Cocharane analysis «Ruiz Garcia V, Burls A, Cabello JB, et al. Certoli...»1, 5 randomized controlled trials (RCTs), total 2 394 subjects for efficacy and 2 094 for safety, study duration 12-52 weeks, sertolitsumab dose 50-400 mg s.c, three trials comparing placebo in combination with methotrexate, two trials comparing placebo sertolitsimab pegol 200 mg s.c. with or without methotrexate, comparison with placebo with or without methotrexate in adult patients with rheumatoid arthritis with active disease despite DMARDs. Duration of the studies varied 12-24 weeks. Both ACR20 and ACR70 responses were obtained: ACR20 at 24 weeks: risk ratio (RR) 2.57 (95% confidence interval (CI) 2.16-3.05) and at 52 weeks: RR 2.06 (95% CI1.61-2.62). At all doses used, ACR70 response at 24 weeks: RR 3.93 (95% CI 2.41-6.41); at 24 weeks: RR 3.14 (95% CI 1.86-5.29), at all doses used.
More severe infections occurred in those taking sertolizimab than in the control group: in the group taking sertolizimab 200 mg (odds ratio (OR) 3.30, 95% CI 1.45-7.51) and in the group taking sertolizimab 400 mg (OR 3.25, 95% CI 1.65-6.39).
A systematic literature review «Launois R, Avouac B, Berenbaum F, et al. Compariso...»2 was carried out from January 1, 1980, to June 30, 2009, in the following databases: Medline (from 1996), Embase (from 1980), and Cochrane Library (Central Register of Controlled Trials, from 1993). This review was completed by a manual search in the proceedings of the American College of Rheumatology (ACR) and European League Against Rheumatism congresses since 2004.
The studies searched were the controlled, randomized, double-blind trials published in the English language that included adult patients with RA who had an inadequate or no response to DMARD including MTX. In addition, the studies evaluated anticytokine biotherapies indicated for the treatment of RA versus placebo in combination with continuation of inadequate conventional DMARD. Biologics should be used according to their Summary of Product characteristics. Clinical efficacy should have been assessed by the ACR20, ACR50, and ACR70 response rates14. ACR20 criterion, which characterizes a minimal therapeutic response and was the primary efficacy criterion used in the majority of studies, was retained as the major efficacy outcome in the multiple-treatment metaanalysis. ACR50 response, which possesses better clinical significance, and ACR70 response were used as secondary efficacy criteria. Efficacy evaluation had to be available at 24 ± 8 weeks of treatment. According to the defined inclusion criteria, studies were excluded from the analysis if they included patients with RA naive to DMARD or with inadequate or no response to a previous anti-TNF-α, as well as those that did not report ACR20 rates after about 6 months of treatment.
All the selected randomized studies were comparative versus placebo (therefore the common comparator of the multiple-treatment metaanalysis): 14 of them evaluated the efficacy of an anti-TNF-α therapy (infliximab, etanercept, adalimumab, golimumab, CZP) and 5 an anti-interleukin treatment (anakinra, tocilizumab). The metaanalysis thus involves a total of 7158 patients, of whom 3174 received placebo and 3984 received an anticytokine treatment: 698 were treated with infliximab in 4 studies, 160 with etanercept in 2 studies, 657 with adalimumab in 4 studies, 124 with golimumab in 2 studies, 639 with CZP in 2 studies, 250 with anakinra in 1 study, and 1456 with tocilizumab in 4 studies. The evidence network made up of the 19 selected studies enables
For the ACR50 criterion, sertolitsumab has a high OR (10.81; 95% CI 4.41-21.02), comparable to etanercept (11.45; 95% CI 3.45-31.02) and clearly, but not statistically significantly, higher than other treatments.
For the ACR70 criterion, sertolitsumab has the highest OR (15.8; 95% CI 4.64-43.89), which is not statistically significantly different from the values of the other treatments due to the large CIs.
A systematic review and meta-analysis «Tarp S, Furst DE, Dossing A, et al. Defining the o...»3 showed that certolizumab was effective in the treatment of rheumatoid arthritis (OR 4.18, 95% CI 1.99–8.76, compared with placebo) «Tarp S, Furst DE, Dossing A, et al. Defining the o...»3.
Applicable to the Finnish population.
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