Author:
Fabienne L. S.,Costecalde C.,Dramé M.,Deligny C.,Numeric P.,Blettery M.,Petit C.,De Bandt M.,Suzon B.
Abstract
BackgroundMortality and morbidity related to rheumatoid arthritis (RA) has remarkably improved over the last twenty years since using biologics DMARDs1. However, their effectiveness remains questionable in Afro-descendants (AD) due to their large under-representation in RA clinical trials2,3. Martinique is a French Caribbean region with a majority of AD population4, with free access to healthcare, including biotherapies, and a unique university hospital and rheumatology unit.ObjectivesTo evaluate effectiveness of Tocilizumab (TCZ), an interleukin-6 inhibitor, in an afro descendant RA population.MethodsRetrospective cohort of 171 patients who received at least 1 infusion of Tocilizumab (IV TCZ) at Martinique University Hospital Center between 2008 and 2019. Inclusion Criteria: Patients over 18 y/o meeting RA 2010 ACR/EULAR criteria, having received at least 4 courses of IV TCZ starting at 8mg/kg every 4 weeks, with available baseline clinical/biological data. Exclusion criteria: Patients having received subcutaneous TCZ (SC TCZ) prior to IV TCZ, not living in Martinique. Primary endpoint was proportion of patients in remission (R) and low disease activity (LDA) according to DAS28 CRP at 12, 24, 36 weeks. Secondary endpoint was proportion of patients achieving good (GR) and moderate (MR) EULAR response criteria 5 at 12, 24 and 36 weeks, and TCZ retention at 1 year defined as the proportion of patient receiving TCZ at 1 year follow up.ResultsOut of 171 patients receiving IV TCZ, we identified 138 RA and 80 patients met inclusion criteria: 90% were women, mean age was 56.8 (± 11.8) y/o, mean duration of RA was 11.6 (± 8.9) years, ACPA and Rheumatoid Factor were positive in 72.1% and 73% of cases, 69.6% of patients had erosions and 77.8% had received at least 1 biologic prior to IV TCZ. At baseline, 8 patients were in R, 8 had LDA but presented steroid dependency over 10 mg per day of prednisone and mean dose of prednisone was 6.9 (+/- 6.7) mg per day.At 12, 24, 36 weeks, R was achieved in 44.8%, 55.2% and 51.2% of patients and LDA in 37.3%, 17.2% and 20.9%, respectively (Figure 1). At 12, 24, 36 weeks, GR was achieved in 44.8 %, 60.3% and 48.8% of patients respectively, MR was achieved in 20.9%, 20.7% and 27.9% of patients respectively (Figure 1) and mean dose of prednisone per day was 5.1 (± 4.9) mg, 4.9 (± 5.6) mg and 3.3 (± 5.1) mg respectively. At 1 year, 78.8% of patients were still on TCZ. During follow up: 15 patients experienced 19 infectious events; 6 patients liver cytolysis; 12 patients neutropenia. No patient died.ConclusionThis is the first study evaluating efficacy and safety of TCZ in an AD RA cohort. TCZ is safe and effective in our AD population with comparable data observed in other ethnicities6,7.References[1]Lacaille, D., Avina-Zubieta, J. A., Sayre, E. C. & Abrahamowicz, M. Improvement in 5-year mortality in incident rheumatoid arthritis compared with the general population—closing the mortality gap. Ann. Rheum. Dis.76, 1057–1063 (2017).[2]Strait, A. et al. Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review. JAMA Netw. Open2, e1914745 (2019).[3]Dunbar-Jacob, J. et al. Factors associated with attrition of African Americans during the recruitment phase of a clinical trial examining adherence among individuals with rheumatoid arthritis: Attrition of African Americans. Arthritis Care Res.51, 422–428 (2004).[4]Levinson, D. Ethnic Groups Worldwide : a ready handbook. (1998).[5]Fransen, J. & van Riel, P. L. C. M. The Disease Activity Score and the EULAR Response Criteria. Rheum. Dis. Clin. N. Am.35, 745–757 (2009).[6]Gottenberg, J.-E. et al. Comparative effectiveness of rituximab, abatacept, and tocilizumab in adults with rheumatoid arthritis and inadequate response to TNF inhibitors: prospective cohort study. BMJ l67 (2019) doi:10.1136/bmj.l67.[7]Mori, S. et al. Retention of tocilizumab with and without methotrexate during maintenance therapy for rheumatoid arthritis: the ACTRA-RI cohort study. Rheumatology58, 1274–1284 (2019).Disclosure of InterestsNone declared
Subject
General Biochemistry, Genetics and Molecular Biology,Immunology,Immunology and Allergy,Rheumatology