Table 3 Overview of TEAEs during the double-blind treatment phases of phase III trials
Combination therapy with MTX in MTX-IR patients | Combination therapy with csDMARDs in TNFi-INT/IR patients | Monotherapy in MTX-INT/IR patients | |||||||
|---|---|---|---|---|---|---|---|---|---|
52 weeks | 24 weeks | 24 weeks | |||||||
Placebo | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Placebo | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Adalimumab 40 mg q2w | Sarilumab 200 mg q2w | Total | |
TEAE, n/N (%) | |||||||||
With diabetes | 20/27 (74.1) | 21/27 (77.8) | 36/37 (97.3) | 17/23 (73.9) | 18/23 (78.3) | 13/21 (61.9) | 11/16 (68.8) | 7/10 (70.0) | 143/184 (77.7) |
Without diabetes | 226/370 (61.1) | 279/374 (74.6) | 276/359 (76.9) | 73/158 (46.2) | 101/158 (63.9) | 107/163 (65.6) | 106/168 (63.1) | 111/174 (63.8) | 1279/1924 (66.5) |
Treatment-emergent SAE, n/N (%) | |||||||||
With diabetes | 4/27 (14.8) | 3/27 (11.1) | 5/37 (13.5) | 1/23 (4.3) | 2/23 (8.7) | 2/21 (9.5) | 1/16 (6.3) | 0/10 | 18/184 (9.8) |
Without diabetes | 17/370 (4.6) | 34/374 (9.1) | 40/359 (11.1) | 5/158 (3.2) | 4/158 (2.5) | 8/163 (4.9) | 11/168 (6.5) | 9/174 (5.2) | 128/1924 (6.7) |
TEAE leading to death, n/N (%) | |||||||||
With diabetes | 1/27 (3.7) | 0/27 | 0/37 | 0/23 | 0/23 | 0/21 | 0/16 | 0/10 | 1/184 (0.5) |
Without diabetes | 1/370 (0.3) | 2/374 (0.5) | 1/359 (0.3) | 1/158 (0.6) | 0/158 | 0/163 | 0/168 | 1/174 (0.6) | 6/1924 (0.3) |
TEAE leading to treatment discontinuation, n/N (%) | |||||||||
With diabetes | 2/27 (7.4) | 1/27 (3.7) | 5/37 (13.5) | 1/23 (4.3) | 3/23 (13.0) | 2/21 (9.5) | 2/16 (12.5) | 1/10 (10.0) | 17/184 (9.2) |
Without diabetes | 18/370 (4.9) | 50/374 (13.4) | 49/359 (13.6) | 7/158 (4.4) | 11/158 (7.0) | 15/163 (9.2) | 11/168 (6.5) | 10/174 (5.7) | 171/1924 (8.9) |