Table 2.
Rates of worsening in organ domains at 52 weeks
| Standard therapy plus | |||
|---|---|---|---|
| Organ domain | Placebo | Belimumab 1 mg/kg | Belimumab 10 mg/kg |
| BILAG: number with worsening/without A domain score at baseline (%)* | |||
| Musculoskeletal | 26/515 (5.0) | 20/515 (3.9) | 20/528 (3.8) |
| Mucocutaneous | 24/538 (4.5) | 23/531 (4.3) | 29/541 (5.4) |
| Haematological | 51/561 (9.1) | 31/557 (5.6)‡ | 37/559 (6.6) |
| General | 18/557 (3.2) | 16/558 (2.9) | 19/560 (3.4) |
| Renal | 42/561 (7.5) | 27/553 (4.9) | 34/560 (6.1) |
| Vasculitis | 9/548 (1.6) | 2/543 (0.4) | 3/544 (0.6) |
| Cardiovascular/respiratory | 5/558 (0.9) | 5/554 (0.9) | 6/561 (1.1) |
| Neurological | 4/562 (0.7) | 3/556 (0.5) | 6/562 (1.1) |
| SELENA–SLEDAI: number with worsening/with no organ domain involvement at baseline (%)* | |||
| Musculoskeletal | 13/190 (6.8) | 12/197 (6.1) | 8/195 (4.1) |
| Mucocutaneous† | 12/93 (12.9) | 14/103 (13.6) | 14/109 (12.8) |
| Immunological | 23/123 (18.7) | 17/114 (14.9) | 8/108 (7.4)‡ |
| Haematological | 34/522 (6.5) | 24/512 (4.7) | 17/521 (3.3)‡ |
| Constitutional | 4/552 (0.7) | 4/549 (0.7) | 6/551 (1.1) |
| Renal | 40/470 (8.5) | 22/469 (4.7)‡ | 31/478 (6.5) |
| Vasculitis† | 2/525 (0.4) | 2/523 (0.4) | 3/525 (0.6) |
| Serositis | 10/530 (1.9) | 4/523 (0.8) | 4/526 (0.8) |
| CNS | 2/551 (0.4) | 3/544 (0.6) | 2/544 (0.4) |
For BILAG organ domains, worsening was defined as a step up from an E, D, C or B score to a B or A score. For SELENA–SLEDAI organ domains, worsening was defined as a positive score shift. Missing data were analysed using last observation carried forward.
In the original SLEDAI paper, ‘mucocutaneous’ was denoted as ‘dermal’; for purposes of this analysis, ‘mucocutaneous’ has been used to match BILAG terminology as both terms represent similar cutaneous manifestations.10 In addition, the term ‘vascular’ has been changed to ‘vasculitis’, because no cerebrovascular accidents were reported and all data refer to cases of vasculitis.
p<0.05 versus placebo.
BILAG, British Isles Lupus Assessment Group; CNS, central nervous system; SELENA–SLEDAI, Safety of Oestrogens in Lupus National Assessment–Systemic Lupus Erythematosus Disease Activity Index.