Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Are the Switch to Subcutaneous Administration of MTX or the Addition of Cyclosporine to Oral MTX Useful Steps in a Tight Control Strategy for RA?
Bakker, Marije F., Jacobs, Johannes W.G., Welsing, Paco M.J., Bijlsma, Johannes W.J., Lafeber, Floris P.J.G.
Methotrexate (MTX) is widely used as the DMARD of first choice in the treatment of rheumatoid arthritis (RA) patients. In an earlier strategy trial (CAMERA) in early RA patients, a tight control MTX strategy proved to be more effective when compared to conventional MTX treatment. However, a substantial number of patients do not respond favorably enough to the maximally (tolerable) dose MTX and need more intensified treatment. Within the CAMERA strategy these intensified treatment steps were defined as subcutaneous (sc) MTX instead of oral MTX treatment; in case this was not effective enough, was contraindicated or caused adverse effects, cyclosporine was added to oral MTX treatment with a simultaneous reduction of the dose MTX to a maximum of 15mg/wk. The aim of this study was to investigate the effectiveness of these two treatment strategy steps.
The change in disease activity (DAS28) over one month after taking the scMTX step was compared to the average 3 monthly change before taking the step. For the cyclosporine strategy step the change in DAS28 over 3 months after taking this step (since cyclosporine has a slow onset of action) was compared to the average 3 monthly change before taking this step. Analyses were performed separately for patients who needed the step because of insufficient effect and for those who needed it because of adverse effects. Additionally, analyses of individual responses and time on treatment were performed.
Of the 151 patients within the tight control strategy arm of the CAMERA study, 57 needed the scMTX strategy step (21 because of adverse events, 36 because of insufficient effect) and 40 the cyclosporine strategy step (20 and 20, respectively). These patients had a mean age of 54 years, 69% was female, and 54% was RF+. For the scMTX strategy step the DAS28 decreased over the 4 months evaluation period (p=0.47 for adverse events, p<0.01 for insufficient effect). The decrease in DAS28 between baseline and 4 months was 0.4 and 0.6 points for adverse events and insufficient effect, respectively. For the cyclosporine strategy step no (significant) trend in DAS28 over time was observed. For patients taking the scMTX strategy step because of adverse events, the mean improvement in DAS28 exceeded the mean 3 month improvement in DAS28 before this step by 0.08 units (p=0.83); for patients taking the step for insufficient effect this was 0.29 DAS28 units (p=0.08). For patients taking the cyclosporine strategy step because of adverse events the DAS28 increased with 0.26 units (p=0.44) and for those needing the step because of insufficient effect, the decrease was 0.15 units (p=0.68).
Although not statistically significantly (probably due to low numbers), the scMTX strategy step seems to be effective in early RA patients needing this step because of insufficient effect of oral MTX. The cyclosporine strategy step appears not to be effective, possibly due to concomitant lowering of the MTX dose.
To cite this abstract, please use the following information:
Bakker, Marije F., Jacobs, Johannes W.G., Welsing, Paco M.J., Bijlsma, Johannes W.J., Lafeber, Floris P.J.G.; Are the Switch to Subcutaneous Administration of MTX or the Addition of Cyclosporine to Oral MTX Useful Steps in a Tight Control Strategy for RA? [abstract]. Arthritis Rheum 2009;60 Suppl 10 :423