Ab0441 therapy With Tofacitinib in a Colombian Population With Rheumatoid Arthritis: Results of the Daily Clinical Practice

Abstract

Background:Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects the quality of life and reduces life expectancy. It is characterized by the presence of autoantibodies and erosive synovitis that mainly involves small joints (1). Tofacitinib is the first oral Janus Kinase (JAK) inhibitor approved in 2012 for the treatment of patients with active, moderate to severe RA that does not respond to other therapies (2).Objectives:The objective was to describe demographic and clinical results of a cohort of Colombian patients with RA treated with tofacitinib.Methods:Descriptive observational study of a historical cohort of RA patients in a specialized center for the management of inflammatory arthropathies, from April 2014 to February 2018. The following variables are described: age, sex, time evolution of the disease, type of AR, comorbidities, disease activity (DAS-28), schedule and treatment time. For the descriptive analysis, categorical variables are presented as absolute and relative frequencies; while continuous variables are presented as mean and standard deviation (SD) or median and interquartile range (IQR) according to distribution. The outcome of DAS 28 ≤ 3.2 was estimated by incidence rate, defined as the number of patients who presented the outcome divided by the summation of total exposure time of the patients.Results:Of 59 patients included, 88.1% (52) were women, with a median age of 58.8 years (IQR 49-68 years), 74.6% were seropositive, the median time from diagnosis was 18.2 years (IQR 12- 28.3 years). High blood pressure was the most common comorbidity (40.7%) and 7% had tuberculosis history. The median number of bDMARD prior to tofacitinib was 2 (IQR 1-3). Sixty six percent patients (39) were on monotherapy while 34% (20) were on combination with leflunomide (19) and methotrexate (1). The median time of treatment was 1.2 years (IQR 0.6-2 years). At the beginning, 84.7% patients (50) were in moderate or high disease activity and 15,3% (9) in remission or low activity; at the end of follow-up, 47.5% (28) were in remission or low activity and 52.5% (31) in moderate or high activity (p = 0.000). The mean DAS28 at the beginning of tofacitinib was 4.6 ± 1.55 and at the end of the follow-up was 3.5 ± 1.49, with a difference of means of 1.10 (IC95% 0.62-1.57), (p 0.00). During the follow-up period, the rate of development of remission or low activity was 11.92 (95% CI 8.35-16.51) cases per 100 people-month observed (p 0.00). Only 2 patients developed therapeutic failure.Conclusion:Tofacitinib shows a good profile of effectivity in patients with failure to prior bDMARD. Almost 50% patient reaches low disease activity or remission during follow up and low number of therapeutic failure was found.References[1] Picchianti-Diamanti A, et al. Front Microbiol. 2018;8(2696):1-9[2] Cohen S, et al. Rheumatol Ther. 2018;5(1):283-291Disclosure of Interests:Wilmer Gerardo Rojas Zuleta Speakers bureau: Bristol-Myers Squibb, Novartis, Jannsen, Pfizer, Oscar Jair Felipe Díaz Speakers bureau: Bristol-Myers Sq...

Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention

“…The proportions of patients receiving tofacitinib monotherapy ranged from 16.6-66.1%. [14][15][16][17][18][19][20][21][22][23][24] Where data were available, patients in these RWD analyses tended to be older and have lower baseline disease activity compared with patients in the clinical trials (Table 1). Patients had lower tender and swollen joint counts and were less likely to be bDMARD-naïve in the RWD analyses compared with the RCT and LTE studies (Table 1).…”