The use of adalimumab, etanercept, golimumab and infliximab in rheumatic pathologies: variation between label dosage and real-world use

Abstract

Rheumatoid arthritis (AR), psoriatic arthritis (PSA) and ankylosing spondylitis (AS) are autoimmune systemic diseases characterized by inflammation, pain and joint degeneration. The objective of this study is to evaluate, under the actual conditions of use, dosing patterns of adalimumab, etanercept, golimumab and infliximab in these pathologies, and compare them with the label regimens recommended, as well as evaluating the financial implications of these regimen modifications. The study population included all adult patients diagnosed with RA, PSA or AS who had been treated with adalimumab, etanercept, golimumab and infliximab for at least 6 months between 1 January 2011 and 31 December 2013. The main variable of this study was to assess the dose dispensed for drugs administered subcutaneously and the dose prepared/administered for drugs administered intravenously, and the annual costs of the treatment. A total of 5,428 episodes were included. The mean weekly dose was lower than the standard dose in the three pathologies studied in the patients treated with adalimumab and etanercept (84.3% vs 81.2% for RA, 85.0% vs 78.0% for PSA and 87.8% vs 81.6% for AS). The drugs with highest dose optimization in RA are etanercept (46.3%) followed by adalimumab (46%); however, the highest percentage of patients with major dose optimization corresponds to etanercept (11.6%). Both in the PA and the AS group, we also observed that etanercept is the drug more optimized, corresponding to 53.9 and 43% of patients, respectively. By contrast, 48.5% of patients with RA treated with infliximab required dose intensification; however, infliximab dose intensification in PSA and AS is not so pronounced. The practice of optimization of dose regimens in patients with rheumatic diseases under treatment with anti-TNFα is spreading among professionals, resulting in annual cost reduction in the treatment of rheumatic arthropathies. However, long term follow-up will be necessary to assess the influence of this optimization on health outcomes.

Keywords:

• adalimumab
• ankylosing spondylitis
• antirheumatic agents
• cost
• etanercept
• golimumab
• infliximab
• psoriatic arthritis
• real-world data
• rheumatoid arthritis

Acknowledgements

The authors would like to thank E Tomás-Guillén, Asserta Foundation, for data management and statistical analysis.

Financial & competing interests disclosure

Pfizer, S.L.U. funded the data management and statistical analysis but have not participated in the design of the study nor the analysis of the data nor assisted in the preparation of the manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Early diagnosis and treatment are important to achieve good outcomes in patients with rheumatic pathologies.

• Biological disease-modifying antirheumatic drugs have improved the prognosis of patients with rheumatoid arthritis, but they are expensive and their side-effect profiles are needed to be considered when used.

• Biological disease-modifying antirheumatic drug dose reduction may be possible in those patients who have achieved good disease control.

• According to the study, the mean weekly dose was lower than the standard dose in the three pathologies studied in the patients treated with adalimumab and etanercept.

• The highest percentage of patients with major dose optimization corresponds to etanercept (11.6%). Biological disease-modifying antirheumatic drug dose reduction may be possible in those patients who have achieved good disease control.