Tremfya (Guselkumab) Ranks Highest in Skin Clearance Among 23 Psoriatic Arthritis Therapies in Network Meta-Analysis

News on January 25, 2022 /BioValleyBIOON/ -- Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceuticals recently presented a network meta-analysis (NMA) at the Maui Dermatology 2022 conference, comparing the first-in-class IL-23 inhibitor Tremfya (Chinese trade name: 特诺雅, generic name: guselkumab) with all advanced therapies approved for the treatment of active psoriatic arthritis (PsA). This NMA utilized data from 33 Phase III randomizedClinical Trial(RCT) data.

NMA results are as follows: Among 23 treatment options (15 unique drugs, including IL-23 inhibitors Tremfya and risankizumab, subcutaneous [SC]TumorNecrosis Factor Inhibitor [TNFi], JAK Inhibitor),

-- Skin clearance: assessed by the Psoriasis Area Severity Index 90 (PASI90),Tremfya Ranks Highest in Skin Lesion ClearanceThe two dosing regimens, 100mg every 4 weeks (q4w) and 100mg every 8 weeks (q8w), ranked first and second, respectively.

——Improving joint inflammation: According to the American College of Rheumatology 20 response (ACR20) evaluation,Tremfya is comparable to SC TNFi and most IL-17Ai.. Although the dosing frequency affects the modified van der Heijde Sharp (vdH-S) score,Tremfya 2 Dosing Regimens (q4w and q8w) Show Comparable Improvement to Most Other Therapies, andBoth dosing regimens of Tremfya ranked higher than risankizumab and upadacitinib in the vdH-S score.

——Serious Adverse Event (SAE):Tremfya has a low incidence of SAEs, and both dosing regimens are favorably ranked among 23 treatment options.The number of SAEs for Tremfya is consistent with the established safety profile of Tremfya.

Philip Mease, MD, of the Swedish Medical Center/Providence St. Joseph Health and the University of Washington, commented: "This comprehensive analytical approach will help provide a very useful comparative picture of available psoriatic arthritis drugs. In my experience, such a thorough NMA can assist physicians in discussing treatment options and outcomes with patients in daily practice."

Tremfya is the first approved selective IL-23 inhibitor. The drug is a monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a cytokine and is involved in variousAutoimmunityAn important driving factor in the pathogenesis of sexually transmitted diseases, including psoriatic arthritis (PsA) and plaque psoriasis (PsO).

Tremfya has been approved in many countries and regions worldwide for the treatment of adult patients with active PsA and moderate to severe PsO. For the treatment of adult patients with active PsA, the Tremfya dosing regimen is: 100mg SC injection, administered at weeks 0 and 4 as the initial two doses, followed by once every 8 weeks (q8w).

NMA is a structured, protocol-driven analytical process that is widely accepted and used by regulatory agencies, health technology assessment bodies, and medical guideline committees to comparatively evaluate treatment options when head-to-head data are limited or unavailable. NMA is the most frequently cited and comprehensive method for indirect comparison studies; however, NMA cannot replace, nor should it be considered equivalent to, head-to-head studies.Clinical Trial。

In this NMA by Johnson & Johnson, the timing for evaluating the primary endpoint varied across randomized controlled trials (RCTs). Except for two head-to-head studies, placebo was consistently used as the reference treatment in RCTs. Baseline risk adjustment was applied to account for heterogeneity in study populations. The NMA builds on prior analyses, including an article published in *Rheumatology* in 2021, and now incorporates all recent clinical data updates, such as the COSMOS study of Tremfya in PsA patients with inadequate response to TNFi, along with two new comparator drugs: the IL-23 inhibitor risankizumab and the JAK inhibitor upadacitinib. (Bioon.com)

Source of Original Text:A Newly Published Network Meta-Analysis (NMA) Found TREMFYA® (guselkumab) Ranked Highest for Overall Level of Skin Clearance and Provided Positive Joint Efficacy Among Active Psoriatic Arthritis (PsA) Therapies