Table 1.
Characteristics of the 193 included studies
| No. of trials (%) | % Enrolling malea | |
|---|---|---|
| Overall | 193 (100.0) | 134 (69.4%) |
| Gender distribution | ||
| Both males and females | 134 (69.4) | 134 (100.0%) |
| Females only | 50 (25.9) | N/A |
| Gender not reported | 9 (4.7) | |
| Location | ||
| US included | 79 (40.9) | 62 (78.5) |
| US not included | 101 (52.3) | 64 (63.4) |
| Unknown | 13 (6.7) | 8 (61.5) |
| Race/ethnicity reporting | ||
| Ethnicity only reported | 5 (2.6) | 3 (60.0) |
| Hispanic reported as a separate race group | 28 (14.5) | 23 (82.1) |
| Race only reported (and Hispanic ethnicity was not mentioned) | 67 (34.7) | 48 (71.6) |
| Race and ethnicity reported as separate categories | 22 (11.4) | 21 (95.5) |
| Neither race nor ethnicity was reported | 71 (36.8) | 39 (54.9) |
| Funding source | ||
| Industry | 72 (37.3) | 58 (80.6) |
| NIH | 12 (6.2) | 9 (75.0) |
| Jointly funded | 9 (4.7) | 6 (66.7) |
| Not stated | 100 (51.8) | 61 (61.0) |
| Total enrolment, no. of patients | ||
| ≤ 50 | 84 (43.5) | 51 (60.7) |
| 51 to 100 | 47 (24.4) | 35 (74.5) |
| 101 to 200 | 26 (13.5) | 16 (61.5) |
| ≥ 200 | 36 (18.7) | 32 (88.9) |
| Intervention | ||
| Drug | 174 (90.2) | 127 (73.0) |
| Other | 19 (9.8) | 7 (36.8) |
| Drugs under studyb | ||
| Alkylating agent | 39 (20.2) | 33 (84.6) |
| Biologic DMARD | 45 (23.3) | 44 (97.8) |
| Conventional DMARD | 39 (20.2) | 36 (92.3) |
| Glucocorticoids | 22 (11.4) | 18 (81.8) |
| Hormonal therapy | 27 (14.0) | 3 (11.1) |
| Other | 63 (32.6) | 37 (58.7) |
| Population | ||
| Adults | 163 (84.5) | 112 (68.7) |
| Pediatrics | 10 (5.2) | 6 (60.0) |
| Both | 13 (6.7) | 12 (92.3) |
| Unknown | 7 (3.6) | 4 (57.1) |
| Study included patients with lupus nephritis | ||
| Yes | 58 (30.1) | 52 (89.7) |
| No | 135 (69.9) | 82 (60.7) |
| Publication year | ||
| 1997–2001 | 14 (7.3) | 11 (78.6) |
| 2002–2006 | 38 (19.7) | 18 (47.4) |
| 2007–2011 | 58 (30.1) | 43 (74.1) |
| 2012–2017 | 83 (43.0) | 62 (74.7) |
aThis column represents the proportion of each row that included male representation. For example, 64 (63.4%) out of 101 US-based studies included male enrollees
bThis category does not total 100% because some RCTs may evaluate more than one of these therapeutic ages