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.
- 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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