The following is a summary of “Effects of Disease-Worsening Following Withdrawal of Etanercept or Methotrexate on Patient-Reported Outcomes in Patients With Rheumatoid Arthritis,” published in the January 2023 issue of Clinical rheumatology by Curtis, et al.
For patients in long-term remission from rheumatoid arthritis (RA), the impact of stopping medication on PROs is not well understood. The purpose of this study was to examine the correlation between patient-reported outcome (PRO) changes and the introduction or discontinuation of RA treatment. Patients with RA on methotrexate plus etanercept who were in remission (Simple Disease Activity Index ≤3.3) participated in SEAM-RA (Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Rheumatoid Arthritis), a phase 3, multicenter, randomized withdrawal, double-blind controlled study.
After stopping methotrexate or etanercept, patients were assessed using the Global Assessment of Improvement in Health (GAIH), Patient’s Assessment of Change in Health, Health Assessment Questionnaire-Disability Index (HAQ-DI), and 36-Item Short-Form Health Survey (SF-36) for 48 weeks. The 2-sample t test was used to compare the treatment outcomes of patients with and without disease progression for continuous endpoints, whereas the log-rank test was used to compare the outcomes of patients with and without disease progression across time. From the original group of 253 patients, 121 saw a worsening of their condition, while the remaining 132 did not. All patient-reported outcomes (PRO) scores were similar to those of the general population at baseline and worsened over the course of the trial. When comparing etanercept monotherapy to methotrexate monotherapy, the PtGA and Patient’s Assessment of Joint Pain values worsened less in the etanercept group.
The minimal clinically important difference (MCID) for all evaluated PROs was exceeded more frequently in participants with illness worsening compared to those without worsening. Patients experiencing worsening disease also had worsening PtGA more so than MCID, which preceded worsening Simple Disease Activity Index disease. Superiority in preserving PRO scores was shown with etanercept monotherapy compared to methotrexate. Patients with the worsening disease had a more rapid increase in PtGA above the MCID compared to patients without worsening disease.