medwireNews: Results of a randomized trial suggest that methotrexate can be tapered in patients with rheumatoid arthritis (RA) receiving tocilizumab treatment without compromising disease control.
Methotrexate “presents an unacceptable burden” of adverse events (AEs) for some patients, say Christopher Edwards (University Hospital Southampton, UK) and study co-authors.
Although using biologic treatments alongside DMARDs “has gone some way to improving tolerability,” having “the flexibility to reduce or withdraw [methotrexate] altogether without losing tocilizumab efficacy is highly desirable,” they add.
As reported in Rheumatology, patients with severe active RA were treated with tocilizumab 8 mg/kg and methotrexate for 24 weeks, at which time participants who achieved a good or moderate EULAR response were randomly assigned to either undergo methotrexate tapering every 8 weeks until complete withdrawal at week 48, or to continue stable treatment with methotrexate. Patients in both groups received tocilizumab at a stable dose throughout the study.
In all, 76.5% of 136 patients in the tapering group maintained a good or moderate EULAR response from week 24 to week 60, compared with 65.4% of 136 patients who received a stable dose of methotrexate, a significant difference.
These findings translated into an odds ratio (OR) of 1.8 in favor of tapering methotrexate, and the lower limit of the 95% confidence interval was within the prespecified noninferiority margin, explain Edwards and colleagues.
They note that noninferiority of the tapering regime was demonstrated despite low recruitment and a “higher than expected” dropout rate, meaning that the study was terminated early.
Approximately three-quarters (72.1%) of patients in both treatment groups reported AEs in the randomized part of the study. The most commonly occurring AEs were nasopharyngitis, diarrhea, mouth ulceration, respiratory tract infection, headache, cough, oropharyngeal pain, and arthralgia. Most AEs were mild or moderate in severity, and no unexpected AEs occurred.
“Our findings suggest that after achieving a good/moderate EULAR response, tapering the [methotrexate] dose when in combination with tocilizumab is an appropriate strategy that is not likely to lead to loss of efficacy,” write Edwards and colleagues.
And they conclude: “While this is particularly attractive for patients experiencing AEs related to [methotrexate], it may be appropriate for all patients.”
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