Etanercept in combination with sulphasalazine (SSZ), hydroxychloroquine (HCQ), or intramuscular gold is an effective and well-tolerated treatment for rheumatoid arthritis (RA), according to a new study in the February issue of the Journal of Rheumatology.1 While numerous studies have shown that etanercept is safe and effective when used with methotrexate (MTX), there are no published studies on the safety and efficacy of etanercept with other disease-modifying antirheumatic drugs (DMARDs). Since many patients are treated with DMARDs other than MTX or have an adverse reaction to MTX, this study was undertaken at the request of the US Food and Drug Administration (FDA).

In the prospective open-label study of 119 patients with RA who had active disease despite ongoing therapy with SSZ, HCQ, or intramuscular gold, adding etanercept resulted in significant improvement at both 24 and 48 weeks. Primary efficacy endpoints in the study were American College of Rheumatology (ACR) responses at 24 and 48 weeks.

There was a 9% discontinuation rate for adverse events at 48 weeks. In the HCQ plus etanercept group, adverse events consisted of septic wrist and bilateral pneumonia, rash, optic neuritis, breast cancer, and squamous cancer of the tongue. In the SSZ group plus etanercept group, otitis media, elevated liver function indicators, pericarditis, rash, and gastroenteritis were reported. In the group treated with gold and etanercept, one patient had proteinuria. The most common adverse events not requiring discontinuation from the study were injection site reactions, which occurred in 43% of patients, and upper respiratory type infections, which occurred in 34% of patients.

"The patients did predictably better when we added etanercept," lead researcher James R. O'Dell, MD, chief of rheumatology at the University of Nebraska Medical Center in Omaha, Nebraska, tells CIAOMed. "We were unable to show any concern for toxicity with those drugs. Etanercept can be given safely in conjunction with SSZ, HCQ, and gold." Since the study was not blinded, however, the authors could not draw any definitive conclusions about the efficacy of adding etanercept, "but patients clearly improved in terms of joint count and sedimentation rate," says Dr. O'Dell.

Reference

  1. O'Dell JR, Petersen K, Leff R, et al. Etanercept in combination with sulfasalazine, hydroxychloroquine or gold in the treatment of rheumatoid arthritis. J Rheumatol. 2006;33:213-218.