Background Tofacitinib is a new small molecule, Janus kinase 1 and 3 inhibitor, interfering with the JAK-STAT signaling pathway. The JAK-STAT transmits the extracellular information in the cell nucleus, influencing DNA transcription. Its efficacy and safety in Rheumatoid Arthritis (RA) has been demonstrated in different phase II, III and long-term clinical studies. It has been approved in Argentina for the treatment of patients with moderate to severe rheumatoid arthritis RA with failure to conventional DMARDs.
Objectives To communicate real world safety data from patients with RA under treatment with Tofacitinib.
Methods A retrospective, descriptive study from patients with RA (ACR/EULAR2010) under treatment with Tofacitinib from September 2014 to December 2016 was conducted. Medical records from patients being treated with Tofacitinib were reviewed and demographic data were recorded. Comorbidities, concomitant treatments, and reported adverse effects were documented.
Results 62 patients were treated with Tofacitinib. 53 were female and 9 were male, with a mean age of 57.91±14.72 years and average disease duration of 140.09±130.83 months. 18 patients (29%) had at least one comorbidity, the most frequent being hypertension (77%).
Of the 62 patients studied, 54 (87%) had established RA (duration of illness greater than 24 months) and 8 patients (13%) with early RA (less than 24 months).
In 54 patients Tofacitinib was indicated in combination with another DMARD (87%), and only 6 patients received treatment as monotherapy.
The most commonly used DMARD in combination therapy was methotrexate (MTX) in 92.5%
Treatments were indicated by failure to MTX or other conventional DMARDs, 12/62 treatments were indicated by failure to treatment with 1 biological DMARD and 13/62 treatments were indicated by failure to two or more biological DMARDs.
The maximum exposure time was 21 months.
During the time of exposure to Tofacitinib the following adverse events were observed: Herpes Zoster infection 2 cases (monometameric, no visceral involvement in unvaccinated patients), upper airway infection 1 case, transient increase in liver enzymes 1 case, peripheral facial paralysis 1 case, tachycardia 1 case. There were no cases of serious infections, opportunistic infections, cytopenias, dyslipidemia, or increased CPK.
Three patients discontinued Tofacitinib: one due to tachycardia, another case peripheral facial paralysis and another case due inefficacy.
Conclusions Most patients received combined treatment with DMARDs being the most commonly used Methotrexate. There were no cases of serious infections, opportunistic infections, cytopenias or dyslipidemia. The use of Tofacitinib in RA patients in our cohort showed a comparable safety profile with long-term extension studies in the treatment of patients with RA diagnosed with failure of conventional or biological DMARDs.
Disclosure of Interest None declared