OBJECTIVE: To investigate the long-term effects of the tight control (TC) and conventional (CT) methotrexate-based strategies of the Computer Assisted Management in Early Rheumatoid Arthritis trial in early rheumatoid arthritis and evaluate the predictive value of an early response to treatment.
METHODS: Clinical and radiographic 5-year outcome was compared between initial strategies. Patients were classified according to the EULAR response criteria. The prognostic value of early response to treatment in addition to established predictors was analysed by multiple linear regression analyses.
RESULTS: 5 years of data were available for 205 of 299 patients, with no indication for selective drop-out. At 5 years there was no longer any significant difference for clinical and radiographic outcomes between treatment strategies applied during the first 2 years. Good-responders had a mean disease activity score of 2.39 (1.2) and median yearly radiographic progression rate of 0.6 (0.0 to 2.2) at 5 years; significantly lower (both p<0.02) when compared to moderate- and non-responders. Multiple regression analysis showed that early response to treatment is an independent predictor of 5-year outcome, irrespective of treatment strategy.
CONCLUSIONS: The difference in disease activity between treatment strategies disappeared over the years. Good-response to treatment independently predicts significantly better 5-year clinical and radiographic outcome. The TC principle probably should be continued in the long-term.
Objective: To investigate the effects of a switch from oral methotrexate (MTX) to subcutaneous MTX (scMTX) or adding ciclosporin to oral MTX with a simultaneous reduction of the MTX dose, in case of adverse events (AE) or insuffi cient effect (IE) in rheumatoid arthritis (RA). Methods: The tight control treatment arm of the Computer Assisted Management in Early RA (CAMERA) trial was evaluated. The change in 28-joint Disease Activity Score (DAS28) after taking scMTX (over 1 month) or adding ciclosporin (over 3 months) was compared to the average monthly change in the preceding 3 months. Analyses were performed separately for strategy steps because of AE or IE. Results: Of 151 patients, 57 needed the scMTX strategy step (21 because of AE, 36 because of IE) and 40 the following ciclosporin strategy step (20 and 20, respectively). The decrease in DAS28 after taking the scMTX strategy step was 0.30 points (p<0.05); no significant change in DAS28 was seen after the ciclosporin strategy step. In both strategy steps for AE or IE, quite similar observations were made. Of the patients who took the scMTX strategy step, 63% showed improvement. Conclusion: scMTX seems a useful treatment step after oral MTX in a tight control strategy, whereas the ciclosporin step seems ineffective.
OBJECTIVE: To evaluate toxicity profiles in patients with rheumatoid arthritis (RA) treated either according to an intensive or a conventional treatment strategy approach with methotrexate (MTX) and to study factors associated with MTX-related toxicity.
METHODS: Data were used from the Computer-Assisted Management in Early Rheumatoid Arthritis (CAMERA) study, in which clinical efficacy of an intensive treatment strategy with MTX was more beneficial than a conventional treatment strategy approach. In this study, data on adverse events (AEs) were compared between the two strategy groups. Logistic regression analyses were used to identify possible associations between factors assessed at baseline and withdrawal due to MTX-related AEs or liver toxicity at follow-up.
RESULTS: Although significantly more patients in the intensive strategy group experienced MTX-related AEs than in the conventional strategy group, all recorded AEs were relatively mild. A higher body mass index (BMI) was significantly associated with withdrawal due to MTX-related AEs in the multiple regression analyses (odds ratio=1.207, 95% confidence interval 1.02 to 1.44, p=0.033). There was a trend towards an association between diminished creatinine clearance and MTX withdrawal. For liver toxicity, increased serum liver enzymes at baseline were associated with liver toxicity during follow-up.
CONCLUSION: Although the occurrence of AEs in the intensive strategy group was higher than in the conventional strategy group, the previously observed clinical efficacy of an intensive treatment strategy seems to outweigh the observed toxicity profiles. When starting MTX, attention should be given to patients with a high BMI and those with increased levels of liver enzymes and decreased renal function.
ANTECEDENTES: Para investigar si el tratamiento intensivo con metotrexato (MTX), de acuerdo a un estricto protocolo y un programa informático de decisión es más beneficiosa en comparación con el tratamiento convencional con metotrexato en la artritis reumatoide temprana.
MÉTODOS: En un ensayo multicéntrico de dos años abierta estrategia de marca, 299 pacientes con artritis reumatoide temprana fueron asignados aleatoriamente al grupo de estrategia intensiva o el grupo de estrategia convencional. Los pacientes de ambos grupos recibieron MTX, el objetivo de la remisión de los tratamientos se apliquen. Los pacientes en el grupo de tratamiento intensivo llegó a la consulta externa una vez al mes, el ajuste de la dosis de MTX se adapta a cada paciente sobre la base de los criterios de respuesta predefinidos, utilizando un programa informático de decisión. Los pacientes del grupo de estrategia convencional llegó a la consulta externa una vez cada tres meses, que fueron tratados de acuerdo con la práctica común. La ciclosporina se añadió si los pacientes tenían una respuesta inadecuada a MTX dosis máxima tolerada.
RESULTADOS: Setenta y seis (50%) pacientes del grupo de estrategia intensiva logrado por lo menos un período de remisión durante el juicio de dos años, en comparación con 55 pacientes (37%) en el grupo de estrategia convencional (p = 0,03). Las áreas bajo la curva para casi todas las variables clínicas fueron significativamente menores, es decir, no había un mejor efecto clínico para el grupo de tratamiento intensivo en comparación con el grupo de tratamiento convencional.
CONCLUSIÓN: Los resultados de este estudio muestran que es posible mejorar sustancialmente la eficacia clínica temprano en el curso de la enfermedad mediante la intensificación del tratamiento con MTX, con el objetivo de la remisión, a la medida para cada paciente. Por otra parte, los reumatólogos participantes indicaron que el programa informático de decisión podría ser una herramienta útil en su práctica clínica diaria.
To investigate the long-term effects of the tight control (TC) and conventional (CT) methotrexate-based strategies of the Computer Assisted Management in Early Rheumatoid Arthritis trial in early rheumatoid arthritis and evaluate the predictive value of an early response to treatment.
METHODS:
Clinical and radiographic 5-year outcome was compared between initial strategies. Patients were classified according to the EULAR response criteria. The prognostic value of early response to treatment in addition to established predictors was analysed by multiple linear regression analyses.
RESULTS:
5 years of data were available for 205 of 299 patients, with no indication for selective drop-out. At 5 years there was no longer any significant difference for clinical and radiographic outcomes between treatment strategies applied during the first 2 years. Good-responders had a mean disease activity score of 2.39 (1.2) and median yearly radiographic progression rate of 0.6 (0.0 to 2.2) at 5 years; significantly lower (both p<0.02) when compared to moderate- and non-responders. Multiple regression analysis showed that early response to treatment is an independent predictor of 5-year outcome, irrespective of treatment strategy.
CONCLUSIONS:
The difference in disease activity between treatment strategies disappeared over the years. Good-response to treatment independently predicts significantly better 5-year clinical and radiographic outcome. The TC principle probably should be continued in the long-term.
Diseño del estudio»Ensayo controlado aleatorizado (ECA)
