FEASIBILITY OF INDIRECT TREATMENT COMPARISONS IN RELAPSED POLYMYALGIA RHEUMATICA
Author(s)
Vikash Kumar Sharma, B. Tech1, Malhar Jadhao, M. Tech, BE1, Anup Kumar, MSc, BSc1, Amr Abdelaziz, MSc, MBA2, Devi Raman, MPharm1, RAMAKRISHNA GEDDAM SRI, MBBS, MPH1, Sarah Jane McKenna, MSc, BA3.
1Novartis Healthcare Pvt. Ltd., Hyderabad, India, 2Novartis Pharma, Cairo, Egypt, 3Novartis Ireland Ltd, Dublin, Ireland.
1Novartis Healthcare Pvt. Ltd., Hyderabad, India, 2Novartis Pharma, Cairo, Egypt, 3Novartis Ireland Ltd, Dublin, Ireland.
OBJECTIVES: Polymyalgia rheumatica (PMR) is an inflammatory disorder in adults aged ≥50 years, characterized by pain and stiffness in the shoulder and hip girdles and frequently elevated inflammatory markers. Although glucocorticoids (GCs) remain the standard of care, high relapse rates and prolonged use are associated with substantial adverse effects, highlighting a need for effective GC-sparing therapies. The absence of head-to-head trials limits robust comparison across emerging treatments. This study assessed the feasibility of conducting an indirect treatment comparison (ITC) between secukinumab and alternative GC-sparing therapies in relapsed PMR.
METHODS: A systematic literature review was undertaken to identify studies evaluating GC-sparing therapies in PMR. Studies were assessed for ITC feasibility based on population, inclusion/exclusion criteria, study design, and endpoints. Heterogeneity was evaluated using forest plots and Cochrane’s Q test. Quantitative and qualitative feasibility was assessed to determine whether aggregate characteristics could be matched to available patient-level data.
RESULTS: Of 23 publications, one study (SAPHYR - sarilumab [SAR]) met predefined ITC feasibility criteria. SAPHYR was the only study with a trial population broadly aligned with REPLENISH (secukinumab [SEC]) in relapsing PMR. However, key differences were identified, including differences in duration of the GC tapering schedules (SAR 14-week vs. placebo [PLB] 52-week; SEC 24-week vs. PLB 24-week) and primary endpoint definitions. Although differences in baseline population characteristics can be adjusted for in an ITC, important differences in study design remain.
CONCLUSIONS: Sarilumab represents the only suitable comparator for ITC with secukinumab in relapsed PMR. While a comparison is technically feasible based on available data, statistical adjustment is limited to baseline population characteristics and cannot address key study design differences (e.g. GC tapering schedules). Comparisons with off-label therapies (methotrexate and tocilizumab) are limited by substantial heterogeneity in populations, endpoint definitions, and study designs.
METHODS: A systematic literature review was undertaken to identify studies evaluating GC-sparing therapies in PMR. Studies were assessed for ITC feasibility based on population, inclusion/exclusion criteria, study design, and endpoints. Heterogeneity was evaluated using forest plots and Cochrane’s Q test. Quantitative and qualitative feasibility was assessed to determine whether aggregate characteristics could be matched to available patient-level data.
RESULTS: Of 23 publications, one study (SAPHYR - sarilumab [SAR]) met predefined ITC feasibility criteria. SAPHYR was the only study with a trial population broadly aligned with REPLENISH (secukinumab [SEC]) in relapsing PMR. However, key differences were identified, including differences in duration of the GC tapering schedules (SAR 14-week vs. placebo [PLB] 52-week; SEC 24-week vs. PLB 24-week) and primary endpoint definitions. Although differences in baseline population characteristics can be adjusted for in an ITC, important differences in study design remain.
CONCLUSIONS: Sarilumab represents the only suitable comparator for ITC with secukinumab in relapsed PMR. While a comparison is technically feasible based on available data, statistical adjustment is limited to baseline population characteristics and cannot address key study design differences (e.g. GC tapering schedules). Comparisons with off-label therapies (methotrexate and tocilizumab) are limited by substantial heterogeneity in populations, endpoint definitions, and study designs.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA69
Topic
Study Approaches
Topic Subcategory
Meta-Analysis & Indirect Comparisons
Disease
Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal), No Additional Disease & Conditions/Specialized Treatment Areas