Table 2.
Summary of secondary and exploratory endpoints
| Endpoints | Responders, n/N (%)* | Difference (95% CI)* | Nominal p value† | |
| CRR at week 52‡ | Combined | 27/87 (31.0) | –0.1 (–16.9, 16.8) | 0.993 |
| Basic | 7/43 (16.3) | –14.8 (–32.9, 3.2) | 0.107 | |
| Intensified | 20/44 (45.5) | 14.3 (–5.8, 34.5) | 0.162 | |
| Placebo | 14/45 (31.1) | – | – | |
| aCRR at week 52‡ | Combined | 21/87 (24.1) | 10.8 (–3.3, 25.0) | 0.134 |
| Basic | 3/43 (7.0) | –6.4 (–20.6, 7.8) | 0.380 | |
| Intensified | 18/44 (40.9) | 27.6 (9.4, 45.7) | 0.003 | |
| Placebo | 6/45 (13.3) | – | – | |
| CRR0.5 at week 52‡§ | Combined | 25/87 (28.7) | 2.1 (−14.3, 18.4) | – |
| Basic | 7/43 (16.3) | −10.4 (−28.1, 7.3) | – | |
| Intensified | 18/44 (40.9) | 14.2 (−5.4, 33.9) | – | |
| Placebo | 12/45 (26.7) | – | – | |
| Sustained oral glucocorticoid dosage reduction (≤7.5 mg/day, week 24 to week 52¶) | Combined | 31/67 (46.3) | 12.9 (–7.3, 33.1) | 0.209 |
| Basic | 11/31 (35.5) | 2.2 (–21.4, 25.7) | 0.858 | |
| Intensified | 20/36 (55.6) | 22.2 (–0.8, 45.2) | 0.058 | |
| Placebo | 11/33 (33.3) | – | – | |
| CRR with sustained oral glucocorticoid dosage reduction to ≤7.5 mg/day‡ | Combined | 21/87 (24.1) | –0.3 (–16.1, 15.5) | 0.970 |
| Basic | 6/43 (14.0) | –10.5 (–27.6, 6.6) | 0.229 | |
| Intensified | 15/44 (34.1) | 9.7 (–9.5, 28.8) | 0.323 | |
| Placebo | 11/45 (24.4) | – | – | |
A CRR required 24-hour UPCR ≤0.7 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease ≥20% from baseline, no investigational product discontinuation and no use of restricted medications. An aCRR required all of the above CRR criteria, but with inactive urinary sediment, defined as <10 red blood cells per high-power field. A CRR0.5 required all of the above CRR criteria, but with 24-hour UPCR ≤0.5 mg/mg.
*The response rates, differences between the groups and associated 95% CIs were calculated with a weighted Cochran-Mantel-Haenszel method. Differences between anifrolumab and placebo groups were calculated in percentage points (the percentage in the anifrolumab group minus the percentage in the placebo group).
†Nominal p values are unadjusted as the primary outcome was not significant so all other comparisons are considered non-significant.
‡Patients from France and Italy were excluded from the analysis.
§Analysed post hoc.
¶Analysed in patients with baseline oral glucocorticoid dosage ≥20 mg/day.
aCRR, alternative CRR; CRR, complete renal response; CRR0.5, CRR with UPCR ≤0.5 mg/mg; n, number of patients meeting the criteria for a response; N, number of patients included in the analysis; UPCR, urine protein–creatinine ratio.