Conventional DMARD Regimen Comparable to Biologic, but Patient’s Response Faster with the Biologic Regimen

VBCR - August 2013, Volume 2, No 4 - EULAR Annual Meeting

By Phoebe Starr

Madrid, Spain—A 3-drug regimen of methotrexate, sulfasalazine, and hydroxychloroquine was as effective as a combination of etanercept (Enbrel) and methotrexate, and was $10,200 cheaper annually for patients with active rheumatoid arthritis (RA) who failed to respond to methotrexate, according to a study presented at the European League Against Rheumatism and published online concurrently (O’Dell JR, et al. N Engl J Med. 2013;369:307-318).

But not so fast, say experts. This was a noninferiority, not a superiority, study, and patients feel dramatically better more rapidly with the biologic plus methotrexate than with the 3-agent conventional disease-modifying antirheumatic drug (DMARD) regimen, said Philip J. Mease, MD, Rheumatologist, Swedish Hospital, Seattle, WA, who was not involved in the study.

The horse may already be out of the barn, according to an editorial in the same issue (Bathon JM, McMahon DJ. N Engl J Med. 2013;369:384-385). “We have to consider, however, whether these findings have arrived too late to influence modern practice, in which arguably a TNF inhibitor is the preferred next step when methotrexate alone is inadequate,” Bathon and McMahon wrote. They also noted that it will be interesting to see if third-party payers will change their reimbursement policy to require failure of triple-drug therapy before okaying a biologic.

“Our findings suggest that a strategy of first administering triple therapy, with a switch to etanercept-methotrexate in patients who do not have an adequate response to triple therapy, will allow a substantial percentage of patients to be treated in a more cost-effective way without adversely affecting the clinical outcomes,” stated lead investigator James R. O’Dell, MD, Chief, Rheumatology, VA Nebraska-Western Iowa Health Care System, Omaha Medical Center.

The study randomized 353 patients with active RA despite methotrexate therapy to receive the triple regimen (ie, sulfasalazine, hydroxychloroquine, and methotrexate) versus etanercept plus methotrexate. Nonresponders were switched to the other arm for the next 24 weeks (total of 48 weeks).
Both groups had comparable characteristics at baseline. The mean 28-joint Disease Activity Score (DAS28) was 5.8 and mean disease duration was 5.2 years. Patients had an adequate trial on methotrexate before randomization.

During the first 24 weeks, both groups had comparable and significant improvement from baseline (P <.001), according to the DAS28. Among the 27% of patients in each group with an inadequate response who switched therapy at 24 weeks, both groups of former nonresponders achieved similar and significant improvement on the DAS28 at 48 weeks.

At 48 weeks, the change in disease activity on the DAS28 was –2.1 for triple therapy and –2.3 for etanercept plus methotrexate. Radiographic progression was not significantly different between the 2 groups at 48 weeks, but trended slightly toward etanercept/methotrexate at 24 weeks.
No difference was observed between the groups’ function, pain, and quality of life, and major treatment-related adverse events.

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Last modified: May 21, 2015
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