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Tofacitinib with methotrexate rapidly improved RA patients’ symptoms
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Tofacitinib with methotrexate treatment provided rapid and clinically meaningful improvement in signs and symptoms for patients with rheumatoid arthritis who had an inadequate response to tumor necrosis factor inhibitors, according to recent study results.
In a 6-month, double blind phase 3 study at 82 centers in 13 countries, researchers studied 399 patients with moderate-to-severe rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitors (TNFi). Patients were randomly assigned to receive either twice daily tofacitinib 5 mg (n=133 patients; mean age, 55.4 years; 85% women), tofacitinib 10 mg (n=134; mean age, 54.4 years; 80.3% women) or placebo (n=132; mean age, 55.1 years; 86.6% women), along with methotrexate. Placebo patients were switched to either twice a day tofacitinib 5 mg (n=66) or tofacitinib 10 mg (n=66) at month 3 when primary endpoints were measured.
ACR 20 response rates were 41.7% for patients receiving tofacitinib 5 mg, 48.1% for patients receiving tofacitinib 10 mg and 24.4% for placebo patients. For the 5 mg and 10 mg tofacitinib groups, mean changes from baseline in Health Assessment Questionnaire-Disability Index were –0.43 (P<.0001) and –0.46 (P<.0001), respectively, compared with –0.18 for placebo patients. Rates of Disease Activity Score 28 less than 2.6 were 6.7% (P=.0496) and 8.8% (P=.0105) for the 5 mg and 10 mg tofacitinib cohorts, respectively, compared with 1.7% for the placebo cohort.
In the first three months, 55% of patients in the tofacitinib treatment groups experienced 310 treatment-related adverse events, similar in frequency to the placebo cohort. Diarrhea (4.9%) was the most common adverse event in the tofacitinib groups, and nausea (6.8%) occurred most frequently among placebo patients.
“In this treatment-refractory patient population, in which a third of patients had previously been treated with two or more TNFi, tofacitinib 5 and 10 mg twice a day had rapid, significant and clinically meaningful improvements compared with placebo,” the researchers reported.
Disclosure: See the study for a full list of relevant disclosures.
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