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 Tofacitinib was withdrawn in 40 pts (13.9%) due to lack of efficacy (n=20; 7%), AEs (n=11; 3.8%) or other reasons (n=9; 3.1%), such as loss of follow-up, pregnancy, access issues or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 ...

LETTERS 3. 4. 5.6. 7.8. 9. 11Willkens RF, Watson

Introducción y objetivos: en un contexto de crisis de biodiversidad global, existe un consenso científico y político creciente acerca de la importancia de incorporar el Conocimiento Ecológico Tradicional para la conservación de la naturaleza. Sin embargo, dichos esfuerzos se han centrado en culturas indígenas, dando lugar a una menor atención sobre países industrializados. En este escenario elegimos la Sierra de Andía, un espacio de la Red Natura en España caracterizado por sus antiguos pastos ganaderos, cuyos cambios de gestión recientes podrían conllevar problemáticas para su conservación. En este contexto, el estudio busca contribuir a la valorización y la aplicabilidad del conocimiento ecológico tradicional de un país industrializado, utilizándolo para localizar problemáticas y proponer soluciones de manejo en un área concreta.  M&M: con el fin de descubrir el conocimiento tradicional que pudiera ser beneficioso para el manejo y conservación de la Sierra de Andía, se realizaron entrevistas acerca de Chamaemelum nobile (una popular planta medicinal ligada a estos pastos ganaderos) y se llevó a cabo un estudio de campo sobre la especie.   Resultados: los informantes mostraron un profundo conocimiento sobre la planta, y proveyeron indicadores ecológicos con los que localizar las poblaciones más abundantes y comprender su evolución reciente. A la vez que encontramos numerosas coincidencias entre el conocimiento ecológico tradicional y el científico, también surgió información exclusiva de los informantes.  Conclusiones: este estudio sugiere que el conocimiento ecológico tradicional aportado es preciso, contrastable, y puede ser utilizado para un manejo sostenible de los pastos en la Sierra de Andía.