Table 1.
New and emerging therapies in SLE.
| Molecular target | Treatment | Status |
|---|---|---|
| B CELLS | ||
| BAFF/APRIL | Belimumab | Approved for non-renal SLE Ongoing phase IV for efficacy, safety, and tolerability Ongoing phase III in combination with Rituximab |
| Tabalumab | Phase III without significant effect (terminated) | |
| Blisibimod | Phase III did not meet SRI-6 primary end point | |
| Atacicept | APRIL-SLE study terminated due to increased infection rate ADDRESS II study has acceptable safety profile | |
| CD20 | Rituximab | Phase III failed (nephritis and non-nephritis) |
| Ocrelizumab | Phase III trial completed | |
| CD22 | Epratuzumab | Phase III failed |
| CD19 | XmAb5871 | Phase II trial |
| Proteasome inhibitors | Bortezomib | Phase II trial |
| INTRACELLULAR SIGNALING | ||
| Btk | M2951 | Ongoing phase II |
| Fenebrutinib | Ongoing phase II trial | |
| mTOR | N-acetylcysteine | Small study showed decrease in SLEDAI, no further development |
| Rapamycin | Open-label study showed an effect on BILAG. Larger study planned. | |
| JAK/STAT | GSK2586184 | Ineffective on interferon signature in phase II, safety data do not support further study |
| JAK 2 | Baricitinib | Phase II positive data; Phase III trial ongoing |
| JAK3 | Tofacitinib | Ongoing Phase I/II trial |
| ROCK | Fasudil | Effective in preclinical studies in patient with Raynaud's, phase III completed with uninterpretable data. |
| CO-STIMULATION | ||
| CD40:CD154 | Dapirolizumab | Ongoing phase II trial |
| BI 655064 | Ongoing phase II trial | |
| CD28:B7 | Abatacept | Ineffective in phase III in nephritis and general SLE |
| Lulizumab | Phase II trial terminated—failed to meet protocol objectives | |
| CYTOKINES | ||
| Sifalimumab | Limited effect in phase II and III. No further development | |
| Rontalizumab | Phase II without significant results | |
| Interferon-α | Anifrolumab | Phase II positive data; 2 Phase III trials ongoing (one reported negative) |
| IAGS-009 | Completed phase I, no data released | |
| JNJ-55920839 | In recruiting phase | |
| IFNα-k | Successful phase I; ongoing phase II trial | |
| Interleukin-2 | Aldesleukin | Ongoing open-label phase II trial |
| AMG 592 | Ongoing phase Ib and IIa trial | |
| ILT-101 | Ongoing phase II trial | |
| Interleukin 12/23 | Ustekinumab | Met primary end-point in phase II trial; ongoing phase III trial |
| Interleukin-6 | PF-04236921 | Failed phase II trial; safety compromised |
| Sirukumab | Failed phase II trial | |
| MRA003US | Ongoing phase II trial | |
| Vobarilizumab | Ongoing phase I trial | |
| Interleukin-10 | BT063 | Ongoing phase II trial |
| OTHER | ||
| Lupuzor | Phase III trial failed to meet the primary end point | |