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Taltz ® (ixekizumab) injection
80 mg/mLThis 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.
TALTZ® (ixekizumab): Inflammatory Bowel Disease Adverse Events in the Pediatric Psoriasis Clinical Trial
Pediatric psoriasis is associated with an increased rate of CD. The incidence of IBD in the ixekizumab pediatric psoriasis clinical trial are summarized below.
US_cFAQ_IXE335_INFLAMMATORY_BOWEL_DISEASE_PEDS
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Ixekizumab Label Information Related to Inflammatory Bowel Disease
Patients treated with ixekizumab may be at increased risk of IBD. In clinical trials, CD and UC, including exacerbations, occurred at a greater frequency in the ixekizumab group than in the placebo control group. 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 subjects (2.0%) in the clinical trial.1
Prevalence of Inflammatory Bowel Disease In Pediatric Psoriasis Patients
The US Kaiser Permanente Northern California IBD Registry analyzed the average annual standardized CD incidence per 100 PY from 1996 to 2006, which by age was
- 0.0004 for 0- to 4-years of age
- 0.0013 for 5- to 9-years of age
- 0.004 for 10- to 14-years or age, and
- 0.0064 for 15- to 17-years of ages.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 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 is an ongoing, 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
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 AEs of IBD identified by IBD-related broad MedDRA search terms. This adjudication was prespecified in the IXORA-PEDS protocol.7
Adjudicated cases of IBD reported in the IXORA-PEDS trial are summarized in . The EAIR of IBD in IXORA-PEDS at the November 2019 48-week interim database lock is 1.6 per 100 PY.7 IXORA-PEDS is an ongoing study and the November 2019 database lock represents a total ixekizumab exposure of 253.9 PY.6
Across the entire ixekizumab psoriasis program, including 13 adult trials and IXORA-PEDS (N=6094), as of the March 2019 database lock for adults and November 2019 database lock for pediatrics, the frequency of adjudicated IBD was 0.5% corresponding to an EAIR of 0.2 per 100 PY.7
|
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 exposed to ixekizumab in the induction, maintenance, and extension periods through the 48-week interim database lock (253.9 total PY of exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.
Case summaries of the patients with IBD events are provided in .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; 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; 2020.
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 and 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. http://dx.doi.org/10.1111/pde.13772
6Paller AS, Seyger MMB, Magariños GA, et al. 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
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Paller 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. Talk presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.
Glossary
AE = adverse event
CD = Crohn's disease
EAIR = exposure adjusted incidence rate
IBD = inflammatory bowel disease
IR = incidence rate
MedDRA = Medical Dictionary for Regulatory Activities
PY = patient-years
UC = ulcerative colitis
Date of Last Review: May 05, 2020
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