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European approval for Janssen’s Tremfya in active psoriatic arthritis, either alone or in combo

pharmafile | December 2, 2020 | News story | Research and Development, Sales and Marketing Europe, Janssen, Tremfya 

The European Commission has authorised Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) in the treatment of active psoriatic arthritis (PsA), either as a monotherapy or together with methotrexate.

The approval relates to adult patients for whom prior disease-modifying antirheumatic drug (DMARD) therapy was not successful.

Data drawn from two Phase 3 studies showed that a statistically significant proportion of active PsA patients receiving Tremfya achieved a 20% improvement in their symptoms, according to the American College of Rheumatology scale, meeting the drug’s primary goals. Quality of life scores were also found to be higher in those receiving Tremfya than those receiving placebo.

“Psoriatic arthritis can have a highly detrimental impact on those living with this chronic, inflammatory condition. Symptoms are often debilitating, leading to irreversible joint damage in some, and preventing a majority of people getting on with day-to-day life and work” remarked Professor Iain McInnes, Muirhead Chair of Medicine and Vice Principal & Head of College of Medical, Veterinary and Life Sciences at the University of Glasgow. “There remains a need for additional effective treatment options that improve joint and skin symptoms, and overall quality of life. I welcome the authorisation of guselkumab as a new biologic treatment option for adults with psoriatic arthritis.”

Tremfya is already approved in Europe for the treatment of moderate to severe plaque psoriasis in patients eligible to receive systemic therapy.

Matt Fellows

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