Table 1.
A selection of clinical trials and their endpoints of B cell suppressing/depleting therapies for SLE.
| Targets | Biologicals | Trial/Phase | Country | Number Enrolled |
Primary Outcome |
Result |
|---|---|---|---|---|---|---|
| BAFF | Belimumab | BLISS-76, Phase III (NCT00410384) | 136 centres primarily in 19 countries in North America and Europe. | 819 | SRI-4 at week 52. | Met the primary outcome [64]. |
| BAFF | Belimumab | BLISS-52, Phase III (NCT00424476) |
Multicentres in Latin America, Asia-Pacific, and Eastern Europe. | 867 | SRI-4 at week 52. | Met the primary outcome [65]. |
| BAFF | Belimumab | BLISS-LN, Phase III (NCT01639339) |
107 centres in 21 countries. | 448 | Renal response at week 104. | Met the primary outcome [70]. |
| BAFF/APRIL | Atacicept | ADDRESS II, Phase IIb (NCT01972568) | Multicentres in Europe, Asia, North America, Central and South America. | 306 | SRI-4 at week 24. | Did not meet primary outcome but reduction in disease activity and severe flares was observed [71]. |
| BAFF/APRIL | Telitacicept | Phase III | Multicentres in China. | 249 | SRI-4 at week 48. | Met the primary outcome [72]. |
| CD20 | Rituximab | EXPLORER nonrenal trial, Phase II/III (NCT00137969) |
55 centres in North America. | 257 | Major/partial BILAG response at week 52. | Did not meet the primary outcome. Reduced risk and frequency of SLE flares was observed [74]. |
| CD20 | Rituximab | LUNAR renal trial, Phase III (NCT00282347) | Multicentres in US and Latin America. | 144 | Renal response using predefined parameters at week 52. | Did not meet the primary outcome. Responders had reduction in dsDNA and C3/C4 levels [75]. |
| CD20 | Ocrelizumab | Phase III (NCT00626197) | 123 centres in 23 countries in Latin America, Asia, Western Europe, Eastern Europe, US, Canada, and Africa. | 381 | Renal response rates at week 48. | Initial results suggested some efficacy in treating LN in seropositive patients. Phase III trial was terminated prematurely due to inefficacy [76]. |
| CD20 | Obinutuzumab | Phase II (NCT02550652) | 46 sites in 12 countries in USA, South America and Europe. | 125 | Complete Renal Response at Week 52. | Met the primary outcome [77]. |
| CD22 | Epratuzumab | ALLEVIATE-1 (SL0003; NCT00111306) and ALLEVIATE-2 (SL0004; NCT00383214), Phase III | ALLEVIATE-1: 16 centres in Europe, UK and USA. ALLEVIATE-2: 28 centres in Europe, UK and USA. |
36/54 | The revised primary endpoint was BILAG response with no treatment failure at week 12. | Discontinued prematurely due to interruption in supply of medication [78]. |
| CD22 | Epratuzumab | EMBODY 1 (NCT0 1262365) and EMBODY -2 (NCT01261793), Phase III | USA, Brazil, and Europe. | 793/791 | BICLA response rates at week 48. | Did not meet the primary outcome [79]. |
| CD38 | Daratumumab | Case serious | USA. | 2 | N/A | Induced substantial clinical responses in two active SLE patients [80]. |
BAFF: B-cell activating factor; BICLA: BILAG-based Composite Lupus Assessment; BILAG: British Isles Lupus Assessment Group; dsDNA: double stranded DNA; LN: lupus nephritis; SLE: systemic lupus erythematosus; SRI-4: SLE Responder Index 4.