Table 1.

Randomized, placebo-controlled clinical trials of brodalumab in patients with psoriasis

Clinical trial	Subjects and therapeutic regimen	Main clinical findings
Phase I76	25 patients with moderate-to-severe psoriasis  Single-dose brodalumab   140 mg SC (n=4)   350 mg SC (n=8)   700 mg IV (n=8)  Placebo (n=5)  Follow-up 85 days	700 mg IV group  100% PASI 50, at day 29  88% PASI 75, at day 43  38% PASI 90, at day 43 350 mg SC group  75% PASI 50, during the study  62.5% PASI 75, during the study 140 mg SC group  50% PASI 50, during the study Placebo group  0% PASI 50, during the study Two weeks after 350 mg SC or 700 mg IV  Dose-dependent improvement in PASI and sPGA Similar safety profile for all groups
Phase II75	198 patients with moderate-to-severe psoriasis  Day 1 and weeks 1, 2, 4, 6, 8, and 10   Placebo (n=38)   70 mg SC (n=39)   140 mg SC (n=39)   210 mg SC (n=40)  Day 1 and weeks 4 and 8   280 mg SC (n=42)	Week 12  45% PASI score improvement in 70 mg group  85.9% PASI score improvement in 140 mg group   77% PASI 75   72% PASI 90  210 mg group   86.3% PASI score improvement   82% PASI 75   75% PASI 90  76% PASI score improvement in 280 mg group  16% PASI score improvement in placebo group  140 mg and 210 mg groups   Improvements in sPGA, DQLI, and SF-36 Adverse effects slightly higher than with placebo

Abbreviations: DLQI, Dermatology Life Quality Index; IV, intravenously; PASI, Psoriasis Area and Severity Index; SC, subcutaneously; SF-36, Medical Outcomes Study 36-Item Short-Form Health Survey; sPGA, static Physician Global Assessment.