Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: A network meta-analysis of clinical trial data - 24/04/21

Doi : 10.1016/j.jaad.2021.02.057

Neil H. Shear, MD ^a, Keith A. Betts, PhD ^b, Ahmed M. Soliman, MS, PhD ^c, Avani Joshi, PhD ^c, Yan Wang, ScD ^b, Jing Zhao, PhD ^d, Paolo Gisondi, MD ^e, Ranjeeta Sinvhal, MD ^c, April W. Armstrong, MD, MPH ^f,^⁎
^a Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada
^b Analysis Group, Inc, Los Angeles, California
^c AbbVie, North Chicago, Illinois
^d Analysis Group, Inc, Denver, Colorado
^e Department of Medicine, University of Verona, Verona, Italy
^f Keck School of Medicine, University of Southern California, Los Angeles, California

^∗Correspondence and reprint requests to: April W. Armstrong, MD, MPH, Department of Dermatology, Keck School of Medicine, University of Southern California, HC4 2000 1450 San Pablo, Health Sciences Campus, Los Angeles, CA 90033.Department of DermatologyKeck School of MedicineUniversity of Southern CaliforniaHC4 2000 1450 San Pablo, Health Sciences CampusLos AngelesCA 90033

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Saturday 24 April 2021
Cet article a été publié dans un numéro de la revue, cliquez ici pour y accéder

Abstract

Background

The comparative safety and benefit-risk profiles of moderate-to-severe psoriasis treatment have not been well studied.

Objective

To compare the short-term (12-16 weeks) and long-term (48-56 weeks) safety and benefit-risk profiles of moderate-to-severe psoriasis treatments.

Methods

A systematic literature review of phase II-IV randomized controlled trials of moderate-to-severe psoriasis treatments was conducted (cutoff: July 1, 2020). Any adverse events (AEs), any serious AEs, and AEs leading to treatment discontinuation were compared using Bayesian network meta-analyses (NMAs).

Results

Fifty-two and 7, respectively, randomized controlled trials were included in the short- and long-term NMAs, respectively. In the short-term NMA, the rates of any AEs were the lowest for tildrakizumab (posterior median: 46.0%), certolizumab (46.2%), and etanercept (49.1%). The rates of any serious AE were the lowest for certolizumab (0.8%), risankizumab (1.2%), and etanercept (1.6%). The rates of AEs leading to treatment discontinuation were the lowest for risankizumab (0.5%), tildrakizumab (1.0%), and guselkumab (1.5%). In the long-term NMA, risankizumab had the lowest rates of all 3 outcomes (67.5%, 4.4%, and 1.0%, respectively) and the most favorable benefit-risk profile.

Limitations

The results may not be generalizable to real-world populations.

Conclusions

Anti–interleukin 23 agents were associated with low rates of safety events. Risankizumab had the most favorable benefit-risk profile in the long term.

Le texte complet de cet article est disponible en PDF.

Key words : network meta-analysis, outcomes, psoriasis, safety, treatment

Abbreviations used : AE, CrI, FDA, EMA, IL, NMA, PASI, SAE, SUCRA, TNF, Q2W, Q12W

Plan

Short-term NMA of any AE

Short-term NMA of any SAE

Short-term NMA of AEs leading to treatment discontinuation

Long-term NMAs of any AE, any SAE, and AEs leading to treatment discontinuation

Benefit-risk assessment

Discussion

Conclusions

	Funding sources: Supported by AbbVie.
	Part of this study was presented at the 24th World Congress of Dermatology, June 10-15, 2019, Milan, Italy.
	IRB approval status: This was a network meta-analysis of previously published data; therefore, no institutional board review was required.