Half of patients with early rheumatoid arthritis treated with a combination of etanercept and methotrexate achieved disease remission within 1 year in the first major trial to use remission as the primary end point, Dr. Paul Emery reported in a late-breaking abstract session at the annual meeting of the American College of Rheumatology.
“We have been talking about remission for a long time,” said Dr. Emery, who wrote a viewpoint piece more than a decade ago entitled “Early rheumatoid arthritis: Time to aim for remission?” (Ann. Rheum. Dis. 1995;54:944–7).
“I think we now can say this is a realistic goal,” said Dr. Emery, professor of rheumatology at the University of Leeds (England).
The trial, known as COMET (Combination of Methotrexate and Etanercept in Active Early Rheumatoid Arthritis), compared the clinical efficacy and safety of etanercept plus methotrexate with methotrexate alone in a randomized, double-blind study that included 542 adult patients from 22 countries.
Trial participants had active disease as determined by a Disease Activity Score-28 (DAS28) of 3.2 or greater, and elevations either of erythrocyte sedimentation rate (ESR) to 28 mm/hr or higher or of C-reactive protein to 20 mg/L or more.
All patients were methotrexate naive and had a disease duration of 2 years or less.
Baseline demographics and disease characteristics were similar in the etanercept plus methotrexate and methotrexate-alone groups.
Mean age was 51 years, and median disease duration was 7 months in both groups. Mean baseline DAS28 was 6.5, so the DAS28 was high despite the short disease duration, according to Dr. Emery.
About half had received corticosteroids, and 22% had previously been treated with a disease-modifying antirheumatic drug other than methotrexate.
The primary end point of remission (which was defined as a DAS28 less than 2.6) was achieved by 50% of patients on combination therapy by week 52, compared with 28% of patients receiving methotrexate alone. This represented a statistically significant difference, and “a considerable achievement,” Dr. Emery said.
Low disease activity (defined as a DAS28 of 3.2 or less) was achieved by week 52 in 64% of the patients in the combination group and and 41% of the patients in the methotrexate group, which also was a statistically significant difference.
Moreover, it was “quite remarkable” how quickly remission was achieved, with significant differences being seen at 2 weeks, he said. By weeks 16–20, 40% of patients in the combination group were in remission, he said. “This is a new standard of speed for achieving remission,” Dr. Emory noted.
Responses on the American College of Rheumatology (ACR) scales were evaluated as secondary end points. “It's traditional with most biologics to expect ACR 20, 50, and 70 responses of 60%, 40%, and 20%, but with the combination we saw response rates of 86%, 71%, and 48%, which are very high rates indeed,” Dr. Emery said during his presentation.
These levels of ACR response were seen in 67%, 49%, and 28% of the methotrexate group, respectively.
Levels of C-reactive protein improved dramatically by week 2 and stabilized by week 16. By week 52, 55% of patients had normal Health Assessment Questionnaire (HAQ) scores, meaning that they had normal functional status. There also was a two-thirds reduction in workdays lost, which is important from a cost point of view, Dr. Emery said.
Serious adverse events were reported by 12% of patients in the combination group and by 13% of patients in the methotrexate group, he said.
interesting post. appearse much better outlook nowadays..
shame these meds are not openly available to all who need them
Boney
This is exactly what my RD says and why he wants me to start the biologics. Thing is I'm in remission with MTX and prednisone. Of course once I'm completely off the prednisone....Boney you are right that it's too bad these meds are not readily available to all who need them. Hopefully/maybe that will happen . I do feel so blessed that I am receiving good care and have access to what my doctor is prescribing through good insurance. We really need to advocate for those who aren't getting what they need.
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