Background Tofacinitib is an oral Janus Kinase for the treatment for rheumatoid arthritis (RA). The efficacy and safety of tofacitinib in monotherapy or in combination with other DMARDs has been demonstrated in clinical trials. However previous studies had report hematological changes and infections associated to the use of this medication (1, 2); in the European Union (EU) Tofacitinib is an investigational medicine and has not been approved for use because concernings regarding its safety.
Objectives We aim to describe the safety profile of Tofacitinib in patients with RA in in a real-life setting in Bogotá, Colombia.
Methods During 2015- 2016 we followed patients from a RA specialized center in Colombia receiving Tofacinitib. Patients were treated with therapeutic goals T2T and a multidisciplinary approach. Adverse events were classified according the Common Terminology Criteria for Adverse Events (CTCAE) of the World Health Organization. Descriptive epidemiology for continuous variables, measure of central tendency and dispersion for qualitative and categorical variables through percentages and averages were calculated.
Results We included 56 patients receiving tofacitinib, 80% were woman, 20% men. Mean age was 60±11 years. The mean time with RA was 17 months ± 12. 70% of patients had comorbidities; the most frequent comorbidity was hypertension 30%, followed by osteoporosis 25%, 7.5% Sjogren's syndrome, 7.5% diabetes mellitus among others. 70% of patients received some Anti-TNF drugs before using Tofacitinib; average time receiving tofacitinib was 33±32 weeks, mean DAS28 was 3.7±1.6. Regarding safety profile 10 of 56 patients presented any adverse event. 5 were mild, 4 moderate and 1 severe (1.7%). Diarrhea 1, Infections 1, Abdominal discomfort 3, Mouth papules 1, Rash 1, Sinusitis 1, Headache 1, Folliculitis 1 and Pancreatitis 1.
Conclusions Tofacitinib is a safe and effective medication for patients with AR; regarding safety the proportion of patients with any AE is lower compared to previous studies, but the type of events were similar to clinical trials (1); none of our patients presented hematological changes; none of our patients presented Herpes Zoster infection.
Wollenhaupt J, Silverfield J, Lee EB, Curtis JR, Wood SP, Soma K, et al. Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-label, longterm extension studies. The Journal of rheumatology. 2014;41(5):837–52.
He Y, Wong AY, Chan EW, Lau WC, Man KK, Chui CS, et al. Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis. BMC musculoskeletal disorders. 2013;14:298.
Disclosure of Interest None declared