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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 inflammatory bowel disease with Taltz® (ixekizumab) in pediatric patients?
Pediatric psoriasis is associated with an increased rate of Crohn’s disease. The incidence of inflammatory bowel disease in the ixekizumab pediatric psoriasis clinical trial was 1.2 per 100 patient-years of exposure.
Ixekizumab Label Information Related to Inflammatory Bowel Disease
Patients treated with ixekizumab may be at increased risk of inflammatory bowel disease (IBD). In clinical trials, Crohn's disease (CD) and ulcerative colitis (UC), including exacerbations, occurred at a greater frequency in the ixekizumab group than the placebo control group.1
During ixekizumab treatment, monitor for onset or exacerbation of IBD and if IBD occurs, discontinue ixekizumab and initiate appropriate medical management.1
In IXORA-PEDS, CD occurred at a greater frequency in the ixekizumab group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn's disease occurred in a total of 4 ixekizumab treated patients (2.0%) in the clinical trial.1
Prevalence of Inflammatory Bowel Disease In Pediatric Psoriasis Patients
The average annual standardized CD incidence per 100 PY from 1996 to 2006 according to the US Kaiser Permanente Northern California IBD Registry was
- 0.0004 for children aged 0 to 4 years
- 0.0013 for children aged 5 to 9 years
- 0.004 for children aged 10 to 14 years, and
- 0.0064 for adolescents aged 15 to 17 years.2
Globally, the rates of pediatric IBD, due primarily to the incidence of CD, are rising; however, most countries lack accurate estimates of prevalence and incidence of pediatric IBD. Of 25 studies that calculated pediatric CD incidence over time, 60% reported statistically significant increased incidence of pediatric CD.3
Pediatric psoriasis is associated with an increased rate of CD.4
In a study using a German health insurance database, CD occurred 3-4 times more often in pediatric psoriasis patients compared to pediatric controls without psoriasis.4
Another retrospective United States claims study found the incidence rate (IR) for IBD to be 0.118 per 100 PY in pediatric psoriasis patients vs 0.043 for the non-psoriasis pediatric cohort. Additionally, the IR for CD was 0.097 per 100 PY in the pediatric psoriasis cohort vs 0.029 for the non-psoriasis pediatric cohort.5
Inflammatory Bowel Disease Events in IXORA-PEDS
IXORA-PEDS was a multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of ixekizumab in pediatric patients aged 6 to <18 years with moderate-to-severe plaque psoriasis.6,7
Patients with a history of IBD were not excluded from IXORA-PEDS. However, patients with a presence of a gastrointestinal disorder (not specifically IBD) at screening that, in the opinion of the investigator, posed an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data were excluded from IXORA-PEDS.7
An independent external review committee of gastroenterologists with expertise in IBD adjudicated all potential adverse events (AEs) of IBD identified by IBD-related broad Medical Dictionary for Regulatory Activities (MedDRA) search terms. This adjudication was prespecified in the IXORA-PEDS protocol.8
IXORA-PEDS: Adjudicated Inflammatory Bowel Disease Adverse Events summarizes adjudicated cases of IBD reported in the IXORA-PEDS trial. The IR of IBD in IXORA-PEDS was 1.2 per 100 PY.7
Across 17 adult psoriasis trials (N=6892, accounting for 18,025.7 PY of total ixekizumab exposure) as of the March 19, 2021 database lock, the IR of adjudicated IBD was 0.1 per 100 PY of exposure.9
|
Double-Blind Treatment Period |
Combined Treatment Periods |
|
|
Placebo |
Ixekizumab Q4W |
Total Ixekizumab |
Crohn's disease |
0 |
1 (0.9) |
4 (2.0) |
Ulcerative colitis |
0 |
0 |
0 |
Abbreviations: PY = patient-years; Q4W = every 4 weeks
aAll patients who received at least 1 dose of 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.
IXORA-PEDS: Case Summaries of Patients With Adjudicated Inflammatory Bowel Disease provides case summaries of the patients with IBD events. None of these patients had a family history of IBD.6
Patient Demographics |
Preferred Term |
Risk Factors |
Study Period, Treatment |
Outcome |
9-year-old female |
Diarrhea |
Gastrointestinal inflammation and abdominal pain at day 1 |
Double-blind treatment period day 43, |
Discontinued, AE of gastrointestinal inflammation not resolved |
15-year-old male |
IBD |
None reported |
Maintenance period day 281, |
Discontinued, SAE recovered |
13-year-old female |
CD |
None reported |
Maintenance period days 248 and 255, |
Discontinued, AE ongoing at time of database lock |
9-year-old female |
CD |
History of alopecia areata, atopic dermatitis, and psoriatic arthritis |
Maintenance period days 151, 172, and 177 and Post-treatment period day 118, |
Discontinued, patient recovered from each event |
Abbreviations: AE = adverse event; CD = Crohn's disease; IBD = inflammatory bowel disease; IXE = ixekizumab 80 mg; Q4W = every 4 weeks; SAE = serious adverse event.
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.
2Abramson O, Durant M, Mow W, et al. Incidence, prevalence, and time trends of pediatric inflammatory bowel disease in northern California, 1996 to 2006. J Pediatr. 2010;157(2):233-239.e231. http://dx.doi.org/10.1016/j.jpeds.2010.02.024
3Benchimol EI, Fortinsky KJ, Gozdyra P, et al. Epidemiology of pediatric inflammatory bowel disease: A systematic review of international trends. Inflamm Bowel Dis. 2011;17(1):423-439. http://dx.doi.org/10.1002/ibd.21349
4Augustin M, Glaeske G, Radtke MA, et al. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010;162(3):633-636. http://dx.doi.org/10.1111/j.1365-2133.2009.09593.x
5Paller AS, Schenfeld J, Accortt NA, Kricorian G. A retrospective cohort study to evaluate the development of comorbidities, including psychiatric comorbidities, among a pediatric psoriasis population. Pediatr Dermatol. 2019;36(3):290-297. https://doi.org/10.1111/pde.13772
6Paller 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
7Paller 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
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9Griffiths 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.
10Paller AS, Seyger MMB, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in pediatric patients with moderate-to-severe plaque psoriasis. Abstract presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology (EADV Virtual); October 9-13, 2019; Madrid, Spain.
Date of Last Review: April 21, 2022