IV secukinumab safe and effective for long-term treatment of active PsA

Long-term results of the phase 3 study INVIGORATE-2 showed that intravenous (IV) secukinumab was safe and effective for up to 1 year in participants with active psoriatic arthritis (PsA). Participants who switched from placebo to active treatment at week 16 experienced a continuous increase in efficacy response, comparable to the response observed in the secukinumab group at week 52. There were no new safety signals.

In the FUTURE 2-5 trials, subcutaneous secukinumab resulted in rapid and sustained improvement of symptoms in participants with moderate-to-severe PsA [1-4]. No study has yet evaluated the safety and efficacy of IV secukinumab. The randomised, double-blind, placebo-controlled, phase 3 study INVIGORATE-2 (NCT04209205) was conducted to address this gap [5]. All included participants with active PsA had symptoms for ≥6 months, a tender joint count of 78 joints (TJC78) ≥3, and a swollen joint count of 76 joints (SJC76) ≥3. In this study, 381 patients were randomised to receive IV secukinumab (n=191) or placebo (n=190) during the first 16 weeks. Afterwards, participants from the placebo group switched to IV secukinumab through week 52.

A significantly higher proportion of participants in the secukinumab group (31.4%) reached the primary efficacy endpoint, which was ACR50 response after 16 weeks, compared with the placebo group (6.3%; P<0.0001). The secondary binary efficacy outcomes were also met, including achieving an ACR20 response, minimal disease activity, Psoriasis Area and Severity Index-90 (PASI90), and resolution of dactylitis and enthesitis. Continuous outcome measures improved at 16 weeks as well, including the nail psoriasis severity index, which is notoriously difficult to achieve.

Among participants who were switched to the active treatment after 16 weeks, the ACR50 response rate increased as soon as week 20. Both groups had similar ACR50 responses after 1 year: 58% in the secukinumab group and 64% in the placebo/secukinumab group.

The safety profile was consistent with the known previous findings, without new signals. In the first 16 weeks, the incidences of adverse events (AEs) in the experimental and placebo groups were similar (37.7% vs 38.4%, respectively). The rate of serious AEs was 1.6% and 2.1%, while the AEs rate leading to treatment discontinuation was 0.5% and 1.6%, respectively. No new cases of inflammatory bowel disease or uveitis were reported.

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   1. McInnes IB, et al. Arthritis Res Ther. 2018;20(1):113. 
   2. Nash P, et al. Arthritis Res Ther. 2018;20(1):47.
   3. Orbai AM, et al. J Clin Rheumatol. 2018;24(S3):364.
   4. Mease P, et al. Ann Rheum Dis. 2018;77(6):890–7.
   5. Kivitz A, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: 16- and 52-week results from a randomized, double-blind, phase 3 study. 0776, ACR Convergence 2023, 10–15 November, San Diego, USA.

Medical writing support was provided by Michiel Tent.
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Posted on 1 December 20231 May 2024