LEIDEN, The Netherlands—Combination therapy of etanercept (ETN) and methotrexate (MTX) can produce remissions in many rheumatoid arthritis (RA) patients who were partial responders to long-term monotherapy with either drug, according to a new study published online in the Annals of Rheumatic Diseases.1

"This trial supports the higher therapeutic effect of combination therapy with ETN and MTX in RA patients experiencing moderate disease [compared with] monotherapy with one of the two agents," conclude the researchers led by Desiree van der Heijde, MD, PhD, professor of rheumatology at Leiden University Medical Center in The Netherlands.

"This trial supports the higher therapeutic effect of combination therapy with ETN and MTX in RA patients experiencing moderate disease [compared with] monotherapy with one of the two agents."—Desiree van der Heijde, MD, PhD.
In the new study, 227 RA patients received ETN 25 mg subcutaneously twice weekly and MTX up to 20 mg orally per week for 52 weeks. These patients had formerly completed the 3-year Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) study in which patients received MTX, ETN, or combination therapy. The responses achieved by patients with combination therapy after 3 years were sustained or improved during year 4 of treatment.

The 96 patients randomized to combination therapy had mean R disease activity scores (DAS) of 2.1 at baseline. Patients who were randomized to MTX (n = 55) or ETN (n = 76) had significantly higher DAS scores, 2.5 and 2.6 respectively at baseline, corresponding to moderate disease activity.

Patients who subsequently had ETN added to MTX showed the greatest increase in DAS remission rates from baseline to week 52 (23.6% to 41.8%, P <.01). Patients in the initial combination group (37.6% to 50.5%, P <.01) and those who had MTX added to their ETN treatment (26.7% to 37.3%, P = NS) also demonstrated improvements in DAS remission rates. The results were similar for DAS low disease activity and EULAR responses, the study showed.

Adding the second drug to existing monotherapy did not cause any significant safety problems; there were no cases of tuberculosis, opportunistic infections, systemic lupus erythematosus, multiple sclerosis or other central demyelinating disease. Moreover, serious infections occurred in <3% of patients taking combination therapy, the study showed.

Reference
1. van der Heijde D, Burmester G, Melo-Gomes J, et al. The safety and efficacy of adding etanercept to methotrexate or methotrexate to etanercept in moderately active rheumatoid arthritis patients previously treated with monotherapy. Ann Rheum Dis. 2007; doi:10.1136/ard.2007,076166 [Epub ahead of print].