Biotechnologically produced drugs as second-line therapy for rheumatoid arthritis: Executive summary of final report A10-01, Version 1.0

The aims of the present investigation were: ■. to assess the benefit of treatment with biotechnologically produced drugs compared with each other. ■. to assess the benefit of treatment with biotechnologically produced drugs compared with treatment with non-biotechnologically produced drugs, as well as ■. to assess the benefit of treatment with biotechnologically produced drugs compared with treatment without therapy extension (with or without placebo control); in each case as second-line therapy in patients with RA. The assessment was based on patient-relevant outcomes. In this context, “treatment extension” is understood as continued therapy initiated as a supplementation to existing therapy. For the present commission, for biotechnologically produced drugs (biologic disease modifying anti-rheumatic drugs, bDMARDs), second-line therapy, i.e. therapy after failure of previous treatment, was to be distinguished from first-line therapy, i.e. therapy in treatment-naive patients. In the present benefit assessment, the definition of second-line therapy therefore covered the use of biotechnologically produced drugs in persons who had been pretreated with at least one disease-modifying antirheumatic drug, also including biotechnologically produced ones.