Journal Article

AB0565 BASELINE CHARACTERISTICS AND TREATMENT RESPONSE IN PATIENTS WITH RHEUMATOID ARTHRITIS: DATA FROM RA-BE-REAL PROSPECTIVE OBSERVATIONAL STUDY

Ikeda, K., Ogwu, S., Finckh, A., Laedermann, C., Van de Laar, M., Fakhouri, W., Balsa, A., Schulze-Koops, H., Favalli, E. G., Haladyj, E.

2024

Overview

Background:At present, there are limited data on characteristics of non-responders to antirheumatic treatments for rheumatoid arthritis (RA).Objectives:To characterize patients who were responders/non-responders to assigned treatment for RA.Methods:RA-BE-REAL is a 3-year, multinational, prospective, observational study of adult patients with RA. Patients initiated treatment with baricitinib (cohort A) or any biologic (b) disease-modifying antirheumatic drug (DMARD) or any other targeted synthetic (ts), namely tumour necrosis factor inhibitors (TNFi) or other mechanism of action (OMA) (cohort B), for the first time. This analysis concerns a European subpopulation. [1]. Primary non-response was defined as no remission/ low disease activity (LDA) (based on CDAI) at both 3 months (M) and 6M; response as remission/LDA at both 3M/6M. Baseline characteristics for both groups are presented here descriptively; no comparative testing was conductedResults:68.7%, 56.2% and 63.3% of patients treated with baricitinib, TNFi, and OMA were responders at both 3M and 6M. More responders than non-responders were naïve to b/tsDMARDs with numerically lower HAQ and disease activity at baseline.31.3% of baricitinib treated patients, 43.8% of TNFi patients and 36.7% of those on OMA were non responders at both 3 and 6M (Table 1). Primary non-responders had numerically higher CDAI, higher HAQ-DI, lower quality of life (QoL) and a higher percentage of patients - with pain assessment >20mm reported pain at baseline than responders, and previously failed more often 2 or more b/tsDMARDs. These findings were applicable to all three cohorts (Table 1).Conclusion:We found that primary non-responders were mostly patients who had higher disease severity and physical limitations and had more treatment failures. This subgroup of patient warrants more careful follow-up and earlier intensification of treatment to allow them to achieve early remission/LDA.REFERENCES:[1] Alten R, Burmester GR, Matucci-Cerinic M, et al. Comparative Effectiveness, Time to Discontinuation, and Patient-Reported Outcomes with Baricitinib in Rheumatoid Arthritis: 2-Year Data from the Multinational, Prospective Observational RA-BE-REAL Study in European Patients. Rheumatol Ther. 2023 Dec;10(6):1575-1595.Table 1. Baseline demographics, treatment history, clinical characteristics, and quality of life information for patients who were responders and primary non-responders at six months.Only patients with data on response/ non-response were included in the study.All data are presented as n (%) unless otherwise stated.DMARD, disease-modifying anti-rheumatic drug; bDMARD, biological DMARD; BMI, body mass index; CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic DMARD; HAQ-DI, Health Assessment Questionnaire-Disability Index; RA, rheumatoid arthritis; TNFi, tumour necrosis factor inhibitor; tsDMARD, targeted synthetic DMARD; VAS, visual analogue scale (mm)Acknowledgements:Medical writing support was provided by Mr. Alan Ó Céilleachair, an employee of Eli Lilly and Company Ltd.Disclosure of Interests:Alejandro Balsa has been a speaker for Eli Lilly and Company, UCB, AbbVie, Pfizer, Galapagos, Sanofi, Nordic Pharma, Sandoz, and Gebro, Alejandro Balsa has received consulting fees from Eli Lilly and Company, UCB, AbbVie, Pfizer, Galapagos, Sanofi, Nordic Pharma, Sandoz, and Gebro and has particpated on advisory boards for Eli Lilly and Company, UCB, and Sanofi, Alejandro Balsa has received grants from AbbVie, Pfizer, and UCB, Ennio Giulio Favalli has been paid as a speaker by Galapagos, Pfizer, and Novartis, Ennio Giulio Favalli has received consulting fees from AbbVie, Galapagos, Pfizer, and Eli Lilly and Company Limited., Kei Ikeda has been a paid speaker for AbbVie, Ashai-Kasei, Eisai, Eli Lilly and Company, Gilead, and Novartis, Kei Ikeda has received grants from Mitsubishi-Tanabe, Mart van de Laar has been paid as a speaker for Eli Lilly and Company and Galapagos, Mart van de Laar has been paid as a consultant for Eli Lilly and Company and Galapagos, Mart van de Laar has received grant support from Eli Lilly and Company and Galapagos, Hendrik Schulze-Koops has been paid as a speaker by Eli Lilly and Company, Hendrik Schulze-Koops has participated on advisory boards for Eli Lilly and Company, Ewa Haladyj is a minor shareholder in Eli Lilly and Company Ltd., Ewa Haladyj is an employee of Eli Lilly and Company Ltd., Walid Fakhouri is a minor shareholder in Eli Lilly and Company Ltd., Walid Fakhouri is an employee of Eli Lilly and Company Ltd., Samuel Ogwu is a minor shareholder in Eli Lilly and Company Ltd., Samuel Ogwu is an employee of Eli Lilly and Company Ltd., Cedric Laedermann is a minor shareholder in Eli Lilly and Company Ltd., Cedric Laedermann is an employee of Eli Lilly and Company Ltd., Axel Finckh has been a paid speaker for Astra-Zeneca, AbbVie, Eli Lilly and Company, Pfizer, and MSD, Axel Finckh has received consulting fees from AbbVie, Astra-Zeneca, Eli Lilly and Company Ltd., and Pfizer, Axel Finckh’s institution has received grants from AbbVie, BMS, Eli Lilly and Company Ltd., Galapagos, and Pfizer.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,Elsevier B.V,Elsevier Limited
• Subject: Body mass index / Disease-modifying Drugs (DMARDs) / Observational studies / Pain / Patients / Quality of life / Real-world evidence / Remission / Remission (Medicine) / Rheumatoid arthritis / Scientific Abstracts / Stockholders / Tumor necrosis factor / Tumor necrosis factor-TNF / Tumors