Dupilumab

type	mab
alt	3D structure of dupilumab's antigen binding fragment complexed with a human IL-4 receptor sub-unit alpha
mab type	mab
source	u
target	Interleukin 4 (IL4) receptor alpha
tradename	Dupixent
medlineplus	a617021
dailymedid	Dupilumab
pregnancy au	B1
routes of administration	Subcutaneous
atc prefix	D11
atc suffix	AH05
legal au	S4
legal au comment	‡R1R‡
legal ca	Rx-only
legal ca comment	‡R2R‡‡R3R‡
legal us	Rx-only
legal eu	Rx-only
legal eu comment	‡R4R‡
legal status	Rx-only‡R5R‡
cas number	1190264-60-8
drugbank	DB12159
chemspiderid	none
unii	420K487FSG
kegg	D10354
c	6512
h	10066
n	1730
o	2052
s	46

Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13 receptor signalling (IL-4R, IL-13R), used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis.[6][7][8][9] It is also used for the treatment of eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.[10]

The most common side effects reported by the US Food and Drug Administration (FDA) include injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections. The most common side effects reported by the European Medicines Agency

History

Regeneron Pharmaceuticals and Sanofi Genzyme jointly developed dupilumab,[36] the latter of which provided 130 million dollars to Regeneron for research and development towards monoclonal antibodies.[37] Phase II trials for asthma treatment showed increased lung function with increased forced expiratory volume for patients.[31]

In October 2016, Regeneron completed a phase III trial comparing dupilumab with topical corticosteroids, in which subjects had a larger decrease in symptoms with both dupilumab and topical steroids than with steroids alone.[38] In these trials 38% and 36% of patients respectively, met the primary efficacy goal of the trial, compared to 8% and 10% under placebo.[31]

The efficacy and safety of dupilumab in eosinophilic esophagitis was studied in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial, that included two 24-week treatment periods (Part A and Part B) that were conducted independently in separate groups of participants.[18] In Part A and Part B, participants received either placebo or 300 milligrams of dupilumab every week.[18] The two primary measurements of efficacy were the proportion of participants who achieved a certain level of reduced eosinophils in the esophagus at week 24, as determined by assessing participants' esophageal tissue under a microscope, and the change in the participant-reported Dysphagia Symptom Questionnaire (DSQ) score from baseline to week 24.[18] The DSQ is a questionnaire designed to measure difficulty swallowing associated with eosinophilic esophagitis, with total scores ranging from 0 to 84; higher DSQ scores indicate worse symptoms.[18]

The efficacy and safety of dupilumab to treat prurigo nodularis among adults were evaluated in two clinical trials, EFC16459 (PRIME) and EFC16460 (PRIME2).[20] Each trial evaluated 300 mg of dupilumab administered every 2 weeks following an initial dose of 600 mg.[20] The treatment lasted for 24 weeks.[20] Effectiveness was mainly assessed by the proportion of subjects whose itchy skin (pruritus) improved by more than four points on the Worst Itch Numeric Rating Scale, the proportion of subjects who achieved score of 0 or 1 on Investigator's Global Assessment PN-stage scale (the equivalent of 0-5 nodules), and the proportion of subjects who achieved a response on both scales at week 24.[20]

Dupilumab

Medical uses

History of extension of indications

Side effects

Pharmacology

Mechanism of action

Pharmacokinetics

Society and culture

Legal status

Cost

History

See also

References