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Olokizumab

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Olokizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetIL6
Clinical data
Trade namesArtlegia
Routes of
administration		Subcutaneous
ATC code
Pharmacokinetic data
Elimination half-life31 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Molar mass146000 Da
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Olokizumab (OKZ) sold under the name Artlegia, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis and COVID-19. It is a humanized monoclonal antibody against the interleukin-6 (IL-6). IL-6 is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases. Olokizumab is the first  interleukin-6 (IL-6) inhibitor approved for treatment of rheumatoid arthritis which blocks directly cytokine instead of its receptor.[1] Olokizumab specifically binds to IL-6 at Site 3, blocking IL-6 ability to form hexameric complex.[2] Olokizumab was developed by R-Pharm group, and was launched in 2020.[3]

Medical uses

Rheumatoid arthritis

Olokizumab was approved for medical use in Russia,[3] Kazakhstan, Belarus, Kirgizstan and Azerbaijan under the brand name Artlegia for treatment of patients aged 18 years or older with moderate to severe rheumatoid arthritis in combination with methotrexate who have an inadequate response to methotrexate or tumor necrosis factor inhibitor (TNFi) therapy.[4][5]

COVID-19

Olokizumab was approved for pathogenesis-based therapy of cytokine release syndrome in patients with moderate to severe new coronavirus infection (COVID-19) was approved in Russia,[6] Kirgizstan and Azerbaijan.

Contraindications

  • A history of hypersensitivity to olokizumab or any component of the drug.
  • Active infectious diseases (including tuberculosis).
  • Children under 18 years of age.
  • Hereditary fructose intolerance (the drug contains sorbitol).
  • Breastfeeding

Drug interactions

In all clinical trials in patients with rheumatoid arthritis, olokizumab was used in conjunction with methotrexate. Special clinical studies of drug interactions of olokizumab have not been conducted. Concomitant use with methotrexate did not affect the olokizumab exposure. The effect of olokizumab on the methotrexate exposure is not expected with their simultaneous use. According to the results of the CREDO1–3 clinical trials, no cases of clinically significant drug interactions of olokizumab with other drugs were reported. In an in vitro study on human cryopreserved hepatocytes, olokizumab reversed the inhibitory effect of IL-6 on CYP1A1/2, 2B6, 2C9, 3A4/5 and 2C19 activity, as well as on NTCP activity. Thus, it should be considered that in patients with active rheumatoid arthritis, dose adjustment of drugs metabolized by these CYP isoforms may be necessary after beginning the treatment with olokizumab.

The concentration of the following drugs may decrease when used together with olokizumab (including, but not limited to): statins (simvastatin, lovastatin, atorvastatin); oral contraceptives; calcium channel blockers; glucocorticoids (dexamethasone, methylprednisolone); warfarin; quinidine; theophylline; tizanidine; phenytoin; pimozide; cyclosporine; sirolimus; tacrolimus; benzodiazepines (e.g., diazepam, alprazolam, triazolam, midazolam, bromazepam).

History

Olokizumab efficacy and safety were studied as part of a large-scale program of clinical trials, CREDO, which included 2,444 adult patients with rheumatoid arthritis from 19 countries worldwide. The study of olokizumab continues in the general, open-label, long-term extension.

CREDO 1. Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy.[7][8]

CREDO 2. Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy.Clinical trial number NCT02760407 for "A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy" at ClinicalTrials.gov</ref>[9]

CREDO 3. Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy.[10][8]

CREDO 4. Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis.[11]

References

  1. ^ Abuelazm M, Ghanem A, Mahmoud A, Brakat AM, Elzeftawy MA, Mamdouh Fayoud A, et al. (June 2023). "The efficacy and safety of olokizumab for rheumatoid arthritis: a systematic review, pairwise, and network meta-analysis". Clinical Rheumatology. 42 (6): 1503–1520. doi:10.1007/s10067-023-06519-6. PMC 10202974. PMID 36792848.
  2. ^ Nasonov EL, Feist E (2022-11-10). "Перспективы ингибиции интерлейкина-6 при ревматоидном артрите: олокизумаб (новые моноклональные антитела к ИЛ-6)" [The prospects of interleukin-6 inhibition in rheumatoid arthritis: Olokizumab (novel monoclonal antibodies to IL-6)]. Rheumatology Science and Practice (in Russian). 60 (5): 505–518. doi:10.47360/1995-4484-2022-505-518. ISSN 1995-4492.
  3. ^ a b "Государственный реестр лекарственных средств" [State register of medicinal products]. grls.rosminzdrav.ru (in Russian). Retrieved 2024-04-01.
  4. ^ Abuelazm M, Ghanem A, Mahmoud A, Brakat AM, Elzeftawy MA, Mamdouh Fayoud A, et al. (June 2023). "The efficacy and safety of olokizumab for rheumatoid arthritis: a systematic review, pairwise, and network meta-analysis". Clinical Rheumatology. 42 (6): 1503–1520. doi:10.1007/s10067-023-06519-6. PMC 10202974. PMID 36792848.
  5. ^ Mahmoud AM (2023). "Olokizumab's Effectiveness and Safety in Patients with Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials". Journal of Clinical Densitometry. 26 (1): 61–82. doi:10.1016/j.jocd.2022.12.003. PMID 36535857.
  6. ^ "Государственный реестр лекарственных средств". grls.rosminzdrav.ru. Retrieved 2024-04-01.
  7. ^ Clinical trial number NCT02760368 for "A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy" at ClinicalTrials.gov
  8. ^ a b Feist E, Fatenejad S, Grishin S, Korneva E, Luggen ME, Nasonov E, et al. (December 2022). "Olokizumab, a monoclonal antibody against interleukin-6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by tumour necrosis factor inhibitor therapy: efficacy and safety results of a randomised controlled phase III study". Annals of the Rheumatic Diseases. 81 (12): 1661–1668. doi:10.1136/ard-2022-222630. PMC 9664111. PMID 36109142.
  9. ^ Smolen JS, Feist E, Fatenejad S, Grishin SA, Korneva EV, Nasonov EL, et al. (August 2022). "Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis". The New England Journal of Medicine. 387 (8): 715–726. doi:10.1056/NEJMoa2201302. PMID 36001712.
  10. ^ Clinical trial number NCT02760433 for "A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy" at ClinicalTrials.gov
  11. ^ Clinical trial number NCT03120949 for "A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis" at ClinicalTrials.gov
Scholia has a profile for Olokizumab (Q7088501).
  • "Olokizumab". Drug Information Portal. U.S. National Library of Medicine.
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