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Tofacitinib therapy inhibited structural damage progression in RA patients
Tofacitinib inhibited the progression of structural damage and improved disease activity in patients with rheumatoid arthritis who had inadequate response to methotrexate, according to recent study results.
“Our findings provide the first evidence that tofacitinib reduces the progression of structural damage in RA patients with active disease,” researcher Désirée van der Heijde, MD, PhD, Leiden University Medical Center in the Netherlands, said in a news release.
Désirée van der Heijde
As part of a 24-month, double blind, placebo-controlled phase 3 study, researchers evaluated 797 patients with rheumatoid arthritis (mean age, 53 years; 85.2% women; mean duration of RA, 9 years) who previously had received methotrexate for at least 6 weeks. In combination with methotrexate, patients were randomly assigned 5 mg tofacitinib twice daily (n=321), 10 mg tofacitinib twice daily (n=316) or placebo (n=160). Placebo patients who did not achieve at least 20% improvement in swollen and tender joint counts at month 3 were blindly advanced to 5 mg tofacitinib twice a day (n=81) or 10 mg tofacitinib twice a day (n=79). All other nonresponding placebo patients were switched to tofacitinib at 6 months.
Twelve-month data showed that at month 6, ACR20 response rates for patients receiving either 5 mg or 10 mg tofacitinib twice daily were 51.5% and 61.8%, respectively, compared with 25.3% for placebo patients (P<.0001, both doses). For the 5 mg and 10 mg tofacitinib patients, least squares mean change in van der Heijde modified Total Sharp Score at month 6 were 0.12 (P=.0792) and 0.06 (P≤.05), respectively, compared with placebo, 0.47.
At month 3, LS mean changes in Health Assessment Questionnaire-Disability Index changes were –0.40 (significance not declared) for 5 mg twice a day and –0.54 (P<.0001) for 10 mg tofacitinib twice daily, compared with –0.15 for placebo. Disease Activity Score 28<2.6 defined rates of remission at month 6 of 7.2% (significance not declared) for 5 mg and 16% (P<.0001) for 10 mg tofacitinib twice daily vs. 1.6% for placebo.
Disclosure: See the study for a full list of relevant disclosures.