蘇金單抗治療活動性銀屑病關節炎並不優於阿達木單抗

蘇金單抗治療活動性銀屑病關節炎並不優於阿達木單抗

作者：

小柯機器人

發布時間：2020/5/11 15:33:52

近日，英國格拉斯哥大學Iain B McInnes團隊比較了蘇金單抗與阿達木單抗治療活動性銀屑病關節炎的療效與安全性。2020年5月9日，《柳葉刀》雜誌發表了這一成果。

銀屑病關節炎的頭對頭試驗有助於指導臨床決策。EXCEED研究評估了蘇金單抗與阿達木單抗作為一線生物單一療法治療活動性銀屑病關節炎患者52周的療效和安全性，其主要終點為美國風溼病學會（ACR）20緩解。

2017年4月3日至2018年8月23日，研究組進行了一項平行組、雙盲、主動控制、臨床3b期、多中心試驗，招募了853名18歲以上的活動性銀屑病關節炎患者。按1：1將這些患者隨機分組，其中426例接受蘇金單抗治療，427例接受阿達木單抗治療。兩組患者均治療50周，主要結局為52周時ACR緩解標準（ACR20）改善超過20%的患者所佔比例。

蘇金單抗組中有61名（14％）患者在第52周之前終止治療，而阿達木單抗組中有101名（24％）。就第52周時ACR20緩解來看，蘇金單抗組並不優於阿達木單抗組。蘇金單抗組中有67％的患者在第52周時達到了ACR20緩解，而阿達木單抗組為62％，差異不顯著。蘇金單抗和阿達木單抗的安全性與此前報導一致。 蘇金單抗組中有7名（2％）患者發生嚴重感染，阿達木單抗組中有6名（1％）。蘇金單抗組中有1例患者死於結腸癌，研究人員評估其與研究藥物無關。

總之，蘇金單抗在第52周時ACR20緩解的主要終點指標方面，並不優於阿達木單抗。但蘇金單抗的治療保留率高於阿達木單抗。

附：英文原文

Title: Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial

Author: Iain B McInnes, Frank Behrens, Philip J Mease, Arthur Kavanaugh, Christopher Ritchlin, Peter Nash, Jordi Gratacós Masmitja, Philippe Goupille, Tatiana Korotaeva, Alice B Gottlieb, Ruvie Martin, Kevin Ding, Pascale Pellet, Shephard Mpofu, Luminita Pricop

Issue&Volume: 2020/05/09

Abstract: Background

Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response.

Methods

This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080.

Findings

Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98–1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator.

Interpretation

Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis.

DOI: 10.1016/S0140-6736(20)30564-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30564-X/fulltext