e52 Characteristics of patients treated with biologic monotherapy and combination therapy for moderate or severe rheumatoid arthritis in five European countries

Abstract

Background: In patients with rheumatoid arthritis (RA) who have inadequate response to conventional synthetic disease-modifying anti rheumatic drugs (csDMARDs), the addition of a biological DMARD (bDMARD) is recommended in clinical guidelines for achieving remission or reducing disease activity and reducing pain, inflammation, joint damage and disability, while maintaining or improving physical function and health-related quality of life (HRQoL). Yet, some circumstances deem treatment with bDMARD monotherapy rather than combination therapy appropriate. A better understanding of the clinical profiles and unmet treatment needs of patients with RA administered monotherapy versus combination therapy may assist in optimising health outcomes. Methods: Patient characteristics associated with the use of, and reasons for prescription of bDMARD monotherapy versus bDMARD + csDMARDs combination therapy in patients with RA were evaluated. Data were from the Adelphi Disease Specific Programme, a point-intime survey (Q1 2017) of rheumatologists and their patients with RA. Data were reported by physicians from France, Germany, Italy, Spain, and the UK on patient demographics, disease status, current treatment and level of treatment satisfaction. Patients self-competed the EuroQoL EQ-5D 3 level questionnaire and the Health Assessment Questionnaire Disability Index (HAQ-DI). Differences in demographics, current therapy, disease status, HRQoL, and disability between patients currently receiving bDMARD monotherapy versus combination therapy; bivariate analysis including Mann-Whitney tests for continuous data and Pearson's Chi-Squared or Fisher's Exact tests for categorical data based on a 95% significance level were performed with Stata Statistical Software: Release 15. Results: 1541 patients receiving bDMARDs who ever had moderate or severe RA were evaluated. 404 (26.2%) were receiving monotherapy and 1137 (73.8%) were receiving combination therapy. Mean patient age was 52.7 ≤ 12.8, 69.2% were female and 90.1% were white/Caucasian. 34.7% of retired/unemployed patients younger than age 65 were retired/unemployed due to RA. Monotherapy patients had more comorbidities (1.26 vs 1.06; P < 0.01). Combination therapy patients experienced more pain (7.3) versus monotherapy patients (6.7) on a 1-10 scale (P < 0.0001) immediately prior to initiation of current treatment. However, proportions of patients with currently severe levels of joint tenderness and joint swelling were similar between monotherapy and combination therapy groups (2.2% vs 3.6%; P = 0.195 and 2.0% vs 2.9%, P=0.373, respectively). EQ-5D (0.75 vs 0.70, respectively; P = 0.09) and HAQ scores (0.91 vs 0.89; P = 0.816) were also similar between the groups. In monotherapy patients, intolerance to csDMARDs was the most prevalent reason (48.3%) for monotherapy. Conclusion: Patients on monotherapy versus combination therapy had more comorbidities and less pain immediately prior to treatment initiation. The groups had similar proportions of patients with current severe joint tenderness and swelling; HRQoL and disability were also similarly affected, indicating a continuing unmet medical need in both monotherapy and combination therapy patients.