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Published on: March 24, 2017
[Head-to-head studies on connective tissue diseases and vasculitides]
Bernhard Hellmich1, Johanna Mucke2, Martin Aringer3
1Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Europäisches Vaskulitis-Referenzzentrum (ERN-RITA), medius KLINIKEN KIRCHHEIM & NÜRTINGEN, Akademisches Lehrkrankenhaus der Universität Tübingen, Eugenstr. 3, 73230, Kirchheim unter Teck, Deutschland. b.hellmich@medius-kliniken.de.
Insights
Head-to-head studies compare treatments for connective tissue diseases and vasculitides. These trials inform treatment guidelines for conditions like lupus and ANCA-associated vasculitis.
Area of Science:
- Rheumatology
- Clinical Trials
- Immunology
Context:
- Head-to-head (H2H) studies provide direct comparisons of therapeutic options, complementing placebo-controlled trials.
- A notable number of H2H trials exist for connective tissue diseases (CTDs) and vasculitides, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV).
Purpose:
- To review existing H2H trials for CTDs and vasculitides.
- To discuss the significance of these trials in current treatment algorithms.
Summary:
- H2H trials for SLE, particularly lupus nephritis, have shown the efficacy of low-dose cyclophosphamide, mycophenolate, and azathioprine for maintenance.
- Recent H2H trials have established rituximab as both induction and maintenance therapy for AAV, influencing treatment guidelines.
Impact:
- H2H studies are crucial for evidence-based medicine, guiding treatment decisions in rheumatology.
- Further comparative trials are essential for advancing personalized medicine in treating CTDs and vasculitides.
Abstract:
Head-to-head (H2H) studies enable the direct comparison of several alternative therapeutic approaches and thus provide the evidence-based foundation for the relative position of one treatment as compared to others for a specific indication. These trials constitute an important addition to placebo-controlled clinical trials. Among the controlled clinical trials not performed by the pharmaceutical industry, there are a relevant number of H2H trials for connective tissue diseases (CTDs) and vasculitides, particularly for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This article encompasses a review of the H2H trials for CTDs and vasculitides and discusses their relevance for current treatment algorithms. For SLE the H2H trials were predominantly performed for the treatment of lupus nephritis, demonstrating the impact of low-dose cyclophosphamide and mycophenolate as well as azathioprine for maintenance therapy. In recent H2H trials rituximab could be established as induction and maintenance therapy for AAV, which has now been incorporated into current treatment guidelines. Further comparative trials will be necessary in order to select the most effective and safest treatment for every patient, in the sense of personalized medicine.
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