Impact of Previous Biologic Use on the Efficacy and Safety of Brodalumab and Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis: Integrated analysis of the Randomized Controlled Trials AMAGINE-2 and AMAGINE-3
BACKGROUND: Biologics are being used increasingly to treat moderate-to-severe psoriasis. Efficacy may differ in patients with previous exposure to biologics. OBJECTIVES: To investigate the impact of previous biologic exposure on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. METHODS: Two placebo- and ustekinumab-controlled phase III clinical trials. There was an initial 12-week induction phase where patients were treated with brodalumab [210 mg or 140 mg every 2 weeks (Q2W)], ustekinumab or placebo. Efficacy end points included >/= 75% improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (score of 0 or 1) vs. placebo, PASI 100 vs. ustekinumab, Dermatology Life Quality Index and Psoriasis Symptom Inventory. Adverse events were monitored throughout. RESULTS: In total, 493 patients [334 (27%) brodalumab 210 mg Q2W and 159 (26%) ustekinumab] had received prior biologics; 150 (12%) and 62 (10%), respectively, reported previously failed treatment with a biologic. Brodalumab efficacy in patients with or without previous exposure to biologics was statistically equivalent: 40.9% and 39.5% of biologic-naive and -experienced patients achieved PASI 100 at week 12, compared with 21.1% and 17.0% with ustekinumab (both P < 0.001). In patients where prior biologics had been successful or failed, 41.7% and 32.0% achieved PASI 100, compared with 21.1% and 11.3% with ustekinumab. Tolerability was similar, and did not appear to be influenced by previous treatment with biologics. CONCLUSIONS: The efficacy of brodalumab 210 mg Q2W was similar regardless of prior biological therapy (P = 0.31, 0.32 and 0.64 for PASI 75, 90 and 100, respectively). Almost twice as many patients achieved PASI 100 or complete clearance with brodalumab at week 12 compared with ustekinumab; the differences were most noticeable where previous biologics had failed. Both treatments were well tolerated.
Papp, K., Gordon, K., Langley, R., Lebwohl, M., Gottlieb, A., Rastogi, S., Pillai, R., & Israel, R. (2018). Impact of Previous Biologic Use on the Efficacy and Safety of Brodalumab and Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis: Integrated analysis of the Randomized Controlled Trials AMAGINE-2 and AMAGINE-3. The British Journal of Dermatology, 179 (2), 320-328. https://doi.org/10.1111/bjd.16464