Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib

Figures & data

Table 1 Summary of Efficacy Outcomes for Ruxolitinib 1.5% Cream BID vs Vehicle BID (if Applicable) at Week 8 in Phase I–III Studies

	IGA-TS (%)^a	EASI-75 (%)^b	NRS4 (%)^c	% Reduction in EASI	% Reduction in Itch NRS
Phase I
Ruxolitinib 1.5% (n=41)	56.8	94.6	90.5	− 93.75	N/A
Phase II
Ruxolitinib 1.5% (n=50)	48.0*	N/A	N/A	− 78.5*	− 68.5**
Vehicle (n=52)	9.6	N/A	N/A	− 26.9	− 17.6
Phase III (TRuE-AD1)
Ruxolitinib 1.5% (n=253)	53.8**	62.1**	52.2**	− 77.2**	− 67.3**
Vehicle (n=126)	15.1	24.6	15.4	− 40.5	− 35.3
Phase III (TRuE-AD2)
Ruxolitinib 1.5% (n=228)	51.3**	61.8**	50.7**	− 74.7**	− 62.0**
Vehicle (n=118)	7.6	14.4	16.3	− 28.9	− 32.1

Notes: *p<0.001 vs vehicle, **p<0.0001 vs vehicle. ^aProportion of patients who achieved IGA treatment success, defined as IGA score of 0/1 with a ≥2-grade improvement from baseline, ^bProportion of patients with a ≥75% improvement in the Eczema Area and Severity Index, ^cProportion of patients with a ≥4-point improvement in the itch Numerical Rating Scale score.

Abbreviations: BID, twice daily; EASI, Eczema Area and Severity Index; IGA-TS, Investigator’s Global Assessment – Treatment Success; N/A, not applicable; NRS, Numerical Rating Scale; TRuE-AD1, Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1; TRuE-AD2, Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2.

Table 2 TEAEs for Ruxolitinib 1.5% Cream BID vs Vehicle BID (if Applicable) in Phase I–III Studies

	Phase I	Phase II^a		Phase III^b
	Ruxolitinib 1.5%	Vehicle	Ruxolitinib 1.5%	Vehicle	Ruxolitinib 1.5%
Total number of patients (n)	41	52	50	250	499
Patients with TEAEs, n (%)	13 (31.7)	17 (32.7)	12 (24.0)	83 (33.2)	132 (26.5)
Most common TEAEs
Nasopharyngitis, n (%)	1 (2.4)	4 (7.7)	2 (4.0)	2 (0.8)	13 (2.6)
URI, n (%)	2 (4.9)	3 (5.8)	1 (2.0)	5 (2.0)	12 (2.4)
Headache, n (%)	N/A	2 (3.8)	2 (4.0)	5 (2.0)	11 (2.2)
Application site pain, n (%)^c	N/A	2 (3.8)	1 (2.0)	12 (4.8)	4 (0.8)
Application site pruritus, n (%)	1 (2.4)	N/A	N/A	7 (2.8)	1 (0.2)
AD, n (%)	N/A	4 (7.7)	0	11 (4.4)	2 (0.4)
Serious TEAE, n (%)	1 (2.4)	0	0	2 (0.8)	3 (0.6)
Discontinuation due to TEAE, n (%)	1 (2.4)	1 (1.9)	0	8 (3.2)	4 (0.8)
Treatment-related AEs, n (%)	4 (9.8)	5 (9.6)	3 (6.0	28 (11.2)	24 (4.8)
Most common treatment-related AEs
Application site pain, n (%)^c	N/A	2 (3.8)	1 (2.0)	11 (4.4)	4 (0.8)
Application site pruritus, n (%)	N/A	N/A	N/A	6 (2.4)	0

Notes: ^aResults from the double-blind period. ^bPooled TEAEs from TRuE-AD1 and TRuE-AD2 during the 8-week vehicle-controlled period. ^cApplication site burning was counted towards application site pain.

Abbreviations: AD, atopic dermatitis; AEs, adverse events; BID, twice daily; N/A, not applicable; TEAEs, treatment-emergent adverse events; TRuE-AD1, Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1; TRuE-AD2, Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2; URI, upper respiratory infection.