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Randomized Controlled Trial
. 2018 Mar 15;20(1):47.
doi: 10.1186/s13075-018-1551-x.

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

Peter Nash  1 , Philip J Mease  2 , Iain B McInnes  3 , Proton Rahman  4 , Christopher T Ritchlin  5 , Ricardo Blanco  6 , Eva Dokoupilova  7 , Mats Andersson  8 , Radhika Kajekar  9 , Shephard Mpofu  8 , Luminita Pricop  9 ; FUTURE 3 study group
Affiliations
Randomized Controlled Trial

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

Peter Nash et al. Arthritis Res Ther. .

Abstract

Background: The study aimed to assess 52-week efficacy and safety of secukinumab self-administration by autoinjector in patients with active psoriatic arthritis (PsA) in the FUTURE 3 study ( ClinicalTrials.gov NCT01989468).

Methods: Patients (≥ 18 years of age; N = 414) with active PsA were randomized 1:1:1 to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or placebo at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. Per clinical response, placebo-treated patients were re-randomized to s.c. secukinumab 300 or 150 mg at week 16 (nonresponders) or week 24 (responders) and stratified at randomization by prior anti-tumor necrosis factor (TNF) therapy (anti-TNF-naïve, 68.1%; intolerant/inadequate response (anti-TNF-IR), 31.9%). The primary endpoint was the proportion of patients achieving at least 20% improvement in American College of Rheumatology response criteria (ACR20) at week 24. Autoinjector usability was evaluated by Self-Injection Assessment Questionnaire (SIAQ).

Results: Overall, 92.1% (300 mg), 91.3% (150 mg), and 93.4% (placebo) of patients completed 24 weeks, and 84.9% (300 mg) and 79.7% (150 mg) completed 52 weeks. In the overall population (combined anti-TNF-naïve and anti-TNF-IR), ACR20 response rate at week 24 was significantly higher in secukinumab groups (300 mg, 48.2% (p < 0.0001); 150 mg, 42% (p < 0.0001); placebo, 16.1%) and was sustained through 52 weeks. SIAQ results showed that more than 93% of patients were satisfied/very satisfied with autoinjector usage. Secukinumab was well tolerated with no new or unexpected safety signals reported.

Conclusions: Secukinumab provided sustained improvements in signs and symptoms in active PsA patients through 52 weeks. High acceptability of autoinjector was observed. The safety profile was consistent with that reported previously.

Trial registration: ClinicalTrials.gov NCT01989468 . Registered 21 November 2013. EudraCT 2013-004002-25 . Registered 17 December 2013.

Keywords: Autoinjector; FUTURE 3 study; Interleukin-17a; Psoriatic arthritis; Secukinumab.

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Conflict of interest statement

Ethics approval and consent to participate

The study was conducted in accordance with the principles of the Declaration of Helsinki. The institutional review board at each participating center approved the protocol. Further information related to ethics approval can be found online (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004002-25). All centers received approval from independent ethics committees (IECs) or institutional review boards (IRBs). The names of IECs or IRBs that approved the study and the associated approval numbers where applicable are presented in Additional file 1: Table S1. Patients provided written informed consent before starting the study-related procedures.

Consent for publication

Not applicable.

Competing interests

PN has received research grants for clinical trials and honoraria for lectures and advice from Novartis, AbbVie, Roche, Pfizer, BMS, Janssen, and Celgene. PJM has received grant/research support from AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB; been a consultant for AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB; and on the speakers’ bureau for AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB. IBM has received research grants, consultation fees, or speaker honoraria from AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB. PR has received consulting fees from Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche; and been a consultant for pharmaceutical companies dealing with biologic agents in rheumatology. CTR has received research grants, consultation fees, or speaker honoraria from Amgen, UCB, AbbVie, Novartis, and Janssen. RB has received research grants from AbbVie, MSD, and Roche; consulting fees from AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD; and was on the speakers’ bureau for AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD. ED has no competing interests. MA, RK, SM, and LP are employees of Novartis. RK, SM, and LP own Novartis stock.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient disposition up to week 52
Fig. 2
Fig. 2
ACR20 response rates through week 52 in the overall population (a) and by anti-TNF status (b, c). *p < 0.0001, §p < 0.01, ‡p < 0.05 versus placebo. p values adjusted for multiplicity of testing for overall population at week 24. Missing values imputed as nonresponse (nonresponder imputation) through week 52. ACR20 20% improvement in American College of Rheumatology response criteria, IR inadequate response, s.c. subcutaneous, TNF tumor necrosis factor
Fig. 3
Fig. 3
ACR50 response rates through week 52 in the overall population (a) and by anti-TNF status (b, c). *p < 0.0001, ‡p < 0.05 versus placebo. p values adjusted for multiplicity of testing for overall population at week 24. Missing values imputed as nonresponse (nonresponder imputation) through week 52. ACR50 50% improvement in American College of Rheumatology response criteria, IR inadequate response, s.c. subcutaneous, TNF tumor necrosis factor
See this image and copyright information in PMC

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