Secukinumab 300 mg showed promise in treating patients with palmoplantar pustular psoriasis (PPP), according to clinical trial results published in the Journal of the American Academy of Dermatology. These results illustrate the potential benefit of secukinumab in a challenging patient population.
Secukinumab was evaluated in the clinical trial 2PRECISE (Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab; NCT02008890), a Phase 3b multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing 2 doses of secukinumab with placebo in participants with moderate to severe PPP.
The primary objective of the study was to assess ppPASI75 (palmoplantar psoriasis area and severity index) response with secukinumab at week 16 vs placebo (2.5% significance level). Participants were randomly assigned at a ratio of 1:1:1 to receive either secukinumab 300 mg (n=79), secukinumab 150 mg (n=80), or placebo for 16 weeks (n=78) during treatment period 1.
Participants who completed the first treatment period continued until week 52 in treatment period 2. Participants aged 18 years or older with moderate to severe chronic PPP, ppPASI ≥12, and dermatology life quality index (DLQI) ≥10 were enrolled. Participants with erythrodermic or guttate psoriasis or who had generalized pustular psoriasis were excluded.
Treatment period 1 was completed by 195 participants (82.3%). Adverse events were the most common reason for drug discontinuation during the first 16 weeks of treatment. During the second treatment period, there were 65 (33.5%) discontinuations between weeks 16 and 52; withdrawal rates were higher in the 150 mg group than the 300 mg group. The most common reasons for withdrawal was adverse events or participant decision. The adverse events most commonly observed were nasopharyngitis and upper respiratory tract infection.
At Week 16, a ppPASI75 response was achieved in 26.6% of participants with secukinumab 300 mg vs 14.1% with placebo (P =.0411) and 17.5% with secukinumab 150 mg (P =.5722). The superiority of secukinumab 300 mg to placebo did not reach the 2.5% significance threshold. At week 52, a ppPASI75 response was achieved in 41.8% of participants treated with secukinumab 300 mg vs 35% of participants treated with secukinumab 150 mg. More DLQI 0/1 responses were achieved with secukinumab 300 mg (13%) than placebo (4.3%) at Week 16. At Week 52, the proportion of participants with DLQI 0/1 was considerably higher for secukinumab 300 mg than for all other groups.
Among the study limitations, the investigators acknowledged the small sample size. Additionally, the primary end point may not reflect the characteristics of the PPP disease course because these lesions may take longer to clear than any other psoriatic lesion. Even though the primary end point was not met, the reduction of ppPASI75 by 75% in more than 41% of participants and the achievement of a DLQI of 0 or 1 in 43% of participants treated with secukinumab 300 mg over 52 weeks shows a therapeutic potential. A gold standard treatment for PPP does not exist; therefore, any new therapeutic option is of great interest.
Disclosures: Multiple authors declare associations with the pharmaceutical industry. Please see original reference for a full list of authors’ disclosures.
Mrowietz U, Bachelez H, Burden AD, et al. Secukinumab for moderate to severe palmoplantar pustular psoriasis: Results of the 2PRECISE study [published online February 1, 2019]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.01.066