Efficacy and safety of proactive treatment with twice-weekly topical Cal/BD foam in patients with plaque psoriasis undergoing HPA-axis testing: a PSO-LONG subgroup analysis

Figures & data

Table 1. Patient demographics and baseline characteristics.

	HPA axis group (N = 66)	Randomized patients (N = 545)
Age (years)
Mean (SD)	44.6 (12.4)	52.2 (14.3)
Min/Max	20.0/68.0	19.0/84.0
Sex, n (%)
Female	27 (40.9)	173 (31.7)
Male	39 (59.1)	372 (68.3)
BMI
Mean (SD)	28.1 (5.1)	29.3 (6.4)
Min/Max	19.5/49.8	16.1/64.8
Ethnicity, n (%)^a
White	62 (93.9)	487 (91.4)
Asian	2 (3.0)	35 (6.6)
Black or African American	0 (0.0)	7 (1.3)
Native Hawaiian or other Pacific Islander	1 (1.5)	4 (0.8)
Duration of psoriasis (years)
Mean (SD)	15.0 (11.3)	18.5 (13.6)
Min/Max	1.0/47.0	1.0/74.0
PGA, n (%)
Mild	0 (0.0)	58 (10.6)
Moderate	64 (97.0)	447 (82.0)
Severe	2 (3.0)	40 (7.3)
m-PASI
Mean (SD)	11.4 (3.7)	7.8 (3.8)
Median	10.9	7.1
BSA, %
Mean (SD)	15.2 (6.2)	8.3 (6.3)
Median	12.0	6.0

Note: HPA axis group included in the randomized patients group.

BMI: body mass index; BSA: body surface area; HPA: hypothalamic-pituitary-adrenal; min/max: minimum/maximum; m-PASI: modified Psoriasis Area and Severity Index; PGA: physician global assessment; SD: standard deviation.

^a Data missing for one patient in HPA axis subgroup.

Figure 1. Time to first relapse during the maintenance phase with proactive management or reactive management with Cal/BD in the HPA subgroup. Cal/BD: calcipotriol 50 µg/g and betamethasone dipropionate 0.5 mg/g; HPA: hypothalamic-pituitary-adrenal. Censoring is not displayed for clarity.

Table 2. Number of relapses and time in remission: summary.

	HPA subgroup (N = 63)		FAS (N = 521)
	Proactive (n = 30)	Reactive (n = 33)	Proactive (n = 256)	Reactive (n = 265)
Proportion of days in remission
Mean (SD)	73.8 (22.4)	60.3 (22.6)	70.2 (21.7)	60.8 (20.1)
Number of relapses
Mean (SD)	2.2 (2.0)	3.7 (2.7)	2.0 (1.7)	3.1 (2.2)

FAS: full analysis set; HPA: hypothalamic-pituitary-adrenal; SD: standard deviation.

Figure 2. Mean DLQI score by time during the maintenance phase for proactive and reactive Cal/BD management groups in the HPA subgroup and FAS. Cal/BD: calcipotriol 50 µg/g and betamethasone dipropionate 0.5 mg/g; DLQI: Dermatology Life Quality Index; FAS: full analysis set; HPA: hypothalamic-pituitary-adrenal; OL: open-label.

Table 3. Summary of AEs during the maintenance phase for the HPA subgroup.

AE category	Proactive (N = 32)		Reactive (N = 34)
	Number of AEs	Number of patients (%)	Number of AEs	Number of patients (%)
PYE	24.9		25.8
All AEs	23	12 (37.5)	29	16 (47.1)
Serious AEs	0	0 (0.0)	2	2 (5.9)
Related to IMP^a	2	2 (6.3)	3	2 (5.9)
Leading to withdrawal from trial	0	0 (0.0)	1	1 (2.9)

AE: adverse event; HPA: hypothalamic-pituitary-adrenal; IMP: investigational medicinal product; PYE: patient years of exposure.

^aConsidered possibly or probably related to trial product by the investigator.

Table 4. Treatment-related AEs during the maintenance phase for the HPA subgroup.

System organ class Preferred term	Proactive (N = 32)		Reactive (N = 34)
	Number of AEs	Number of patients (%)	Number of AEs	Number of patients (%)
All AEs	2	2 (6.3)	3	2 (5.9)
Skin and subcutaneous tissue disorders	0	0	1	1 (2.9)
Psoriasis	0	0	1	1 (2.9)
Infections and infestations	1	1 (3.1)	2	2 (5.9)
Bronchitis	0	0	2	2 (5.9)
Folliculitis	1	1 (3.1)	0	0
Injury, poisoning and procedural complications	1	1 (3.1)	0	0
Medication error	1	1 (3.1)	0	0

AE: adverse event; HPA: hypothalamic-pituitary-adrenal.

Table 5. Effect on corticosteroid metabolism.

Patient	Treatment	Visit	Serum cortisol concentration (µg/dL)
			0 mins	30 mins	60 mins
1	Reactive	Baseline	6.3	15.6^a	19.0
2	Proactive	Week 52	0.8	13.0^a	18.9
3	Proactive	Week 52	0.5	17.0^a	22.8
4	Reactive	Week 52	1.2	14.8^a	18.7
5	Proactive	Week 52	18.9	29.8	11.3^a

^aSerum cortisol ≤18 µg/dL.

Figure 3. Patient’s perilesional assessment of local safety and tolerability (redness, dryness, edema, and erosion) relative to relapse in the HPA subgroup and FAS. Percentages are taken out of the total number of assessments done at visits where a relapse has started, a relapse has ended or where a relapse has not started or ongoing (not related to relapse). FAS: full analysis set; HPA: hypothalamic-pituitary-adrenal.