Canakinumab

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Canakinumab
IL-1β
Clinical data
Trade namesIlaris
Other namesACZ885, ACZ-885
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B3
subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6452H9958N1722O2010S42
Molar mass145157.20 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Canakinumab, sold under the brand name Ilaris, is a

interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha.[7]

Common side effects include infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions.[2][3][4]

Medical uses

Canakinumab was approved for the treatment of

Familial Cold Autoinflammatory Syndrome (FCAS), Muckle–Wells syndrome (MWS), and Neonatal-Onset Multisystem Inflammatory Disease (NOMID)
.

In September 2016, the FDA approved the use of canakinumab for three additional rare and serious auto-inflammatory diseases:

familial mediterranean fever (FMF).[10]

In June 2020, canakinumab was approved in the United States for the indication to treat active Still's disease, including adult-onset Still's disease.[4]

In the European Union, canakinumab is indicated for

hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), familial Mediterranean fever (FMF), Still's disease, and gouty arthritis.[3]

In August 2023, the FDA expanded coverage to cover the treatment of gout flares.[6]

Adverse effects

Injection site reactions such as redness and pain are common, occurring in approximately 15.5% of cases.[11] The FDA prescribing information for canakinumab (Ilaris) includes a warning for potential increased risk of serious infections due to IL-1 blockade.[4] Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in people with rheumatic conditions, in particular Still's disease, and should be aggressively treated.[4] Treatment with immunosuppressants may increase the risk of malignancies.[4] People are advised not to receive live vaccinations during treatment.[4][2]

History

Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis, but this trial was completed in October 2009.[12] Canakinumab is also in phase I clinical trials as a possible treatment for chronic obstructive pulmonary disease,[13] gout, and coronary artery disease (the CANTOS trial[14]). It is also in trials for schizophrenia.[15] In gout, it may result in better outcomes than a low dose of a steroid, but costs five thousand times more.[16]

In August 2017, the results of the CANTOS trial were announced at the

National Heart, Lung and Blood Institute feels the "public health impact potential is really substantial," and estimates that in the United States 3 million people might benefit from canakinumab.[17] Further analysis on data from the CANTOS trial also showed a significant reduction in lung cancer incidence and mortality in the canakinumab treated group compared to placebo.[19]

In August 2023, the FDA approved canakinumab for the symptomatic treatment of adults with gout flares in whom nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate based on three studies.[6]

References

  1. PMID 26284424
    .
  2. ^ a b c d "Ilaris- canakinumab injection, powder, lyophilized, for solution Ilaris- canakinumab injection, solution". DailyMed. 14 September 2019. Retrieved 16 June 2020.
  3. ^ a b c d "Ilaris EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 16 June 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ^ a b c d e f g "FDA Approves First Treatment for Adult Onset Still's Disease, a Severe and Rare Disease". U.S. Food and Drug Administration (FDA) (Press release). 16 June 2020. Retrieved 16 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  5. PMID 20065636
    .
  6. ^ a b c "FDA Approves Canakinumab for Gout Flares". Medscape. Retrieved 1 September 2023.
  7. PMID 19494217
    .
  8. ^ "Drug Approval Package: Ilaris (canakinumab) Subcutaneous Injection NDA #125319". U.S. Food and Drug Administration (FDA). 26 August 2009. Retrieved 23 February 2023.
  9. ^ Wan Y (29 October 2009). "Canakinumab (Ilaris) and rilonacept (Arcalyst) approved in EU for treatment of cryopyrin-associated periodic syndrome". National electronic Library for Medicines. Archived from the original on 2 October 2011. Retrieved 14 April 2010.
  10. ^ a b "FDA approves expanded indications for Ilaris for three rare diseases" (Press release). U.S. Food and Drug Administration (FDA). 23 September 2016. Public Domain This article incorporates text from this source, which is in the public domain.
  11. PMID 37533141
    .
  12. ^ Clinical trial number NCT00784628 for "Safety, Tolerability and Efficacy of ACZ885 (Canakinumab) in Patients With Active Rheumatoid Arthritis" at ClinicalTrials.gov
  13. S2CID 29625221
    .
  14. ^ "CANTOS Summary". theCANTOS.org. Archived from the original on 15 October 2017. Retrieved 6 June 2017.
  15. ^ "Canakinumab Add-On Treatment for Schizophrenia (CATS) Study". NeuRA. Archived from the original on 4 November 2016. Retrieved 4 November 2016.
  16. PMID 25177840
    .
  17. ^ a b Johnson C (27 August 2017). "Major drug study opens up vast new opportunities in combating heart disease". The Washington Post.
  18. PMID 29922680
    .
  19. PMID 29666299
    .

External links
Retrieved from "https://en.wikipedia.org/w/index.php?title=Canakinumab&oldid=1214151404"