FDA has approved Tremfya® (guselkumab) from Janssen Pharmaceutical Companies of Johnson & Johnson for adult patients with active psoriatic arthritis (PsA). Tremfya is the first interleukin (IL)-23 approved for active PsA.
The safety and efficacy of Tremfya in PsA have been demonstrated in two pivotal Phase 3 clinical trials. DISCOVER-1 and DISCOVER-2 evaluated the efficacy and safety of Tremfya administered by subcutaneous injection in adults with active PsA compared to placebo. The results, recently published in The Lancet, showed that a significant percentage of patients treated with Tremfya reached the studies’ primary endpoint of ACR20 at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.
In addition, treatment with Tremfya improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index), and SF-36 Physical Component Summaryscore, and soft tissue (enthesitis and dactylitis). Tremfya also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
The overall safety profile observed in patients with PsA treated with Tremfya is generally consistent with the safety profile in patients with plaque psoriasis with the addition of bronchitis and neutrophil count decreased.
Tremfya is administered as a 100mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. Tremfya can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD (e.g., methotrexate).