The safety of ILARIS has been established in ≈500 patients1
Safety profile of ILARIS from pivotal SJIA clinical trials1
Pivotal Studies
SJIA Study 1
SJIA Study 2
(n=43)
(n=41)
(n=177)
(n=50)
(n=50)
AOSD SAFETY
The safety profile of ILARIS in patients with AOSD in a randomized, double-blind, placebo-controlled study in 36 adults, 22 to 70 years old, was similar to what was observed in patients with SJIA.1
- ILARIS has been associated with an increased risk of serious infections. Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with ILARIS1
- Generally, the observed infections in ILARIS clinical trials responded to standard therapy. Isolated cases of unusual or opportunistic infections (eg, aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster) were reported during ILARIS treatment. A causal relationship of ILARIS to these events cannot be excluded1
- Serious infections (eg, pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4% to 5% (0.02 to 0.17 per 100 patient-days) of patients receiving ILARIS in pivotal studies1
Additional safety for ILARIS throughout SJIA clinical trials1
- No injection site reactions led to study discontinuation
- No anaphylactic reactions attributable to treatment with canakinumab were reported
- No neutralizing antibodies were detected†
- ILARIS did not appear to increase the incidence of MAS: Eleven cases of MAS were observed in 201 patients with SJIA treated with ILARIS in clinical trials. Based on the clinical trial experience, ILARIS does not appear to increase the incidence of MAS in Still's disease patients, but no definitive conclusions can be made1
- MAS is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still's disease, and should be aggressively treated
No new or unexpected safety findings emerged in the PFS clinical trial compared with the already approved indication for CAPS2
Safety profile of ILARIS from FMF, HIDS/MKD, and TRAPS clinical trials1
- In Part 2, 90 patients were initially randomized to ILARIS 150 mg and 91 patients were randomized to placebo every 4 weeks
- ILARIS group: 55.6% of patients remained on the initial dose through Week 16, with 6.7% receiving an additional ILARIS dose between Day 7 and Day 15
- Placebo group: 9.9% of patients remained on placebo through Week 16, with 28.6% switching to ILARIS treatment by Day 15
- Overall, there were 58 patients with FMF, 68 patients with HIDS/MKD, and 43 patients with TRAPS in the safety set with a cumulative exposure of 47.61 patient-years. The cumulative exposure in the placebo group was 8.03 patient-years
Most Common Adverse Drug Reactions (≥3%) in Patients Treated With ILARIS
%
- The most common adverse reactions (≥10%) were injection-site reactions and nasopharyngitis
- Serious infections (eg, conjunctivitis, pneumonia, pharyngitis, pharyngotonsillitis) were observed in approximately 2.4% (0.03 per 100 patient-days) of patients receiving ILARIS
Among all 3 patient cohorts in the ILARIS group2:
- No deaths were reported
- No anti-ILARIS antibodies were detected in any patient
- No patients with FMF, 2 patients with HIDS/MKD, and 1 patient with TRAPS discontinued treatment due to AEs
Safety profile of ILARIS from CAPS clinical trials1
AEs by Preferred Term Occurring in >10% of Patients Throughout Entire Study
(N=35)
n (%)
- A total of 9 serious adverse reactions were reported with ILARIS in CAPS clinical trials, including infections and vertigo‡
- 1 patient discontinued treatment due to potential infection
- 9% of patients experienced injection site reactions in Part 1
- Injection site reactions occurred in 1 patient in each arm (7%) of Part 2 and in 1 patient in Part 3
- No severe injection site reactions were reported
- Infections, predominantly of the upper respiratory tract, in some instances serious, were reported with ILARIS
- Generally, the observed infections responded to standard therapy
- Isolated cases of unusual or opportunistic infections (eg, aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster) were reported during ILARIS treatment. A causal relationship of ILARIS to these events cannot be excluded