Benefit-risk analysis of adalimumab versus methotrexate and placebo in the treatment of moderate to severe psoriasis: Comparison of adverse event–free response days in the CHAMPION trial - 24/04/13

Doi : 10.1016/j.jaad.2009.12.029

Kristian Reich, MD, PhD ^a,^⁎ , James Signorovitch, PhD ^b, Karthik Ramakrishnan, MPH ^b, Andrew P. Yu, PhD ^b, Eric Q. Wu, PhD ^b, Shiraz R. Gupta, PharmD, MPH ^c, Yanjun Bao, PhD ^c, Parvez M. Mulani, PhD ^c
^a Dermatologikum Hamburg, Hamburg, Germany
^b Analysis Group Inc, Boston, Massachusetts
^c Abbott Laboratories, Abbott Park, Illinois

Reprint requests: Kristian Reich, MD, PhD, Dermatologikum Hamburg, Stephansplatz 5, Hamburg, Germany 20354.

Abstract

Background

The Comparative Study of Humira versus Methotrexate (MTX) versus Placebo in Psoriasis Patients (CHAMPION) demonstrated superior efficacy of biologic over conventional systemic immunosuppressant therapy in psoriasis.

Objective

We sought to compare the risk-benefit profile of adalimumab (ADA), MTX, and placebo using data from CHAMPION.

Methods

Patients randomized to ADA (n = 107), MTX (n = 110), or placebo (n = 53) were followed up for 16 weeks. Response (≥75% improvement in Psoriasis Area and Severity Index), days free of adverse events (AEs), moderate to severe AEs, infection-related AEs, and study drug–related AEs were analyzed.

Results

ADA treatment was associated with substantially more days (SD) of AE-free response compared with MTX or placebo treatment, respectively: 36.9 (31.1) versus 8.3 (15.9) or 6.7 (18.1) days of response free of any AEs, 43.8 (31.9) versus 11.1 (19.9) or 7.9 (19.9) days of response free of moderate to severe AEs, 48.5 (29.2) versus 12.4 (21.7) or 9.2 (21.8) days of response free of infection-related AEs, and 44.6 (31.4) versus 11.8 (21.1) or 10.0 (24.0) days free of study drug–related AEs (all P < .0001 for ADA vs MTX or placebo).

Limitations

This clinical trial–based analysis may not have captured the full spectrum of AEs in the actual clinical setting. The short (16-week) duration of the trial limited the ability to capture some important but uncommon AEs associated with long-term ADA or MTX use.

Conclusion

With 4 times as many AE-free response days, ADA demonstrated a superior benefit-risk profile.

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Key words : adalimumab, adverse events, benefit-risk analysis, global benefit-risk, health-related quality of life, methotrexate, psoriasis

Abbreviations used : ADA, AE, CHAMPION, EQ, FDA, HRQOL, MTX, NNH, NNT, PASI, PASI 75

Plan

	The work reported here was performed under contract with Abbott Laboratories by Analysis Group Inc.
	Disclosure: Dr Reich has acted as a consultant and speaker for and/or participated in clinical trials sponsored by Abbott, Biogen Idec, Bristol-Myers-Squibb, Centocor, Merck Serono, Schering-Plough, UCB, and Wyeth. Drs Signorovitch, Ramakrishnan, Yu, and Wu are employees of Analysis Group Inc. Drs Gupta, Bao, and Mulani are employees of Abbott Laboratories.