Factors influencing response to ingenol mebutate therapy for actinic keratosis of face and scalp

Table 1 Demographic and response data of the whole study population n (%)

Factors		Value
Age (yr), mean ± SD		72.2 ± 10.3
Gender	M	91 (70)
	F	39 (30)
	Total	130
Head site	Face	101 (77.7)
	Scalp	29 (22.3)
	Total	130
Response	Poor	11 (8.5)
	Partial	61 (46.9)
	Complete	58 (44.6)
	Total	130

Table 2 Number of patients with positive scores and mean values of local skin reaction composite and single scores at each follow up visit

		Day 2	Day 3	Day 8	Day 15	Day 29	Day 57
Erythema	n (%)	130 (100)	130 (100)	129 (99.2)	128 (98.5)	107 (82.3)	49 (37.7)
	mean ± SD	1.82 ± 0.68	2.87 ± 0.58	2.38 ± 0.78	1.86 ± 0.81	1.19 ± 0.77	0.38 ± 0.50
Flaking/scaling	n (%)	4 (3.1)	12 (9.2)	55 (42.3)	112 (86.2)	45 (34.6)	0
	mean ± SD	0.05 ± 0.28	0.11 ± 0.39	0.78 ± 1.00	1.49 ± 0.87	0.43 ± 0.65	0
Crusting	n (%)	2 (1.5)	18 (13.8)	116 (89.2)	57 (43.8)	9 (6.9)	0
	mean ± SD	0.02 ± 0.12	0.17 ± 0.45	2.16 ± 0.98	0.65 ± 0.89	0.10 ± 0.39	0
Swelling	n (%)	114 (87.7)	125 (96.2)	71 (54.6)	11 (8.5)	2 (1.5)	0
	mean ± SD	1.48 ± 0.82	2.38 ± 1.08	0.85 ± 0.98	0.13 ± 0.55	0.02 ± 0.12	0
Vesiculation/pustulation	n (%)	102 (78.5)	123 (94.6)	8 (6.2)	0	0	0
	mean ± SD	1.48 ± 0.93	2.45 ± 0.86	0.06 ± 0.24	0	0	0
Ulceration	n (%)	5 (3.8)	43 (33.1)	22 (16.9)	5 (3.8)	0	0
	mean ± SD	0.04 ± 0.19	0.48 ± 0.74	0.36 ± 0.90	0.08 ± 0.45	0	0
LSR composite	mean ± SD	4.89 ± 2.14	8.43 ± 2.38	6.62 ± 2.44	4.25 ± 1.72	1.66 ± 1.28	0.35 ± 0.49

LSR: Local skin reaction.

Table 3 Univariate logistic regression analysis

			OR	95%CI for OR		P value
				Lower	Upper
Gender			2.30	1.07	4.94	0.033a
Head site			4.07	1.53	10.83	0.005a
Max values	LSR composite		1.55	1.27	1.89	< 0.001a
		Erythema	3.90	1.86	8.19	< 0.001a
		Crusting	1.85	1.18	2.92	0.008a
		Swelling	2.24	1.50	3.35	< 0.001a
		Vesiculation/pustulation	2.76	1.55	4.94	0.001a
Day 2	LSR composite		1.70	1.36	2.12	< 0.001a
		Erythema	3.83	2.05	7.17	< 0.001a
		Vesiculation/pustulation	2.82	1.74	4.56	< 0.001a
		Swelling	2.73	1.64	4.55	< 0.001a
Day 3	LSR composite		1.65	1.34	2.05	< 0.001a
		Erythema	3.90	1.86	8.19	< 0.001a
		Vesiculation/pustulation	2.76	1.55	4.94	0.001a
		Swelling	2.22	1.51	3.28	< 0.001a
		Ulceration	1.72	1.06	2.79	0.028a
Day 8	LSR composite		1.25	1.07	1.47	0.006a
		Erythema	2.44	1.45	4.13	0.001a
		Swelling	1.55	1.06	2.25	0.022a
		Crusting	1.76	1.17	2.64	0.006a
Day 15	LSR composite		1.27	1.02	1.59	0.030a
		Erythema	1.93	1.22	3.05	0.005a
Day 29		Erythema	2.06	1.26	3.37	0.004a
Day 57		Erythema	2.03	1.01	4.09	0.047a

Factors predicting the response to ingenol mebutate 0.015% therapy.

^aP < 0.05. OR: Odds ratio; LSR: Local skin reaction.

Table 4 Multivariate logistic regression backward analysis¹

	OR	95%CI for OR		P value
		Lower	Upper
Head site	5.19	1.51	17.86	0.009a
LSR composite day 2	1.46	1.08	1.97	0.014a
Crusting day 8	1.94	1.18	3.20	0.009a
LSR composite max	1.50	1.02	2.21	0.038a

¹Factors predicting response to ingenol mebutate 0.015% therapy. Logistic backward multivariate regression model. Reported OR mutually adjusted for all variables in the model. Variables in the model: Gender: Male (M), female (F); head site: Scalp, face; erythema at day 2, 3, 8, 15, 29, 57 and max; crusting at day 8 and max; swelling at day 2, 3, 8 and max; vesiculation/pustulation at day 2, 3 and max; ulceration at day 3; LSR composite at day 2, 3, 8, 15 and max.

^aP < 0.05. OR: Odds ratio; LSR: Local skin reaction.