Background Infliximab ('Remicade') has been authorized in the EU since 1999. It has a license for use in major rheumatic diseases and inflammatory bowel disease. The biosimilar 'Inflectra' received its license in Europe in September 2013. It was first launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry. Inflectra was introduced to Cyprus in 2014 and soon after that, every patient with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis would receive this agent when a biologic agent was required. At first there was significant concern amongst the medical community regarding efficacy and safety of biosimilars. Careful observation and pharmacovigilance are therefore required to analyse the effectiveness and safety of biosimilar agents since the significant price difference means that they will be used extensively from now on.
Objectives The aim of this study was to record statistics of use, effectiveness and safety of the first biosimilar 'Inflectra' following its introduction in Cyprus.
Methods Cypriot rheumatologists completed an online form for every patient who was prescribed 'Inflectra' from the introduction of the biosimilar in 2014, until late 2016. Collected data included patient characteristics, diagnosis, whether the patient remains on the drug or not, reasons for discontinuation, side effects and physician impression of effectiveness.
Results 160 patients were entered. Male: Female ratio was roughly equal and 90% were taking a biologic for the first time ('biologic naive'). Indications were Rheumatoid arthritis in 40%, Ankylosing spondylitis in 33%, psoriatic arthritis and other spondyloarthropathies in 20% and a few patients were treated for eye disease and other 'off-label' indications. At the time of recording, 25% of patients were on the drug for less than 3 months, 25% 3–6 months, 25% 6–12 months and 25% over a year. Overall 30% of patients had to discontinue and 70% remain on the drug. Of those who discontinued, 65% did so within 6 months of starting. Of all patients treated with Inflectra, 10% stopped due to side effects, 7% had immediate non-effectiveness and 3% had secondary lack of efficacy. 80% of patients experienced no adverse effect. Amongst the 160 patients, recorded adverse events included 8 infections, 8 skin rashes, 9 headaches and 5 severe allergic reactions. Amongst the infections were 2 respiratory, 2 herpes zoster, 1 sinusitis 1 cellulitis, 1 urinary and 1 gastroenteritis. 94% knew they were taking a biosimilar and 80% had no objection. Patient concerns included safety and effectiveness. The treating doctor was 'quite' or 'very' happy with achievement of the therapeutic target in 66% of cases and 'unhappy' in only 15%.
Conclusions Despite understandable concerns with the introduction of biosimilars, the experience with our first 160 patients was good; numbers remaining on the drug and adverse effects were similar to previous large studies of infliximab. Rheumatologists feel happy the therapeutic target has been met in a significant majority of cases. Continuous observation and pharmacovigilance are required as with the introduction of any new agent.
Disclosure of Interest None declared