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Taltz ® (ixekizumab) injection
80 mg/mL
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What is the incidence of inflammatory bowel disease with Taltz® (ixekizumab)?
During ixekizumab treatment, monitor for onset or exacerbation of IBD and if IBD occurs, discontinue ixekizumab and initiate appropriate medical management.
Inflammatory Bowel Disease Summary
Cases of new or exacerbations of Crohn's disease (CD) and ulcerative colitis (UC) have been reported. Overall, these events are uncommon (less than 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, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), the overall IBD frequency is reported as uncommon (less than 1%) for the placebo-controlled periods.
The exposure adjusted incidence rate (EAIR) as of March 2022 is
Crohn's Disease and Ulcerative Colitis Events
Psoriasis Clinical Trials
Per external adjudication, 31 adult 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 17 adult psoriasis trials (N=6892 patients with 18,025.7 PY of exposure) as of March 2022 (Summary of Adjudicated Inflammatory Bowel Disease Events in Adult Psoriasis Clinical Trials: Frequency and Exposure-Adjusted Incidence Rates (All Ixekizumab Exposures as of March 2022)). Of the 31 patients with IBD events, 20 discontinued ixekizumab treatment at the discretion of the investigator.1,5
|
Induction Periodb |
Maintenance Periodc |
17 Adult PsO Trials |
||
Placebo |
Ixekizumab |
Placebod |
Ixekizumab |
All Ixekizumab Exposures |
|
Total PY |
180 |
534.5 |
188.2 |
627.6 |
18,025.7 |
Inflammatory bowel disease, n (%) |
0 |
3 (0.13) |
3 (0.75) |
4 (0.49) |
26 (0.4)d |
IR/100 PY |
0 |
0.56 |
1.59 |
0.64 |
0.1 |
Crohn's disease, n (%) |
0 |
1 (0.04) |
3 (0.75) |
1 (0.12) |
10 (0.1) |
IR/100 PY |
0 |
0.19 |
1.59 |
0.16 |
0.1 |
Ulcerative colitis, n (%) |
0 |
2 (0.09) |
0 |
3 (0.36) |
16 (0.2) |
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).
dTwenty-six cases were listed as treatment-emergent adverse events of IBD. Five additional cases were listed as adverse events of IBD, and these occurred when patients were not on ixekizumab (either occurring when patients were on placebo during the randomized withdrawal period of UNCOVER-2 [n=2], or during follow-up [1 patient each from UNCOVER-2, UNCOVER-3, and IXORA-R]).
New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 17 Adult Psoriasis Trials as of March 2022 summarizes adjudicated IBD events based on self-reported history of IBD from the March 2022 data set. Across the 17 adult psoriasis trials, the number of patients who self-reported a history of IBD was 44. Of the 44 patients with self-reported history of IBD, 41 patients reported no events of IBD during the trials.1
|
All Ixekizumab Psoriasis Exposures |
Total Exposure as of March 2022, PY |
18,025.7 |
Patients with a self-reported history of IBD, n (%) |
44 (0.6)a |
Total inflammatory bowel disease, n (%) [IR/100 PY] |
26 (0.4) [0.1]b |
Crohn's disease, n (%) [IR/100 PY] |
10 (0.1) [0.1] |
Patients with greater than or equal to 1 event and a self-reported history of IBD, n |
1 |
Patients with ≥1 event and no known history of IBD, n |
9 |
Ulcerative colitis, n (%) [IR/100 PY] |
16 (0.2) [0.1] |
Patients with greater than or equal to 1 event and a self-reported history of IBD, n |
2 |
Patients with ≥1 event and no known history of IBD, n |
14 |
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.
aOf the 44 patients with self-reported history of IBD, 41 reported no events of IBD during the trials.
bTwenty-six cases were listed as treatment-emergent adverse events of IBD. Five additional cases were listed as adverse events of IBD, and these occurred when patients were not on ixekizumab (either occurring when patients were on placebo during the randomized withdrawal period of UNCOVER-2 [n=2], or during follow-up [1 patient each from UNCOVER-2, UNCOVER-3, and IXORA-R]).
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 2022 (Summary of Adjudicated Inflammatory Bowel Disease Events in Psoriatic Arthritis Clinical Trials: Frequency and Exposure-Adjusted Incidence Rates (All Ixekizumab Exposures as of March 2022)). Of the 3 patients with IBD events, 1 discontinued ixekizumab treatment at the discretion of the investigator.3,4,7
|
Placebo Through 24 Weeksb |
Ixekizumab Through 24 Weeksb |
All Ixekizumab Exposures Across 4 Psoriatic Arthritis Trials |
Total PY |
85.7 |
193.8 |
2248 |
Inflammatory bowel disease, n (%) |
0 |
0c |
|
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.
eThree patients had events of IBD confirmed by adjudication. One patient had more than 1 event.
New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 4 PsA Trials as of March 2022 summarizes adjudicated IBD events based on self-reported history of IBD from the March 2022 data set. The number of patients with self-reported history was 14 across the 4 PsA trials. None of the 14 patients with self-reported history of IBD reported an IBD event during the trials.1
All Ixekizumab PsA Exposures |
|
Total exposure as of March 2022, PY |
2248 |
Patients with a self-reported history of IBD, n (%) |
14 (1.0)a |
Total inflammatory bowel disease, n (%) [IR/100 PY] |
|
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.
cThree patients had events of IBD confirmed by adjudication. One patient had more than 1 event.
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=0.3 per 100 PY) across 4 axSpA trials (N=932 patients with 2097.7 PY of exposure) as of March 2022 (Summary of Adjudicated Inflammatory Bowel Disease Events in Axial Spondyloarthritis Trials as of March 2022). Of the 17 patients with IBD events, 9 discontinued ixekizumab treatment at the discretion of the investigator.1,8
Placebo Through 16 Weeksb
(N=294) |
All Ixekizumab Exposures Across 4 axSpA Trials
(N=932) |
||
Total PY |
89.9 |
175.8 |
2097.7 |
Inflammatory bowel disease, n (%) |
5 (0.9) |
17 (1.8)e |
|
IR/100 PY |
1.1 |
2.8 |
0.8 |
Crohn's disease, n (%) |
1 (0.3)f |
4 (0.7) |
7 (0.8) |
IR/100 PY |
1.1 |
2.3 |
0.3 |
Ulcerative colitis, n (%) |
0 |
1 (0.2) |
10 (1.1) |
IR/100 PY |
0d |
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.
cOne patient from COAST-W was reported as a case of UC and later adjudicated as a case of CD.
dThere was 1 patient from COAST-X with a history of UC and reported as a case of UC but adjudicated as “insufficient information."
eOne additional event occurred during safety follow-up in the COAST Program and is not counted as a TEAE.
fOne patient from COAST-W was reported as a case of UC and later adjudicated as CD.
New Onset and Exacerbation of Crohn’s Disease and Ulcerative Colitis in Patients Treated With Ixekizumab From 4 axSpA Trials (as of March 2022), summarizes adjudicated IBD events based on self-reported history of IBD from the March 2022 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
All Ixekizumab axSpA Exposures |
|
Total exposure as of March 2022, PY |
2098 |
Patients with a self-reported history of IBD, n (%) |
30 (3.2)b |
Total inflammatory bowel disease, n (%) [IR/100 PY] |
17 (1.8) [0.8]a |
Crohn's disease, n (%) [IR/100 PY] |
7 (0.8) [0.3] |
Patients with greater than or equal to 1 event and a self-reported history of IBD, n |
1 |
Patients with greater than or equal to 1 event and no known history of IBD, n |
6 |
Ulcerative colitis, n (%) [IR/100 PY] |
10 (1.1) [0.5] |
Patients with greater than or equal to 1 event and a self-reported history of IBD, n |
4 |
Patients with greater than or equal to 1 event and no known history of IBD, n |
6 |
Abbreviations: axSpA = axial spondyloarthritis; IBD = inflammatory bowel disease; IR = incidence rate; PY = patient-years; TEAE = treatment-emergent adverse event.
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.
Enclosed Prescribing Information
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; 2024.
3Deodhar A, Blauvelt A, Schwartzman S, et al. Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis. Abstract presented at: American College of Rheumatology/ARP - 2022 Annual Scientific Meeting; November 10-14, 2022; Philadelphia, Pennsylvania. Accessed March 5, 2024. https://acrabstracts.org/abstract/long-term-safety-of-ixekizumab-in-adult-patients-with-psoriasis-psoriatic-arthritis-and-axial-spondyloarthritis/
4Deodhar A, Blauvelt A, Lebwohl M, et al. Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials. Arthritis Res Ther. 2024;26(1):49. https://doi.org/10.1186/s13075-023-03257-7
5Griffiths 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. Dermatol Ther (Heidelb). 2022;12(6):1431-1446. https://doi.org/10.1007/s13555-022-00743-9
6Reich 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
7Deodhar AA, Combe B, Accioly AP, et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022;81(7):944-950. https://doi.org/10.1136/annrheumdis-2021-222027
8Schwartzman S, Deodhar A, Combe B, et al. Safety profile of ixekizumab for the treatment of psoriatic arthritis and axial spondyloarthritis up to 3 years: an updated integrated safety analysis. Poster presented at: Annual Meeting of the America College of Rheumatology (ACR Convergence Virtual); November 1-10, 2021.
Date of Last Review: March 29, 2024