Details

Autor(en) / Beteiligte

• Reich, K.
• Körber, A.
• Mrowietz, U.
• Sticherling, M.
• Sieder, C.
• Früh, J.
• Bachhuber, T.

Titel

Secukinumab 2‐weekly vs. 4‐weekly dosing in patients with plaque‐type psoriasis: results from the randomized GAIN study

Ist Teil von

• British journal of dermatology (1951), 2021-05, Vol.184 (5), p.849-856

Ort / Verlag

England: Oxford University Press

Erscheinungsjahr

2021

Quelle

Wiley Online Library - AutoHoldings Journals

Beschreibungen/Notizen

• Background Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin‐17A and shows long‐lasting efficacy and safety in plaque psoriasis. More evidence is required to optimize secukinumab dosing according to clinical response. Objectives GAIN compared the efficacy and safety of secukinumab 300 mg every 2 weeks (q2w) with 300 mg every 4 weeks (q4w) in patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) but not PASI 90 after 16 weeks. Methods In total, 772 patients with moderate‐to‐severe plaque psoriasis received secukinumab 300 mg subcutaneously at baseline and weeks 1, 2, 3 and 4, then q4w until week 16. At week 16, patients with PASI ≥ 75 to PASI < 90 were randomized 1: 1 to continue q4w dosing (n = 162) or switch to q2w (n = 163) to week 32. The primary endpoint was superiority of q2w to q4w dosing for PASI 90 response at week 32. Results PASI 90 response at week 32 was numerically greater with secukinumab 300 mg q2w than with secukinumab 300 mg q4w in suboptimal responders, but this did not reach statistical significance (64·4% vs. 57·4%; odds ratio 0·64, 95% confidence interval 0·39–1·07; P = 0·087). Although the primary endpoint was not met, absolute PASI was significantly lower at week 32 in q2w vs. q4w patients (2·11 vs. 2·84, P = 0·024). Significantly more patients with q2w vs. q4w dosing showed minimal disease activity (Investigator’s Global Assessment score 0 or 1: 73·0% vs. 64·1%, P < 0·05) and improved quality of life (Dermatology Life Quality Index score 0 or 1: 58·9% vs. 50·6%, P < 0·05) at week 32. No new or unexpected safety signals arose. Conclusions Most patients achieved PASI 90 response with secukinumab q4w. There was potential benefit of q2w dosing in some suboptimal responders. Continued q4w treatment can improve response even after 16 weeks. What is already known about this topic? Dose adjustments of biologic treatments for psoriasis according to response may occur in clinical practice, but systematic evidence for increased or individualized dosing in suboptimal responders is lacking. Secukinumab has shown long‐lasting efficacy in psoriasis, and the GAIN study compared shortened dose intervals of every 2 weeks (q2w) with the standard dose of 300 mg every 4 weeks (q4w) in suboptimal responders (≥ 75% to < 90% improvement in Psoriasis Area and Severity Index). What does this study add? GAIN shows potential benefit of q2w dosing in some patients who do not respond optimally to q4w secukinumab treatment. Although there was no statistically significant difference in PASI 90 response between patients dosed q2w and q4w, benefits were seen with the shortened treatment interval in absolute PASI, Investigator’s Global Assessment and Dermatology Life Quality Index. Continued treatment with the approved q4w dose also improved response after 16 weeks in over half of suboptimal responders. Linked Comment: Tsai. Br J Dermatol 2021; 184:791–792.