Tocilizumab was safe and effective for RA patients in comparison to tocilizumab plus DMARD therapy.
Tocilizumab was safe and effective as monotherapy or in combination with disease-modifying anti-rheumatic drugs (DMARDs) in a population of rheumatoid arthritis (RA) patients, according to research published in Clinical Rheumatology.
Researchers from the Hospital for Special Surgery in New York studied 1,681 total participants in order to compare the safety and efficacy of tocilizumab monotherapy with tocilizumab in combination with DMARDs over a 24 week period. The participants had established RA for a median duration of 9.6 years, with high disease activity, and were highly treatment experienced. There were 239 RA patients who received tocilizumab monotherapy (8 mg/ kg intravenously every 4 weeks) and the remaining 1,442 patients received combination therapy (with an additional methotrexate/ other DMARD). Methotrexate was used as the DMARD in combination therapy for 79 percent of the combination therapy group.
Patients achieved American College of Rheumatology (ACR) 20/ 50/ 70/ 90 responses by week 24 at rates of 66.9 percent, 46.6 percent, 26.4 percent, and 8.7 percent, respectively. These results were similar in both treatment groups, the researchers noted. ACR 20/ 50/ 70/ 90 responses were seen as early as week 4 and improved through week 24.
No differences were found among treatment groups for patients with good or moderate responses, patients who were in remission, and patients with low disease activity. Also similar between the treatment groups were decreases in joint counts from baseline to week 24. By the end of the study, decreases in Health Assessment Questionnaire Disability Index (HAQ DI) were comparable between the groups but a higher percentage of combination therapy patients (73.4 percent) than monotherapy patients (68.4 percent) achieved what the researchers termed “clinically meaningful improvement in HAQ DI.”
“Tocilizumab had a comparable safety profile and was similarly effective when used as monotherapy or as combination therapy with DMARDs in a broader population of patients,” the researchers concluded, while noting a larger study would be necessary to duplicate these results across serious infections. “These data further support that tocilizumab monotherapy is a feasible treatment alternative for patients for whom combination therapy with methotrexate is not an option.”
The frequency of adverse events, serious adverse events, and adverse events which lead to withdrawal were similar among patients in the tocilizumab monotherapy group (82.4 percent, 7.9 percent, and 5.4 percent, respectively). In the combination therapy group, these adverse events occurred 76.6 percent, 7.8 percent, and 5.1 percent, respectively.
The researchers also noted that the effectiveness overlap between the tocilizumab monotherapy and DMARD combination therapy groups is common for this type of double blind study. But, they advised, a larger study would make for a more appropriate comparison.