medwireNews: A post-hoc analysis of the PRESERVE trial suggests that factors including age and disease activity could help identify rheumatoid arthritis (RA) patients who are likely to achieve remission with etanercept treatment, and predict whether treatment tapering is likely to be successful.
Of the 834 patients with moderately active RA who were given induction treatment with etanercept 50 mg once weekly plus methotrexate for 36 weeks, those who were aged 40 years or younger were significantly more likely than older patients to achieve remission, defined as a Disease Activity Score at 28 joints (DAS28) lower than 2.6 points, with a hazard ratio (HR) of 0.59.
Furthermore, patients with baseline DAS28 scores of 4.1 points or lower were significantly more likely to achieve DAS28 remission than patients with scores above 4.7 points (HR=0.34), and those with Health Assessment Questionnaire (HAQ) scores of 0.5 points or lower had a significantly higher likelihood of achieving remission than those with HAQ scores of greater than 1.5 points (HR=0.39).
Similarly, patient age, HAQ score, and disease activity at baseline were significant predictors of remission at 36 weeks according to Simplified Disease Activity Index (SDAI; ≤3.3 points) or Clinical Disease Activity Index (CDAI; ≤2.8 points) scores.
After week 36, all patients who achieved low disease activity (DAS28 ≤3.2 points) were randomly assigned to continue with their treatment regimen, to receive etanercept at a lower dose of 25 mg once weekly plus methotrexate, or to receive placebo alongside methotrexate, for a further 52 weeks in the double-blind phase of the study.
Previous findings from the trial demonstrated that “[t]he conventional full-dose or reduced-dose etanercept-methotrexate combination regimens were […] more effective in maintaining [low disease activity] than methotrexate alone after etanercept withdrawal,” explain Josef Smolen (Medical University of Vienna, Austria) and study co-authors in Arthritis Research & Therapy.
In the post-hoc analysis, patients in all groups who did not achieve sustained remission (DAS28 ≤2.6 points at weeks 12, 20, 28, and 36) during induction treatment were significantly more likely than those who did to experience loss of remission during the double-blind period of the study, with hazard ratios of 1.85–2.59 after adjustment for baseline disease activity.
Higher disease activity at baseline and 1 month, and an increase in disease activity and patient-reported outcomes from baseline to the 1-month follow-up, were also significantly associated with loss of DAS28 remission.
Patients “who achieve an early, strong, and durable response to induction therapy are most likely to experience a sustained response after biologic tapering or withdrawal,” summarize Smolen and team.
Taken together, the findings of the post-hoc analysis suggest that “targeting sustained and stringently defined clinical remission in patients receiving full-dose combination etanercept-plus-methotrexate therapy before considering dose or regimen changes may help improve the likelihood that patients will remain in clinical remission 1 year after the changes are made,” they conclude in Arthritis Research & Therapy.
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