Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Graviditet, fertilitet och amning

Det finns otillräckligt med data från människor för att fastslå hur säkert ixekizumab är vid graviditet.

Short Answer Summary

Pregnancy

There is a limited amount of data from the use of ixekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or post-natal development. As a precautionary measure, it is preferable to avoid the use of ixekizumab during pregnancy.1

Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.1

Ixekizumab is a humanized IgG4 monoclonal antibody.2

  • Human IgG is known to cross the placental barrier.3,4

  • Therefore, ixekizumab may be transmitted from the mother to the developing fetus.

Lactation

It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys. A decision should be made whether to discontinue breast-feeding or to discontinue ixekizumab taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.1

Fertility

The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.1

Information from the Clinical Trials

There are limited safety data on the use of ixekizumab in pregnant women exposed to ixekizumab.5

Pregnant and breastfeeding women were excluded from ixekizumab clinical trials. Women who became pregnant were discontinued from the trials.6-11

All women agreed to use a reliable method of birth control during ixekizumab clinical trials.6-9,11

Pregnancy Outcomes

Psoriasis and Psoriatic Arthritis Clinical Trials

In the case of pregnancy in a female study patient, discontinuation from study treatment was required per protocol.12

Out of 2499 female patients exposed to ixekizumab in 16 PsO and PsA clinical trials through September 20, 2018, 50 cases of pregnancy were identified and the outcome is known for 44 of the pregnancies. All but 4 women were known to have been exposed to ixekizumab during their first trimester of pregnancy.12

Information on these pregnancy cases is summarized in Table 1.

Table 1. Cumulative Summary of Pregnancies: Female Clinical Trial Participants Exposed to Ixekizumab in Psoriasis and Psoriatic Arthritis Trials12

 

Female Patients Exposed to Ixekizumab in RCTs
(N=2499)

Pregnancies, n (%)

50 (2.0)

Mean age, years (±SD)

30.2 (±6.1)

Exposure during first trimester, n (%)

46 (92)

Pregnancies with known outcomea, n

44

Live birthb, n (%)

24 (54.5)

Spontaneous abortion, n (%)

9 (20.5)

Induced abortion, n (%)

11 (25.0)

Abbreviation: RCT = randomized controlled trial.

a No congenital malformations were reported.

b Of the 24 live births, 18 (75.0%) were full term, 4 (16.7%) were premature, and details were unknown for the remaining 2 (8.3%) patients.

Axial Spondyloarthritis Trials

Two pregnancies were reported in female patients enrolled in axSpA trials (including AS/r-axSpA and nr-axSpA trials) as of April 1, 2019. These 2 patients were enrolled in the COAST-X trial in patients with nr-axSpA. Both pregnancies led to term deliveries.13

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Liu 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

3. Pitcher-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/

4. Kane 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

5. Kaushik 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.

6. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, 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

7. Gordon KB, Blauvelt A, Papp KA, et al. 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

8. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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

9. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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

10. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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

11. Deodhar A, van der Heijde D, Gensler LS, et al. 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

12. Egeberg A, Kimball AB, Feldman SR, et al. Ixekizumab and pregnancy outcomes in patients with psoriasis or psoriatic arthritis. Poster presented at: 28th European Academy of Dermatology and Venereology Congress; October 9-13, 2019; Madrid, Spain.

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

Glossary

AE = adverse event

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

IgG = immunoglobulin G

IgG4 = immunoglobulin G subclass 4

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M03 18


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