BackgroundTofacitinib is an oral JAK inhibitor for the treatment of RA. Tofacitinib can be given as monotherapy or with csDMARDs. Published data on real world (RW) tofacitinib use in Latin America (LA) are limited. We characterise the patient (pt) population starting tofacitinib and gain insights into the safety profile in the RW LA setting.MethodsInitial tofacitinib therapies in adult RA pts from 10 private/public centres in 6 countries (Argentina, Brazil, Colombia, México, Panamá, Perú) were considered. Data were retrospectively obtained via a standardised format, focusing on demographics, drug history, adverse events (AEs), safety events of special interest, latent tuberculosis (TB) screening, selected confirmed laboratory abnormalities and discontinuation rates. Tofacitinib use as monotherapy or with csDMARDs was at the rheumatologist's discretion.Results288 pts with severe active RA were included; most were female (n=263; 91%), mean (SD) age was 51.3 (6.36) years (yrs) and mean (SD) disease duration was 10.4 (4.0) yrs. 89% of pts were RF+ or ACPA+. The max (range) follow-up period was 22 (10–34) months. Tofacitinib was given as 2nd-line therapy (post-csDMARD) in 44% of pts, after one biologic DMARD (bDMARD) in 18% of pts and after ≥2 bDMARDs in 38% of pts. Tofacitinib was given as monotherapy in 117/283 (41%) pts and with csDMARDs in 171/283 (59%) pts. Tofacitinib usage corresponds to 13% of advanced therapies (JAK inhibitors, bDMARDs and biosimilars). Thirty-eight AEs were observed; upper respiratory infections (n=11), skin infection (n=5), herpes zoster (HZ; n=4) and urinary infections (n=4) were most common. Gastrointestinal intolerance was seen in 2 pts. Three (1%) pts had serious infection events (SIEs); no opportunistic infections (OIs), including TB, occurred. All HZ cases (n=4; 1.4%) were monomeric, non-serious and resolved without complication after antiviral therapy. Before starting tofacitinib, 5 pts (1.7%) were vaccinated against HZ and 5.6% were diagnosed with latent TB. No active TB cases occurred with tofacitinib treatment. One malignancy (thyroid cancer) was reported. Severe (>3 ULN) elevation of liver enzymes or increases of CPK above normal were infrequent (<1%); no severe cytopenias were reported. Lipid increases occurred in 10% of pts. Tofacitinib was withdrawn in 40 pts (13.9%) due to lack of efficacy (n=20; 7%), AEs (n=11; 3.8%) or other reasons (n=9; 3.1%), such as loss of follow-up, pregnancy, access issues or travel. Limitations include limited pt numbers and follow-up of exposure.ConclusionsIn the RW LA setting, tofacitinib was used mostly as 2nd-line therapy; no new safety signals emerged vs clinical trials. SIEs and HZ were uncommon; no cases of TB/other OIs occurred, but were seen in the clinical program.AcknowledgementsThis study was sponsored by Pfizer Inc. Editorial support was provided by K Irving of CMC and funded by Pfizer Inc.Disclosure of InterestE. Schneeberger: None declared, A. Salas Speakers bureau: AbbVie, Pfizer Inc, L. F. Medina: None declared, J. B. Zacariaz: None ...

BackgroundTofacitinib 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.ObjectivesTo communicate real world safety data from patients with RA under treatment with Tofacitinib.MethodsA 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.Results62 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.ConclusionsMost 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 InterestNone declared