The immediate use of a biological agent associated with more side effects and higher costs in the treatment of rheumatoid arthritis yields no better results than a less aggressive plan with the delayed use of biological agents where necessary. These are the findings of a study, led by Josef Smolen, Director of the Clinical Department of Rheumatology at the Medical University of Vienna, which has now been published in the highly respected journal The Lancet.
In the randomised OPTIMA study, the scientists discovered that six months of treatment with the most common anti-rheumatoid drug Methotrexate and subsequent combination therapy with a biological agent in patients who did not respond adequately to Methotrexate produced results that were just as good as those obtained in patients who were given combined Methotrexate and biological agent treatment right from the start. Says Smolen: "The crucial factor, however, is that the biological agent therapy – which in this case involved the tumour necrosis factor blocker Adalimumab – is added relatively quickly after the failure of Methotrexate, i.e. around six months later. Moreover, the patients in this study had a high risk of severe progression of their rheumatoid arthritis."
Paradigm shift in the treatment of rheumatoid arthritis?
The team led by Josef Smolen, who is the third most-quoted rheumatology expert in the world, also discovered that it should be possible, in cases of the early use of combination therapy involving the biological agent with Methotrexate, to discontinue the biological agent after six months if low disease activity has been achieved and still be able to maintain this status.
Says Smolen: "The option of switching the combination therapy back to non-biological treatment would be a paradigm shift in the treatment of rheumatoid arthritis, however more studies along the same lines are needed to confirm this."
The large, 18-month study involved a cohort of around 1,000 high-risk patients from 161 locations who had high disease activity, increased risk of infection and joint swelling. This high level of disease activity affects just under 50 per cent of patients with rheumatoid arthritis. Around three to five per cent of the population has inflammatory rheumatism (in Austria, this equates to around 250,000 to 400,000 people) and around 1% have rheumatoid arthritis (around 80,000 people in Austria).
The paper has been published in the world-leading journal The Lancet and has also received praise: "We believe that the study was an excellent one; it has been meticulously analysed and interpreted correctly. We would like to congratulate Josef Smolen and his team for tackling the problem of rheumatoid arthritis from a very different perspective," says the editorial in the magazine, which has an impact factor of 39.
"Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial". Josef S Smolen, Paul Emery, Roy Fleischmann, Ronald F van Vollenhoven, Karel Pavelka, Patrick Durez, Benoît Guérette, Hartmut Kupper, Laura Redden, Vipin Arora, Arthur Kavanaugh. The Lancet, published online October 26, 2013. dx.doi.org/10.1016/S0140-6736(13)61751-1