If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Taltz ® (ixekizumab) injection
80 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the incidence of infections with Taltz® (ixekizumab) in pediatric patients?
Ixekizumab may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Infection-Related Label Information
Ixekizumab may increase the risk of infection. Instruct patients treated with ixekizumab to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves.1
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ixekizumab. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab. Consider anti-TB therapy prior to initiating ixekizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ixekizumab should be monitored closely for signs and symptoms of active TB during and after treatment.1
In clinical trials of patients with plaque psoriasis, the ixekizumab group had a higher rate of infections than the placebo group (27% vs 23%).
Infections that occurred more frequently in the ixekizumab group than in the placebo group were
- upper respiratory tract infections
- oral candidiasis
- conjunctivitis, and
- tinea infections.1
Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with ixekizumab Q4W is consistent with the safety profile in adult patients with plaque psoriasis with the exception of
- conjunctivitis (adults, less than 1%; pediatrics, 2.6%)
- influenza (adults, less than 1%; pediatrics, 1.7%), and
- urticaria (adults, less than 1%; pediatrics, 1.7%).1
Treatment-Emergent Infections in IXORA-PEDS
IXORA-PEDS: Treatment-Emergent Infections in the Double-Blind Treatment Period and Combined Treatment Periods Through the 108-Week Final Database Lock provides a summary of treatment-emergent infections reported in ≥3% of ixekizumab-treated patients in IXORA-PEDS. A list of all infections reported in patients receiving ixekizumab in IXORA-PEDS is available in the supplementary material of the Paller et al manuscript.2
During the double-blind treatment period, none of the patients
In the all ixekizumab exposure population through the 108-week final database lock
- 2 patients (1.0%) reported serious infections (1 each of otitis media acute and tonsillitis)
- no patients discontinued study drug due to an infection-related AE
- one case each of varicella zoster virus infection and herpes simplex virus infection were reported. Both infections were mild, and neither event met the criteria for an opportunistic infection as defined in the program safety analysis plan, and
- one patient reported a treatment-emergent adverse event of fungal infection, which was a mild oral Candida infection of 5 days duration.2,4,5
12-Week Double-Blind Treatment Period |
Combined Treatment Periods, All Ixekizumab Safety Populationb |
||
|
Placebo |
Ixekizumab Q4W |
Total Ixekizumab |
Infections overall |
14 (25.0) |
37 (32.2) |
145 (74.0) |
Serious infections |
0 |
0 |
2 (1.0)c |
Opportunistic infections |
0 |
0 |
0d |
Candida |
0 |
0 |
1 (0.5)e |
Nasopharyngitis |
4 (7.1) |
13 (11.3) |
43 (21.9) |
Upper respiratory tract infection |
4 (7.1) |
6 (5.2) |
41 (20.9) |
Pharyngitis |
0 |
2 (1.7) |
22 (11.2) |
Tonsillitis |
2 (3.6) |
1 (0.9) |
19 (9.7) |
Conjunctivitis |
0 |
3 (2.6) |
16 (8.2) |
Impetigo |
0 |
1 (0.9) |
13 (6.6) |
Influenza |
0 |
2 (1.7) |
13 (6.6) |
Viral upper respiratory tract infection |
0 |
2 (1.7) |
13 (6.6) |
Pharyngitis streptococcal |
0 |
2 (1.7) |
12 (6.1) |
Viral infection |
2 (3.6) |
2 (1.7) |
10 (5.1) |
Gastroenteritis |
0 |
0 |
10 (5.1) |
Folliculitis |
0 |
1 (0.9) |
9 (4.6) |
Urinary tract infection |
0 |
0 |
9 (4.6) |
Pharyngotonsillitis |
0 |
1 (0.9) |
8 (4.1) |
Ear infection |
1 (1.8) |
1 (0.9) |
7 (3.6) |
Hordeolum |
1 (1.8) |
1 (0.9) |
7 (3.6) |
Oral herpes |
0 |
0 |
7 (3.6) |
Otitis externa |
0 |
2 (1.7) |
7 (3.6) |
Gastroenteritis viral |
0 |
0 |
6 (3.1) |
Otitis media |
0 |
1 (0.9) |
6 (3.1) |
Abbreviation: Q4W = every 4 weeks.
aOccurring in ≥3% of ixekizumab-treated patients or adverse event of special interest.
bAll patients exposed to ixekizumab in the induction, maintenance, and extension periods through the 108-week final database lock (342.81 total patient-years of exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.
cOne case each of otitis media acute and tonsillitis.
dOne case each of varicella zoster virus infection and herpes simplex virus infection were reported. Both infections were mild, and neither event met the criteria for an opportunistic infection as defined in the program safety analysis plan.
eOne patient (0.5%) reported a TEAE of fungal infection, which was a mild oral Candida infection of 5 days duration. Based on the program safety analysis plan, fungal infection is not a preferred term included in Candida infections and thus is not captured in the Paller et al 2022 publication.
Integrated Safety Across All Ixekizumab Psoriasis Clinical Trials
An integrated safety analysis was conducted from all ixekizumab adult psoriasis exposures (N=6892; 18,025.7 patient-years [PYs]) across 17 adult plaque psoriasis clinical trials as of March 19, 2021. The proportion of patients with
- any infection was 62.5% [incidence rate (IR)=23.9 per 100 PYs of exposure]
- serious infection was 3.4% [IR=1.3 per 100 PYs of exposure]
- all Candida infections was 4.9% [IR=1.9 per 100 PYs of exposure], and
- opportunistic infections was 4.6% [IR=1.8 per 100 PYs of exposure].6
The IR of infections did not increase with longer ixekizumab exposure, up to 5 years.7
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Paller AS, Seyger MMB, Magariños GA, et al; IXORA-PEDS Investigators. Long-term efficacy and safety of up to 108 weeks of ixekizumab in pediatric patients with moderate to severe plaque psoriasis: the IXORA-PEDS randomized clinical trial. JAMA Dermatol. Published online April 13, 2022. https://dx.doi.org/10.1001/jamadermatol.2022.0655
3Paller AS, Seyger MMB, Magariños GA, et al; IXORA-PEDS Study Group. Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. 2020;183(2):231-241. https://doi.org/10.1111/bjd.19147
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Paller AS, Seyger MMB, Magariños GA, et al. Long-term efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in pediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS) up to 108 weeks. Poster presented at: Annual Meeting of the American Academy of Dermatology (AAD); March 25-29, 2022; Boston, MA.
6Griffiths CEM, Gooderham M, Colombel JF, et al. Safety of ixekizumab in adult patients with moderate-to-severe psoriasis: data from 17 clinical trials with over 18,000 patient-years of exposure. Poster presented at: Annual Meeting of the American Academy of Dermatology (AAD); March 25-29, 2022; Boston, MA.
7Griffiths CEM, Reich K, Gooderham M, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis up to 5 years: pooled data from 16 clinical trials. Poster presented at: 29th Annual Meeting of the European Academy of Dermatology and Venereology (EADVirtual); October 29-31, 2020.
Date of Last Review: May 19, 2022