Background Adding infliximab (IFX) or sulfasalazine+hydroxychloroquine (SSZ+HCQ) to methotrexate (MTX) in patients with active, early rheumatoid arthritis (RA), resulted in superior radiographic outcome in the IFX group, while disease-activity, utility and work loss improved in both arms, without detectable between-group differences at 21 months[1-3].
Objectives To evaluate the cost-effectiveness of biologic vs. conventional combination treatment in early RA-patients responding insufficiently to MTX.
Methods This multicenter, randomised, controlled, open-label trial enrolled RA-patients (symptoms<1y) in Sweden between 2002 and 2005. After 3-4 months of MTX monotherapy, patients with a remaining DAS28>3.2 were randomised to addition of IFX or SSZ+HCQ. The incremental cost-effectiveness ratio (ICER=€/quality-adjusted life-year [QALY]) was assessed during 21 months from randomisation. Costs of RA-related medications, non-primary healthcare utilisation and work loss were retrieved from nationwide registers, while EuroQol 5-Dimensions utility was collected quarterly. Undiscounted analyses including all patients were performed from the societal (human capital method) and healthcare perspectives. Confidence intervals were estimated by non-parametric bootstrapping.
Results Of 487 patients initially enrolled, 128 and 130 were randomised to biologic and conventional treatment, respectively. The biologic group had higher drug and healthcare costs (€27,487 vs. 10,364; adjusted mean difference 16,956 [95%CI 14,647;19,162]), while no difference was seen in productivity losses (€33,804 vs. 29,220; 3,961 [-3,986;11,850]), resulting in higher societal cost, as compared to the conventional treatment arm (€61,291 vs. 39,584; 20,916 [12,800;28,660]). Mean accumulated QALYs were 1.10 in the biologic and 1.12 in the conventional treatment group (adjusted mean difference 0.01 [95%CI -0.07;0.08]). The resulting ICER, comparing the biologic to the conventional treatment option, was €2,404,197/QALY from the societal (Figure), and €1,948,919/QALY from the healthcare perspective.
Conclusions In early MTX-refractory RA, the addition of IFX, as compared to addition of SSZ+HCQ, was not cost-effective over 21 months at willingness to pay levels generally considered acceptable.
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Disclosure of Interest None Declared