JOHNSON & JOHNSON
The NMA concluded TREMFYA ranked highestb for skin clearance based on Psoriasis (PsO) Area Severity Index (PASI)c 90 response among 23 treatment regimens (15 unique treatments including IL-23 inhibitors like TREMFYA and risankizumab, subcutaneous [SC] tumor necrosis factor inhibitors [TNFi], and Janus kinase inhibitors [JAKi]).1 In terms of joint inflammation improvement, both TREMFYA dosing regimens (100 mg every four weeks [q4w] and every eight weeks [q8w])d were comparableb to most other treatments for the modified
'This comprehensive analytical approach helps to provide a useful comparative picture of available psoriatic arthritis medicines,' said Philip J. Mease,g M.D.,
NMA is a structured, protocol-driven analytical process widely accepted and utilized by regulatory agencies, health technology assessment agencies and medical guideline committees to comparatively evaluate treatment options where head-to- head data are limited or unavailable.3-5 NMA is the most cited and the most comprehensive method available to compare studies indirectly; however, NMAs cannot replace and should not be considered the same as head-to-head clinical trials. In this NMA, the timing of primary endpoint assessment varied across RCTs, and placebo was used as the reference treatment throughout with the exception of two head-to-head studies.1 Baseline risk adjustment was used to account for heterogeneity across study populations. The NMA builds on previous analyses, including a 2021 publication in Rheumatology, and now incorporates all recent clinical data updates, including the COSMOS study of TREMFYA in PsA patients who had an inadequate response to TNFi, as well as data for two new comparators, the IL-23i risankizumab and the JAKi upadacitinib.1,6,7
About the Network Meta-Analysis1
A systematic literature review was conducted to identify randomized controlled trials up to
This NMA adheres to all governing standards and requirements as demanded by global health technology assessment agencies, journal review committees and regulatory authorities. The NMA was funded by
About COSMOS (NCT03796858)7
COSMOS was a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of TREMFYA in 285 patients with active PsA and IR to TNFi therapy. The primary endpoint was ACR20 response at week 24. Participants were randomized (2:1) to receive TREMFYA 100 mg at weeks 0, 4 and q8w thereafter, or placebo. The study included two periods: a 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of TREMFYA compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of TREMFYA. Through week 48, non-responder imputation (NRI) rules were used for missing data (after the application of treatment failure rules [TFR]). Safety was monitored throughout the study to week 56.
About DISCOVER-1 (NCT03162796)8
DISCOVER-1 was a randomized, double-blind, multicenter Phase 3 study evaluating the efficacy and safety of TREMFYA administered by SC injection in participants with active PsA, including those previously treated with one or two TNF inhibitors. DISCOVER-1 evaluated 381 participants who were treated and followed through approximately one year. The primary endpoint was response of ACR20 at week 24 and primary endpoint data were previously presented at scientific congresses and published in
About DISCOVER-2 (NCT03158285)9
DISCOVER-2 is a randomized, double-blind, multicenter Phase 3 study evaluating the efficacy and safety of TREMFYA administered by SC injection in biologic-naive patients with active PsA. DISCOVER-2 evaluated 739 participants who were treated and followed through approximately two years. The primary endpoint was response of ACR20 at week 24 and primary endpoint data were previously presented at scientific congresses and published in
The study consisted of a screening phase of up to six weeks, a blinded treatment phase of approximately 100 weeks that included a placebo-controlled period from week 0 to week 24 and a blinded active treatment period from week 24 to week 100. It also included a safety follow-up phase through week 112 (i.e., approximately 12 weeks after the last administration of study agent at week 100). Clinical efficacy, radiographic efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker, and pharmacogenomics evaluations were performed in the study on a defined schedule.
About Psoriatic Arthritis (PsA)
PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (severe inflammation of the fingers and toes), axial disease, and the skin lesions associated with plaque PsO.20-22 In addition, in patients with PsA, comorbidities, such as obesity, cardiovascular diseases, anxiety and depression are often present.23 Studies show up to 30 percent of people with plaque PsO also develop PsA.24 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.24 Nearly half of patients with PsA experience moderate fatigue and about 30 percent suffer from severe fatigue as measured by the modified fatigue severity scale.25 Although the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.26
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