Background The Early Rheumatoid Arthritis Clinic (EAC) was established in 2010 to meet NICE recommendations for treatment of early RA . Locally developed protocol of rapid escalation of treatment with combination of conventional DMARDs was used. High remission and low disease activity (LDA) rates after 1 year of this treatment were reported earlier . In order to control disease activity many patients had to go on combination of Methotrexate (MTX), Hydroxychloroquine (HCQ) and Leflunomide (LEF).
Objectives To analyse tolerance and efficacy of combination of MTX, HCQ and LEF in EAC patients.
Methods Patients were adults with diagnosis of RA ≤ 2 years and active disease (DAS > 3.2). Target of treatment was DAS28 remission (DAS28 < 2.6) or LDA (DAS28 < 3.2). We used our protocol for treatment escalation. Therapy started with MTX, with rapid escalation from 15mg to 25 mg per week. If activity persisted, HCQ was added. If DAS28 remained above 3.2, patients were given LEF (10mg, increased to 20mg if necessary). If the disease still remained active, treatment with biologic drugs started. We did not use LEF if patients planned childbirth. The patients were seen every 4-6 weeks, and DAS28 CRP was calculated on each visit.
Results Of 148 who have continued to attend the EAC, 47 patients (32%) needed treatment with the combination of LEF + HCQ + MTX. The female to male ratio was 1.7:1. At the first visit, all patients had DAS28 > 3.2, and 79% of them were seropositive. 22 of 47 patients (46%) had to stop LEF because of side effects (such as abnormal liver tests, diarrhoea, cytopenia or rash), compliance issues or an onset of a-TNF treatment. All side effects were reversible and not severe. The remaining 25 pts (54%) continued treatment and were still on the MTX+ HCQ + LEF combination at the last visit to the EAC. Almost all patients were on combination of 25mg of MTX (20mg in 3 cases), HCQ 200mg (except 3 cases of intolerance) and LEF 10 mg or 20 mg (12 and 13 patients, respectively). Results of treatment are shown in Table 1.
Conclusions 54% of the patients tolerated the treatment and among these it was highly effective and resulted in LDA or remission in 24 of 25 patients (96%). Our results agree well with limited available data on LEF+MTX efficacy [3, 4]. In the 46% of patients who could not tolerate the combination all of the side effects were reversible. Due to close monitoring of patients in the EAC, LEF could be stopped at the very first signs of intolerance, with serious side effects avoided.
NICE, Feb 2009.
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Sakellariou GT et al., Clin. Rheumatol. 2011, Sept 9 (Epub ahead of print).
Sakellariou GT et al., Rheumatol. Int. 2012, Nov 5 (Epub ahead of print).
Disclosure of Interest None Declared