Pfizer Announces Positive Top-Line Results from Second Phase 3 Trial of Oral XELJANZ® (Tofacitinib Citrate) In Adults with Psoriatic Arthritis

Pfizer Igea Luca Dezzani

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June 7, 2016

Pfizer Inc. has announced top-line results from Oral Psoriatic Arthritis trial (OPAL) Beyond. This is the second Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA). This study assessed the safety and efficacy of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active Psoriatic Arthritis who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi), making it the first PsA study for focusing exclusively on TNFi-IR patients. Primary efficacy endpoints were met by OPAL Beyond, demonstrating a statistically significant (p<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compared to placebo treatment as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months and response by American College of Rheumatology 20 (ACR20).

“There is a significant need for additional PsA treatment options as many people living with the condition do not respond well to available therapies. The positive results of both Phase 3 PsA studies, OPAL Broaden in DMARD-IR patients and OPAL Beyond in TNFi-IR patients, demonstrate that tofacitinib, if approved, may have potential to be an important treatment option to help address unmet needs for patients with PsA,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business.

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