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CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis

pharmafile | October 19, 2020 | News story | Sales and Marketing CHMP, EMA, Janssen, Tremfya 

Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) has scored a recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of active psoriatic arthritis (PsA), it has emerged.

Data drawn from two Phase 3 studies incorporating over 1,000 active PsA patients – 381 already treated with anti-tumour necrosis factor (TNF) alpha biologics and 739 biologic-naïve patients – and published in The Lancet earlier in the year showed that, 24 weeks following treatment, both statistically significant proportions of both groups, receiving either 100mg every four or eight weeks, achieved an American College of Rheumatology (ACR) scale score of 20 compared to those receiving placebo.

Furthermore, patients in the Tremfya groups reported improvements in quality of life over those receiving placebo, with significant improvements observed in those receiving the therapy every four weeks.

Patients receiving Tremfya also reported higher response rates over the placebo group according to scores of 75, 90 and 100 on the Psoriasis Area and Severity Index.

“This positive opinion brings us closer to the addition of guselkumab to the drug armoury for the management of psoriatic arthritis, which is of critical importance for patients,” explained Professor Iain McInnes, Muirhead Professor of Medicine and Director of the Institute of Infection Immunity and Inflammation at the University of Glasgow. “Psoriatic arthritis is an impactful, multifaceted and currently incurable disease. Long-term control of the diverse symptoms in joints, skin and soft tissue is required. If approved, guselkumab would be a welcome addition to our therapeutic options in the management of this disease.”

Tremfya is already approved in the EU in moderate to severe plaque psoriasis in adult candidates for systemic therapy, while it is also approved for the treatment of active PsA in adults across the US, Canada, Brazil, Japan and Ecuador.

Matt Fellows

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