Sonelokimab exhibits favorable data in active psoriatic arthritis: Results from the phase II ARGO trial

On November 5, 2023, positive topline results were announced from the phase II ARGO trial (NCT05640245) of sonelokimab (also known as M1095), a therapeutic that inhibits IL-17A and IL-17F.¹  The primary and secondary endpoints were met in patients with active psoriatic arthritis (PsA).¹

Key findings¹

A total of 207 patients with active PsA were enrolled in the phase II ARGO trial. In this population:

• The primary endpoint, a 50% improvement in American College of Rheumatology response criteria (ACR50), was met by Week 12 in patients who received sonelokimab 60 mg and 120 mg with induction:
  • 46% and 47% of patients achieved ACR50, respectively (p < 0.01 versus placebo);
  • 78% and 72% of patients achieved ACR20, respectively; and
  • 29% and 26% of patients achieved ACR70, respectively.
• The secondary endpoint, a 90% improvement in the Psoriasis Area and Severity Index (PASI90), was met for all doses with induction:
  • At Week 12, 77% of patients responded to the 60 mg dose (intention-to-treat population; p < 0.001 versus placebo), and 58% of patients achieved complete skin clearance (PASI100).
  • Approximately 60% of patients responded at Week 12 to the 120 mg dose.
• Secondary endpoints, including Minimal Disease Activity, modified Nail Psoriasis Severity Index, the Leeds Enthesitis Index, and the patient self-reported Psoriatic Arthritis Impact of Disease, displayed promising results at Week 12.

These results indicate that sonelokimab may be a safe and efficacious treatment option for this patient population.¹