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Etanercept TEMPO Trial Shows Significant Remission Scores for Combination Rheumatoid Arthritis Therapy: Presented at ACR

By Bruce Sylvester

ORLANDO, FL -- October 28, 2003 -- Radiographic evidence indicates that etanercept monotherapy slows joint damage in rheumatoid arthritis more than methotrexate monotherapy and that concurrent combination therapy with etanercept and methotrexate achieves significantly better efficacy results at 52 weeks when compared with either drug used alone, researchers reported here on October 25^th at the Annual Meeting of the American College of Rheumatology (ACR).

"A large proportion of the combination therapy subjects achieved clinical remission, and we saw, for the first time, evidence of negative RA [rheumatoid arthritis] progression scores," said Désirée van der Heijde, MD, lead investigator of the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO). Dr. van der Heijde is also a professor of rheumatology, University of Maastricht, Maastricht, The Netherlands.

Investigators enrolled 686 subjects in the double blind, parallel-group global TEMPO study, of which 642 were included in this radiographic analysis. The subjects were randomised to etanercept 25 mg/day, methotrexate up to 20 mg/day or etanercept with methotrexate.

Primary radiographic end point was change from baseline in van der Heijde-modified total Sharp Score (TSS) at 52 weeks. Secondary radiographic endpoints were changes in total erosions, changes in total joint space narrowing, number of eroded joints, non-progression (TSS change <=0.5 and <=3.0) and progression greater than smallest detectable difference (SDD). Two observers blinded for the sequence of the films, treatment mode and patient identity scored each X-ray. The investigators used the average of observer scores for their analysis.

At week 52, TSS had improved to a significantly greater extent in patients taking combination therapy or etanercept alone, compared with those taking methotrexate alone.

"Patients treated with the combination had less progression than patients treated with either monotherapy alone," the researchers reported. "Therapy with the combination resulted in statistically significant lowering of TSS compared with baseline with the entire 95% confidence interval below zero. Statistically significant differences between the groups were already present after 24 weeks of follow-up. Various sensitivity analyses, including a mixed model approach were performed and confirmed the results of the primary analysis."

Dr. van der Heijde said that 37% of subjects treated with etanercept plus methotrexate achieved clinical remission of their disease at one year, as measured by Disease Activity Score (DAS) criteria. Eighty percent of combination subjects showed no progression of joint damage, and 51% of the same subjects reported significant improvement in functionality at week 52. "The results of this study reinforce the need for aggressive treatment of RA and help us understand the value of combination therapy," she said.


[Study title: Radiographic Outcomes Of A Double-blind Study Of Etanercept And Methotrexate, Alone And Combined, In Patients With Active Rheumatoid Arthritis (the Tempo Trial. Abstract 206]

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