Clinical trials of novel therapeutics in systemic lupus erythematosus (SLE) have so far been disappointing. A high placebo response rate in these trials owing to continued use of background immunosuppressive therapy could be confounding results. Could patient stratification and minimization of entry medications improve the effect size and interpretability of SLE trials?
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References
Mok, C. C. Treat-to-target in systemic lupus erythematosus: are we there yet? Expert Rev. Clin. Pharmacol. 9, 675–80 (2016).
Merrill, J. T. et al. The Biomarkers of Lupus Disease study: a bold approach may mitigate interference of background immunosuppressants in clinical trials. Arthritis Rheumatol. http://dx.doi.org/10.1002/art.40086, (2017).
van Vollenhoven, R. F. et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann. Rheum. Dis. 71, 1343–1349 (2012).
Merrill, J. T. et al. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann. Rheum. Dis. 75, 332–340 (2016).
Merrill, J. T. et al. Efficacy and safety of atacicept in patients with systemic lupus erythematosus: results of a 24-week randomized, placebo-controlled, phase IIb study [abstract]. Arthritis Rheumatol. 68 (Suppl. 10), 12L (2016).
Gordon, C. et al. Post hoc analysis of the phase II/III APRIL-SLE study: association between response to atacicept and serum biomarkers including BLyS and APRIL. Arthritis Rheumatol. 69, 122–130 (2017).
Cambridge, G. et al. B cell depletion therapy in systemic lupus erythematosus: relationships among serum B lymphocyte stimulator levels, autoantibody profile and clinical response. Ann. Rheum. Dis. 67, 1011–1016 (2008).
Khamashta, M. et al. Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann. Rheum. Dis. 75, 1909–1916 (2016).
Furie, R. et al. Anifrolumab, an anti-interferon alpha receptor monoclonal antibody, in moderate to severe SLE. Arthritis Rheumatol. 69, 376–386 (2017).
Rovin, B. H. et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 64, 1215–1226 (2012).
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Mok, C. Withdrawing standard of care therapies in SLE trials?. Nat Rev Rheumatol 13, 328–330 (2017). https://doi.org/10.1038/nrrheum.2017.59
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DOI: https://doi.org/10.1038/nrrheum.2017.59