Efficacy of dimethyl fumarate treatment for moderate-to-severe plaque psoriasis: presentation extracts from the 29^th EADV virtual congress, 29-31 October 2020

Figures & data

Table 1. Studies on DMF included

	BRIDGE Study Presentation Extract 1	DIMESKIN 1 Study Presentation Extracts 2 and 3	SKILL Study Presentation Extract 4
Clinical trial registration	NCT01726933	EudraCT number 2017–001368-40	Not applicable
Study design	Randomized, double-blind, active and placebo-controlled phase III clinical trial	Open-label, phase IV, non-interventional, prospective clinical trial	Non-interventional, prospective study
Treatment period	16-week	52-week	24-month
Study population	Patients with moderate-to-severe psoriasis	Patients with moderate-to-severe psoriasis (Presentation extract 2) Patients with moderate psoriasis (Presentation extract 3)	Patients with moderate-to-severe psoriasis
Objective	To assess the efficacy of DMF by body region	To assess the efficacy of DMF by body region (Presentation extract 2) To assess the efficacy of DMF (Presentation extract 3)	To assess the effectiveness and safety of DMF in routine clinical practice
Analysis presented at the 29^th EADV Congress	Post-hoc analysis at week 16	Interim analysis at week 24	Interim analysis at week 24
Analysis population for efficacy	FAS (i.e., all patients who were randomized and received ≥1 dose of investigational medicinal product, and with ≥1 post-baseline PASI value)	ITT population (i.e., all patients treated with ≥1 dose of DMF as per its SmPC, and with ≥1 post-baseline PASI value) (Presentation extract 2) Subgroup of patients with moderate psoriasis from the ITT population (Presentation extract 3)	All of the DMF- treated patients with data available at week 24

DMF (dimethyl fumarate); FAS (full analysis set); ITT (intention-to-treat); PASI (Psoriasis Area and Severity Index); SmPC (Summary of Product Characteristics).

Table 2. Mean percentage improvements in regional PASI at week 16

	DMF	Active comparator	Placebo
Head and neck
Patients, n	240	253	124
Baseline regional PASI, mean (SD)	1.7 (1.2)	1.7 (1.3)	1.6 (1.3)
Percentage improvement at week 16, mean (SD)	69.2 (49.2)	72.0 (44.8)	33.5 (51.1)
Upper extremities
Patients, n	266	270	131
Baseline regional PASI, mean (SD)	3.2 (1.4)	3.3 (1.6)	3.3 (1.7)
Percentage improvement at week 16, mean (SD)	68.4 (36.3)	71.9 (36.6)	27.0 (45.3)
Lower extremities
Patients, n	264	271	130
Baseline regional PASI, mean (SD)	7.5 (3.3)	7.6 (3.7)	7.5 (3.1)
Percentage improvement at week 16, mean (SD)	65.8 (36.8)	68.2 (33.8)	28.7 (50.1)
Trunk
Patients, n	257	261	128
Baseline regional PASI, mean (SD)	4.4 (2.7)	4.3 (2.7)	4.1 (2.1)
Percentage improvement at week 16, mean (SD)	62.2 (101.6)	70.6 (42.0)	20.8 (69.8)

p < 0.0001, for all week 16 versus baseline comparisons.

DMF (dimethyl fumarate); PASI (Psoriasis Area Severity Index); SD (standard deviation).

Figure 1. Erythema – Percentage of patients with a severity level of 0–1 (no or slight signs) at baseline and at week 16 per body region

AC (active comparator); DMF (dimethyl fumarate)

Figure 2. Induration – Percentage of patients with a severity level of 0–1 (no or slight signs) at baseline and at week 16 per body region

AC (active comparator); DMF (dimethyl fumarate)

Figure 3. Desquamation – Percentage of patients with a severity level of 0–1 (no or slight signs) at baseline and at week 16 per body region

AC (active comparator); DMF (dimethyl fumarate).

Table 3. Baseline characteristics

	ITT population (N = 175)
Male, n (%)	128 (73.1)
Age (years), mean (SD)	46.2 (13.1)
Weight (kg), mean (SD)	82.1 (16.1)
PASI, mean (SD)	13.2 (5.9)
Body surface area (%), mean (SD)	17.8 (12.7)

ITT (intention-to-treat); PASI (Psoriasis Area Severity Index); SD (standard deviation).

Table 4. Mean percentage improvements in regional PASI at week 24

	ITT population (N = 175)
Head and neck	n = 145
Baseline regional PASI, mean (SD)	1.1 (1.0)
Regional PASI at week 24, mean (SD)	0.2 (0.3)
Percentage improvement at week 24, mean (SD)	78.9 (36.8)
Upper extremities	n = 174
Baseline regional PASI, mean (SD)	2.5 (1.4)
Regional PASI at week 24, mean (SD)	0.8 (1.1)
Percentage improvement at week 24, mean (SD)	66.8 (56.4)
Trunk	n = 165
Baseline regional PASI, mean (SD)	3.7 (2.4)
Regional PASI at week 24, mean (SD)	1.0 (1.5)
Percentage improvement at week 24, mean (SD)	73.5 (48.9)
Lower extremities	n = 175
Baseline regional PASI, mean (SD)	6.3 (3.5)
Regional PASI at week 24, mean (SD)	1.5 (2.0)
Percentage improvement at week 24, mean (SD)	72.7 (38.3)

ITT (intention-to-treat); PASI (Psoriasis Area Severity Index); SD (standard deviation).

Figure 4. Erythema – Percentage of patients with a severity level of 0–1 (no or slight signs) at baseline and at week 24 per body region

Figure 5. Induration – Percentage of patients with a severity level of 0–1 (no or slight signs) at baseline and at week 24 per body region

Figure 6. Desquamation – Percentage of patients with a severity level of 0–1 (no or slight signs) at baseline and at week 24 per body region

Table 5. Baseline characteristics

	Moderate population* (N = 130)
Male, n (%)	91 (70.0)
Age (years), mean (SD)	46.0 (13.1)
Weight (kg), mean (SD)	81.5 (15.5)
Body mass index (kg/m^2), mean (SD)	28.1 (4.7)
Time since diagnosis (years), mean (SD)	16.8 (13.3)
Number of relapses in previous year, median (range)	1.0 (0.0–12.0)
Previous topical treatment, n (%)	111 (85.4)
Previous systemic treatment, n (%)	85 (65.4)
Previous phototherapy treatment, n (%)	53 (40.8)

* Patients with moderate psoriasis from the intention-to-treat population. SD (standard deviation).

Figure 7. Evolution of median absolute PASI after 24 weeks of dimethyl fumarate treatment

*p < 0.001. LOCF (Last-Observation-Carried-Forward); OC (Observed Cases); PASI (Psoriasis Area Severity Index)

Figure 8. Evolution of median body surface area affected after 24 weeks of dimethyl fumarate treatment

*p < 0.001. LOCF (Last-Observation-Carried-Forward); OC (Observed Cases)

Figure 9. Evolution of median pruritus VAS scores after 24 weeks of dimethyl fumarate treatment

*p < 0.001. LOCF (Last-Observation-Carried-Forward); OC (Observed Cases); VAS (visual analogue scale).

Figure 10. Evolution of median DLQI scores after 24 weeks of dimethyl fumarate treatment

*p < 0.001. DLQI (Dermatology Life Quality Index); LOCF (Last-Observation-Carried-Forward); OC (Observed Cases)

Table 6. Baseline characteristics

	N = 673
Male, n (%)	402 (59.7)
Age (years), mean (SD)	47.6 (15.4)
Weight (kg), mean (SD)	83.9 (17.4)
Body mass index (kg/m^2), mean (SD)	27.7 (5.2)
Disease duration (years), mean (SD)	15.2 (13.9)
PASI, mean (SD)	14.6 (9.6)
DLQI, mean (SD)	11.5 (7.7)
Body surface area (%), mean (SD)	23.6 (17.8)
Psoriatic arthritis, n (%)	34 (5.1)
Scalp psoriasis, n (%)	252 (78.0)
Nail psoriasis, n (%)	246 (36.6)
Palmoplantar psoriasis, n (%)	208 (30.9)
Previous systemic treatment*, n (%)	208 (30.9)
Previous topical treatment, n (%)	573 (85.1)
Previous phototherapy treatment, n (%)	308 (45.8)

* Including 142 patients receiving prior fumaric acid esters (switched to DMF). DLQI (Dermatology Life Quality Index); DMF (dimethyl fumarate); PASI (Psoriasis Area Severity Index); SD (standard deviation).

Figure 11. Evolution of absolute PASI <3 and <5 after 24 weeks of dimethyl fumarate treatment

n = 659 (week 0), n = 328 (week 24, OC); n = 446 (week 24, LOCF). LOCF (Last-Observation-Carried-Forward); OC (Observed Cases); PASI (Psoriasis Area Severity Index)

Figure 12. Evolution of scalp PGA 0 or 1 (clear or almost clear) after 24 weeks of dimethyl fumarate treatment

n = 672 (week 0), n = 343 (week 24, OC); n = 460 (week 24, LOCF). LOCF (Last-Observation-Carried-Forward); OC (Observed Cases)

Figure 13. Improvement of nail psoriasis after 24 weeks of dimethyl fumarate treatment

Figure 14. Improvement of palmoplantar psoriasis after 24 weeks of dimethyl fumarate treatment

Figure 15. Evolution of itch (NRS <3) after 24 weeks of dimethyl fumarate treatment

n = 657 (week 0), n = 330 (week 24, OC); n = 452 (week 24, LOCF). LOCF (Last-Observation-Carried-Forward); NRS (numerical rating scale); OC (Observed Cases)

Table 7. Most frequent adverse events (>5 events)

Preferred term*, n (%)	N = 673
Diarrhea	75 (11.1)
Lymphopenia	56 (8.3)
Flush	52 (7.7)
Abdominal pain	47 (7.0)
Upper abdominal pain	42 (6.2)
Abdominal complaints	19 (2.8)
Nausea	17 (2.5)
Pruritus	10 (1.5)
Vertigo	8 (1.2)
Emesis	7 (1.0)
Fatigue	7 (1.0)

*Medical Dictionary for Regulatory Activities 22.0