New Biologics for the Treatment of Atopic Dermatitis: Analysis of Efficacy, Safety, and Paradoxical Atopic Dermatitis Acceleration

Table 1

Summary of the new biologics for atopic dermatitis in clinical trials (drugs that did not achieve the primary endpoint).

Drug; Mechanism f action	Phase trial; ClinicalTrials.gov identifier	(ratio), age	Duration	TCS (Y/N/R)	Primary endpoint	% achieving primary endpoint
Fezakinumab (ILV-094); Anti-IL-22	Phase IIa [60]; NCT01941537	60 (2 : 1), adults	20 wks	N	SCORAD	Entire population: 300 mg iv Q2W: vs. placebo: ,; subgroup: 300 mg: vs. placebo: ,
Mepolizumab (SB240563); Anti-IL-5	Phase II [61]; N/A	34 (1 : 1), adults	20 wks	N	IGA 0/1 plus ≥ 2-point (week 16)	Failed (100 mg SC Q4W)
	N/A [62]	43, adults	30 days	R	PGA (14 days)	Failed: two single doses of 750 mg iv,
Secukinumab; Anti-IL-17A	Phase II [63]; NCT02594098	41 (2 : 1), adults	16 wks	N	Reduction of epidermal thickness; EASI (week 16)	Failed: 300 mg qw through week 4, followed by Q4W to week 16
Tezepelumab (AMG 157/MEDI9929); Anti-TSLP	Phase IIa [64]; NCT02525094	113 (1 : 1), adults	24 wks	Y	EASI 50 (week 12)	Failed: 280 mg SC Q2W: 64.7% vs. placebo: 48.2%,
Ustekinumab; Anti-IL12/23p40	Phase II [65]; NCT01806662	33 (1 : 1), adults	32 wks	Y	SCORAD 50 (week 16)	Failed (45 mg or 90 mg SC 3 doses)
	Phase II [66]; N/A	79 (1 : 1 : 1) (Japanese), adults	24 wks	Y	EASI score (week 12)	Failed (45 mg or 90 mg SC 2 doses)

PGA: physician’s global assessment. Fezakinumab (ILV-094): the subgroup achieved the primary endpoint.