Migraine-Specific Quality-of-Life Questionnaire [MSQ]), headache impact (Headache Impact Test–6 [HIT-6]), migraine-related disability (Migraine Disability Assessment [MIDAS] test), and pain interference (Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference Scale short form 6b).ResultsImprovements were observed for all endpoints in both erenumab groups at month 3, with greater changes relative to placebo observed at month 1 for many outcomes. All 3 MSQ domains were improved from baseline with treatment differences for both doses exceeding minimally important differences established for MSQ–role function-restrictive (≥3.2) and MSQ–emotional functioning (≥7.5) and for MSQ–role function-preventive (≥4.5) for erenumab 140 mg. Changes from baseline in HIT-6 scores at month 3 were −5.6 for both doses vs −3.1 for placebo. MIDAS scores at month 3 improved by −19.4 days for 70 mg and −19.8 days for 140 mg vs −7.5 days for placebo. Individual-level minimally important difference was achieved by larger proportions of erenumab-treated participants than placebo for all MSQ domains and HIT-6. Lower proportions of erenumab-treated participants had MIDAS scores of severe (≥21) or very severe (≥41) or PROMIS scores ≥60 at month 3.ConclusionsErenumab-treated patients with CM experienced clinically relevant improvements across a broad range of patient-reported outcomes.Clinicaltrials.gov identifierNCT02066415.Classification of evidenceThis study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.

scholarly journals P365 Correlation between patient-reported outcomes (PROs) and patient-reported disease activity in Ulcerative Colitis (UC): Findings from the ICONIC study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S382-S383
Author(s):  
S Ghosh ◽  
F Casellas ◽  
K Kligys PhD ◽  
Y Sanchez Gonzalez ◽  
L Peyrin-Biroulet
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Patient Reported Outcomes ◽  
Work Productivity ◽  
Total Activity ◽  
Total Work ◽  
Activity Impairment ◽  
Patient Reported ◽  
Inflammatory Bowel

Abstract Background This analysis aimed to examine the correlation of patient-reported outcomes (PROs) with patient-reported disease activity, and to identify individual questions of the Patient Simple Clinical Colitis Activity Index (P-SCCAI) associated with Work Productivity and Activity Impairment (WPAI) questionnaire domains in patients from the ICONIC study.1 Methods ICONIC enrolled unselected outpatients (N=1804) with recent-onset UC.1 Correlations between PRO measures (Rating Form of Inflammatory Bowel Disease Patient Concerns [RFIPC], Patient Health Questionnaire-9 [PHQ-9], and Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) at baseline (visit [V]1) and 2 years (V5) were assessed using Spearman’s rank correlation coefficient. WPAI domains and PHQ-9 were evaluated at V1 and V5 using a multivariable logistic regression model with individual P-SCCAI questions. Results Significantly higher work productivity impairment scores, lower reported quality of life (QoL), and higher worries/concerns at V1 and V5 were observed in patients with active disease (P-SCCAI ≥5) vs inactive disease (P-SCCAI &lt;5) (Figures 1 and 2). A strong correlation (0.70–0.89) was found between the SIBDQ and the P-SCCAI and PHQ-9 (Table 1). WPAI presenteeism, total activity impairment and total work productivity impairment were moderately correlated (0.40–0.69) with P-SCCAI and PHQ-9 (Table 1). At V1, a significant positive association of disease severity and nocturnal bowel urgency was observed with WPAI presenteeism, absenteeism, and total activity impairment. At V1 and V5, lower patient-assessed PHQ-9 scores were significantly associated with female gender, no bowel urgency, and no joint pain. Conclusion These observational data in patients with UC suggest strong correlations between some PRO measures and patient-reported disease activity. Nocturnal bowel urgency was a key driver of total work productivity impairment, suggesting it is an important PRO to monitor when assessing overall patient QoL. Reference

scholarly journals A real-world analysis of patient-reported outcomes in patients with migraine by preventive treatment eligibility status in the US and Europe

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Janet H. Ford ◽  
Shonda A. Foster ◽  
Russell M. Nichols ◽  
Antje Tockhorn-Heidenreich ◽  
Wenyu Ye ◽  
...  
Keyword(s):  
Real World ◽  
Patient Reported Outcomes ◽  
Preventive Treatment ◽  
Patient Reported ◽  
The Us

scholarly journals Real-world patient-reported outcomes of women receiving initial endocrine-based therapy for HR+/HER2− advanced breast cancer in five European countries

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Alison Davie ◽  
Gebra Cuyun Carter ◽  
Alex Rider ◽  
James Pike ◽  
Katie Lewis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Advanced Disease ◽  
Advanced Breast ◽  
Activity Impairment ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Abstract Background Endocrine therapy (ET)-based regimens are the mainstay of treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer. With the introduction of new treatment classes, it is important to examine patient symptoms and health-related quality of life (HRQoL) at the start of this changing therapeutic landscape. This real-world study describes the patient-reported outcomes (PROs) of women with HR+/HER2− advanced breast cancer receiving ET-based regimens who were naïve to systemic treatment in the advanced setting across five European countries (EU5). Methods Data were collected between March and July 2017 from surveyed oncologists and their patients at a single time point using the multinational Adelphi Advanced Breast Cancer Disease Specific Programme™. Patients completed PRO questionnaires on HRQoL (EORTC QLQ-C30), pain severity and interference, and work and activity impairment. A multiple linear regression model explored factors associated with HRQoL. Results Across EU5, 226 physicians provided data on 781 women with HR+/HER2− advanced breast cancer taking their first ET-based regimen for advanced disease, of whom 252 provided PRO data. This subset had a mean age of 67.1 years, 94% were postmenopausal, 89% were diagnosed with advanced breast cancer at initial presentation, 79% had stage IV disease (66% of these patients had bone metastases and 38% had visceral metastases, including 18% with liver metastases) and 77% were on endocrine-only therapy as their initial treatment for advanced disease. The mean EORTC QLQ-C30 global health score (50.9) was worse than the reference value for patients with advanced breast cancer (60.2). Fatigue, pain, and insomnia were the most severe symptoms, and mean functioning scores were also worse than reference values. “Worst pain” and “pain interference” were moderate/severe for 42 and 80% of patients. Mean activity impairment was 44%, and greater activity impairment was associated with poorer HRQoL. Conclusions Despite receiving first-line ET-based regimens for advanced disease, these women had a poor HRQoL and high levels of symptoms, pain, pain interference and activity impairment. New treatments that maintain a stable disease state and reduce activity impairment may have a positive effect on the HRQoL of those living with advanced breast cancer.

scholarly journals Association of Hemophilia a Inhibitor Status and Patient-Reported Outcomes with Work Productivity and Health-Related Quality of Life

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4069-4069
Author(s):  
Megan M. Ullman ◽  
Marilyn J Manco-Johnson ◽  
Jonathan C. Roberts ◽  
Nicole Crook ◽  
Rahul Khairnar ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Research Funding ◽  
Patient Reported Outcomes ◽  
Work Productivity ◽  
Joint Stiffness ◽  
Activity Impairment ◽  
Active Inhibitor ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Abstract Introduction: Persons with hemophilia suffer from recurrent bleeds, especially hemarthrosis, which results in joint damage. Hemophilia inhibitor status impacts bleeding, which is associated with acute and chronic pain. To better characterize the impact of inhibitor status, we compared patient-reported outcomes (bleed rate, pain, and joint health), work productivity and activity impairment (WPAI), and health-related quality of life (HRQoL) by inhibitor status, and investigated the correlation of patient-reported outcomes with WPAI and HRQoL. Methods: The U.S. Hematology Utilization Group Studies Part VIII prospectively collected data to examine the cost and burden of hemophilia in persons with hemophilia A (PwHA) aged ≥2 years obtaining care at four federally-supported hemophilia treatment centers. From April 2019 to May 2021 we enrolled PwHA with and without inhibitors at a 1:2 ratio. Parents/adult participants completed a survey at enrollment to collect sociodemographic and clinical characteristics, self-reported bleeds in the last month, pain, and joint stiffness (5-item scale). We also measured WPAI and HRQoL using EQ-5D-3L. Clinical chart review documented hemophilic severity, inhibitor level and treatment regimen. Participants were classified into three groups: 1) active inhibitor (inhibitor titer ≥1.0 Bethesda Units (BU) six months prior to enrollment), 2) tolerized inhibitor (history of inhibitor titer ≥1.0 BU, immune tolerance induction (ITI) and/or currently using factor VIII for prophylaxis), and 3) no inhibitor. Patient-reported data were compared across these groups using Chi-square tests for categorical variables and generalized linear models for continuous variables. Association of bleeds, pain, and joint stiffness with HRQoL and WPAI were assessed using Pearson correlation. Results: Among 80 PwHA enrolled, 9 (11%) had active inhibitors, 22 (27.5%) had tolerized inhibitors, and 49 (61.3%) had no inhibitors. Mean age was 24.9±14.3 (standard deviation) years, 66.3% were adults, 87.5% had severe hemophilia, and 87.5% used prophylaxis. Mean age of the non-inhibitor group (29.3±13.5) was older than the tolerized inhibitor group (16.3±9.5 years, p&lt;0.05) or the active inhibitor group (21.9±19.1, p&gt;0.05). The non-inhibitor group had a lower rate of severe hemophilia (81.6%) or prophylactic treatment (81.6%) than those in the active (100%) or tolerized groups (95.5%, p=0.13). Larger proportions of participants with active inhibitors (66.7%) and no inhibitors (57.1%) reported having bleeds in the last month compared to those with tolerized inhibitors (22.7%, p=0.01). Participants without inhibitors had a greater mean number of bleeding episodes (1.09±standard error (SE) 0.26 vs. 0.23±0.38, p=0.03), specifically joint bleeds (0.58±0.16 vs. 0.08±0.24, p=0.03,) than the tolerized group. Those with active inhibitors reported significantly higher mean joint stiffness scores (35.1±2.6 vs. 27.5±1.9, p=0.006) or more joint pain (77.8% vs. 54.5%, p=0.23) than the tolerized group. Mean EQ-5D index score was significantly lower in the active inhibitor group (0.79±SE (0.07) than in the tolerized group (0.96±0.05, p=0.03). Joint bleeding, chronic pain, and joint stiffness were negatively correlated with the EQ-5D visual analogue scale, and index scores (all correlation coefficients |r|&gt;0.43, all p&lt;0.001). Number of bleeds and the joint stiffness score in children were positively correlated with their parents' level of impairment while working (r=0.41, p=0.04; r=0.62, p=0.001) and overall work impairment (r=0.41, p=0.046; r=0.60, p=0.002). Joint bleeding, chronic pain, and joint stiffness in adults were positively correlated with proportion of work time missed (r=0.31, p=0.03; r=0.39, p=0.006; r=0.48, p=0.0004), overall work impairment (r=0.37, p=0.007; r=0.41, p=0.003; r=0.42, p=0.002), and activity impairment (r=0.33, p=0.02; r=0.63, p&lt;0.0001; r=0.59, p&lt;0.0001), respectively. Conclusions: This study is limited to a small sample skewed toward a younger age in the tolerized inhibitor group. PwHA in the active and no inhibitor groups experienced greater clinical burden as measured by bleeds compared to the tolerized group. Those with active inhibitor displayed lower HRQoL scores than the tolerized inhibitor group. Bleeds, chronic pain and joint stiffness were inversely correlated with HRQoL, resulting in lower work productivity and activity. Figure 1 Figure 1. Disclosures Roberts: Takeda; Speakers Bureau: Novo Nordisk, Octapharma, Sanofi, Takeda.: Research Funding; Genentech, Novo Nordisk, Octapharma, Pfizer, Sanofi, Takeda, uniQure: Consultancy. Khairnar: University of Maryland, Baltimore: Ended employment in the past 24 months; Roche: Current equity holder in publicly-traded company; Genentech Inc - A Member of The Roche Group: Current Employment. Decker-Palmer: Genentech Inc. --A member of the Roche Group.: Current Employment, Current equity holder in publicly-traded company. Curtis: Pfizer, Bayer, and Novo Nordisk: Consultancy; University of Southern California: Consultancy. Wu: Baxalta US Inc., Bannockburn, IL (a Takeda Company), CSL Behring L.L.C., Octapharma USA, Inc., Genentech Inc.: Research Funding. Nichol: Pfizer, Genentech Inc., Baxalta US Inc., Bannockburn, IL (a Takeda Company), Octapharma, CSL Behring, Global Blood Therapeutics, and Novo Nordisk: Research Funding.

scholarly journals SAT0429 SECUKINUMAB IMPROVES CLINICAL AND PATIENT-REPORTED OUTCOMES AT 6 MONTHS AMONG PATIENTS WITH PSORIATIC ARTHRITIS IN THE US-BASED CORRONA PSORIATIC ARTHRITIS/SPONDYLOARTHRITIS (PsA/SpA) REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1169.1-1169
Author(s):  
P. J. Mease ◽  
T. Blachley ◽  
M. Glynn ◽  
B. Dube ◽  
R. Mclean ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Real World ◽  
Global Assessment ◽  
Patient Reported Outcomes ◽  
Work Productivity ◽  
Research Support ◽  
Patient Reported ◽  
The Mean ◽  
Secondary Outcomes

Background:Secukinumab, an interleukin-17 antagonist approved for the treatment of PsA, improves all PsA manifestations in the GRAPPA-OMERACT core domain set.1Few US-based studies have evaluated the real-world effectiveness of secukinumab in patients with PsA.Objectives:To examine clinical and patient-reported outcomes (PROs) in patients with PsA enrolled in the Corrona PsA/SpA registry initiating secukinumab with ≥ 1 follow-up visit.Methods:Included were adult patients with PsA in the Corrona registry who initiated secukinumab after April 1, 2017 and remained on secukinumab at their 6-month (window, 5-8 months) follow-up visit. The primary outcome was achievement of minimal disease activity (MDA) at 6 months among patients not in MDA at secukinumab initiation. MDA was defined as meeting 5 of the 7 following criteria: tender joint count (TJC) ≤ 1, swollen joint count (SJC) ≤ 1, psoriasis affected body surface area (BSA) < 3%, patient assessment of pain on visual analog scale (VAS) ≤ 15, patient global assessment VAS ≤ 20, HAQ-DI ≤ 0.5, and tender entheseal points ≤ 1 using the Leeds Enthesitis Index (LEI). Secondary outcomes included the proportion of patients who achieved resolution (0 sites) of TJC, SJC, enthesitis (using the LEI), and dactylitis among those with ≥ 1 site at initiation and improvement from baseline in clinical outcomes (BSA, nail psoriasis, physician global assessment, TJC, SJC, and DAPSA) and PROs (patient-reported pain, patient global assessment, HAQ-DI, and Work Productivity and Activity Impairment questionnaire) at 6 months. Outcomes were evaluated in the overall population and in potentially recalcitrant patients with failure of or intolerance to ≥ 3 previous biologics to examine if the later line biologic could be adequately effective.Results:A total of 100 patients with PsA who initiated and maintained secukinumab after 6 months were included. The mean (SD) age was 51.6 (11.6) years, 54.3% were male, and 96.8% were white. The mean (SD) symptom and disease duration were 10.8 (9.7) and 7.0 (7.0) years, respectively. Thirty patients (30.0%) initiated secukinumab 150 mg and 70 (70.0%) initiated secukinumab 300 mg. Most (83.0%) were biologic experienced; 17 patients initiated secukinumab as a 1st biologic, 34 as 2nd, 26 as 3rd, and 23 as ≥ 4th. At initiation, 75/90 patients (83.3%) were not in MDA; 26/71 (36.6%) of those with follow-up data available achieved MDA at 6 months (Figure 1). In the overall population, 28 patients (41.2%) with TJC ≥ 1, 24 (44.4%) with SJC ≥ 1, 17 (60.7%) with enthesitis, and 9 (75.0%) with dactylitis at initiation achieved resolution at 6 months (Table 1). Improvement was observed at 6 months in clinical outcomes and PROs in the overall population (Figures 1 and 2) and in patients who initiated secukinumab as a ≥ 4th-line biologic.Table 1.Resolution of Peripheral Arthritis, Enthesitis, and Dactylitis at 6 Months Among Patients With ≥ 1 Site at InitiationSecondary OutcomesInitiation,Mean (SD) [n]6-Month Follow-Up,Resolution (Count = 0), n (%)TJC (1-68)9.0 (9.7) [68]28 (41.2)SJC (1-66)4.7 (4.2) [54]24 (44.4)Enthesitis (1-6)1.9 (1.1) [28]17 (60.7)Dactylitis (1-20)2.1 (1.3) [12]9 (75.0)Conclusion:In the Corrona registry, most secukinumab initiators with PsA were biologic experienced and were not in MDA at time of initiation. Consistent with clinical trials, real-world patients treated with secukinumab achieved MDA as well as improvement in clinical manifestations, PROs, and work productivity.References:[1]Orbai AM, et al.J Rheumatol.2019 Oct 15. [Epub ahead of print].Disclosure of Interests:Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Taylor Blachley Employee of: Corrona, LLC, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Blessing Dube Employee of: Corrona, LLC, Robert McLean Employee of: Corrona, LLC, Nina Kim Employee of: Postdoctoral fellow at the University of Texas at Austin and Baylor Scott and White Health, providing services to Novartis Pharmaceuticals Corporation, Peter Hur Employee of: Novartis Pharmaceuticals Corporation, Alexis Ogdie Grant/research support from: Pfizer to Penn, Novartis to Penn, Amgen to Forward/NDB, Consultant of: Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Eli Lilly, Novartis, Pfizer

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