Table 1.
AEs in patients during treatment in pooled MUSE, TULIP-1 and TULIP-2 data
| Anifrolumab 300 mg (n=459) |
Placebo (n=466) |
EAIR risk difference (anifrolumab 300 mg – placebo) (95% CI) | |||
| n (%) | EAIR | n (%) | EAIR | ||
| Any AE* | 399 (86.9) | 290.1 | 370 (79.4) | 225.2 | NR |
| SAE | 54 (11.8) | 13.6 | 78 (16.7) | 20.7 | −7.2 (−12.5 to −1.9) |
| Death | 2 (0.4) | 0.5 | 0 | 0 | 0.5 (−0.5 to 1.7) |
| DAE | 19 (4.1) | 4.5 | 24 (5.2) | 6.0 | −1.4 (−4.7 to 1.7) |
| AESI†‡ | 61 (13.3) | 15.5 | 47 (10.1) | 12.2 | 3.3 (–1.5 to 8.2) |
| Non-opportunistic serious infections | 22 (4.8) | 5.4 | 26 (5.6) | 6.6 | −1.3 (−4.7 to 2.1) |
| Opportunistic infections | 1 (0.2) | 0.2 | 1 (0.2) | 0.2 | −0.0 (−1.2 to 1.1) |
| Anaphylaxis | 0 | 0 | 0 | 0 | 0 |
| Malignancy | 3 (0.7) | 0.7 | 3 (0.6) | 0.7 | −0.0 (−1.5 to 1.4) |
| Herpes zoster | 28 (6.1) | 6.9 | 6 (1.3) | 1.5 | 5.4 (2.8 to 8.4) |
| Active TB | 0 | 0 | 0 | 0 | 0 |
| Latent TB§ | 4 (0.9) | 1.0 | 1 (0.2) | 0.2 | 0.7 (−0.5 to 2.2) |
| Influenza | 12 (2.6) | 2.9 | 9 (1.9) | 2.3 | 0.6 (−1.7 to 3.0) |
| Non–SLE-related vasculitis | 0 | 0 | 2 (0.4) | 0.5 | −0.5 (−1.8 to 0.4) |
| Major adverse cardiovascular event | 1 (0.2) | 0.2 | 3 (0.6) | 0.7 | −0.5 (−2.0 to 0.7) |
EAIR was reported per 100 patient-years and calculated as the number of patients with an event/[sum of time at risk in days/(365.25×100)].
*AEs were coded by MedDRA V.22.1. An AE during intervention period was defined as an AE with a date of onset on or after the day of the first dose of anifrolumab or placebo and on or before the day of the last dose of anifrolumab or placebo plus 28 days.
†AESIs differed from the individual MUSE and TULIP trials and were identified using standardised MedDRA queries and custom preferred term groupings.
‡Hypersensitivity was included as an AESI in MUSE but not in the TULIP trials and is not included in this table.
§Patients with latent TB (not active TB) were interferon gamma release assay positive without radiographic or clinical manifestations of active TB.
AE, adverse event; AESI, AE of special interest; DAE, AE leading to discontinuation of investigational product; EAIR, exposure-adjusted incidence rate; MedDRA, Medical Dictionary for Regulatory Activities; NR, not reported; SAE, serious AE; TB, tuberculosis.