Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® (ixekizumab): Kliniska prövningar om reproduktionsrisker hos män med psoriasis, psoriasisartrit och axial spondyloartrit

Det finns begränsade säkerhetsdata om gravida kvinnor som exponeras för ixekizumab via en manlig partner som fått ixekizumab.

SE_cFAQ_IXE009_Z2_MALE_REPRODUCTIVE_RISKS_PsO_PsA_axSpA
SE_cFAQ_IXE009_Z2_MALE_REPRODUCTIVE_RISKS_PsO_PsA_axSpA
en-GB

Short Summary

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

Limited safety data are available on pregnant women exposed to ixekizumab via a male partner who received ixekizumab.2

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).3-7

Information regarding pregnancy, lactation, and fertility in female patients is available in the Taltz summary of product characteristics.1

Psoriasis and Psoriatic Arthritis Trials

Of 4517 male patients exposed to ixekizumab in 16 PsO and PsA clinical trials through September 20, 2018, 76 cases of paternal exposure were identified and the outcome is known for 64 of the pregnancies.8

Cumulative Summary of Pregnancies: Potential Fetal Exposures via Fathers Exposed to Ixekizumab8

 

Paternal Exposures to Ixekizumab in RCTs
(N=4517)

Pregnancies, n (%)

76 (1.7)

Pregnancies with known outcome,a n

64

Live birth,b n (%)

51 (79.7)

Spontaneous abortion, n (%)

10 (15.6)

Induced abortion, n (%)

3 (4.7)

Abbreviation: RCT = randomized controlled trial.

aFive cases of congenital malformations were reported, including 1 case each of heart abnormality, multiple gestation (triplets) with low birth weight, abnormal growth on ultrasound, webbed finger, and widening of the right pelvis.

bOf the 51 live births, 44 (86.3%) were full-term, 5 (9.8%) were premature, and details were unknown for the remaining 2 (3.9%) births.

Axial Spondyloarthritis Trials

In partners of male patients exposed to ixekizumab during their participation in ixekizumab studies, 5 pregnancies occurred as of April 1, 2019. The following numbers 1 to 5 represent the outcomes of the 5 separate cases, as of the data cut off.

  1. Partner of the patient did not consent to follow-up.
  2. No complications related to the pregnancy were reported. 
  3. No complications related to the pregnancy were reported.
  4. Lost to follow-up, as patient did not agree to provide further information about the pregnancy as of April 1, 2019.
  5. No AEs were reported for the male patient, the female partner of the patient, the fetus, or related to the pregnancy.2

References

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

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Gordon 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

4Nash 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

5Deodhar 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

6Deodhar 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

7van 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

8Egeberg 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.

Glossary

AE = adverse event

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

axSpA = axial spondyloarthritis

IgG = immunoglobulin G

IgG4 = immunoglobulin G subclass 4

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

Datum fӧr senaste ӧversyn March 18, 2020


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