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Rituximab treatment effective at 6 years for RA patients
Rituximab treatment during the course of multiple years was effective and tolerable as routine care for patients with rheumatoid arthritis, according to recent study results.
Researchers in Germany conducted a multicenter, prospective, noninterventional study of 2,484 patients with rheumatoid arthritis (RA; mean age, 56.4 years; 76.7% women) with a mean disease duration of 11.7 years who received rituximab (RTX) therapy. A subgroup of 564 patients received RTX as monotherapy. Disease Activity Score 28 (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI) were used to evaluate efficacy of treatment.
Data were studied for approximately 6 years, with a median follow-up of 14.7 years.
“RTX treatment led to improvements in DAS28 and HAQ-DI that were sustained over multiple courses,” the researchers reported.
Higher rheumatoid factor levels up to 50 IU/mL correlated positively with DAS28 improvements.
A majority of patients and physicians rated response and tolerability as good or very good. For the first 400 enrolled patients and the last 400 enrolled patients, mean treatment intervals were 10.5 months and 6.8 months, respectively. The most frequently reported adverse events were infections (9.1%; 11.39/100 patient-years), with approximately 1% of patients stopping therapy because of AEs.
“The results … indicate that RTX is efficacious and well tolerated in routine care in Germany, including in older patients, with improved efficacy results in RF-positive patients,” the researchers concluded. “In addition, the results demonstrate that RTX monotherapy and in combination with [leflunomide] may represent an alternative for some patients intolerant to [methotrexate].
“This study also provides evidence that changes in the use of RTX to treat RA have occurred in recent years, thus indicating that physicians have adopted this therapy and have developed how it is used in routine care.”
Disclosure: See the study for a full list of relevant disclosures.