NYMC Faculty Publications
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
DOI
10.1111/bjd.16464
Journal Title
The British Journal of Dermatology
First Page
320
Last Page
328
Document Type
Article
Publication Date
August 2018
Department
Dermatology
Abstract
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 Physicians 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.
Recommended Citation
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