LH and SE correlated significantly with disease activity, functional capacity, and perceived pain. Levels of SE were higher in patients in remission compared to those with active disease as opposed to levels of LH, which were lower in patients in remission compared to those with active disease. These results show that cognitive factors are related to disease activity and their modifications may have importance in the management of RA.

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 ...

ObjectivesThe aim of the study was to translate and validate the ASAS Health Index (ASAS-HI) for Argentinean patients with spondyloarthritis.MethodsTranslation was done using a forward-backward procedure and qualitative interview were done with the translation. Patients fulfilling ASAS classification criteria for either axial (axSpA) or periphereal SpA (pSpA) were included to test psychometric properties. Test-retest reliability was assessed by intraclass correlation coefficient (ICC) in patients without treatment changes (stable disease state). In patients who required therapeutic modifications due to changes of disease activity, responsiveness was evaluated using a standardized response mean (SRM). Construct validity against other health outcomes was evaluated by Spearman correlation. Internal consistency (Cronbach-alfa) and discriminative ability between ASAS-HI and ASDAS were assessed.ResultsTranslation into Argentinean Spanish was accepted with minor changes. Fifty two patients were recruited [65% male, mean (SD) age 39. 5 (12.5) years and median (IQR) disease duration 72 (45–138) months]. Most of the patients had axSpA diagnosis (AS: 26, nr-axSpA: 18) while the rest had pSpA (8). The total score of the ASAS-HI was 7.4 (SD: 4.4), BASDAI: 4.4 (SD: 2.7), BASFI: 4.0 (SD: 3.1), ASDAS-CRP: 2.4 (SD: 0.9). Test-retest reliability (n: 20) was good ICC: 0.88 (95%IC 0.76 to 0.98). Sensitivity to change was tested in 13 patients and SMR was -0.61 for those patients receiving TNF inhibitors (n: 11). Convergent validity ranged as hypothesized with Spearman correlations from low (age: 0.27) to good (pain: 0.65), (table 1). The ASAS-HI discriminated well between patients with different stages of disease activity and function irrespective of the measure applied (ASDAS, BASDAI and BASFI) (table 2). The internal consistency according to Cronbach's alfa was 0.81.Table 1.Spearmen correlation coefficientCharacteristicsSpearmen correlation coefficient ASAS-HI (0–17)p value Age0.27<0.05Pain (0–10)0.65<0.001Night spinal pain (0–10)0.54<0.001ASDAS0.51<0.001BASDAI (0–10)0.60<0.001BASFI (0–10)0.54<0.001SF-36 Total0.46<0.001Table 2.ASDAS Status GroupsASDAS Status Groups Inactive (n: 9)Moderate (n: 9)High (n: 29)very high (n: 5) ASAS-HI (0–17)3.44 (± 3.9)5.77 (± 4.79)9. 06 (± 3.49)10.05 (± 4.5)BASFI (0–10)0,53 (± 0,35)1.41 (± 1.40)5.5 (± 2.46)6.46 (± 3.12)BASDAI (0–10)1.21 (± 0.49)2.37 (± 1.7)5.73 (± 1.91)6.46 (± 3.38)ConclusionsThe Argentinean version of the ASAS-HI was comprehensive and reliable by patients with SpA. The ASAS-HI is a valid tool for assessing overall functioning and health in spondyloarthritis.References The ASAS Health Index (ASAS HI)a new tool to assess the health status of patients with spondyloarthritis, Clin Exp Rheumatol 2014;32:S105-S108. Disclosure of InterestV. Duarte Employee of: Novartis Argentina, U. Kiltz: None declared, V. Navarro-Compán: None declared, N. Lloves: None declared, G. Crespo Amaya: None declared, L. Ferreyra: None declared, C. Orozco: None declared, E. Schneeberger: None declared, H. Mald...

BackgroundNon-alcoholic fatty liver disease, characterised by hepatic steatosis (HS), is a major cause of chronic liver disease in many countries. Limited data are available on liver enzyme elevation in patients (pts) with HS who are receiving medications for inflammatory conditions, such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and psoriasis (PsO). Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA and PsA, and has also been studied in PsO.ObjectivesTo describe baseline characteristics and liver enzyme abnormalities in pts from the tofacitinib RA, PsA and PsO clinical programmes with/without HS at baseline.MethodsPts randomised to the tofacitinib (5 or 10 mg twice daily; doses pooled) and placebo arms of 25 studies in the RA, PsA and PsO programmes were included in this pooled post hoc analysis. Most studies allowed or mandated concomitant treatment with disease-modifying antirheumatic drugs. HS was determined by the investigator and captured per the Medical Dictionary for Regulatory Activities term at baseline. Baseline characteristics, incidence of elevated total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >1 x and >3 x the upper limit of normal (ULN) up to Month (M) 3, and change from baseline in C-reactive protein (CRP) at M3 – all by HS at baseline – are reported.ResultsA total of 10 212 pts were included in the analysis. The prevalence of HS was 1.6% across indications (RA: 87/6729 [1.3%]; PsA: 27/710 [3.8%]; PsO: 45/2773 [1.6%]). Baseline characteristics were generally similar in pts with or without HS (table 1). However, baseline obesity, diabetes, triglycerides and liver enzymes were numerically higher, and CRP was numerically lower, in pts with HS than in those without HS (table 1). In both tofacitinib- and placebo-treated pts, incidence of elevated total bilirubin, AST and ALT>1 x ULN up to M3 was higher in pts with HS than in those without HS, across indications (table 1). Incidence of elevated total bilirubin, AST and ALT>3 x ULN up to M3 was low across indications, irrespective of HS (table 1). Among tofacitinib-treated pts, CRP was reduced at M3 in pts with or without HS, but to a lesser extent in those with HS, across indications. Among placebo-treated pts, changes in CRP were small, irrespective of HS (table 1).Abstract FRI0099 – Table 1Baseline characteristics and liver function up to Month 3, by HS at baselineConclusionsIn this exploratory analysis, prevalence of HS at baseline was 1.6% across the tofacitinib RA, PsA and PsO programmes. After up to 3 months of tofacitinib treatment, incidence of mildly elevated liver enzymes was higher in pts with HS than in those without HS. Incidence of severely elevated liver enzymes was low overall, and similar in pts with or without HS. Further studies are needed to evaluate the effects of tofacitinib on CRP and liver enzymes, and the potential impact on clinical response, in pts with RA, PsA or PsO who have comorbid HS.AcknowledgementsStudy sponsored by Pfizer Inc. Medical writing suppor...

Background: Methotrexate (MTX) is the most frequently used medication in patients with Rheumatoid Arthritis (RA). However, several authors have questioned its success due to the presence of adverse events and the lack of adherence. Objectives: to determine cumulative survival of MTX, frequency and type of adverse events and causes of discontinuation in patients with RA. Methods: consecutive patients 18 years and older with a diagnosis of RA (ACR/EULAR 2010 criteria), who had begun treatment with MTX during their disease were included. Sociodemographic, clinical and therapeutic data were collected. Date of initiation and suspension of MTX, route of administration, concomitant treatments, consumption of coffee and tobacco, presence of adverse events (AE) were all consigned. Adherence was evaluated using the Compliance Questionnaire Rheumatology questionnaire 5-item summary version (CQR5). Statistical analysis: descriptive statistics. Chi2 test or Fisher’s exact test; Survival of treatment by Kaplan-Meier and log Rank. Multiple logistic regression. A p value <0.05 was considered significant.