Skip To Main Content
Lilly
Menu closed
Lilly
  • Account Login / Register
  • Medical Home
    • Medical Information
  • Medical Education
  • Science
Ask Lilly

We're here to help.

Chat
Chat with us Chat with us
Question Contact Us
Expand contact lilly
Lilly

You are now leaving the LillyMedical.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to LillyMedical.com.

  1. Medical Information Right
  2. Immunology Right
  3. Taltz (ixekizumab) injection Right
  4. What is the incidence of inflammatory bowel disease with Taltz® (ixekizumab) in pediatric patients?
Search Taltz (type in keywords)
Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

Loading icon

Taltz ® (ixekizumab) injection

80 mg/mL

Full Prescribing Information

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.

US_cFAQ_IXE335_INFLAMMATORY_BOWEL_DISEASE_PEDS
US_cFAQ_IXE335_INFLAMMATORY_BOWEL_DISEASE_PEDS
en-US

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

IXORA-PEDS: Adjudicated Inflammatory Bowel Disease Adverse Events6,7,10

 

Double-Blind Treatment Period

Combined Treatment Periods
Through Week 108a

 

Placebo
(N=56)
n (%)

Ixekizumab Q4W
(N=115)
n (%)

Total Ixekizumab
(N=196)
n (%)

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

IXORA-PEDS: Case Summaries of Patients With Adjudicated Inflammatory Bowel Disease6

Patient Demographics

Preferred Term
(Adjudication)

Risk Factors

Study Period, Treatment

Outcome

9-year-old female

Diarrhea
(probable CD)

Gastrointestinal inflammation and abdominal pain at day 1

Double-blind treatment period day 43,
IXE Q4W

Discontinued, AE of gastrointestinal inflammation not resolved

15-year-old male

IBD
(probable CD)

None reported

Maintenance period day 281, 
IXE Q4W

Discontinued, SAE recovered 

13-year-old female

CD
(probable CD)

None reported

Maintenance period days 248 and 255, 
IXE Q4W

Discontinued, AE ongoing at time of database lock

9-year-old female

CD
(probable CD)

History of alopecia areata, atopic dermatitis, and psoriatic arthritis

Maintenance period days 151, 172, and 177 and Post-treatment period day 118, 
IXE Q4W

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

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

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

Are you satisfied with this content?

Can't find what you're looking for? Contact us for answers to your medical questions.

  • Copyright
  • Terms of Use
  • Privacy Statement
  • Accessibility Statement
  • Sitemap

    This site is intended for US Healthcare Professionals only.

    4.0.17 02/2023 | GLOOTH00001 04/2015 | © Lilly USA, LLC 2023. All rights reserved.

    Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates

    facebook twitter linkedin
    visit www.phactmi.org
    Lilly