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Tofacitinib demonstrated efficacy, safety in patients with PsA

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WASHINGTON — Patients with psoriatic arthritis demonstrated a rapid and sustained response to treatment with tofacitinib, according to results of a phase 3 study presented at the American College of Rheumatology Annual Meeting.

Study researcher Philip J. Mease, MD, of the Swedish Medical Center and University of Washington in Seattle, noted the study was the first to demonstrate the efficacy of a Janus kinase inhibitor in psoriatic arthritis (PsA).

Philip J. Mease

“The primary endpoints were achieved at month 3, with an onset of efficacy as early as week 2,” he said. “The overall rates of laboratory changes were consistent with those observed for tofacitinib [Xeljanz, Pfizer] in rheumatoid arthritis. Thus, we conclude that tofacitinib is a potential future treatment option for patients with PsA.”

Mease and colleagues conducted a randomized, placebo- and active-controlled, double-blind, multicenter study of tofacitinib in patients with PsA. The analysis included 107 patients treated with tofacitinib 5 mg twice a day, 104 patients treated with tofacitinib 10 mg twice a day, 106 patients treated with adalimumab 40 mg by subcutaneous injection once every 2 weeks, 52 patients initially treated with placebo and then treated with tofacitinib 5 mg, and 53 patients initially treated with placebo and then treated with tofacitinib 10 mg.

ACR20 and change in Health Assessment Questionnaire Disability Index (HAQDI) at 3 months served as the primary outcome measures. Researchers also looked at ACR50 and ACR70, laboratory parameters and radiographic progression at 12 months. Of the 422 patients who were randomized, 373 completed the study.

The primary endpoint of ACR20 response at 3 months was reached by 50% of patients in the tofacitinib 5-mg arm, by 61% of those in the 10-mg arm, by 52% of those in the adalimumab arm and by 33% of patients treated with placebo.

“We observed a rapid onset of action with a significant improvement at week 2,” Mease said. “The effect was sustained, if not slightly improved, up to 12 months.”

He added that HAQDI was statistically significantly better in all three active treatment groups compared with placebo. “HAQDI response had a fairly rapid effect and was linear over time,” he said.

Radiographic analysis indicated non-progression of disease rates above 90% for all treatment groups. Skin response also was noted at 3 months. Enthesitis declined by about 50% at 3 months in the tofacitinib 10-mg group, according to Mease.

The adverse event profile indicated no deaths and few discontinuations through 3 months.

“We did see some serious infections through 12 months, and two cases of herpes zoster in the tofacitinib arms,” Mease said. — by Rob Volansky

References:

Mease PJ, et al. Abstract #2983. Presented at: The American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.

Disclosure: Mease reports associations with AbbVie, Amgen, BMS, Celgene, Crescendo, Corrona, Dermira, Eli-Lilly, Genetech, Janssen, Novartis, Pfizer Inc, Sun, UCB and Zynerba.