SAFETY PROFILE: EVALUATION THROUGH WEEK 482,3

SEQUENCE was a Phase 3, multicenter, randomized, open-label, study of SKYRIZI and STELARA (ustekinumab) in adult patients with moderate to severe Crohn's disease who have failed anti-TNF therapy.

TREATMENT EMERGENT ADVERSE EVENTS
THROUGH
WEEK 48
STELARA® (ustekinumab)* SKYRIZI
  (N=265, PYs=269.9)
% (E/100 PYs)
(N=262, PYs=257.6)
% (E/100 PYs)
Any AE 82.6 (282.7) 85.1 (341.2)
Serious AE 17.4 (23.7) 10.3 (14.0)
AE leading to discontinuation of study drug 4.9 (5.2) 3.8 (3.9)
Death 0 0
Infections 44.5 (62.6) 53.8 (90.4)
Serious infection 4.2 (5.2) 3.1 (3.9)
Opportunistic infection (excluding TB/Herpes Zoster) 0 0.4 (0.4)
Malignant tumors 0.4 (0.4) 0.4 (0.4)
Adjudicated
MACEa
0.4 (0.4) 0
Active TB 0 0
Herpes Zoster 0.4 (0.4) 0.4 (0.4)
Serious hypersensitivity 0 0
Adjudicated anaphylactic reaction 0 0
Hepatic events 5.3 (8.5) 6.9 (10.1)
Injection site reactions 2.3 (3.0) 1.9 (1.9)

For the safety population, 7 patients randomized to SKYRIZI received 1200 mg IV and/or 180 mg SC and were included only in the safety analysis.
Safety Data presented includes all patients who received at least 1 dose of study drug.

*Active Comparator: 31 patients received US approved ustekinumab. All other patients received European Union approved ustekinumab. The comparability between US and Non US approved ustekinumab has not been established.

®STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.

The safety profile of SKYRIZI was generally consistent
with previously reported studies and as described in the
full Prescribing Information.

The Safety Rates observed in clinical trials may not reflect
clinical practice.