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Head-to-head trial shows secukinumab superior to ustekinumab in psoriatic arthritis

Presented by
Prof. Frank Behrens , Fraunhofer Institute for Translational Medicine and Pharmacology, Germany
Conference
ACR 2025
In a head-to-head comparison, secukinumab, a human monoclonal antibody targeting interleukin-17 (IL-17), demonstrated better disease control and fewer treatment discontinuations than ustekinumab in patients with psoriatic arthritis (PsA) who had previously received tumour necrosis factor-alpha (TNFα) inhibition.

The AgAIN trial (NCT04632927) is a randomised, double-blind, active-controlled, multicentre trial assessing secukinumab versus ustekinumab across 28 centres in Germany. Prof. Frank Behrens (Fraunhofer Institute for Translational Medicine and Pharmacology, Germany) presented the results [1]. Eligible participants were included if they had met the Classification Criteria for Psoriatic Arthritis (CASPAR) for ≥6 months before randomisation, had ≥3 tender joints and ≥3 swollen joints, inadequate response or intolerance to ≥1 TNFα inhibitor and to conventional disease-modifying antirheumatic drugs (cDMARDs), and active or history of psoriasis. Participants were randomised 1:1 to receive secukinumab 300 mg (weekly for 4 weeks, then every 4 weeks thereafter up to week 24), or ustekinumab 45 or 90 mg (weeks 4, 8 and 16). Efficacy was assessed at week 28 using the Health Assessment Questionnaire-Disability Index (HAQ-DI) tool. In total, 119 participants were randomised.

HAQ-DI scores continuously increased over time in both groups, but showed a higher rate of response at week 28 with secukinumab compared to ustekinumab (57.1% vs 27.0%). Among participants with concurrent active psoriasis, more achieved a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) (60.7% vs 46.0%) and PASI-90 (48.2% vs 39.7%) responses with secukinumab compared to ustekinumab. Both therapies had expected safety profiles, but treatment discontinuations due to adverse events were less frequent with secukinumab (3.6% vs 12.7%).

Overall, this head-to-head trial demonstrated that secukinumab provides superior disease control and tolerability compared with ustekinumab in patients with PsA who have been previously exposed to TNFα inhibitors and cDMARDs.

  1. Behrens F, et al. AgAIN Study: First head-to-head trial of secukinumab vs. ustekinumab in TNFα inhibitor-experienced psoriatic arthritis patients reveals better efficacy across multiple domains. ACR Convergence, 24–29 October 2025, Chicago, IL, USA.

Medical writing support was provided by Mihai Surducan, PhD.

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