(Vienna, 15 November 2016) For the first time, a multicentre study headed up by MedUni Vienna has compared the action of two rheumatoid arthritis drugs from the same class. The study established that the two TNF inhibitors investigated are equally effective. It was also shown that, if treatment is failing, patients can benefit from an "on-the-fly" switch from one drug to the other. For example, 40% of patients responded positively to the "new" drug. This could result in a paradigm shift in the treatment of rheumatoid arthritis. The study has now been published in the leading journal "The Lancet".
In a large-scale study (EXXELERATE, funded by the company UCB) with around 1,000 volunteers, the research group headed up by rheumatoid arthritis specialist Josef Smolen (Head of the Department of Medicine III at MedUni Vienna and Vienna General Hospital) compared the two drugs certolizumab pegol and adalimumab (with methotrexate in each case). These drugs are two of the five TNF inhibitors currently in clinical use for treating rheumatoid arthritis. The Tumour Necrosis Factor (TNF) is an important proinflammatory cytokine that releases certain messenger substances and activates various cell population, contributing to the development of fever and inflammatory responses. TNF inhibitors are drugs that block TNF and therefore have an anti-inflammatory effect and are used to combat a number of chronic inflammatory diseases.
The volunteers in both groups displayed similar responses to the drugs after 12 and 104 weeks, thereby demonstrating that they are equally effective. However, the study volunteers who had not experienced any beneficial effect after 12 weeks (primary treatment failure) switched to the other drug – but, this time, without first discontinuing the previous drug for an extended period. This "immediate" switch-over nevertheless brought about a measurable improvement of the condition in 40% of volunteers – and a very good one in 10%.
Ineffective treatment can quickly be changed
Hitherto it has been often recommended that, if treatment with a TNF inhibitor fails, one should switch over to a drug of another class. However, the results of this study prove that this is not necessary. "If treatment fails, it is possible to switch over to a drug of the same class," explains lead investigator Josef Smolen, "that still has a beneficial effect in many cases." If treatment with one drug does not bring about any improvement within three months, it is possible to change over to the other immediately. "This improves the quality of life for patients and saves costs, because ineffective biologic drugs can be discontinued after short time and replaced by a new one," explains the rheumatoid arthritis expert from Vienna.
Service: The Lancet
Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study
Josef S Smolen, Gerd-Rüdiger Burmester, Bernard Combe, Jeffrey R Curtis, Stephen Hall, Boulos Haraoui, Ronald van Vollenhoven, Christopher Cioffi , Cécile Ecoffet, Leon Gervitz, Lucian Ionescu, Luke Peterson, Roy Fleischmann. dx.doi.org/10.1016/S0140-6736(16)31651-8