Background/Purpose: Biologic (b) and targeted synthetic (ts) DMARDs have demonstrated efficacy for the treatment of rheumatoid arthritis (RA) in clinical trials; however, real-world evidence on the effectiveness of bDMARDs/tsDMARDs has demonstrated a high unmet need reaching remission or LDA, even for the non-stringent DAS28 definitions. This systematic literature review (SLR) and meta-analysis was conducted to quantify real-world DAS28 clinical response rates, due to its high frequency of DAS28 reporting in the past literature, among patients with moderate to severe RA after 6 months of their first bDMARD/tsDMARD treatment.

Methods: An SLR was conducted using the MEDLINE and EMBASE databases and ACR (2015–2017) and EULAR (2015–2018) congress databases. The SLR included single- and multi-arm real-world observational studies that reported DAS28 remission outcomes (DAS28 < 2.6) at 6 months after bDMARD/tsDMARD treatment initiation in biologic-naïve adults with RA (N ≥50 per treatment arm). A traditional random-effects meta-analysis was conducted to estimate the DAS28 remission rates overall. Heterogeneity of studies for each treatment was assessed using the Cochran’s Q statistic and I² statistic. In addition to DAS28 remission, DAS28 LDA rates, SDAI and CDAI remission rates were summarized descriptively.

Results: A total of 20 studies reported 6-month DAS28 remission data and were included in the analysis; only studies using bDMARDs met the inclusion criteria. Based on the meta-analysis (8,637 patients from studies conducted in 11 countries), the overall DAS28 remission rate was 24.1% (95% credible interval [CrI]: 19.4%, 29.5%; Figure). Remission rates by DAS28 measurement type were similar: DAS28–CRP, 24.5% [CrI 20.2%, 29.4%]; DAS28–ESR, 29.8% [CrI 24.8%, 35.4%]. Among the 20 included studies, a total of 9 reported the percentage of patients with LDA at 6 months, with some studies defining LDA as DAS28 ≥2.6 to < 3.2 while others as DAS28 ≥2.3 to < 2.7. The LDA rates ranged between 15% and 60% for DAS28 ≥2.6 to < 3.2 and between 11% and 56% for DAS28 ≥2.3 to < 2.7.

Conclusion: Despite treatment with bDMARDs, a large proportion of patients with RA do not achieve remission, even by the least stringent definition of remission, as by the DAS28 criteria (the rates of which are often higher than ACR70 response rates). Results from stringent remission criteria, e.g. the ACR/EULAR remission, have been reported too infrequently, but would show even much lower numbers indicative of a high unmet need in the RA treatment landscape and call for better treatment strategies.

Medical writing services provided by Brandy Menges (Fishawack Group, US) and funded by AbbVie.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/systematic-literature-review-and-meta-analysis-of-das28-clinical-response-rates-among-advanced-therapies-in-biologic-naive-patients-with-rheumatoid-arthritis/