Ab0452 survival Rate of Baricitinib in a Large Cohort of Rheumatoid Arthritis Patients: Analysis of Real-World Data

Abstract

BackgroundRecently, the new class of drugs, namely targeted synthetic (ts) DMARDs, has broadened the possibilities of treating rheumatoid arthritis (RA). In particular, Janus Kinase inhibitors (JAKi) are used in RA and are currently represented by four drugs: baricitinib, tofacitinib, upadacitinib and filgotinib. One of the first to be used in Italy was baricitinib, a JAKi acting on JAK1 and JAK2.ObjectivesThe aim of this study was to evaluate the clinical efficacy of baricitinib in a real-life setting in a cohort of RA patients.MethodsThis multicenter retrospective observational study included patients from 25 rheumatology centers diagnosed with RA and treated with baricitinib. The following were recorded for each patient: gender; age; duration of disease; presence of rheumatoid factor and anti-citrulline antibodies; concomitant treatment with conventional synthetic (cs) DMARDs; previous treatments with biological (b) or ts DMARDs. In order to evaluate the clinical efficacy, the retention rate was evaluated, calculated by means of the Kaplan-Meier method. The variables under examination were reported as frequencies and median with relative interquartile range.ResultsWe included 478 patients of which 380 (79.5%) were female. 286 (60.1%) patients tested positive for rheumatoid factor (RF) and 264 (55,2%) for anti-citrulline antibody (ACPA). The parameters analyzed are shown in Table 1. 105 (22.0%) patients were treated with baricitnib as first line (after csDMARD), the remaining patients had failed at least one bDMARD and 9 (1.9%) also failed a tsDMARD. In 34,7% of cases baricitinib was used as monotherapy, the most frequently used csDMARD was methotrexate (29.2%). The median period of therapy was 674 days (298-1087).The survival rate at 6 months was 94.6%, at 12 months it was 87,9%, at 24 months was 81.7% and at 48 months was 53.4% (Figure 1).The main causes that led to the discontinuation of baricitinib therapy were: primary ineffectiveness (7,3%), secondary ineffectiveness (4.2%) and adverse events (3,7% 5 TEP/DVT). The concomitant steroid therapy seems to be a negative prognostic factor (HR 1,65 95% CI 1.03-2.63; p=0.035) as well as the line of therapy (HR 1.35 95% CI 1.15-1.58; p=0.000).Table 1.CharacteristicsValueM:F98:380Age, median [IQR] yrs60 [51-70]Smokers, n (%) (**)YesFormerNo84 (18,8)76 (17,0)288 (64,2)Body Mass Index, median [IQR] kg/m^2 (*)24,8 [23,0-27,0]Disease Duration, median [IQR], months78 [32-163]RF positivity, n (%)286 (60,1)ACPA positivity, n (%)264 (55,2)SJC, median [IQR]5 [3-8]TJC, median [IQR]8 [4-12]ESR, median [IQR], mm/h33 [20-46]CRP, median [IQR], mg/dl1,3 [0,5-2,9]VAS Patient (0-100), median [IQR]70 [50-80]DAS28, median [IQR]5,4 [4,8-6,1]Line of treatment, [IQR]2 [2-3]Concomitant csDMARDs use, n (%)MTXLFNSSZHCQ140 (29,2)11 (2,3)3 (0,6)12 (2,5)Concomitant steroids use, n (%)237 (49,6)Steroids dose (PDN-Eq), median, mg/die5 [4-5]Prior bDMARDs use, n (%)TNFiIL6iIL1iCD20iCD80i164 (34,3)84 (17,6)08 (1,7)54 (11,3)Prior tsDMARDs use, n (%)Tofacitinib9 (1,9)Concomitant relevant disease, n (%)DiabetesHypercholesterolemiaMACEArterial HypertensionCancer36 (7,5)119 (24,9)28 (5,9)179 (37,4)24 (5,0)Figure 1.4 year retention rate of baricitinibConclusionThe efficacy of baricitinib in the treatment of RA in a real-life context appears consistent with what was reported by the pivotal studies. Furthermore, from this preliminary experience, seropositivity and combo therapy seems to not correlate with a better retention rate, while concomitant steroid therapy and line of treatment are a negative prognostic factor.References[1] Guidelli GM et al. Clin Exp Rheumatol. 2021 Jul-Aug;39(4):868-873.[2] Spinelli FR et al. Clin Exp Rheumatol. 2021 May-Jun;39(3):525-531.Acknowledgements:NIL.Disclosure of InterestsNone Declared.