June 08, 2016
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Phase 3 study shows positive results with tofacitinib citrate for psoriatic arthritis

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Pfizer Inc. announced positive results from its phase 3 study that evaluated tofacitinib citrate in patients with active psoriatic arthritis, according to a recent press release.

The phase 3 study of tofacitinib citrate (Xeljanz), known as Oral Psoriatic Arthritis Trial (OPAL) Beyond, assessed 395 adult patients with active psoriatic arthritis (PsA) who did not respond to at least one tumor necrosis factor inhibitor (TNFi). Results showed that, compared to a placebo, the twice daily treatment of tofacitinib 5 mg and 10 mg significantly improved the 3-month ACR20 and Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. The study showed no new safety findings.

“There is a significant need for additional PsA treatment options, as many people living with the condition do not respond well to available therapies,” Michael Corbo, category development lead of Inflammation & Immunology at Pfizer Global Innovative Pharmaceuticals Business, said in the release. “The positive results of both phase 3 PsA studies, OPAL Broaden in [disease-modifying antirheumatic drug-inadequate response] 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.”

Reference:

www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_second_phase_3_trial_of_oral_xeljanz_tofacitinib_citrate_in_adults_with_psoriatic_arthritis