Summary of safety
| Double-blind period* | Week 52† | ||
| Abatacept (n=213) | Placebo (n=211) | Cumulative abatacept population (n=398) | |
| Deaths | 0 | 0 | 0 |
| SAEs | 6 (2.8) | 9 (4.3) | 34 (8.5) |
| Treatment related | 1 (0.5)‡ | 1 (0.5) | 5 (1.3)§ |
| Leading to discontinuation | 3 (1.4) | 3 (1.4) | 8 (2.0)¶ |
| AEs | 116 (54.5) | 112 (53.1) | 273 (68.6) |
| Treatment related | 33 (15.5) | 24 (11.4) | 81 (20.4) |
| Leading to discontinuation | 3 (1.4) | 4 (1.9) | 13 (3.3) |
| AEs reported in ≥5% of patients | |||
| Nasopharyngitis | 9 (4.2) | 11 (5.2) | 25 (6.3) |
| Upper RTI | 6 (2.8) | 14 (6.6) | 28 (7.0) |
| Bronchitis | 7 (3.3) | 5 (2.4) | 26 (6.5) |
| AEs of special interest | |||
| Infections | 57 (26.8) | 63 (29.9) | 162 (40.7) |
| Malignancies | 0 | 2 (0.9) | 4 (1.0) |
| Autoimmune events | 0 | 0 | 1 (0.3) |
| Local ISRs | 1 (0.5) | 1 (0.5) | 5 (1.3) |
Data are presented as n (%) of patients.
Investigators were instructed not to report psoriasis or psoriatic arthritis as AEs unless they were new forms of psoriasis or SAEs.
*Includes data up to 56 days after the last dose in the double-blind period or the first dose in the open-label period, whichever occurred first.
†Includes data from the first day of the double-blind period for patients in the abatacept group and from the first day of the open-label period for patients treated initially with placebo up to 56 days after the last abatacept dose up to week 52.
‡Pneumocystis jirovecii infection (see text).
§Pyelonephritis (n=1), dyspnoea (n=1), erythrodermic psoriasis (n=1), transitional cell carcinoma (n=1), plus the event of P. jirovecii infection in the double-blind period. The event of erythrodermic psoriasis occurred following treatment with topical corticosteroids and intramuscular dexamethasone in a female patient with severe plaque psoriasis at baseline (PASI score=27.6); the patient had discontinued earlier from the study due to lack of efficacy.
¶Gastroenteritis (n=1), P. jirovecii infection (n=1), prostate cancer (n=1), transitional cell carcinoma (n=1), uterine leiomyoma (n=1), colitis (n=1), biliary dilatation plus an AE of upper abdominal pain (n=1) and interstitial lung disease (n=1).
AE, adverse event; ISR, injection-site reaction; PASI, Psoriasis Area and Severity Index (range 0–72); RTI, respiratory tract infection; SAE, serious adverse event.