Patient-reported outcomes in topical field treatment of actinic keratosis in Swedish and Danish patients

Figures & data

Table 1. Included topical treatments for actinic keratosis.

Drug	Strength	Indication in label	Treatment regimen
Diclofenac gel (Solaraze^®)	3%	AK lesions	2/day for 60–90 consecutive days
Imiquimod cream (Zyclara^®)	3.75%	AK lesions on face/scalp	1/day for 2 weeks – 2 weeks without treatment –1/day for 2 week
Imiquimod cream (Aldara^®)	5%	AK lesions on face/scalp	3/week for 4 weeks – 4 weeks without treatment – If the lesions are not fully healed: 3/week for another 4 week
Ingenol mebutate gel (Picato^®)	150 μg/g	AK lesions on face/scalp	1/day for 3 consecutive days
Ingenol mebutate gel (Picato^®)	500 μg/g	AK lesions on trunk/extremities	1/day for 2 consecutive days

All treatment details, for all treatments, were gathered from (29).

Table 2. Patient and lesion characteristics.

	Diclofenac		Imiquimod		Ingenol Mebutate		Total
Background variable	n	%	n	%	n	%	n	%	p value
n	40	9%	147	33%	259	58%	446	100%	–
Nationality, Danish	40	100%	96	65%	107	41%	243	47%	<.001
Age, mean (SD)^a	70.8	(7.8)	70.8	(8.1)	69.1	(9.6)	69.9	(9.0)	.326
Gender, female	9	23%	57	39%	130	50%	196	44%	.001
Previous AK diagnosis	31	78%	112	76%	190	73%	333	75%	.747
Previously treated AK^b	32	80%	108	73%	192	74%	332	74%	.237
Previous skin cancer
SCC	1	3%	14	10%	14	5%	29	7%	.152
BCC	10	25%	57	39%	87	34%	154	35%	.238
Melanoma	–	–	9	6%	13	5%	22	5%	.284
Comorbidity^c	21	53%	75	51%	159	61%	255	57%	.105
Fitzpatrick skin type^d									.748
I	5	13%	28	19%	45	17%	78	17%
II	32	80%	99	67%	172	66%	303	68%
III	3	8%	19	13%	40	15%	62	14%
IV	–	–	1	1%	2	1%	3	1%
Body part of current AK lesion									.984^e
Face	17	43%	103	70%	194	75%	314	70%
Scalp	20	50%	32	22%	45	17%	97	22%
Trunk	2	5%	8	5%	9	3%	19	4%
Extremities	1	3%	4	3%	11	4%	16	4%
Mean number of lesions, (SD)	20.0	(13.7)	9.0	(7.9)	8.1	(5.9)	9.4	(8.2)	<.001
Mean lesion size, cm^2 (SD)	54.9	(72.2)	24.8	(39.9)	18.6	(14.8)	23.8	(34.6)	<.001
Field previously treated for AK	25	64%	87	60%	144	56%	256	57%	.562
Number of treatment cycles prescribed^f									<.001
1	30	75%	63	43%	247	95%	340	76%
2	7	18%	83	56%	4	2%	94	21%
3	–	–	–	–	7	3%	7	2%
4, or more	3	8%	1	1%	1	0%	5	1%

SD: standard deviation.

^a Age was patient-reported. Age information was missing for 93 ingenol mebutate patients, 34 imiquimod 5% patients, 7 imiquimod 3.75% patients and 15 diclofenac patients.

^b There were three missing values in the diclofenac group.

^c Comorbidities include heart/circulation problems, depression, anxiety, chest/respiratory problems, gut/bowel problems, joint problems, diabetes, cancer (not including skin cancer), skin disorders and immunosuppressed diseases.

^d There are six Fitzpatrick skin types (I–VI). Only four of these were represented among the Danish and Swedish AK-patients in the RAPID-ACT study; Type I – always burn, never tans; Type II – usually burn, then tans; Type III – may burn, tans well; Type IV – rarely burns, tans well.

^e Test refers to proportion with lesions on face/scalp versus trunk/extremities.

^f Missing values and 0 cycles were interpreted as one treatment cycle, as that was an inclusion criteria of the RAPID-ACT study.

Figure 1. Treatment satisfaction in terms of treatment effectiveness, treatment convenience and global treatment satisfaction based on the TSQM-9 instrument.

Table 3. Patient-reported TSQM-9 score at follow-up, MMAS scores at follow-up, AKQoL index at baseline and EQ-5D-5L & EQ-VAS at baseline as well as follow-up and the difference there between.

Instrument	Median	Mean	SD	Min	Max	p value
TSQM-9 effectiveness
Diclofenac	50.0	52.9	26.3	0	100	.022
Imiquimod	66.7	60.8	22.7	0	100
Ingenol mebutate	66.7	64.3	19.4	0	100
TSQM-9 convenience
Diclofenac	77.8	79.3	16.6	44	100	.537
Imiquimod	77.8	78.4	15.1	33	100
Ingenol mebutate	77.8	76.4	14.7	0	100
TSQM-9 global satisfaction
Diclofenac	57.1	60.8	23.1	0	100	.146
Imiquimod	64.3	64.2	21.0	0	100
Ingenol mebutate	57.1	59.6	21.6	0	100
MMAS
Diclofenac	0.0	0.7	0.9	0	3	<.001
Imiquimod	0.0	0.2	0.4	0	2
Ingenol mebutate	0.0	0.1	0.3	0	2
AKQoL
Diclofenac	7.0	7.2	4.5	0	21	.060
Imiquimod	5.0	5.6	4.4	0	23
Ingenol mebutate	5.0	5.4	4.2	0	19
EQ-5D-5L
Diclofenac
Baseline	0.946	0.919	0.130	0.347	1.000	.916
Follow-up	1.000	0.919	0.150	0.331	1.000
Difference	0.000	0.001	0.098	−0.330	0.181
Imiquimod
Baseline	1.000	0.950	0.075	0.670	1.000
Follow-up	1.000	0.951	0.118	0.188	1.000
Difference	0.000	0.001	0.109	−0.640	0.260
Ingenol Mebutate
Baseline	0.942	0.930	0.097	0.299	1.000
Follow-up	0.942	0.934	0.095	0.289	1.000
Difference	0.000	0.004	0.084	−0.488	0.328
EQ-VAS
Diclofenac
Baseline	90.00	83.00	13.80	50.00	100.00	.266
Follow-up	80.00	81.00	14.50	45.00	100.00
Difference	0.00	−2.00	12.30	−40.00	30.00
Imiquimod
Baseline	85.00	84.50	11.70	40.00	100.00
Follow-up	90.00	85.10	13.30	20.00	100.00
Difference	0.00	0.60	11.10	−55.00	25.00
Ingenol Mebutate
Baseline	85.00	82.80	13.40	35.00	100.00
Follow-up	85.00	83.20	13.80	30.00	100.00
Difference	0.00	0.50	9.91	−40.00	30.00

SD: standard deviation.

FASS. Available from: www.fass.se. Accessed June 3, 2016.

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