References
- Durcan L, Petri M. Immunomodulators in SLE: clinical evidence and immunologic actions. J Autoimmun. 2016;74:73–84.
- Kleinmann JF, Tubach F, Le Guern V, et al. International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus. Autoimmun Rev. 2017;16:650–657.
- Bertsias G, Ioannidis JP, Boletis J, et al. EULAR recommendations for the management of systemic lupus erythematosus. Report of a task force of the EULAR standing committee for international clinical studies including therapeutics. Ann Rheum Dis. 2008;67:195–205.
- Touma Z, Gladman DD. Current and future therapies for SLE: obstacles and recommendations for the development of novel treatments. Lupus Sci Med. 2017;4:e000239.
- Morand EF, Mosca M. Treat to target, remission and low disease activity in SLE. Best Pract Res Clin Rheumatol. 2017;31:342–350.
- Tesar V, Hruskova Z. Belimumab in the management of systemic lupus erythematosus - an update. Expert Opin Biol Ther. 2017;17:901–908.
- Isenberg DA, Merrill JT. Why, why, why de-lupus (does so badly in clinical trials). Expert Rev Clin Immunol. 2016;12:95–98.
- Liossis SC, Staveri C, Cell-Based B. Treatments in SLE: past experience and current directions. Curr Rheumatol Rep. 2017 4;19:78.
- Mok MY, Shoenfeld Y. Recent advances and current state of immunotherapy in systemic lupus erythematosus. Expert Opin Biol Ther. 2016;16:927–939.
- Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomised, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010;62:222–233.
- Rovin BH, Furie R, Latinis K, et al. Efficacy and safety of rituximab in patients with active proliferative nephritis: the lupus nephritis assessment with rituximab study. Arthritis Rheum. 2012;64:1215–1226.
- Merrill J, Buyon J, Furie R, et al. Assessment of flares in lupus patients enrolled in a phase II/III study of rituximab (EXPLORER). Lupus. 2011;20:709–716.
- Mysler EF, Spindler AJ, Guzman R, et al. Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study. Arthritis Rheum. 2013;65:2368–2379.
- Medina-Rosas J, Al-Rayes H, Moustafa AT, et al. Recent advances in the biologic therapy of lupus: the 10 most important areas to look for common pitfalls in clinical trials. Expert Opin Biol Ther. 2016;16:1225–1238.
- Isenberg DA, Petri M, Kalunian K, et al. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016;75:323–331.
- Tanaka Y, Takeuchi T, Akashi N, et al. Efficacy and safety of tabalumab plus standard of care in Japanese patients with active systemic lupus erythematosus: subgroup analyses of the ILLUMINATE-1 study. Mod Rheumatol. 2017;27:284–291.
- Merrill JT, Van Vollenhoven FR, Buyon JP, 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. 2016;75:332–340.
- Wallace DJ. Epratuzumab: reveille or requiem? teachable moments for lupus and sjogren’s clinical trials. Arthritis Rheumatol. 2018 Jan 30;70: 633–636.
- Wallace DJ, Kalunian K, Petri MA, et al. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014;73:183–190.
- Clowse ME, Wallace DJ, Furie RA, et al. Efficacy and safety of epratuzumab in moderately to severely active systemic lupus erythematosus: results from the phase 3, randomized, double-blind, placebo-controlled trials. Arthritis Rheumatol. 2017;69:362–375.
- Gottenberg JE, Dörner T, Bootsma H, et al. Efficacy of epratuzumab, an anti-CD22 monoclonal IgG antibody, in systemic lupus erythematosus patients with associated sjögren’s syndrome: post-hoc analyses from the EMBODY trials. Arthritis Rheumatol. 2018;70:763–773.
- Postal M, Sinicato NA, Appenzeller S, et al. Drugs in early clinical development for systemic lupus erythematosus. Expert Opin Investig Drugs. 2016;25:573–583.
- Ginzler EM, Wax S, Rajeswaran A, et al. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012;14:R33.
- Isenberg D, Gordon C, Licu D, et al. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015;74:2006–2015.
- Gordon C, Wofsy D, Wax S, 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. 2017;69:122–130.
- Merrill JT, Wallace DJ, Wax S, et al. Efficacy and safety of atacicept in patients with systemic lupus erythematosus: results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled, parallel-arm, phase IIb study. Arthritis Rheumatol. 2018;70:266–276.
- Rovin BH, Van Vollenhoven RF, Aranow C, et al. A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment with sirukumab (CNTO 136) in patients with active lupus nephritis. Arthritis Rheumatol. 2016;68:2174–2183.
- Kalunian KC, Merrill JT, Maciuca R, et al. A phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016;75:196–202.
- ACCESS Trial Group. Treatment of lupus nephritis with abatacept: the abatacept and cyclophosphamide combination efficacy and safety study. Arthritis Rheumatol. 2014;66:3096–3104.
- Furie R, Nicholls K, Cheng TT, et al. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol. 2014;66:379–389.
- Anders HJ, Jayne DR, Rovin BH. Hurdles to the introduction of new therapies for immune-mediated kidney diseases. Nat Rev Nephrol. 2016;12:205–216.
- Furie R, Toder K, Zapantis E. Lessons learned from the clinical trials of novel biologics and small molecules in lupus nephritis. Semin Nephrol. 2015;35:509–520.
- Yuen SY, Pope JE. Learning from past mistakes: assessing trial quality, power and eligibility in non-renal systemic lupus erythematosus randomized controlled trials. Rheumatology (Oxford). 2008;47:1367–1372.
- Tesar V, Hruskova Z. Lupus nephritis:a different disease in european patients? Kidney Dis (Basel). 2015;1:110–8.35.
- Abrahamowicz M, Esdaile JM, Ramsey-Goldman R, et al. Development and validation of a novel evidence-based lupus multivariable outcome score for clinical trials. Arthritis Rheumatol. 2018 Apr 12. DOI:10.1002/art.40522
- Franklyn K, Lau CS, Navarra SV, et al. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS). Ann Rheum Dis. 2016;75:1615–1621.
- Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012;64:3660–3665.
- Wofsy D, Hillson JL, Diamond B. Comparison of alternative primary outcome measures for use in lupus nephritis clinical trials. Arthritis Rheum. 2013;65:1586–1591.
- Oon S, Huq M, Godfrey T, et al. Systematic review, and meta-analysis of steroid-sparing effect, of biologic agents in randomized, placebo-controlled phase 3 trials for systemic lupus erythematosus. Semin Arthritis Rheum. 2018 Jan 6. pii: S0049-0172(17)30579-6. Epub ahead of print.
- Alberici F, Smith RM, Fonseca M, et al. Association of a TNFSF13B (BAFF) regulatory region single nucleotide polymorphism with response to rituximab in antineutrophil cytoplasmic antibody-associated vasculitis. J Allergy Clin Immunol. 2017;139:1684–1687.e10.
- Magro-Checa C, Zirkzee EJ, Huizinga TW, et al. Management of neuropsychiatric systemic lupus erythematosus: current approaches and future perspectives. Drugs. 2016;76:459–483.
- The American college of rheumatology nomenclature and case definitions for neuropsychiatric lupus syndromes. Arthritis Rheum. 1999;42:599–608.