In terms of cost-efficacy, the most efficient biological drug was adalimumab. The robustness of this finding was confirmed by sensitivity analysis.

Background:The Janus Kinase (JAKi) inhibitors Baricitinib (BAR) and Tofacitinib (TOF) are indicated for moderate to severe active rheumatoid arthritis (RA). Data about safety, effectiveness in refractory patients and adherence in real clinical practice in our population are scarce.Objectives:An evaluation of safety, adherence and reasons to consider suspension of JAKi in routine clinical practice.Methods:Retrospective observational study of patients with RA treated with BAR and TOF according to usual clinical practice between September 2017 - December 2019. Data were collected from the electronic medical record and from the Dominion® Outpatient Drug Dispensing program.Demographic, clinical, laboratory and treatment-related variables were collected, including reasons for discontinuing JAKi (inefficiency and toxicity). Adherence was calculated using the Compliance Questionnaire on Rheumatology (CQR-5), and the average possession ratio (RMP), which is defined as the number of days with treatment dispensed between the total days of the period analyzed, considering the adherent patient when RMP had a ≥ 0.8.Laboratory abnormalities were defined according to normal limit values (NLV) and specifications of data sheet. A descriptive analysis was performed using proportions, medians and interquartile ranges (IQR) using the SPSS v.15 program.Results:Thirty patients were included in treatment with BAR and nine with TOF. The median age was 62.9 (RIQ 49.9-74.4), 34 (87.2%) were women, 28 (71.2%) anti-CCP and 32 (82.1%) were rheumatoid factor positive, with erosive disease in 34 (87,2%) patients. In the previous treatment, 9 (23.1%) were naive to biological, 6 (15.4%) had received 1 biological, 18 (46.1%) 2 biologicals, and 6 (15.4%) ≥ 3 biologicals. The median treatment time was 8.4 months (RIQ 6.5-20.3) in BAR and 13.2 (RIQ 3.9-20.7) in TOF.The reasons for consider suspension shown in Table 1.Table 1.Treatment DiscontinuationBARICITINIBInitial DAS28[median (IQR)]Final DAS28[median (IQR)]Continue treatmentn (%): 17/30 (55.6)4.20 (2.95-5.72)2.60 (1.70-2.77)Reasons for suspension-Refractory n (%): 7/13 (55.8%)4.38 (4.16-5.43)4,16 (3.56-5.23)-Side effects n (%): 4/13 (30.7)4.16 (3.45-4.84)3.15 (2.69-4.41) ◦Thrombocytosis (1) ◦Herpes Zoster (1) ◦Anemia (1) ◦Tubaritis (1)-Patient decisión n (%): 2/13 (15.4)TOFACITINIBContinue treatmentn (%): 6/9 (66.6)4.82 (3.28-6.20)2.61 (2.45-3.70)Reasons for suspension-Refractory n (%): 2/3 (66.6)5.27 (5.23-5.31)5.48 (5.04-5.92)-Side effects n (%): 1/3 (33.33)Based on the CQR5 questionnaire, all patients treated with BAR and TOF were adherent “HIGH” class, and a median of RMP = 1.01 (IQR = 0.93-1.06) was obtained for BAR and RMP = 1, 00 (IQR = 0.91-1.01) for TOF, all adherents (≥ 0.8).Table 2.Safety results of the treatment shows the safety results.Side EffectBaricitinib(n, %)Tofacitinib(n, %)Hb <11 g/dl7 (23,3)0Hb < 8 g/dl0 (0)/Hb Recovery >11 g/dl2/7 (28,6)/Neutrophils < 1500/mm30 (0)/Lymphocytes < 1000/mm33 (10,0)2 (22,2)Platelets > 600 × 103/mm31 (3,3)0AST o ALT > 1 NLV4 (13.3)0 (0)Hypercholesterolemia (> 1 NLV)13 (43.3)5 (55.5)Infections13 (43.3)0 (0)Herpes zoster6 (20,0)0 (0)Conclusion:In our population, mostly refractory to biological, more than half of the patients maintain treatment with JAKi, with optimal adherence. The main reason for the suspension of both drugs was inefficiency. The most frequent adverse effects were hypercholesterolemia in both groups and infections in BAR, with a high frequency of herpes zoster. No cardiovascular or thromboembolic events were observed.Disclosure of Interests:Cristina Valero: None declared, Alberto Calvo Garcia: None declared, Noelia García Castañeda: None declared, Ana Ortiz: None declared, Irene Llorente Speakers bureau: Gebro, Janssen, Sanofi, Lilly., Blanca Varas: None declared, Santos Castañeda: None declared, Rosario Garcia de Vicuna Grant/research support from: BMS, Lilly, MSD, Novartis, Roche, Consultant of: Abbvie, Biogen, BMS, Celltrion, Gebro, Lilly, Mylan, Pfizer, Sandoz, Sanofi, Paid instructor for: Lilly, Speakers bureau: BMS, Lilly, Pfizer, Sandoz, Sanofi, Esther Ramirez: None declared

BackgroundAdherence to treatment in rheumatoid arthritis (RA) is influenced by numerous factors. Although patients with RA are aware that compliance is important for disease control, there is evidence that they often drop out the prescribed use of synthetic DMARDs.ObjectivesThe OBSERVAR Study aims to confirm the lack of adherence to synthetic DMARDs in patients with RA and look for the main reasons for dropping out.MethodsBetween July and August 2014, 18 Spanish consultant rheumatologists were asked, using a two-round Delphi process, to determine the degree of agreement with multiple causes of non-compliance. These reasons were selected by a systematic literature search in PubMed and Google Scholar, based on scientific publications. 66 reasons were selected, divided into 3 blocks, related to patients, to healthcare professionals and inherent to the DMARD treatment itself. The degree of agreement with each of these was identified on a scale from 1 to 9 (minimum and maximum agreement). The consistency of these agreements was determined by two criteria: based on the group mean, and based on simultaneous observance of mean and median ≥7, standard deviation and interquartile range ≤1.00, and coefficient of variation ≤0.25.ResultsThere was agreement with most of the statements selected (75.76%) and only one disagreement. Most frequent among the patient-related reasons were insufficient knowledge of the disease and importance of treatment adherence. The main reasons related to healthcare professionals were insufficient follow-up, lack of screening for non-compliant patients and lack of implementation of procedures aimed at improving adherence. With respect to treatment, general aspects were agreed such as the total number of pills or lack of reminder tools. When we applied the criterion of consistency of agreement, three reasons were highlighted (4.5%): not knowing what to do when the patient suffered an adverse event with the DMARD, lack of screening to detect non-compliant patients and lack of implementation of procedures to improve therapeutic compliance.ConclusionsThe lack of strict adherence by patients in the treatment of RA with synthetic DMARDs is relatively common. Most of the reasons given for this have been confirmed in our study. The situation must be improved by: establishing objectives agreed with the patient; teaching them properly about the disease, treatment, expected side effects, the importance of adherence and its consequences; and by trying to identify potentially non-compliant patients early and subsequent continuous monitoring of their adherence.AcknowledgementsRoche Farma SpainDisclosure of InterestNone declared

Moreover, communication about patients' care was poor in view of our interviewees' declarations. Conclusion and relevance Patients' perception of the role of antibiotics in general or in surgical use is imprecise, and is related to their perception of infections associated with care. It is therefore essential to strengthen a clear dialogue between healthcare professionals and patients in relation to care. REFERENCES AND/OR ACKNOWLEDGEMENTSWe thank the 'Académie de Recherche et d'Enseignement Supérieur' (ARES) for funding this work.

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