Ixekizumab
Interleukin 17A (IL-17A) | |
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Clinical data | |
Pronunciation | ix-ee-KIZ-ue-mab[1] |
Trade names | Taltz |
AHFS/Drugs.com | Monograph |
MedlinePlus | a616025 |
License data |
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Pregnancy category |
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Subcutaneous injection | |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | 60–81%[7] |
Metabolism | Presumably proteolysis |
Elimination half-life | 13 days[8] |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
ChEMBL | |
Chemical and physical data | |
Formula | C6492H10012N1728O2028S46 |
Molar mass | 146192.34 g·mol−1 |
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Ixekizumab, sold under the brand name Taltz, is an injectable medication for the treatment of
The most common side effects include upper respiratory infections, injection site reactions and fungal (
The drug was developed by
Medical uses
In the United States, ixekizumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, active psoriatic arthritis, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis with objective signs of inflammation.[14] In the European Union it is indicated for the treatment of moderate-to-severe plaque psoriasis[6] and as a second-line therapy for active psoriatic arthritis.[6][10]
In studies, the drug reduced the Psoriasis Area and Severity Index by at least 75% (PASI75) in 82–89% of patients during the first three months of treatment (depending on the dosing scheme), and 40% of patients experienced a complete absence of psoriasis symptoms (PASI100). In the placebo group, PASI75 was reached in 4% of patients, and PASI100 in none; in the group of patients receiving etanercept, an older anti-psoriasis drug, PASI75 was reached in 48%. Until the 60th study week, 11–44% of ixekizumab treated patients relapsed (again, depending on the dosing scheme), as compared to 84% under placebo.[10][15]
Contraindications
The medication is contraindicated for patients with certain infections such as active tuberculosis.[10][contradictory]
Adverse effects
In studies, ixekizumab increased the rate of infections (27% of ixekizumab treated patients, compared to 23% under
In a review of 18,025 patient years (n=6892 patients), no
Ixekizumab does not have an increased risk of adverse effects in the elderly.[18]
Overdose
Up to fourfold doses have been given in studies without causing serious side effects.[10]
Interactions
No interaction studies have been done. Ixekizumab and interleukin 17 are not known to interact with cytochrome P450 (CYP) liver enzymes. Since inflammation suppresses CYP activity, it is theorized that ixekizumab could neutralize this effect and lower blood plasma concentrations of drugs that are metabolized by CYP enzymes, such as warfarin.[10]
Pharmacology
Mechanism of action
Ixekizumab binds to interleukin 17 (IL-17A), a pro-inflammatory cytokine, and blocks its action. Among other things, IL-17A stimulates proliferation and activation of keratinocytes in the skin.[10] This mechanism is similar to that of another anti-psoriasis antibody, brodalumab, which binds to the interleukin-17 receptor.[19]
The antibody has affinity to the
Pharmacokinetics
After
Like other
The volume of distribution is 7.11 L.[8] Mean clearance is 0.39 L/day.[8] There is no difference in rate of clearance between elderly and younger patients.[18] Increased body weight increases the volume of distribution and clearance rate.[8] Ixekizumab displays linear pharmacokinetics across doses.[20]Pharmacokinetic data is similar for
Chemistry
Ixekizumab is a complete monoclonal antibody of the subclass
History
Ixekizumab was approved by the US Food and Drug Administration (FDA) in March 2016, for the treatment of adults with moderate-to-severe plaque psoriasis[12] and by the European Medicines Agency (EMA) in April 2016.[6] The safety and efficacy of ixekizumab were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy.[12] The FDA approved ixekizumab based on the evidence from three clinical trials of 1958 participants with moderate to severe psoriasis.[23] The trials were conducted in the US, Canada, Europe, Russia, Mexico, Chile, Argentina, Japan and Australia.[23]
In December 2017, the FDA approved it for active psoriatic arthritis.[24]
References
- ^ "12 Difficult-to-Pronounce Drug Names". Pharmacy Times. 7 February 2018. Archived from the original on 21 March 2018. Retrieved 22 March 2018.
- ^ "Ixekizumab (Taltz) Use During Pregnancy". Drugs.com. 27 November 2019. Retrieved 27 March 2020.
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ "Taltz 80 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 21 August 2019. Retrieved 27 March 2020.
- ^ a b c d e "Taltz EPAR". European Medicines Agency (EMA). 2 May 2016. Retrieved 27 March 2020.
- ^ PMID 27690669.
- ^ PMID 31530049.
- ^ a b "Statement On A Nonproprietary Name Adopted By The USAN Council: Ixekizumab" (PDF). American Medical Association.
- ^ a b c d e f g h i j k Haberfeld H, ed. (2015). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
- PMID 23499509.
- ^ a b c "FDA approves new psoriasis drug Taltz". U.S. Food and Drug Administration (FDA) (Press release). 22 March 2016. Retrieved 27 March 2020. This article incorporates text from this source, which is in the public domain.
- ^ "Taltz (ixekizumab) Injection". U.S. Food and Drug Administration (FDA). 3 May 2016. Retrieved 27 March 2020.
- ^ "Taltz- ixekizumab injection, solution". DailyMed. 23 August 2019. Retrieved 27 March 2020.
- ^ Klement A (4 June 2016). "Taltz". Österreichische Apothekerzeitung (in German) (14/2016): 12.
- PMID 29462229.
- ^ PMID 35624407. Retrieved 2 April 2024.
- ^ PMID 30032682. Retrieved 2 April 2024.
- ^ a b "Neue Antikörper in der Pipeline". Pharmazeutische Zeitung (in German) (12). 2012.
- ^ PMID 25748485.
- ^ "Assessment report: Taltz" (PDF). European Medicines Agency. 25 February 2016. p. 7.
- ^ Clinical trial number NCT01624233 for "A Study in Japanese Participants With Moderate-to-Severe Psoriasis" at ClinicalTrials.gov
- ^ a b "Drug Trials Snapshots: Taltz". U.S. Food and Drug Administration (FDA). 22 March 2016. Retrieved 24 September 2020. This article incorporates text from this source, which is in the public domain.
- ^ "FDA approves Taltz for psoriatic arthritis in adults". Healio. 4 December 2017. Retrieved 23 September 2020.