Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting.

OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting. MATERIALS AND METHODS: Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed. RESULTS: Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%). CONCLUSIONS: In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.

Eficacia y seguridad de la terapia combinada con fármacos modificadores de la enfermedad sintéticos en la artritis reumatoide: revisión sistemática de la literatura / Efficacy and safety of combined therapy with synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: systematic literature review

OBJETIVO: 1) Revisar sistemática y críticamente la evidencia sobre eficacia y seguridad de la terapia combinada con fármacos modificadores de la enfermedad (FAME) sintéticos en la artritis reumatoide (AR); 2) Emitir recomendaciones prácticas sobre su uso. MÉTODOS: Se realizó una revisión sistemática de la literatura con una estrategia de búsqueda bibliográfica sensible en Medline, Embase y Cochrane Library. Se seleccionaron ensayos clínicos aleatorizados que analizasen la eficacia y/o seguridad de 1) la terapia combinada con FAME sintéticos comparada con la terapia secuencial con FAME sintético en la AR de inicio; y 2) la combinación metotrexato+leflunomida o la triple terapia de FAME sintéticos en la AR establecida refractaria a FAME sintéticos. Dos revisores realizaron la primera selección por título y abstract y 11 la selección tras lectura en detalle y la recogida de datos. La calidad se evaluó con la escala de Jadad. En una reunión de grupo nominal en base sus resultados se consensuaron una serie de recomendaciones. RESULTADOS: Finalmente no se incluyó ningún artículo en la RSL. Del análisis de los artículos revisados se encontró la eficacia en las AR de inicio del tratamiento precoz con FAME sintéticos siguiendo una estrategia «treat to target» y en AR establecidas refractarias a FAME sintéticos la de la terapia combinada con FAME sintéticos. Con ello se generaron 5 recomendaciones sobre la terapia combinada con FAME sintéticos. CONCLUSIONES: Estas recomendaciones pretenden facilitar la toma de decisiones con el uso de la terapia combinada con FAME sintéticos en la AR

OBJECTIVE: 1) To systematically and critically review the evidence of combined therapy with synthetic disease-modifying antirheumatic drugs (DMARD) in rheumatoid arthritis (RA); 2) To design practical recommendations on their use. METHODS: A systematic literature review (SLR) was performed with a sensitive bibliographic search strategy in Medline, EMBASE and Cochrane Library. We selected randomized clinical trials that analyzed the efficacy and/or safety of 1) combined therapy of synthetic compared with sequential therapy of synthetic DMARD in early RA; and 2) combination of methotrexate+leflunomide or triple therapy with synthetic DMARD in established RA refractory to synthetic DMARD. Two reviewers made the first selection by title and abstract and 11 performed the selection after detailed review of the articles and data collection. The quality of the studies was evaluated with the Jadad scale. Based on the results, related recommendations were agreed upon in a nominal group meeting. RESULTS: Ultimately, no articles were included in the SLR. The analysis of the reviewed articles demonstrated the effectiveness of the treatment with synthetic DMARD following a "treat to target" strategy in early RA patients, and of combination therapy of synthetic DMARD in established RA refractory to synthetic DMARD. This resulted in 6 recommendations concerning combination therapy with synthetic DMARD. CONCLUSIONS: These recommendations aim to facilitate decision-making with the use of combined therapy with DMARD in RA

Prevalence and characteristics associated with dactylitis in patients with early spondyloarthritis: results from the ESPeranza cohort.

OBJECTIVES: Dactylitis is a typical feature of psoriatic arthritis. However, dactylitis was included as a spondyloarthritis (SpA) feature for both (axial and peripheral) of the ASAS classification criteria, but data about its prevalence are scarce, especially in patients with a recent onset of the disease. Our objective was to determine the prevalence and characteristics associated with dactylitis in patients with early SpA. METHODS: A baseline dataset from the ESPeranza cohort was used. This programme included patients who were suspected of having SpA (age <45 years, symptoms duration of 3-24 months and with inflammatory back pain, or asymmetrical arthritis, or spinal/joint pain plus ≥1 of the SpA features). For this study, 609 patients who were diagnosed with SpA by their physician were included. Descriptive, univariable and multivariable logistic regression analyses were employed to investigate the association between the presence of dactylitis and the characteristics associated with SpA. RESULTS: Fifty-eight (9.5%) patients currently or previously had dactylitis. In the multivariable analysis, dactylitis was independently associated with peripheral arthritis (OR= 4.83; p<0.001), enthesitis (OR= 2.49; p=0.01), psoriasis (OR= 3.62; p<0.01) and the physician's visual analogue scale (OR= 0.82; p=0.01). However, 67% of the patients who had dactylitis did not have peripheral arthritis or psoriasis and 15% had predominantly axial disease. CONCLUSIONS: Dactylitis is a frequent manifestation in patients with SpA, even during the early stages of the disease. Its presence is mainly associated with peripheral manifestations and psoriasis. Nevertheless, dactylitis is not exclusive of patients with PsA or peripheral manifestations.