Xeljanz/Methotrexate Combination Provides Benefit

Xeljanz/Methotrexate Combination Provides Benefit.

Among people with rheumatoid arthritis (RA) and an inadequate response to a type of drug known as a TNF inhibitor, treatment with Xeljanz® (tofacitinib) and methotrexate reduces RA disease activity and symptoms. These results were published in Lancet.

Treatment of RA often begins with methotrexate or another disease-modifying antirheumatic drug (DMARD). If this initial treatment does not adequately control the RA, patients may move on to treatment with a newer, biologic DMARD. TNF inhibitors are commonly used biologic DMARDs.

Xeljanz is a new type of drug known as a Janus kinase (JAK) inhibitor. Janus kinases are enzymes that play a role in inflammation and RA. Xeljanz—which is taken orally—blocks the activity of these enzymes.

To evaluate the effect of Xeljanz among patients with moderate-to-severe RA and an inadequate response to at least one TNF inhibitor, researchers conducted a Phase III clinical trial that enrolled 399 patients from 13 countries. Patients were treated twice a day with 5 mg of Xeljanz, 10 mg of Xeljanz, or placebo, all in combination with methotrexate.

  • After three months of treatment, an ACR20 response (at least a 20% reduction in symptoms) occurred in 42% of patients treated with 5 mg of Xeljanz, 48% of patients treated with 10 mg of Xeljanz, and 24% of patients treated with placebo.
  • Low disease activity (a DAS28-4ESR score less than 2.6) was achieved by 7% of patients treated with 5 mg of Xeljanz, 9% of patients treated with 10 mg of Xeljanz, and 2% of patients treated with placebo.
  • The most common side effects among patients treated with Xeljanz were diarrhea, nasopharyngitis, headache, and urinary tract infection.

These results suggest that Xeljanz may benefit patients who have refractory, difficult-to-treat RA.

Reference: Burmester GR, Blanco R, Charles-Schoeman C et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. Early online publication January 5, 2013.

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