Effectiveness of methotrexate and leflunomide as corticoid-sparing drugs in patients with polymyalgia rheumatica.

Objectives: The need for glucocorticoid-sparing drugs (GCSD) remains an important issue and is an unmet need in the treatment of polymyalgia rheumatica (PMR). We therefore aimed to assess the effectiveness and safety of methotrexate (MTX) and of leflunomide (LEF) in daily clinical practice in PMR patients from Argentina. Methods: A multicentre and observational study (medical records review) of PMR patients seen between 2007 and 2023, who had at least three months of follow-up after starting a GCSD, either MTX or LEF, was performed. Results are expressed as medians and interquartile ranges [25th-75th (IQR)] for continuous variables and percentages for categorical ones. The two treatment groups were compared using χ2 test for categorical variables, Mann-Whitney U test for continuous variables and the log-rank test for time-to-event data. Crude and adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using logistic regression. In all cases, a p-value <0.05 was considered statistically significant. Results: One-hundred and eighty-six patients (79% female) with a median age of 72 years (IQR, 65-77 years) were included. One-hundred and forty-three patients (77%) were prescribed MTX (15, IQR 10-15) and 43 (23%) LEF (20 mg, fixed dose). Flare-ups (relapses and recurrences) occurred in 13 patients (7%) and were comparable between both groups. Persistent GCSD intake was observed in 145 patients (78%). Glucocorticoid (GC) withdrawal was achieved in 67 of these 145 patients (46%) and this occurred more frequently in the LEF group (P = 0.001). Furthermore, time until prednisone discontinuation was shorter in the LEF-treated patients (4.7 months, IQR 3-20 on LEF versus 31.8 months, IQR 10-82 on MTX, P = 0.000). Remission was found more frequently in the LEF group (P = 0.003). In the multivariate analysis, the probability of remission was higher with LEF therapy (P = 0.010) and this finding persisted in the subgroup analysis who were followed up < 40 months (OR 3.12, 95% CI = 1.30-7.47, P = 0.011). Conclusions: This study demonstrated the clinical effectiveness of LEF and even its superiority in achieving remission when compared with MTX as GCSD in PMR patients. Further research is needed to support these findings.

Risk Factors for Relapse and/or Prolonged Glucocorticoid Therapy in Polymyalgia Rheumatica: Multicenter Study in 185 Patients.

BACKGROUND: In polymyalgia rheumatica (PMR) relapses and long-term GC dependency are common. We assessed risk factors for higher relapse rate and/or prolonged glucocorticoid therapy in PMR patients. METHODS: A multicenter and observational study (chart review) of PMR patients seen between 2006 and 2021 who had at least a 3-month follow-up period after starting GCs was performed. Results were expressed as median and interquartile range 25th-75th or mean ± standard deviation for numerical variables and percentage for categorical ones. Relapse versus nonrelapse groups were compared using Cox proportional analysis. Hazards ratios (HRs) with 95% confidence intervals (CIs) are reported. In all cases, a p value <0.05 was considered to indicate statistical significance. RESULTS: We included 185 patients (69.1% female). The median follow-up time was 17.1 months (interquartile range, 6.8-34.7). Incidence of relapses was 1.2 per 100 persons/month. In univariate analysis, PMR patients with a previous history of dyslipidemia had a lower risk of relapse (HR, 0.55; 95% CI, 0.33-0.94; p = 0.03); high-dose GC (HR, 2.35; 95% CI, 1.42-3.87; p = 0.001) and faster GC dose reduction had higher risk of relapse (HR, 3.04; 95% CI, 1.77-5.21; p = 0.001). In multivariate analysis, a previous history of dyslipidemia had a lower risk of relapse (HR, 0.54; 95% CI, 0.32-0.92; p = 0.023), and high dose of GC (HR, 2.46; 95% CI, 1.49-4.08; p = 0.001) remained the only risk factors for relapse. CONCLUSIONS: Lower doses of corticosteroids and a slow rate of reduction are critical to avoid relapse in PMR. Risk factors for higher relapse rate rely on therapy more than clinical characteristics of the patients at the time of diagnosis of PMR.

Asociación entre Artritis Reumatoidea y otras enfermedades autoinmunes / Association between Rheumatoid Arthritis and other autoimmune diseases

Objetivos: Determinar la frecuencia de enfermedades autoinmunes (EAI) en pacientes con Artritis Reumatoidea (AR) y comparar la frecuencia de EAI entre pacientes con AR y sin AR ni otra EAI reumatológica. Material y Métodos: Estudio multicéntrico, observacional, analítico, retrospectivo. Se incluyeron pacientes consecutivos con AR (ACR/EULAR 2010) y como grupo control pacientes con diagnóstico inicial de Osteoartritis primaria (OA). Resultados: Se incluyeron 1549 pacientes: 831 con AR (84% mujeres, edad media 55.2 años [DE 13.6]) y 718 con OA (82% mujeres, edad media 67 años [DE 11.1]). La frecuencia de EAI en el grupo AR fue del 22% (n=183). Estos presentaron mayor frecuencia de EAI reumatológicas (9.4 vs 3.3%, p< 0.001), y menor frecuencia de EAI no reumatológicas que aquellos con OA (15.3 vs 20.5, p=0.007). La EAI reumatológica más prevalente fue el Síndrome de Sjögren, el cual fue más frecuente en el grupo AR (87.2 vs 29.2%, p< 0,001). La frecuencia de EAI reumatológicas en los pacientes con AR fue mayor en la forma erosiva (11 vs 6.8%, p=0.048). Conclusión: La frecuencia de EAI en los pacientes con AR fue del 22%, en quienes predominaron las de etiología reumatológica mientras que, las no reumatológicas predominaron en pacientes con OA.

Objectives: To determine the frequency of autoimmune diseases (AID) in Rheumatoid Arthritis (RA) patients and to compare this frequency between patients with and without RA or other rheumatologic AID. Methods: Multicenter, observational, analytical, retrospective study. Consecutive patients with diagnosis of RA (ACR/EULAR 2010) were included. Patients with initial diagnosis of primary ostearthritis (OA) were used as control group. Results: A total of 1549 patients were included: 831 RA (84% women, mean age 55.2 [±13.6]) and 718 OA (82% women, mean age 67 [± 11.1]). The frequency of AID in the RA group was 22% (n=183). RA patients showed higher frequency of rheumatologic AID (9.4 vs 3.3%, p< 0.001), and lower frequency of non-rheumatologic AID than OA patients (15.3 vs 20.5%, p= 0.007). The most prevalent rheumatic AID was Sjögren's Syndrome, which was more frequent in the AR group (87.2 vs 29.2%, p<0.001). The frequency of rheumatologic AID in RA patients was higher in those with erosive RA (11 vs 6.8%, p=0.048). Conclusion: The frequency of AID in RA patients was 22%. Rheumatologic AID were more frequent in RA patients, whereas non-rheumatologic AID prevailed in OA patients.

Adaptación de la versión para pacientes de las recomendaciones para el tratamiento hacia un objetivo (T2T) en artritis reumatoidea para su uso en Argentina / Adaptation of the treat to target patients versión in Argentinean patients with rheumatoid arthritis

En el año 2008 fueron publicadas las recomendaciones para eltratamiento hacia el objetivo en artritis reumatoidea (treat to target:T2T). Originalmente diseñadas como recomendaciones para guiar areumatólogos en el tratamiento de la AR, en el año 2011 se publicóla primera versión para pacientes de estas recomendaciones eninglés.Objetivo: validar la versión para pacientes de las recomendacionesT2T para su uso en Argentina a través de la adaptación transculturalde la versión original.Método: Se realizó un proceso de adaptación transcultural a partirde la versión original. De este proceso de traducción y retraduccióny del análisis por parte de un comité de expertos, se obtuvo unaversión prefinal.Esta versión fue sometida a una prueba de campo mediante unaentrevista a pacientes alfabetos consecutivos con diagnósticode AR en diferentes centros de Buenos Aires, Ciudad de BuenosAires y Santa Fe. En esta entrevista se evaluó validez de forma,equivalencia conceptual, interpretabilidad y aceptabilidad. Elresultado obtenido de estas entrevistas fue discutido con el comitédesignado de investigadores para desarrollar una versión final dela pieza validada.Durante la entrevista se permitió leer la versión en español prefinaly se invitó a calificar de 0 a 10 cada oración de acuerdo al gradode comprensión del texto. A su vez se exploró el grado de acuerdoy de adaptabilidad a su problema de salud y se reemplazaron laspalabras que ofrecieron mayores dificultades...

In 2008 recommendations for the treatment towards the targetin rheumatoid arthritis (treat to target: T2T) were published.Originally designed as recommendations to guide rheumatologistsin the treatment of RA, in 2011 the first patient version of theserecommendations was published in English.Objective: To validate the Spanish version of the patient version ofthe T2T recommendations through cross-cultural adaptation of theoriginal version.Method: A cross-cultural adaptation process was made from theoriginal version. In this process of translation and back translationand analysis by a committee of experts, a prefinal version wasobtained.This version was subjected to a field test by interviewing alphabetsconsecutive patients diagnosed with RA at different centers inBuenos Aires, CABA and Santa Fe. Construct validity, cross-culturaladaptability, interpretation and acceptability were evaluated andlater discussed with the committee to get the final version.After reading patients had to point each sentence from 0 to 10according to the degree of understanding of the text. The degreeof agreement and adaptability to their health problem was exploredand words that offered greater difficulties were replaced...