The chronic autoimmune skin disorder, plaque psoriasis, is very common. It causes thick red patches and scales on the skin. The affected skin cells swell due to a pro-inflammatory cytokine called IL-17A. Dermatologists prescribe an antibody called Secukinumab to neutralize these signaling molecules selectively. This study evaluates the optimal dosage and its corresponding clinical responses. The objective of this GAIN study is to compare Secukinumab’s safety and efficacy.
A total of 772 patients with moderate to severe psoriasis were the study subjects who received 300 mg dosage every two weeks (q2w). Those who did not reach PASI90 but had PASI>=75 got divided into two groups. One continued receiving q2w, and the other received q4w (once every four weeks). The randomization of the patients at 1:1 took place after week 16. They continued the 2 and 4-week dosages up to week 32. The superiority of q2w to the later for PASI190 was the primary endpoint.
After week 32, PASI190 favored those who took Secukinumab q2w. Without statistical significance, these suboptimal responders were 64.4% in q2w and 57.4% in q4w. Although the primary endpoint left unmet, absolute PASI was in favor of q2w. The q2w and q4w minimal disease activity were 71.2% to 61.7%. Quality of Life at week 32 also favored q2w at 58.9% over 50.5% of q4w.
No new or unexpected safety signals arose in the study. Q4w therapy improves responses after 16 weeks, whereas the q2w offers potential benefits for sub-optimal responders.