Ab0318 characteristics of Patients With Rheumatoid Arthritis Who Have Withdrawn the Last Biological Drug: Real-Life Results From a Local Registry

Abstract

Objectives:To assess the characteristics of patients with rheumatoid arthritis (RA), who have withdrawn the last biological drug (bDMARD), and to know the reasons for withdrawal of treatment.Methods:Retrospective and cross-sectional study on December 31, 2019, of patients with RA, treated with any of the bDMARDs, including JAK (JAKi) inhibitor drugs, commonly used, from 1/1/2000 to 12/31/2019. General data were collected from patients, and RA: time of evolution, presence of rheumatoid factor (RF) and anti-citrullinated peptide antibodies (ACPA), type of bDMARD, time in bDMARD, and cause of withdrawal.Results:Of 252 patients, who have received some bDMARD, 81 (32%) patients had withdrawn on 12/31/2019. 62 (77%) patients were women, with a mean age at diagnosis of RA of 48 years (SD: 16.5 years) and 59.5 (15) years at the beginning of the first bDMARD (F1), with an average evolution of RA 10.2 (2.5) years. 68% and 74% of patients were positive for RF and ACPA, respectively.In 64 (79%) patients, bDMARD was withdrawn as second to fifth bDMARD received (F2 to F5): as F2: 37/81 (46%) patients, F3: 14 (18%), F4: 8 (10%) and as F5: (6%) patients.When comparing the last bDMARD received, before the suspension as F1 vs F2-F5, 95% vs. 61% of patients (p <0.0001), the drug was an anti-TNF (TNFi); Abatacept: 1 (1%) vs 9 (14%); Tocilizumab: 0% vs 8 (12%); Rituximab: 1 (1%) vs 5 (8%) and JAKi: 4 (5%) vs 3 (5%). The mean time in treatment with some bDMARD was 2.6 (SD: 3) years in the F1 group vs 1.7 (2) years in the F2-F5 group (p = 0.034). Among the F3-F5 patients, 9 (14%) patients had failed at 2 different previous therapeutic targets and 6 (9%) at 3 targets.No differences were detected between the F1 group vs F2-F5, regarding the causes of withdrawal of bDMARD: whether it had occurred due to 1) loss of efficacy (25/31% patients vs 19/30%); 2) adverse events (31/38% vs. 29/45%): infection: 18/81 (22%) patients, malignancy: 5 (6%), malaise/pain: 11 (14%), laboratory parameters alteration: 7 (9%), death: 5 (6%), others: 14 (17%); 3) change of address/loss of follow-up (20/25% vs. 7/11%) or by 4) voluntary abandonment of treatment by the patient (5/6% vs. 9/14%).Conclusion:1. 32% of patients with RA withdraw the bDMARD. 2. The group treated with TNFi withdraws it significantly higher among the F1 group. 3. Survival of bDMARD is significantly higher in group F1 compared to F2-F5. 4. No differences were detected between the groups regarding the cause of withdrawal of bDMARD. 25% -30% of patients withdraw it due to loss of follow-up or voluntary abandonment of bDMARD.Acknowledgments:The study was supported by a research grant from the Association for Research in Rheumatology of the Marina Baixa (AIRE-MB).Disclosure of Interests:None declared

Real-world evidence of tofacitinib in rheumatoid arthritis patients in Spain

“…Other studies reported data, such as that of Reed et al (32) based on the registry of Corrona (402 patients, 238 in monotherapy and 164 in combination treatment), and Mueller et al (36), based on the records of the hospitals of St. Gallen and Aarau in Switzerland. In general, all the studies showed a higher percentage of women, and the mean age of the patients was very similar, between 48 and 61 years (43,44). Nevertheless, compared to the Australian study by Bird et al (35), with ages ranging between 55 and 74, Spanish RA patients treated with tofacitinib are younger in that series (median age ranges 61-62,9 and ages range 40-74.4), and in the BIOBADASER 3.0 the mean age of patients treated with JAK inhibitors was 59.6 (12.3 SD) (54).…”

“…The mean duration on biologic therapy before switching was 3.9 years (range: 1.2-10.9 years). In the second study, the mean time in treatment with a bDMARD was 2.6 years (SD: 3.0 years) (44). The reasons to switch therapy in 81/252 patients were: loss of efficacy (25/81, 30.9%); AEs (31/81, 38.3%); change of address/loss of follow-up (20/81, 24.7%); and voluntary abandonment of treatment by the patient (5/81, 6.2%).…”

“…Between 2019 and 2021, 16 retrospective studies reported the tofacitinib experience in patients with RA on routine clinical practice in Spain (38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53). Data from case-series were obtained from medical records and databases of a hospital's Rheumatology Service (Supplementary Table S1, http://www.ddtjournal.com/ action/getSupplementalData.php?ID=94).…”

“…One study reported CCP+ (19/28, 67.9%)(43), and another study reported RF+ (55/81, 68.0%) and CCP+ (61/81, 74.0%)(44) for any JAK inhibitors. Three studies reported these values separately: RF+ (32/39, 82.1%)/CCP+ (28/39, 71.2%)(46), and RF+ (9/9, 100.0%) / CCP+ (7/9, 77.8%)(42), and RF+ (87.5%, 35/40) / CCP+ (30/40, 75.0%) (39), in patients treated with tofacitinib.…”