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FDA approves adding radiographic data to Xeljanz label

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The FDA approved a supplemental new drug application to update the label of Pfizer’s tofacitinib citrate 5 mg tablets with data from two phase 3 trials demonstrating a reduction in radiographic progression in patients with rheumatoid arthritis, the company announced.

Xeljanz, an oral Janus kinase inhibitor, is indicated for treating adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response or intolerance to methotrexate (MTX). It may be used as monotherapy or combined with MTX or other non-biologic disease-modifying antirheumatic drugs, with a recommended dose of 5 mg twice-daily (BID).

“The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinical meaningful outcome for patients,” Steven Romano, MD,global medicines development lead for the Pfizer Global Innovative Pharmaceutical business, said in a press release.

Radiographic response data from the ORAL Scan study at 6 months and the ORAL Start study at 6 and 12 months will be on the updated US label, according to the release. Progression of structural joint damage as measured by mean change from baseline in van der Heijde modified Total Sharp Score (mTSS) and components, erosion score and joint space narrowing score were evaluated. The researchers also assessed the proportion of patients with no radiographic progression.

Seventy-four percent of patients in the placebo plus MTX cohort in the ORAL Scan study experienced no radiographic progression at 6 months compared with 84% of patients receiving treatment of Xeljanz BID plus MTX. In the ORAL Start study, 55% of patients receiving MTX therapy displayed no radiographic progression at 6 months compared with 77% of patients treated with Xeljanz 5 mg BID.

“The ORAL Start study showed that Xeljanz 5 mg BID, as a single agent, was statistically significantly superior to MTX, providing a greater inhibition of progression of structural joint damage, as measured by mean change from baseline in mTSS at month 6 [primary endpoint], and sustained at 12 months,” the release stated.

Serious infections, lymphoma and other malignancies have been reported in patients treated with Xeljanz, according to the release.