Background Oral methotrexate (MTX) is frequently used in the treatment of patients with rheumatoid arthritis (RA). Subcutaneous (SC) MTX is increasingly being prescribed in clinical practice as an alternative since, at the same dose, it has been shown to be more efficacious than oral MTX1 and better tolerated.2,3 Patients who have switched from oral to SC MTX due to intolerance or lack of efficacy respond well,1 and have reported an improved quality of life.4 Routine use of SCMTX following oral MTX failure may also avoid the need for costly biologic therapy in selected patients.5 There are, however, few published data on the use of SCMTX in real-life clinical setting.
Objectives To identify clinical outcomes of RA patients in the clinical context of a District General Hospital following a switch to SCMTX after failure of oral MTX.
Methods RA patients who has received SCMTX at the Royal Surrey County Hospital, Guildford were identified from medical records. 103 patients were eligible for inclusion. Demographic data, reasons for switch from oral to SCMTX, continuation rates, biologic therapy, disease activity scores (DAS), swollen and tender joint counts (SJC and TJC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels and visual analogue scale (VAS) scores were recorded.
Results The average age for the diagnosis of RA in our cohort was 50 years. 79% of patients were female. Mean duration of oral therapy was 8.8 years, at a mean weekly dose of 20.3 mg (range 7.5-25.0 mg/week). 43% of all patients were on one DMARD and 12% on two DMARDs. Reasons for switching to SCMTX included lack of efficacy (45%) and intolerance/adverse events (27%). When switched 89 patients were receiving SCMTX without biologic (mean dose 20.8 mg/week); 14 patients (mean dose 18.4 mg/week) were already on a biologic. For the total cohort continuation rate at the end of year 1 was 94% and at the end of year 2 was 82%. Treatment continuation at the end of year 1 for patients on SCMTX alone was similar to that of patients on SCMTX and a biologic (94% vs.93%, respectively), but lower at the end of year 2 (77% vs. 92%, respectively). In total 9 patients discontinued SCMTX over the 2-year period due to adverse events (5), efficacy (1), other/unknown reason (3). DAS assessments at 3, 6 and 12 months showed continued DAS improvement over time and a rise in both significant improvements ΔDAS28 >1.2 and remission rates (DAS <2.6). Improvements in SJC, TJC, ESR, CRP levels and VAS scores were also seen over time.
Conclusions Analysis of our audit suggest that there is added benefit of switching patients to SCMTX at the same dose, for those who fail to respond to or tolerate oral MTX. Patients responded well with high continuation rates after 1 and 2 years' therapy. Reductions in DAS and levels of remission, either with or without biologic therapy, were also seen. Based on these findings SCMTX could be considered as a routine before introducing a biologic agent.
Braun J, et al. Arthritis Rheum 2008;58:73-81.
Rutkowska-Sak L, et al. Reumatologia 2009;47:207-11.
Dalkilic E, et al. Mod Rheumatol 2013;23:525-8.
Striesow F, et al. Ther Adv Musculoskelet Dis 2012;4:3-9.
Fitzpatrick R, et al. Clin Rheumatol 2013;32:1605-12.
Acknowledgements This study was supported by medac UK.
Disclosure of Interest None declared