Randomised trial results for Inflectra™, demonstrates comparable reductions in disease activity to Remicade® over one year
Hospira, the world's leading provider of injectable drugs and infusion technologies, shared data this week showing that the company's biosimilar monoclonal antibody InflectraTM demonstrated comparable and sustained reductions in disease activity to European reference product Remicade(®) over one year in patients with rheumatoid arthritis and ankylosing spondylitis. The results, shared at the European League Against Rheumatism (EULAR) congress, added to the body of evidence supporting the use of Inflectra - the first biosimilar monoclonal antibody to be approved in Europe - as an alternative to Remicade.(1,2)
The data comprise secondary endpoints of two randomised active-comparator studies, the PLANETRA (Programme evaLuating the Autoimmune disease iNvEstigational drug cT-p13 in RA patients), study in rheumatoid arthritis (RA) and the PLANETAS (Programme evaLuating the Autoimmune disease iNvEstigational drug cT-p13 in AS patients) study in ankylosing spondylitis (AS). In the PLANETRA study of nearly 500 patients, Inflectra was shown to be comparable to Remicade across a range of primary and secondary efficacy endpoints in RA after 54 weeks, including mean decrease in Disease Activity Score 28 (DAS28; -2.4 in both treatment groups), Clinical Disease Activity Index (CDAI; -25.7 with Inflectra and -24.0 with Remicade), and Simplified Disease Activity Index (SDAI; -26.3 with Inflectra and -24.6 with Remicade). The effect of anti-drug antibody was also measured and the degree of change in the ADA positive versus negative populations was observed to be the same in both Inflectra and Remicade treatment group. Overall, no statistical difference in clinical responses was observed between the two treatment groups.(1) Data for these endpoints have been previously reported at week 30.(3)
In the PLANETAS study of approximately 250 patients, Inflectra was shown to be comparable to Remicade in terms of secondary endpoints reducing disease activity, relieving disability and improving mobility in people with AS after 54 weeks. Overall no statistical difference in clinical responses was observed between the two treatment groups.(2) Disease activity was measured via the Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20/ASAS40) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The study measured disability via the Bath Ankylosing Spondylitis Functional Index (BASFI) and mobility via the Bath Ankylosing Spondylitis Metrology Index (BASMI).(2)Data for these endpoints have been previously reported at week 30.(3)
Overall, the type and incidence of adverse events reported with Inflectra and Remicade in the RA and AS trials appeared generally similar to the type and incidence of adverse events reported in the European product label for Remicade.
"The additional data on reduction in disease activity from the PLANETRA and PLANETAS studies provide further evidence that Inflectra can deliver the treatment benefits of Remicade at a reduced cost to healthcare systems," said Paul Audhya, M.D., Vice President, Medical Affairs, Hospira. "This is exciting, as we are truly seeing the potential of biosimilars to make complex biologic treatments ever more accessible to the people who need them."
Biologic treatments are important therapeutic options for RA and AS but can be very expensive, and studies have shown that this can limit patient access and lead to inequalities developing across Europe.(4) Licensed biosimilars offer a considerable opportunity to reduce healthcare spending by offering clinicians an alternative, more affordable treatment option, while maintaining the same quality, efficacy and safety of treatment. Biosimilar monoclonal antibodies are expected to deliver cost savings of between €1.8-20. 4 billion across Europe by 2020.(5)
The primary endpoints from the PLANETRA and PLANETAS studies have been reported previously. PLANETRA met its primary endpoint of therapeutic equivalence between Inflectra and Remicade as measured by ACR20* at week 30 (3mg/kg both arms).(1) PLANETAS was principally a pharmacokinetics study and met its primary endpoint of demonstrating similar bioavailability between Inflectra and Remicade (5mg/kg both arms) as measured by maximum serum concentration at steady state and area under the concentration-time curve over a dosing interval of both drugs between Weeks 22 and 30.(2)
Inflectra is a biosimilar version of the anti-TNFα blockbuster Remicade, and is the first monoclonal antibody to be approved through the European Medicines Agency biosimilars regulatory pathway. Inflectra was approved by the European Commission on 10th September 2013 for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and ankylosing spondylitis.