Summary of safety through week 16 and week 24 among all patients who received at least one study agent injection
| Week 16 (placebo-controlled period)* | Week 24* | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (N=104) | UST 45 mg (N=103) | UST 90 mg (N=104) | Combined UST (N=207) | Placebo (N=104) | Placebo→UST 45 mg (N=31) | UST 45 mg (N=103) | UST 90 mg (N=104) | All UST (N=238) | |
| Average weeks of follow-up | 15.1 | 16.0 | 15.9 | 16.0 | 19.4 | 8.2 | 23.8 | 23.3 | 21.6 |
| AEs, n (%) | 57 (54.8) | 65 (63.1) | 63 (60.6) | 128 (61.8) | 66 (63.5) | 13 (41.9) | 73 (70.9) | 72 (69.2) | 158 (66.4) |
| Common AEs† | |||||||||
| Nasopharyngitis | 5 (4.8) | 8 (7.8) | 10 (9.6) | 18 (8.7) | 8 (7.7) | 0 (0.0) | 10 (9.7) | 13 (12.5) | 23 (9.7) |
| Headache | 4 (3.8) | 5 (4.9) | 5 (4.8) | 10 (4.8) | 5 (4.8) | 2 (6.5) | 7 (6.8) | 6 (5.8) | 15 (6.3) |
| Arthralgia | 1 (1.0) | 5 (4.9) | 4 (3.8) | 9 (4.3) | –‡ | – | – | – | – |
| Upper respiratory tract infection | 4 (3.8) | 5 (4.9) | 3 (2.9) | 8 (3.9) | 4 (3.8) | 3 (9.7) | 10 (9.7) | 6 (5.8) | 19 (8.0) |
| Fatigue | 0 (0.0) | 5 (4.9) | 2 (1.9) | 7 (3.4) | – | – | – | – | – |
| Nausea | 2 (1.9) | 4 (3.9) | 3 (2.9) | 7 (3.4) | – | – | – | – | – |
| Back pain | 0 (0.0) | 1 (1.0) | 4 (3.8) | 5 (2.4) | – | – | – | – | – |
| Diarrhoea | 3 (2.9) | 4 (3.9) | 1 (1.0) | 5 (2.4) | – | – | – | – | – |
| Oropharyngeal pain | 0 (0.0) | 4 (3.9) | 1 (1.0) | 5 (2.4) | – | – | – | – | – |
| Psoriasis | 3 (2.9) | 4 (3.9) | 1 (1.0) | 5 (2.4) | – | – | – | – | – |
| Psoriatic arthropathy | 5 (4.8) | 4 (3.9) | 1 (1.0) | 5 (2.4) | – | – | – | – | – |
| Discontinued study agent due to AEs, n (%) | 8 (7.7) | 2 (1.9) | 2 (1.9) | 4 (1.9) | 11 (10.6) | 0 (0.0) | 2 (1.9) | 3 (2.9) | 5 (2.1) |
| Serious AEs, n (%)§ | 5 (4.8) | 0 (0.0) | 1 (1.0) | 1 (0.5) | 5 (4.8) | 1 (3.2) | 0 (0.0) | 2 (1.9) | 3 (1.3) |
| Investigator-reported infection, n (%) | 25 (24.0) | 30 (29.1) | 26 (25.0) | 56 (27.1) | 30 (29.7) | 4 (12.9) | 42 (40.8) | 36 (34.6) | 82 (34.5) |
AEs with ‘–’ did not meet the criteria for a ‘common’ events at that time point (see footnotes † and ‡).
*At week 16, patients with <5% improvement from baseline in both tender and swollen joint counts entered blinded early escape, such that patients receiving ustekinumab 45 mg increased to 90 mg and patients receiving placebo switched to ustekinumab 45 mg; patients receiving ustekinumab 90 mg continued with their blinded dose regimen. AEs through week 24 are cumulative and include those reported through week 16.
†AEs occurring in >2% of patients in the combined ustekinumab (week 16) or > 5% of patients in the all ustekinumab (week 24) groups; AEs are ordered according to decreasing frequency for the combined ustekinumab group at week 16.
‡AEs did not occur in >5% of patients in the All UST group.
§Serious AEs through week 16 included hyperglycaemia, depression, pyrexia, chronic cholecystitis/hypertension/cerebrovascular insufficiency, and interstitial lung disease in five placebo-treated patients and acute renal injury/syncope in one ustekinumab 90 mg patient. From weeks 16 to 24, an additional placebo patient had a serious event of suicidal ideation after early escape to ustekinumab 45 mg and an additional ustekinumab 90 mg patient had a serious event of arthritis.
AE, adverse event; UST, ustekinumab.