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Baricitinib taken with or without methotrexate may help some patients with RA

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Recently presented data from a phrase 3 study showed patients with moderate-to-severe, early rheumatoid arthritis who received baricitinib monotherapy or in combination with methotrexate were more likely to respond positively to treatment compared with patients who received methotrexate alone.

Researchers compared 210 patients who received methotrexate alone, 159 patients who received only 4 mg of baricitinib, a Janus kinase (JAK)1 and JAK2 inhibitor (Eli Lilly, Incyte), and 215 patients who received both 4-mg baricitinib and methotrexate. Patients had active rheumatoid arthritis and no prior treatment with disease-modifying anti-rheumatic drugs other than up to 3 doses of methotrexate. Patients were randomized to treatment groups and received either initial therapy of 10-mg methotrexate titrated to 20 mg once a week during a period of 8 weeks alone or with 4-mg baricitinib daily, or 4-mg baricitinib daily as monotherapy for up to 52 weeks. No rescue medications were permitted prior to 24 weeks, at which time efficacy was assessed.

About 87% of patients who received methotrexate alone, 91% of patients who received baricitinib alone and 89% of patients who received methotrexate plus baricitinib completed 24 weeks of treatment. At week 24, 62% of patients who received methotrexate alone, 77% of patients who received baricitinib alone and 78% of patients who received baricitinib plus methotrexate demonstrated an American College of Rheumatology (ACR) response criteria of 20% (ACR20). An ACR response criteria of 50% was met by 43%, 60% and 63% of patients who received methotrexate alone, baricitinib alone and baricitinib plus methotrexate, respectively. Investigators found 21%, 42% and 40% of patients, respectively, reached an ACR response criteria of 70%. The Disease Activity Score in 28 joints (DAS28) with C-reactive protein at or below 3.2 mg/L was met by 38%, 57% and 60% of patients who received methotrexate alone, baricitinib alone and baricitinib plus methotrexate, respectively. No gastrointestinal perforations were observed. Investigators also noted the baricitinib alone group had fewer instances of laboratory abnormalities compared with the other treatment groups. - by Shirley Pulawski

Reference:

Fleischmann R, et al. Paper #1045. Presented at: American College of Rheumatology Annual Meeting; Nov. 7-11, 2015; San Francisco.

Disclosures: Fleischmann reports the receipt of funding from Pfizer and Eli Lilly. Please see the full study for a list of all other authors’ relevant financial disclosures.