Triple DMARD therapy equally effective as MTX/etanercept in treating RA patients
A triple therapy of sulfasalazine, hydroxychloroquine and methotrexate was noninferior to etanercept plus methotrexate for patients with rheumatoid arthritis who lacked response to methotrexate alone, according to recent study results.
Researchers conducted a 48-week, randomized, double blind study of 353 patients with rheumatoid arthritis (RA) who had active disease despite receiving methotrexate (MTX). One hundred seventy-eight patients (mean age, 57.8 years; 56.7% men) received triple therapy of disease-modifying antirheumatic drugs (DMARDs; MTX, sulfasalazine and hydroxychloroquine), while 175 patients (mean age, 56 years; 51.4% men) received etanercept plus MTX. At 24 weeks, patients who did not improve based on a prespecified threshold were switched blindly to the other therapy. Disease Activity Score 28 (DAS28) improvement was the primary outcome at week 48.
During the first 24 weeks, both groups had significant DAS28 improvement when compared with baseline (P=.001). At 24 weeks, 27% of patients in each group required a switch to the other therapy, with patients in both groups showing improvement after the switch (P<.001). The difference in response between groups after switching treatments was not significant (P=.08).
DAS28 improvements from baseline to 48 weeks between triple therapy and etanercept/MTX cohorts were similar (–2.1 vs. –2.3; P=.26). Researchers wrote that triple therapy was noninferior to etanercept/MTX, since the upper confidence limit of 0.41 for the difference in DAS28 change was below the 0.6 margin for noninferiority (P=.002).
Radiographic progression, pain and health-related quality of life, as well as major adverse events associated with the drugs, were not significantly different between cohorts.
“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,” the researchers concluded.
Disclosure: See the study for a full list of relevant disclosures.