Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
458 patients with rheumatoid arthritis (RA) and inadequate response to traditional DMARDs alone and/or TNFα blocking agents were treated with the IL-1 receptor antagonist anakinra. The initial analysis showed no difference between TNFα blocker non-responders and TNFα blocker naïve RA patients (1). In order to identify factors that could predict response to anakinra treatment we performed a post hoc analysis of the original study data.
Methods
Original study data including demographic parameters, concomitant diseases and other anti-rheumatic treatment were subject to multivariate statistical analysis to identify independent factors that impact on the DAS score difference and EULAR response after one year of anakinra treatment. Cohort analyses of patients leaving the study were performed to identify characteristics predictive for study dropout. Data from patients leaving the study prematurely were imputed based on the LOCF (last observation carried forward) methodology.
Results
Patients leaving the study prematurely (non-completers) were characterised by less DAS improvement and higher age than completers. Adverse events did not increase the risk of dropout. 79% of patients had high disease activity at baseline which was reduced to 48% after one month’s treatment. Over the 12-month study most patients obtained moderate disease activity or better and 15-19% reached low disease activity or remission. A multivariate analysis of DAS score reduction over time concluded that the most predictive factors were disease severity (DAS28) at baseline (p<0.001), previous use of biologics (p<0.05), no or low-dose steroids (≤7.5 mg prednisolone/day, p=0.06) and the prevalence of diabetes (p=0.14).
Conclusion
In a study with 458 RA patients treated with anakinra, further post hoc analysis of the raw data suggests that higher disease severity, no or low-dose steroid use or concomitant diabetes are predictive of a better response to anakinra treatment. We speculate that there may be two distinct cohorts of RA patients, one with a more autoimmune, steroid responsive disease, the other with a more autoinflammatory, steroid non-responsive disease.
References: (1) Langer H E, Missler-Karger B (2003). Int J Clin Pharm Res 23: 119-128.
Disclosure:
B. Missler-Karger,
Swedish Orphan Biovitrum AB,
5;
H. E. Langer,
Swedish Ophan Biovitrum AB,
5;
M. Leinonen,
Swedish Orphan Biovitrum AB,
5;
B. Pilström,
Swedish Orphan Biovitrum AB,
1,
Swedish Orphan BIovitrum AB,
3.
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