Update on clinical trials in systemic lupus erythematosus.
With advancement in our understanding of pathogenic mechanisms in systemic lupus erythematosus (SLE), there is tremendous enthusiasm in examining drugs, old and new, to improve outcomes. This review highlights recent trials' successes and impasses that have come to fore.



Among B-cell therapies, belimumab continues its run of successes with sustained safety and tolerability documented in a long-term extension as well as the likely approval of a subcutaneous formulation in the near future. With greater antibody-dependent cytotoxicity and less immunogenicity, there is hope for obinituzumab to succeed where its anti-CD 20 predecessors have failed. Drugs targeting type I interferons - sifalimumab and anifrolumab - have been efficacious albeit with an increase in incidence of Herpes zoster infections. There is also renewed interest in evaluating the efficacy of calcineurin inhibitors, specifically tacrolimus in the induction and maintenance of lupus nephritis. Introspection into clinical trial designs have highlighted the effects of entry criteria, end points, background medications and geographical differences on study outcomes.



There are at least 50 drugs and targets being evaluated in SLE. In addition to developing new drugs to treat lupus, future trials have to focus on more effective study designs to improve chances of trial success.
Division of Rheumatology Northwell Health, Hofstra Northwell School of Medicine and the Program in Novel Therapeutics, Great Neck, New York, USA.
Sonali
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Narain
Richard
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Furie
D000069594:Abatacept; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D001402:B-Lymphocytes / Q000276:immunology; D002986:Clinical Trials as Topic; D016572:Cyclosporine / Q000627:therapeutic use; D006562:Herpes Zoster / Q000209:etiology / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007370:Interferon Type I; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology; D008181:Lupus Nephritis / Q000188:drug therapy*; D060046:Maintenance Chemotherapy; D010446:Peptide Fragments / Q000627:therapeutic use; D010950:Plasma Cells / Q000276:immunology; D015363:Quinolones / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012074:Remission Induction; D013601:T-Lymphocytes / Q000276:immunology; D016559:Tacrolimus / Q000627:therapeutic use; D016896:Treatment Outcome
C000604956:AMG 811; C573858:AMG623 peptibody; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D007370:Interferon Type I; D010446:Peptide Fragments; D015363:Quinolones; D011993:Recombinant Fusion Proteins; C516151:edratide; C511911:belimumab; D000069594:Abatacept; D016572:Cyclosporine; C476223:laquinimod; C470330:toralizumab; C577244:rontalizumab; C543332:obinutuzumab; C575974:tabalumab; D016559:Tacrolimus; C568334:sifalimumab