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

Background The Comparative Study of Human versus Methotrexate (MTX) vet sus Placebo in Psoriasis Patients (CHAMPION) demonstrated superior efficacy of biologic over conventional systemic immuno-suppressant therapy in psoriasis. Objective We sought to compare the risk-benefit profile of idalimumab (ADA), MTX, and placebo using data nom 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 Seventy Index), days flee of adverse events (AEs), moderate to severe AEs, infection-related AEs, and study drug-related AEs were analyzed. Result ADA treatment was associated with substantially more days (SD) of AE-free response compared with MIX cm 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) vet sus 11.1 (19.9) or 7.9 (19.9) clays 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 flee of infection-related AEs, and 44.6 (31.4) vet sus 11.8 (21.1) cm 10.0 (24.0) days flee of study drug-related AEs (all P < .0001 for ADA vs MIX or placebo). Limitations This clinical trial-based analysis may not hive captured the full spectrum of AEs in the actual clinical setting. The short (16-week) duration of the n tal limited the ability to capture some important but uncommon AEs associated with long-tetra ADA or MIX use. Conclusion With 4 times as many AE-free response clays, ADA demonstrated a superior benefit-risk profile.