Table 2.
Study and patient characteristics of identified studies
| Citation trial name | Study characteristics | Patient characteristicsa | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Country | Collection type | Inclusion/exclusion criteria | N | Age, years | Female, % | Disease duration, years | Baseline severity | Other | |
| Andreoli (2014) [21] | Italy | NR | ACR classification for SLE | 18 |
39.6 (22–55) |
100 |
12.3 (1–26) |
NR | 11 patients had flare in prior year |
| Anjo (2019) [22] | Spain | Retrospective | SLE by ACR/EULAR criteria | 23 | 41.5 (10.5) | 100 | 171.8 (131.1) months | NR | |
|
Collins (2016) [23] OBSErve |
USA |
Pre-belimumab: retrospective Post-belimumab: prospective |
SLE, age ≥ 18 years, ≥ 6 months documented medical history prior to belimumab; received ≥ 8 IV infusions of belimumab 10 mg/kg Enrolled in a clinical trial |
501 | 41.3 (12.10) | 89.0 |
< 1 year (3.4%); 1–5 years (42.3%); 6–10 years (24.4%); > 10 years (20.0%) |
Mild (2.2%); Moderate (77.6%); Severe (24.2%) |
|
| Fanouriakis (2018) [24] | Greece | Prospective | 1982 ACR criteria for SLE or SLICC criteria; active SLE despite ≥ 1 conventional immunosuppressive therapy; treatment with belimumab for ≥ 3 months | 91 | 45.9 (12.5) | 94.5 | 9.7 (median, range, 0.2–36.2) | NR |
9 patients with history of LN 9 patients with history of CNS-SLE |
| Gatto (2020) [30] | Italy | Retrospective | ACR classification for SLR; Active disease classified as SLEDAI > 0 or refractory to standard of care; using IV belimumab; have monthly follow-up | 466 | 41.4 (11.2) | 91.6 |
11.6 (8.8) |
NR |
DAS-28: 3.8 (1.3) CLASI activity 1 (0–4) |
| Hui-Yuen (2015) [31] | USA, Sweden | Prospective |
Diagnosis of SLE, met at least 4 of 11 ACR or SLICC classification criteria, started treatment with belimumab after approval by regulatory agencies Previously participated in belimumab clinical trials: met fewer than 4 ACR classification criteria Severe renal or neuropsychiatric involvement |
195 | 41.8 (12.7) | 82 |
11.9 (8.1) |
NR |
Some patients aged 15–17 years included |
| Iaccarino (2018) [25] | Italy | Prospective |
1982 ACR criteria for SLE; active SLE with SLEDAI-2 K > 6; refractory SLE manifestations; positive anti-dsDNA antibodies; low C3 or C3 serum levels Severe and active LN; severe and active neuropsychiatric lupus |
188 | 40.7 (10.1) | 92.5 |
12.7 (8.5) |
NR |
Mean CLASI: 4 (2–8) |
| Iaccarino (2017) [26] | Italy | Prospective |
1982 ACR criteria for SLE; active SLE: SLEDAI-2 K > 6; refractory SLE manifestations; positive anti-dsDNA antibodies; low C3 or C3 serum levels Severe and active LN; severe and active neuropsychiatric lupus |
67 | 39.3 (10.2) | 91.0 |
12.8 (8.3) |
NR |
Mean CLASI: 5 [1–14] |
| Parodis (2019) [34] | Sweden | Prospective | 1982 ACR criteria for SLE and SLICC criteria with minimum ≥ 1 year of follow-up | 34 | 40.6 (12.3) | 88.2 |
9.4 (7.5) |
NR | |
| Prete (2018) [44] | Italy | Not reported | SLE according to ACR classification | 20 | 44.15 (2.14) | 75 |
10.37 (6.81) |
NR | |
| Scheinberg (2014) [8] | NR | Not reported | 1997 ACR criteria for SLE | 20 |
36 (9.2) |
100 |
≤ 1 year: (30%); 1–5 years (55%); 6–10 years (15%) |
NR |
Mean (SD) FACIT: 37.6 (3.8) |
| Scheinberg (2016) [29] | Brazil | Not reported |
Active SLE not responsive to standard approaches; 2012 Petri classification of SLE |
48 | 32.6 (19–61) | 93.8 |
11.6 (1.5–18) |
NR | |
|
Schwarting (2016) [28] OBSErve |
Germany | Retrospective |
Age ≥ 18 years, belimumab naïve with confirmed diagnosis of SLE, treatment with belimumab initiated ≥ 6 months before the study Current enrollment in an SLE-related trial or initiation of belimumab therapy as part of a clinical trial interventional arm |
102 | 42.5 (13.83) | 91 |
< 1 year (1%); 1–5 years (23%); 6–10 years (19%); > 10 years (58%) |
Mild (8%); Moderate (60%); Severe (25%); unknown (7%) |
26 patients with LN |
| Sthoeger (2017) [27] | Israel | Retrospective | SLE according to ACR classification; patients with active lupus without severe active CNS/renal disease | 36 | 41.6 (12.2) | 78 |
15.7 (9.6) |
NR | |
|
Touma (2017) [32] OBSErve |
Canada | Retrospective |
Age ≥ 18 years with a diagnosis of SLE, received ≥ 8 belimumab infusions (6 months of continuous treatment); ≥ 6 months of documented medical history prior to belimumab initiation Enrolled in any other SLE-related clinical trial |
52 | 46.5 (10.8) | 94.2 |
0–5 years (23.1%); 6–10 years (23.1%); > 10 years (53.8%) |
Mild (5.8%); Moderate (76.9%); Severe (17.3%) |
|
|
Von Kempis (2019) [45] OBSErve |
Switzer-land | Retrospective |
Adults aged ≥ 18 years, confirmed SLE diagnosis, initiated belimumab plus ST ≥ 6 months before inclusion, medical history available up to 6 months pre-index, and whose treatment outcomes were available at 6 months post-index or at discontinuation Enrolled in an SLE-related clinical trial, or who started belimumab as part of a clinical trial in an intervention arm |
53 | 46.7 (13.6) | 81% |
< 1 year (1.9%); 1–5 years (43.4%); 6–10 years (34.0%); > 10 years (18.9%); unknown (1.9%) |
Mild (43.4%); Moderate (43.4%); Severe (13.2%) |
|
| Yoneva (2014) [33] | Bulgaria | NR |
Age > 18 years, diagnosis with at least 4/11 ACR, lack of efficacy of standard treatment for ≥ 6 months, SLEDAI > 6, Positive ANA (above (1;80) and/or high levels of anti-dsDNA antibodies Active LN, cerebrovasculitis, or very high disease activity who are to be treated with high dose corticosteroids and cyclophosphamide |
10 | 37.4 | 90% |
7.2 (3–17) |
NR | |
ACR American College of Rheumatology, ANA anti-nuclear antibodies, CLASI Cutaneous Lupus Erythematosus Disease Area and Severity Index, CNS central nervous system, DAS-28 Disease Activity Score 28, dsDNA double-stranded deoxyribonucleic acid, FACIT Functional Assessment of Chronic Illness Therapy, EULAR European League Against Rheumatism, IV intravenous, LN lupus nephritis, NR not reported, SD standard deviation, SLE systemic lupus erythematosus, SLEDAI SLE Disease Activity Index, SLEDAI-2 K, SLE Disease Activity Index 2000; SLICC Systemic Lupus International Collaborating Clinics, ST standard therapy
aValues are mean (SD) or mean (range), unless otherwise specified