Table 2.

Non-B-cell targeted biologic therapies in SLE

Mechanism of action and scientific rationale	Pivotal clinical trials	Ongoing trials
Abatacept CTL4-Ig fusion protein	Failed Phase II trial in nonrenal lupus101 Phase II/III trial in lupus nephritis failed,102 however, a very strict end definition of complete renal response was used A reanalysis of the same study data using alternate definitions of complete renal response and showed a positive outcome in favor of abatacept103	Trial of abatacept plus CYCLO versus CYCLO alone in the lupus nephritis (NCT00774852)
Sifalimumab Humanized anti-IFNα monoclonal antibody	Safety demonstrated in Phase I and II trials. Inhibition of type I interferon mRNA signature seen in moderately active SLE patient.109–111	No current trials
Rontalizumab Humanized anti-IFNα monoclonal antibody	Safe and well tolerated in a Phase I, dose-escalation study in mildly active SLE patients112 Failed Phase II study (NCT00962832)	Not for further development currently
Anifrolumab Humanized anti-IFNα receptor 1 monoclonal antibody113	Anifrolumab was shown to have a more significant and sustained impact on the interferon gene signature as compared to sifalimumab and a Phase III study of this agent is planned114	Phase III study planned
Tocilizumab Humanized anti-IL-6 monoclonal antibody115–120	Well tolerated in a Phase I trial with reduction in active urinary sediment and autoantibody titres121 A further study of tocilizumab in 15 SLE patients with mild-to-moderate disease activity showed reduced activated T- and B-cells122	No current trials

Note: Information regarding ongoing clinical trials in SLE obtained from ClinicalTrials.gov.

Abbreviations: CYCLO, cyclophosphamide; IFN, interferon; Ig, immunoglobulin; IL, interleukin; mRNA, messenger RNA; SLE, systemic lupus erythematosus.