Pfizer’s tofacitinib hits main goal in Phase 3 juvenile idiopathic arthritis study

pharmafile | November 12, 2019 | News story | Manufacturing and Production, Research and Development Pfizer, pharma, tofacitinib 

Pfizer has lifted the lid on new Phase 3 data exploring the efficacy of tofacitinib in the treatment of juvenile idiopathic arthritis (JIA) in paediatric and adolescent patients younger than 18 but older than two years old, confirming that the drug met its primary endpoint.

In a withdrawal study encompassing 225 patients with polyarticular course JIA, psoriatic arthritis or enthesitis-related arthritis, the drug successfully reduced the occurrence of disease flare compared to placebo after 44 weeks of treatment, meeting the study’s main goal.

The full results are due to be revealed at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting this week.

“Paediatric patients living with juvenile idiopathic arthritis need additional options, including oral therapies, to treat this chronic inflammatory disease,” commented Michael Corbo, Chief Development Officer, Inflammation & Immunology at Pfizer. “We are encouraged by the results from our pivotal Phase 3 investigational study of tofacitinib in patients with polyarticular juvenile idiopathic arthritis and look forward to filing for this indication with the FDA in 2020.”

Pfizer confirmed it has plans to submit applications for the drug to regulatory bodies next year.

Matt Fellows

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