A clinical and health economical observational study of anti-tumor necrosis factor therapy in the treatment of rheumatoid arthritis in Finland
Year: 2014
Type: dissertation
Study design: Observational Study
Abstract: Biological antirheumatic drugs are biotechnologically produced antibodies or fusion proteins that are used if rheumatic inflammation is not sufficiently ameliorated with conventional antirheumatic drugs. Approximately 10% of Finnish rheumatoid arthritis (RA) patients use biological drugs. Biological antirheumatic drugs target inflammatory mediators and cells. Tumor necrosis factor inhibitors (TNFi) have been used since the beginning of the 2000s, and they are still the primarily used type of biological antirheumatic drug. The efficacy and safety has been assessed in clinical drug trials usually of 6 to 12 months duration with strict inclusion and exclusion criteria. In practice these drugs are used for much longer and in very diverse patient populations. In this work, the effectiveness and adverse events (AEs) of TNFi treatment in a routine care setting were assessed using the national register of biological drugs. Biological drugs are expensive, and therefore also their cost-effectiveness and the outcomes of switching a TNFi to another one were assessed. The effectiveness of the TNFi infliximab (IFX) was similar to its efficacy in clinical trials. In about 2/3 of the patients clinically significant symptom relief was achieved within 3 months, and 42% achieved remission within the first year. The need of glucocorticoid and pain medication was reduced. In addition to methotrexate assessed in clinical trials, also other conventional antirheumatic drugs were suitable concomitant drugs. The most frequent AEs of TNFi treatment were infections, eczemas, and infusion reactions. AEs were reported in 17% of patients using biologicals, serious ones in 3.1%. No unexpected AEs were reported. 76% of RA patients benefited from IFX in terms of quality-adjusted life years (QALY); their functional capacity and subjective health improved. The median price of a QALY was 51884 . The best cost-effectiveness was achieved in patients with particularly high disease activity and significant response to the treatment. The IFX dose and methotrexate use also affected the cost-effectiveness. Switching a TNFi to another one was useful in cases where initial effectiveness was lost, and in cases of AEs such as infusion reactions, eczemas, or local injection site reactions, which did not require discontinuation of TNFi treatment altogether; in these cases the switch led to a similar or even better effect. The register research indicates that TNFi treatment is effective and relatively safe in RA refractory to other treatments. It was cost-effective in a significant portion of the patients; new drug alternatives (including biosimilars) and the contemporary treatment aim of remission may further improve the cost-effectiveness.
Source: Työväentutkimus Vuosikirja
Author: Liisa Virkki
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W1932457913