Success of etanercept withdrawal linked to pre-withdrawal remission status
medwireNews: The likelihood of maintaining remission following etanercept withdrawal is highest among rheumatoid arthritis (RA) patients with the greatest degree of remission prior to the start of withdrawal and decreases with decreasing remission status, research shows.
The findings were based on an analysis of data from three etanercept down-titration studies – PRESERVE, PRIZE, and Treat-to-Target (T2T) – and showed the same trends in each despite different patient populations and regardless of whether remission was measured using DAS28-ESR (except in PRIZE), ACR/EULAR Boolean, or CDAI criteria.
In PRESERVE, 81% of 133 patients with DAS28 sustained deep remission (DAS28≤1.98 at weeks 28 and 36) maintained remission at week 88 following etanercept dose reduction at week 36.
The corresponding proportions were 67% among the 136 patients in deep remission (DAS28≤1.98 at week 36), 58% among the 96 in sustained remission (DAS28>1.98 and <2.6 at weeks 28 and 36), 56% among the 116 in remission (DAS28>1.98 and <2.6 at week 36), and 36% in the 113 patients with low disease activity (LDA; DAS28 ≥2.6 to <3.2 at week 36), with statistically significant differences between the groups.
A similar significant trend was observed when etanercept was discontinued, with 61%, 30%, 29%, 21%, and 5%, respectively, maintaining remission at week 88.
Furthermore, patients who achieved sustained remission at weeks 28 and 36 based on the ACR/EULAR Boolean criteria (tender joint count [TJC] ≤1, swollen joint count [SJC] ≤1, C-reactive protein ≤1 mg/dL, and patient global assessment ≤1 at weeks 28 and 36) and then discontinued etanercept were significantly more likely to maintain remission than those who achieved remission or did not achieve remission, at 29% versus 16% and 3%, respectively.
Using the CDAI criteria, remission maintenance rates were 30%, 12%, 9%, and 0% for patients who achieved sustained remission (CDAI 0.0–2.8 at weeks 28 and 36), remission (CDAI 0.0–2.8 at week 36) , LDA (CDAI >2.8–10.0), or moderate disease activity (CDAI >10.0–22.0), respectively.
In addition, the researchers observed significant differences in the proportion of patients who maintained remission according to the different remission categories across all measurement criteria in the T2T study and with the ACR/EULAR Boolean and CDAI, but not DAS28 criteria in the PRIZE study, even though the sample sizes were much smaller.
Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu, Japan) and co-investigators also found that across the three studies, sustained deep remission, normal erythrocyte sedimentation rate, and swollen and tender joint counts of zero immediately prior to etanercept withdrawal were significant predictors of sustained remission post-withdrawal.
They comment in Arthritis Research & Therapy that their findings “add to the published evidence that some patients can successfully decrease the dose or discontinue [biologic] DMARD therapy,” but caution that the data may not be applicable to patients with mild or low RA disease activity or those treated with interleukin-6 or Janus kinase inhibitors.
The authors conclude: “These results suggest that patients achieving disease control according to a stringent definition, such as sustained ACR/EULAR Boolean or CDAI remission, or a new definition of sustained deep remission by DAS28, have a higher probability of remaining in remission or LDA following etanercept dose reduction or withdrawal.”
By Laura Cowen
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