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Similar efficacy seen between tocilizumab as monotherapy vs combination therapy
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The efficacy of tocilizumab as a monotherapy was similar to its efficacy as a combination therapy with conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis, according to recently published findings.
“Almost similar efficacy can be expected between tocilizumab monotherapy and combination therapy with methotrexate within patient[s] with active rheumatoid arthritis unable to tolerate conventional [disease-modifying antirheumatic drugs] DMARDs,” Xavier M. Teitsma, epidemiologist in the Department of Rheumatology and Clinical Immunology at University Medical Center Utrecht, told Healio Rheumatology. “Although patients achieve DAS28 remission slightly more often with tocilizumab combination therapy, this is at the cost of an increased risk for serious adverse events.”
Patients with rheumatoid arthritis who failed treatment with conventional synthetic DMARDs (csDMARDs) can receive tocilizumab (Actemra, Genentech) as a second-line therapy, the researchers wrote. Previous studies have shown tocilizumab is effective as a monotherapy for these patients, but have not shown whether it as effective as a combination therapy with other csDMARDs.
To determine this, the researchers performed a systematic review and meta-analysis of 13 randomized, clinical trials that involved 6,679 patients. The researchers collected information on DAS28, ACR20, ACR50, ACR70 and adverse events. They used a random-effect model to pool the relative risks and confidence intervals. They also used a sensitivity analysis to evaluate the differences in study duration.
They found a slightly greater proportion of patients who achieved DAS28 (relative risk = 1.21) and ACR50 (relative risk = 1.14) underwent combination therapy. However, the risk of serious adverse events was higher in patients who underwent combination therapy (relative risk = 1.40). According to the researchers, the data demonstrated the statistical superiority of switching to either tocilizumab strategy vs. continuing with csDMARDs alone.
The researchers concluded that a similar efficacy can be expected in each strategy. However, combination therapy comes at an increased risk for adverse events.
“[I]n the management of active RA, switching to TCZ [monotherapy] is a good option for patients who cannot tolerate csDMARDs, whereas similar efficacy can be expected compared to TCZ [combined] therapy,” the researchers wrote. – by Will Offit
Disclosure: The researchers reported no relevant financial disclosures.
Perspective
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Calvin R. Brown Jr., MD
During the past 25 years, methotrexate (MTX) has become the standard of care as the mainstay conventional synthetic disease-modifying antirheumatic drug (DMARD) in the treatment of adult rheumatoid arthritis (RA), but methotrexate alone is not enough to achieve low disease activity in most patients. The addition of biologics and newer targeted synthetic DMARDs to methotrexate therapy have certainly helped to reach the desired target, but about 30% of patients receiving these new therapies end up on them alone as a monotherapy, whether intended or not. Therefore, clinical data on the effectiveness of a biologic as a monotherapy is important both for patients who decline or have a contraindication to methotrexate, as well as those who discontinue it.
Therefore, this meta-analysis of efficacy and safety reported in randomized controlled trials of tocilizumab as monotherapy or combination therapy for treating active RA is important. It establishes that in the management of active RA, almost similar efficacy can be expected in patients unable to tolerate methotrexate and other conventional synthetic DMARDs who switch to tocilizumab monotherapy compared to inadequate responders switching to add-on tocilizumab. This can inform treatment decision in the significant number of RA patients not on methotrexate or other conventional DMARDs.
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