Taltz ® (ixekizumab)

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Is Taltz® (ixekizumab) safe to use in pregnancy?

Human data are insufficient to establish the safety of ixekizumab during pregnancy.

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What is the effect of ixekizumab in pregnancy?

Developmental toxicity studies conducted in pregnant monkeys that were exposed ixekizumab revealed no evidence of harm to the fetus or infant.1

Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody.2 Human immunoglobin G is known to cross the placental barrier.3,4 Therefore, ixekizumab may be transmitted from the mother to the developing fetus.

Further information regarding pregnancy is available in the

Pregnancy information regarding maternal exposure

Limited safety data are available on the use of ixekizumab in pregnant women who are exposed to ixekizumab.6

Pregnant and breastfeeding women were excluded from ixekizumab clinical trials. Women who became pregnant were discontinued from the trials.7-12

All women agreed to use a reliable method of birth control during ixekizumab clinical trials and for at least 12 weeks following the last dose of ixekizumab.7-10,12

Pregnancy outcomes 

As of the March 22, 2019 database cutoff, 58 female patients in clinical trials were exposed to ixekizumab while pregnant and the outcome is known for 52 of the pregnancies.13  

All exposures occurred during the first trimester except for 2 cases in which the trimester of exposure was not reported.13  

Owing to study protocol discontinuation criteria, all but 2 women discontinued ixekizumab treatment.13

Additionally, 41 maternal exposures were reported during postmarketing surveillance and the outcome is known for 18 of the pregnancies. In cases with known exposure timing, all exposures occurred during the first trimester.13

Exposure Information and Outcomes for Maternal Ixekizumab Exposure Pregnancies13

 

Clinical Trials
(N=58)
n (%)

Postmarketing Surveillance
(N=41)
n (%)

Indicationa

Psoriasis

52 (89.7)

31 (75.6)

Psoriatic arthritis

4 (6.9)

1 (2.4)

Axial spondyloarthritis

2 (3.5)

0

Other/unknown

0

9 (22.0)

Exposure timinga

First trimester

56 (96.6)

19 (46.3)

All trimesters

0

2 (4.9)b

Trimester unknown

2 (3.5)

20 (48.8)

Ixekizumab discontinuation statusa

Discontinuedc

56 (96.6)

30 (73.2)

No discontinuation

2 (3.5)d

4 (9.8)

Unknown

0

7 (17.1)

Pregnancy outcomea

Live birth

28 (48.3)

11 (26.8)

Non-live birthe

0

0

Spontaneous abortion or miscarriage

11 (19.0)

3 (7.3)

Elective termination

13 (22.4)

4 (9.8)

Lost to follow-up or unknown

6 (10.3)

23 (56.1)

Live birthsf

Full term

22 (78.6)

5 (45.5)

Preterm

5 (17.9)

1 (9.1)

Term unknown

1 (3.6)

5 (45.5)

Infant outcome

Congenital malformation

0

1g

aPercentages were calculated using the total number of pregnancies in the relevant setting as the denominator.

bFetal outcome unknown in one patient. The other infant had no fetal abnormalities or complications during pregnancy.

cIncludes one patient who discontinued ixekizumab during the first trimester, but later restarted ixekizumab just before giving birth.

dOne patient underwent elective termination of her pregnancy without discontinuing ixekizumab. The other patient experienced a spontaneous abortion after 12 weeks of pregnancy and did not interrupt ixekizumab treatment.

eStillbirth and infant death within 28 days postpartum.

fPercentages were calculated using the number of live births in the relevant setting as the denominator.

gFollow-up information was only available for 1 live-birth infant, who had a congenital malformation (esophageal atresia with tracheoesophageal fistula and hypospadias).

Pregnancy information regarding paternal exposure

Limited safety data are available on pregnant women exposed to ixekizumab via a male partner who received ixekizumab.1

All men agreed to use a reliable method of birth control during ixekizumab clinical trials (and for at least 12 weeks following the last dose of ixekizumab in the axSpA trials).7-10,12

Pregnancy outcomes 

As of the March 22, 2019 database cutoff, 91 pregnancies were reported in 86 partners of male patients in ixekizumab clinical trials and outcomes are known for 75 of the pregnancies.13

Additionally, 3 partner pregnancies of male patients exposed to ixekizumab were reported in the post-marketing surveillance data. Very limited additional data are available, including no information on the pregnancy or infant outcomes.13

Exposure Information and Outcomes for Paternal Ixekizumab Exposure Pregnancies13

 

Clinical Trials
(N=91)
n (%)

Indication

Psoriasis

81 (89.0)

Psoriatic arthritis

7 (7.7)

Axial spondyloarthritis

3 (3.3)

Ixekizumab discontinuation status

Discontinued

3 (3.3)

No discontinuation

83 (91.2)

Unknown

5 (5.5)

Pregnancy outcome

Live birth

63 (69.2)

Spontaneous abortion or miscarriage

9 (9.9)

Elective termination

3 (3.3)

Unknown

16 (17.6)

Live birthsa

Full term

53 (84.1)

Preterm

7 (11.1)

Term unknown

3 (4.8)

Infant outcome

Congenital malformation

3b

aPercentages were calculated using the number of live births (n=63) as the denominator.

bCongenital malformations were reported in 3 infants and included heart abnormality, syndactyly, and widened pelvis.

References

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

2Liu L, Lu J, Allan BW, et al. Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. J Inflamm Res. 2016;9:39-50. http://dx.doi.org/10.2147/JIR.S100940

3Pitcher-Wilmott RW, Hindocha P, Wood CB. The placental transfer of IgG subclasses in human pregnancy. Clin Exp Immunol. 1980;41(2):303-308. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1537014/

4Kane SV, Acquah LA. Placental transport of immunoglobulins: a clinical review for gastroenterologists who prescribe therapeutic monoclonal antibodies to women during conception and pregnancy. Am J Gastroenterol. 2009;104(1):228-233. https://journals.lww.com/ajg/Fulltext/2009/01000/Placental_Transport_of_Immunoglobulins__A_Clinical.37.aspx

5Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

6Kaushik SB, Lebwohl MG. Psoriasis: Which therapy for which patient: focus on special populations and chronic infections. J Am Acad Dermatol. 2019;80(1):43-53. http://dx.doi.org/10.1016/j.jaad.2018.06.056.

7Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

8Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

9Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599-611. http://dx.doi.org/10.1002/art.40753

10van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441-2451. http://dx.doi.org/10.1016/s0140-6736(18)31946-9

11Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

12Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X

13Egeberg A, Iversen L, Kimball AB, et al. Pregnancy outcomes in patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis receiving ixekizumab. J Dermatolog Treat. Published online September 21, 2021. https://dx.doi.org/10.1080/09546634.2021.1976375

Date of Last Review: 09 November 2021


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