Taltz ® (ixekizumab) injection

80 mg/mL

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How often does inflammatory bowel disease occur with TALTZ® (ixekizumab) treatment for psoriasis, psoriatic arthritis, and axial spondyloarthritis?

During ixekizumab treatment, monitor for onset or exacerbation of IBD and if IBD occurs, discontinue ixekizumab and initiate appropriate medical management.

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en-US

Inflammatory Bowel Disease Summary

Cases of new or exacerbations of CD and UC have been reported. Overall, these events are uncommon (<1%). Caution should be exercised when prescribing ixekizumab to patients with IBD, including CD and UC, and patients should be monitored closely.1 

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 the placebo control group.2

During ixekizumab treatment, monitor for onset or exacerbation of IBD and if IBD occurs, discontinue ixekizumab and initiate appropriate medical management.2

In the ixekizumab phase 3 clinical trial program across psoriasis, PsA, and axSpA, the overall IBD frequency is reported as uncommon (<1%) for the placebo-controlled periods.

The frequency of IBD as of March 2020 is

  • 0.5% with an EAIR of 0.2 per 100 PYs for the adult psoriasis program as of the 5-year exposure data set (N=6449)
  • 0.2% with an EAIR of 0.1 per 100 PYs for the PsA program as of the 3-year exposure data set (N=1401), and
  • 1.8% with an EAIR of 0.9 per 100 PYs for the axSpA program as of the 3-year exposure data set (N=932).1

Crohn's Disease and Ulcerative Colitis Events

Psoriasis Clinical Trials

Per external adjudication, 31 patients with psoriasis had reported cases of IBD which were adjudicated as UC (n=18, IR=0.1 per 100 PY) and CD (n=13, IR=0.1 per 100 PY) across 15 adult psoriasis trials (N=6449 patients with 17,599 PY of exposure) as of March 2020 (Summary of Adjudicated Inflammatory Bowel Disease Events in Adult Psoriasis Clinical Trials: Frequency and Exposure-Adjusted Incidence Rates (All Ixekizumab Cutoff March 2020)). Of the 31 patients with IBD events, 19 discontinued ixekizumab treatment at the discretion of the investigator.

Summary of Adjudicateda Inflammatory Bowel Disease Events in Adult Psoriasis Clinical Trials: Frequency and Exposure-Adjusted Incidence Rates (All Ixekizumab Cutoff March 2020)1,3

 

Induction Periodb

Maintenance Periodc

15 Adult PsO Trials


Placebo
N=791

Ixekizumab
N=2328

Placebod
N=402

Ixekizumab 
N=824

All Ixekizumab Exposures 
N=6449

Total PY

180

534.5

188.2

627.6

17,599

Inflammatory bowel disease, n (%)

0

3 (0.13)

3 (0.75)

4 (0.49)

31 (0.5)

IR/100 PY

0

0.56

1.59

0.64

0.2

Crohn's disease, n (%) 

0

1 (0.04)

3 (0.75)

1 (0.12)

13 (0.2)

 IR/100 PY

0

0.19

1.59

0.16

0.1

Ulcerative colitis, n (%)

0

2 (0.09)

0

3 (0.36)

18 (0.3)

 IR/100 PY

0

0.37

0

0.48

0.1

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; PsO = psoriasis; PY = patient-years.
Note: Incidence rate was calculated as the total of “definite” and “probable” cases, divided by total PYs, and then multiplied by 100.

aData on suspected IBD, as identified by events possibly indicative of ulcerative colitis and Crohn’s disease, were collected and the events were adjudicated by an external Clinical Evaluation Committee with expertise in IBD.

bUNCOVER-1, -2, and -3 (week 0-12).

cUNCOVER-1 and -2 (week 12-60).

dPatients received ixekizumab during the induction period.

New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab from 15 Adult Psoriasis Trials as of March 2020 summarizes adjudicated IBD events based on self-reported history of IBD from the March 2020 data set. Across the 15 adult psoriasis trials, the number of patients who self-reported a history of IBD was 35. Of the 35 patients with self-reported history of IBD, 31 patients reported no events of IBD during the trials.1

New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab from 15 Adult Psoriasis Trials as of March 20201

 

All Ixekizumab Psoriasis Exposures 
N=6449

Total Exposure as of March 2020, PY

17,599

Patients with a self-reported history of IBD, n (%) 

35 (0.5)a

Total inflammatory bowel disease, n (%) [IR/100 PY]

31 (0.5) [0.2]

Crohn's disease, n (%) [IR/100 PY]

13 (0.2) [0.1]

Patients with ≥1 event and a self-reported history of IBD, n

1

Patients with ≥1 event and no known history of IBD, n

12

Ulcerative colitis, n (%) [IR/100 PY]

18 (0.3) [0.2]

Patients with ≥1 event and a self-reported history of IBD, n

3

Patients with ≥1 event and no known history of IBD, n

15

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; PY = patient-years.
Note: Incidence rate was calculated as the total of “definite” and “probable” cases, divided by total PYs, and then multiplied by 100.

a31 of the 35 patients with self-reported history of IBD reported no events of IBD during the trials.

Psoriatic Arthritis Clinical Trials

Per external adjudication, 3 patients with PsA had reported cases of IBD which were adjudicated as UC (n=1, IR=0.0 per 100 PY) and CD (n=2, IR=0.1 per 100 PY) across 4 PsA trials (N=1401 patients with 2248 PY of exposure) as of March 2020 (Summary of Adjudicated Inflammatory Bowel Disease Events in Psoriatic Arthritis Clinical Trials: Frequency and Exposure-Adjusted Incidence Rates (All Ixekizumab Cutoff March 2020)) . Of the 3 patients with IBD events, 1 discontinued ixekizumab treatment at the discretion of the investigator.1

Summary of Adjudicateda Inflammatory Bowel Disease Events in Psoriatic Arthritis Clinical Trials: Frequency and Exposure-Adjusted Incidence Rates (All Ixekizumab Cutoff March 2020)1,4

 

Placebo Through 24 Weeksb
N=224

Ixekizumab Through 24 Weeksb
N=454

All Ixekizumab Exposures Across 4 Psoriatic Arthritis Trials 
N=1401

Total PY

85.7

193.8

2248

Inflammatory bowel disease, n (%)

0

0c

3 (0.2)d

IR/100 PY

0

0

0.1

Crohn's disease, n (%)

0

0

2 (0.1)

IR/100 PY

0

0

0.1

Ulcerative colitis, n (%)

0

0

1 (0.1)

IR/100 PY

0

0

0.0

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; PY = patient-years.
Note: Incidence rate was calculated as the total of “definite” and “probable” cases, divided by total PYs, and then multiplied by 100.

aData on suspected IBD, as identified by events possibly indicative of ulcerative colitis and Crohn’s disease, were collected and the events were adjudicated by an external Clinical Evaluation Committee with expertise in IBD.

bData are from first 24 weeks of SPIRIT-P1 and SPIRIT-P2 trials.

cOne patient had an anal abscess and anal fistula. This event was considered consistent with IBD, but was not adjudicated as Crohn's disease or ulcerative colitis due to insufficient information.

dOne additional patient had an anal abscess and anal fistula. This event was considered consistent with IBD, but was not adjudicated as Crohn's disease or ulcerative colitis due to insufficient information.

New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 4 PsA Trials as of March 2020 summarizes adjudicated IBD events based on self-reported history of IBD from the March 2020 data set. The number of patients with self-reported history was 14 across 4 PsA trials. None of the 14 patients with self-reported history of IBD reported an IBD event during the trials.1

New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 4 PsA Trials as of March 20201

All Ixekizumab PsA Exposures
N=1401
n (%)

Total exposure as of March 2020, PY

2248

Patients with a self-reported history of IBD, n (%)

14 (1.0)a

Total inflammatory bowel disease, n (%) [IR/100 PY]

3 (0.2) [0.1]b

Crohn’s disease, n (%) [IR/100 PY]

2 (0.1) [0.1]

 Patients with ≥1 event and a self-reported history of IBD, n

0

 Patients with ≥1 event and no known history of IBD, n

2

Ulcerative colitis, n (%) [IR/100 PY]

1 (0.1) [0.0]

Patients with ≥1 event and a self-reported history of IBD, n

0

Patients with ≥1 event and no known history of IBD, n

1

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; PY = patient-years.
Note: Incidence rate was calculated as the total of “definite” and “probable” cases, divided by total PYs, and then multiplied by 100.

aNone of the 14 patients with self-reported history of IBD reported an IBD event during the trials.

bOne additional patient had an anal abscess and anal fistula. This event was considered consistent with IBD, but was not adjudicated as Crohn's disease or ulcerative colitis due to insufficient information.

Axial Spondyloarthritis Trials

Per external adjudication, 17 patients had reported cases of IBD which were adjudicated as UC (n=10, IR=0.5 per 100 PY) and CD (n=7, IR=0.4 per 100 PY) across 4 axSpA trials (N=932 patients with 1849 PY of exposure) as of March 2020 (Summary of Adjudicated Inflammatory Bowel Disease Events in Axial Spondyloarthritis Trials as of March 2020). Of the 17 patients with IBD events, 6 discontinued ixekizumab treatment at the discretion of the investigator.

Summary of Adjudicateda Inflammatory Bowel Disease Events in Axial Spondyloarthritis Trials as of March 20201,5

Placebo Through 16 Weeks
N=294b

Ixekizumab Through 16 Weeks
N=574c

All Ixekizumab Exposures Across 4 axSpA Trials
N=932

Total PY

89.9

175.8

1849

Inflammatory bowel disease, n (%)

1 (0.3)d,e

5 (0.9)

17 (1.8)

IR/100 PY

1.1

2.8

0.9

Crohn's disease, n (%)

1 (0.3)f

4 (0.7)

7 (0.8)

IR/100 PY

1.1

2.3

0.4

Ulcerative colitis, n (%)

0

1 (0.2)

10 (1.1)

IR/100 PY

0g

0.6

0.5

Abbreviations: AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis; axSpA = axial spondyloarthritis; CD = Crohn's disease; IBD = inflammatory bowel disease; IR = incidence rate; nr-axSpA = nonradiographic axial spondyloarthritis; PY = patient-years; UC = ulcerative colitis.
Note: Incidence rate was calculated as the total of “definite” and “probable” cases, divided by total PYs, and then multiplied by 100.

aData on suspected IBD, as identified by events possibly indicative of UC and CD, were collected and the events were adjudicated by an external Clinical Evaluation Committee with expertise in IBD.

bData are from first 16 weeks of COAST-V, COAST-W (AS/r-axSpA), and COAST-X (nr-axSpA) trials.

cData are from first 16 weeks of COAST-V, COAST-W (AS/r-axSpA), and COAST-X (nr-axSpA) trials.

dOne patient from COAST-W was reported as a case of UC and later adjudicated as a case of CD.

eThere was 1 patient from COAST-X with a history of UC and reported as a case of UC but adjudicated as “insufficient information."

fOne patient from COAST-W was reported as a case of UC and later adjudicated as CD.

gThere was 1 patient from COAST-X with a history of UC and reported as a case of UC but adjudicated as “insufficient information."

New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 4 axSpA Trials (as of March 2020) summarizes adjudicated IBD events based on self-reported history of IBD from the March 2020 data set. The number of patients with a self-reported history was 30. Of the 30 patients with self-reported history of IBD, 25 patients reported no events of IBD during the trials.1

New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 4 axSpA Trials (as of March 2020)a1,5


All Ixekizumab axSpA Exposures
N=932
n (%)

Total exposure as of March 2020, PY

1849

Patients with a self-reported history of IBD, n (%)

30 (3.2)b

Total inflammatory bowel disease, n (%) [IR/100 PY]

17 (1.8) [0.9]

Crohn's disease, n (%) [IR/100 PY]

7 (0.8) [0.4]

Patients with ≥1 event and a self-reported history of IBD, n

1

Patients with ≥1 event and no known history of IBD, n

6

Ulcerative colitis, n (%) [IR/100 PY]

10 (1.1) [0.5]

Patients with ≥1 event and a self-reported history of IBD, n

4

Patients with ≥1 event and no known history of IBD, n

6

Abbreviations: axSpA = axial spondyloarthritis; IBD = inflammatory bowel disease; IR = incidence rate; PY = patient-years.
Note: Incidence rate was calculated as the total of “definite” and “probable” cases, divided by total PY, and then multiplied by 100.

aOne patient who received placebo in COAST-W reported ulcerative colitis, and was later adjudicated as Crohn's disease. In addition, 1 patient in COAST-X who received placebo had a history of ulcerative colitis and was reported as a case of ulcerative colitis, but was adjudicated as insufficient information.

bTwenty-five of the 30 patients with self-reported history of IBD reported no events of IBD during the trials.

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

3Reich K, Leonardi C, Langley RG, et al. Inflammatory bowel disease among patients with psoriasis treated with ixekizumab: a presentation of adjudicated data from an integrated database of 7 randomized controlled and uncontrolled trials. J Am Acad Dermatol 2017;76(3);441-448.e2. https://dx.doi.org/10.1016/j.jaad.2016.10.027

4Genovese MC, Colombel JF, Gellett AM, et al. Incidence of inflammatory bowel disease among patients treated with ixekizumab: an update on adjudicated data from an integrated database of patients with psoriasis and psoriatic arthritis. Presented at: American College of Rheumatology/AHRP 2018 Annual Scientific Meeting; October 19-24, 2018; Chicago, IL.

5Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November 5-9, 2020.

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

CD = Crohn's disease

EAIR = exposure adjusted incidence rate

IBD = inflammatory bowel disease

nr-axSpA = nonradiographic axial spondyloarthritis

PY = patient-years

UC = ulcerative colitis

Date of Last Review: December 10, 2020


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