Médecine interne: libre accès
Libre accès
ISSN: 2165-8048
ISSN: 2165-8048
Beenken AE
From the literature research the belimumab studies were the only ones to meet the primary and some of the secondary endpoints. Introduction: Systemic Lupus Erythematosus (SLE) is a multiorganic autoimmune disease caused by an immune reaction against DNA. Despite continuous research progress, the mortality of SLE patients is still 2‐4 times higher than the healthy populations and the standard drugs’ adverse effects (especially corticosteroids) hamper the patients’ quality of life. That is why there is an urgent need for new therapies. This paper reviews all phase III clinical trials of new SLE medication that were published since 2011 and analyses the drugs for their respective effects.
Methods: MEDLINE (PubMed), Livivo, The Cochrane Library and Embase were systematically searched for relevant publications. Only randomized, placebo-controlled and double blind studies that were published no earlier than 2011 were included. Exclusion criteria were analysis of one organ manifestation only (e.g. lupus nephritis), insufficient power or lack of full text availability. The studies were analyzed for their respective drug’s efficiency and possible adverse effects.
Results: 7 studies were shortlisted Tabalumab showed significant improvement in biomarkers, but clinical effects were low and the primary endpoint was met in one treatment group only. None of the secondary endpoints were met. Atacicept showed some beneficial effects in the 150 mg treatment group, but these results must be viewed skeptically, as this arm was terminated prematurely due to the death of two patients. The 75 mg arm did not meet the primary endpoint. Epratuzumab treatment showed no significant effects.
Conclusion: Out of all analyzed drugs, belimumab shows the best efficiency and can therefore be recommended for SLE patients. Further research of tabalumab and atacicept is needed, with a special focus on the latter’s potential side effects. Studies of epratuzumab have had disappointing results and that drug can therefore not be recommended.