Tofacitinib is a safe and effective combination therapy for patients with active rheumatoid arthritis who do not achieve adequate responses with methotrexate, according to new study results.
The article, published in a recent Arthritis & Rheumatology issue, reveals adding a daily regimen of tofacitinib can help patients control their rheumatoid arthritis and limit structural damage.
“Our findings indicate that clinical and radiography treatment effects are sustained in months 12 to 24 in patients with rheumatoid arthritis receiving tofacitinib 5 mg or 10 mg twice daily plus methotrexate,” said study author Carol Connell, Ph.D., Pfizer’s senior director of clinical research. “The safety profile is consistent with that of other tofacitinib studies.”
This study is the first phase III trail, researchers said, to analyze the patient response, including structural damage progression, safety, and efficacy of tofacitinib-methotrexate combination therapy in individuals who don’t respond well to methotrexate monotherapy.
To determine the efficacy and safety of tofacitinib in this patient group, researchers randomized 539 patients to receive tofacitinib 5 mg twice daily, 10 mg twice daily, a placebo switched to 5 mg twice daily, or a placebo switched to 10 mg twice daily. Investigators used the American College of Rheumatology criteria to determine condition improvement and assessed disease activity in 28 joints.
According to findings, responses were similar between all patients receiving 5 mg and 10 mg tofacitinib therapy. These patients maintained condition improvement and uninterrupted low disease activity or remission during the 12-to-24 month observation period. Additionally, based on radiographs, these tofacitinib patients, including those who switched from placebo, also saw no new erosions and experienced minimal progression of structural damage.
While adverse events were common during the study timeframe, affecting approximately 87 percent of tofacitinib patients, the problems were mild-to-moderate, researchers said. Runny nose, upper respiratory infection, headache, urinary tract infections, bronchitis, and shingles occurred most frequently.
Overall, investigators said, the study results were similar to existing data that examines tofacitinib use over 12 months, demonstrating tofacitinib’s safety and tolerability profile through 24 months.
Van der Heijde D, Strand V, Tanaka Y, Keystone E, Kramer J, Zerbini C, Cardinal M, Cohen S, Nash P, Song, YW, Tegzova D, Gruben D, Wallenstein G, Connell C, Fleischmann R, Tofacitinib in Combination With Methotrexate in Patients With Rheumatoid Arthritis: Clinical Efficacy, Radiographic and Safety Outcomes From a Twenty-Four-Month, Phase III Study. Arthritis & Rheumatology (2019), doi: 10.1002/art.40803