Kevzara (sarilumab)

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Kevzara (sarilumab)

Manufacturer Sanofi-Aventis
Disease Rheumatoid Arthritis
Indication Moderately to severely active rheumatoid arthritis
Mode of Action Interleukin-6 (IL-6) receptor antagonist
Approval Status EMA approved (EU); FDA approved (USA)
Strength 150 mg/1.14 mL, 200 mg/1.14 mL

Who is sarilumab for?

Kevzara (sarilumab) is indicated for the treatment of patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs) [1].

Recommended dose

Complete information about sarilumab dosage and administration can be found here [1].
Kevzara (sarilumab) may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.
The standard dosage is:
  • 200 mg once every two weeks, administered as a subcutaneous injection
  • Dose modification might be considered for certain patients
  • Sarilumab is not recommended in patients with certain conditions (ANC less than 2000/mm3, platelets less than150,000/mm3 or liver transaminases above 1.5 times ULN).
Consult your treating doctor for personalised dosing.

What is sarilumab and how does it work?

Kevzara (sarilumab) is a human monoclonal antibody  — an interleukin-6 (IL-6) receptor antagonist — indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs [1].
IL-6 is a cytokine — a small protein involved in the communication among cells [2] — that, in excess and over time, can contribute to the inflammation associated with rheumatoid arthritis. Sarilumab binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling [3].

What is sarilumab’s approval status?

Kevzara (sarilumab) was approved by:
  • FDA (USA) on May 22, 2017 [3]
for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more DMARDs, such as methotrexate (MTX) [1].
The approvals were based on 2 randomised, double-blind, placebo-controlled multicentre studies (MOBILITY and TARGET) involving 1,197 and 546 adults [1].
An important measure in patients with rheumatoid arthritis is the ACR 20, 50 or 70 which is a criteria to measure the improvement of patients of 20 %, 50 % or 70 % based on the following measures: swollen joint count, tender joint count, patient assessment of global status, acute phase reactant (dramatic increase in hepatic synthesis of plasma proteins which accompanies acute phases of tissue injury and inflammation), health professional assessment of global status, physical function, and pain [4].
The MOBILITY group of patients had moderately to severely active rheumatoid arthritis and had an inadequate clinical response to methotrexate (MTX). Patients received subcutaneous sarilumab 200 mg, sarilumab 150 mg, or placebo every two weeks with concomitant MTX. After week 16, patients with an inadequate response could have been rescued with sarilumab 200 mg every two weeks [1].
The TARGET group of patients had moderately to severely active rheumatoid arthritis and had an inadequate clinical response or were intolerant to one or more TNF-α antagonists. Patients received subcutaneous sarilumab 200 mg, sarilumab 150 mg, or placebo every two weeks with concomitant conventional DMARD(s) (MTX, sulfasalazine, leflunomide, and/or hydroxychloroquine). After week 12 in Study 2, patients with an inadequate response could have been rescued with sarilumab 200 mg every two weeks [1].
In the MOBILITY study, treatment with Kevzara plus MTX reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage, compared to placebo plus MTX [3].
At 24 weeks, 66 % of the patients treated with Kevzara  200 mg, achieved ACR20, compared with 58 % of patients treated with Kevzara 150 mg, and 33 % of those on placebo [3].
In the TARGET study, treatment with Kevzara (sarilumab) plus DMARD reduced signs and symptoms and improved physical function, compared to placebo plus DMARD [3]. At 24 weeks, 61 % of patients treated with Kevzara (sarilumab) plus DMARD achieved an ACR20 response, compared with 56 % of the patients on sarilumab 150 mg, and 34 % of those on placebo [3].
Patients treated with Kevzara (sarilumab) are at increased risk of developing serious infections that may lead to hospitalization or death. The most common adverse reactions (incidence of at least 3 %) are neutropenia, increased ALT (alanine aminotransferase), injection site erythema, upper respiratory infections and urinary tract infections [3].
References
[1] Summary of Product Characteristics [FDA]: Kevzara (sarilumab), Sanofi-Aventis, May 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
[2] Wikipendia. Cytokine. Cited on: 27/09/2017.
https://en.wikipedia.org/wiki/Cytokine
[3] Drugs.com. FDA approves Kevzara, 22/05/2017.
https://www.drugs.com/newdrugs/sanofi-regeneron-announce-fda-approval-kevzara-sarilumab-rheumatoid-arthritis-4537.html
[4] Pincus T. The American College of Rheumatology (ACR) Core Data Set and derivative “patient only” indices to assess rheumatoid arthritis. Clin Exp Rheumatol 2005; 23(39):109–113.
http://www.clinexprheumatol.org/article.asp?a=2695

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