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Study: Triple conventional therapy was more durable than MTX-etanercept for RA
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For patients with rheumatoid arthritis and a suboptimal response to methotrexate, triple conventional therapy — consisting of methotrexate, sulfasalazine and hydroxychloroquine — was more durable than combination therapy with methotrexate and etanercept, according to recently published data.
“Demonstrating that triple therapy is more durable than methotrexate-etanercept, while providing similar disease control, contributes additional evidence to support the use of conventional [disease-modifying antirheumatic drugs] DMARDs, rather than biologics, if methotrexate monotherapy has failed,” Shana M. Peper, MD, in the Department of Internal Medicine at Nebraska Medical Center, told Healio Rheumatology.
They assessed 353 patients with rheumatoid arthritis (RA) and a suboptimal response to methotrexate who were randomized to receive either the triple therapy or combination therapy of methotrexate and etanercept for 48 weeks in a non-inferiority trial. Patients who had no clinical improvement after 24 weeks were given the alternative treatment. Mean follow-up was 11 months.
Researchers found the rates of continued conventional therapy at year 1 were 78% for triple therapy and 63% for combination therapy. A greater number of patients switched from etanercept to triple therapy vs. those who switched from triple therapy to the comparison treatment. DAS28 was similar for each group and stable at follow-up.
“In the age of soaring healthcare costs and an increasing emphasis on cost-conscious care, the use of combination conventional DMARDs prior to biologic therapy has the potential to offer significant positive economic consequences for patients and the healthcare industry,” Peper said. – by Will Offit
Disclosures: Peper reports no relevant financial disclosures. Please see the full study for a list of all other relevant financial disclosures.
Perspective
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John R.P. Tesser, MD
This is the extension of the original 48-week RACAT study, the results of which demonstrated the efficacy of triple therapy was statistically within the non-inferiority margin as etanercept plus methotrexate (ET/MTX). Interestingly, switching at 24 weeks for inefficacy from one arm to the other was about equally effective. This new analysis is an extension of up to an additional 72 weeks, but the mean duration of follow-up was only 11 months. More patients remained on triple therapy than ET/MTX. The authors posit that triple therapy is a viable equally effective, a more durable and certainly a more cost-effective first step prior to biologic therapy. Several observations arise regarding the results.
1 – Most of the ET/MTX switchers did so immediately at the start of the follow-up phase. Why?
2 – When the early switchers are removed from the analysis, there is no difference in the durability of the two groups. The authors readily state they did not collect the reasons for the discontinuations from either group.
3 – The authors point out that statistically more patients in the VA and Canada sites switched than the RAIN sites. They offer a possible explanation of better insurance access in the private sector vs. the public clinics and the lower cost of triple therapy. How much does this affect the significance of the difference in durability of the two treatment arms?
4 – In the context of significant non-adherence to medications overall, is the reason these patients were so compliant to effect clinical improvement due to clinical study conditions? How do these results relate to real-world experience?
5 – Is everyone okay that, overall, these patients remained in low moderate DAS28 range with about 4 active joints regardless of which therapy they are on? This is in the context of the authors stating: Since clinicians were free to make changes if warranted, we assume adequate clinical control of disease activity if no changes were made to the treatment regimen.
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