In patients with active rheumatoid arthritis (RA) initiating treatment with certolizumab pegol (CZP), Clinical Disease Activity Index (CDAI) nonresponse at 3 months was the strongest predictor of failure to achieve low disease activity (LDA) at month 12, according to a study published in RMD Open.
Although RA treatment guidelines recommend a treat-to-target strategy and switching treatment following an inadequate response, a lack of early clinical markers of nonresponse vs response exists that can be used to guide treatment adaptations in clinical practice. This protocol-specified analysis of interim data from the 3-year, longitudinal, prospective, observational, multicenter study, ÉCLAIR, was conducted to identify potential clinical criteria for predicting late treatment failure in patients in France with active RA initiating CZP treatment. Measures included CDAI, Health Assessment Questionnaire Disability Index (HAQ-DI), and Disease Activity Score-28 with erythrocyte sedimentation rate (DAS28[ESR]). Early nonresponse to CZP was measured at month 3, and failure to achieve LDA was measured at month 12.
Of the 792 participants enrolled, 730 (92.2%) were analyzed, and 3-month follow-up data were available for 574. At month 3, the number of participants available for predictability analyses was 532 for CDAI, 434 for DAS28(ESR), and 496 for HAQ-DI. Month-12 follow-up data for all measures were available for 341 participants.
The proportion of participants classified as nonresponders at 3 months varied according to the index considered, ranging from 46.8% for the HAQ-DI to 16.7% for the CDAI.
At month 12, the proportions of participants not achieving LDA were 53.4% for CDAI, 54.8% for DAS28(ESR), and 66.3% for HAQ-DI. Of the 3 indexes, the highest predictor of nonresponse (PoNR) value was seen for CDAI, which had a PoNR of 88.8% (95% CI, 81.0-94.1) and a 96.0% specificity, indicating that less than 5% of month-12 CDAI responders had not responded at month 3. Performance was similar between participants with high baseline disease activity and those with low or moderate disease activity, as well as between those who had and had not been previously treated with biologic disease-modifying antirheumatic drugs (bDMARDs).
The study demonstrated that for patients with RA, high CDAI scores at month 3 of CZP treatment are a predictor of treatment failure at month 12. “In addition, we observed high level of predictability with CDAI regardless of disease severity at baseline or treatment history, although this observation should be considered with caution in light of the low patient numbers in these subgroups. DAS28(ESR) also demonstrated good predictability, but only in patients with high disease activity at baseline and/or those previously treated with a bDMARD.”
Disclosure: This clinical trial was supported by UCB Pharma. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Saraux A, Flipo RM, Fagnani F, et al. Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study. RMD Open. 2020;6(1):e000991.