Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumor necrosis factor inhibitors: Results through one year of a phase IIIb, randomized, controlled study (COSMOS)

Annals of Rheumatic DiseasesCoates LC, Gossec L, Theander E, et al. | November 29, 2021


In patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumor necrosis factor inhibitors (TNFi), significant improvements in joint and skin manifestations as well as in physical function were conferred by guselkumab, a fully human interleukin−23 p19-subunit inhibitor. The benefit–risk profile, through 1 year, was favorable.

  • In patients with TNFi-IR PsA, lower response rates to additional TNFi are frequently noted, and only one switch within the TNFi class prior to selecting an alternate mechanism of action is generally supported by current treatment guidelines.

  • The phase III, randomized, placebo-controlled COSMOS study involved 285 adults with active PsA (≥3 swollen and ≥3 tender joints) who discontinued ≤2 TNFi because of IR (lack of efficacy or intolerance).

  • Patients (female (52%), one (88%) or two (12%) prior TNFi) were randomized (2:1) to subcutaneous guselkumab 100 mg or placebo at week 0, week 4, then every 8 weeks (Q8W) through week 44.

  • At week 24, significantly higher response rates and greater mean improvements in assessments of the signs and symptoms of PsA were observed among guselkumab-treated patients vs placebo; maintained or improved response rates and mean improvements were noted through 1 year in the guselkumab group.

  • Safety results were identified to be consistent with the known safety profile of guselkumab in biologic-naïve patients with PsA.

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