Long-Term Treatment with Dimethyl Fumarate for Plaque Psoriasis in Routine Practice: Good Overall Effectiveness and Positive Effect on Impactful Areas

Abstract

Introduction: Dimethyl fumarate (DMF) is an oral compound to treat plaque psoriasis. Data on the treatment of patients with psoriasis affecting impactful areas are scarce. In this interim analysis of the prospective, noninterventional SKILL study, we summarized results of DMF treatment regarding effectiveness (overall and in impactful areas) and safety.

Methods: Data from 676 patients suffering from moderate-to-severe plaque psoriasis were analyzed after 52 weeks of DMF treatment. Of these, 257 had data available after 52 weeks. The considered impactful areas were nails, palms, soles, and scalp. Data analysis included observed cases (OC) and last observation carried forward (LOCF).

Results: All effectiveness parameters improved after 52 weeks. The Psoriasis Area and Severity Index score was reduced by 79.5% (OC) and 65.7% (LOCF). Compared with baseline, improvements were shown for 70.2% of the patients in their nail psoriasis [nail-Physician Global Assessment (PGA)] and for 57.3% in palmoplantar disease (palmoplantar-PGA). The proportion of patients with scalp-PGA 0/1 (clear/almost clear) increased significantly to 79.8% (OC) and 69.3% (LOCF, both p < 0.001) (versus 37.5% and 36.6% at baseline, respectively). Significant reduction of pruritus (p < 0.001) was also observed. No unexpected adverse drug reactions were observed.

Conclusion: Long-term treatment with DMF in routine practice showed good overall effectiveness and safety, and a positive effect on plaque-psoriasis-affected impactful areas.

Keywords: Dimethyl fumarate; Impactful areas; Nail; Palmoplantar; Psoriasis; Scalp.

Fig. 1

Maintenance dose of DMF at week 52. Distribution of daily DMF dose at week 52 (observed cases, OC, n = 241); dose per tablet: 30 mg and 120 mg. Treatment with DMF is initiated at 30 mg once daily and escalated further up to a maximum dose of 720 mg per day, taking into account individual tolerability and treatment response

Fig. 2

a Absolute PASI from baseline to week 52. p < 0.001 versus baseline, using OC and LOCF, Wilcoxon signed-rank test. b Proportion of patients with PASI < 3 and PASI < 5. n = 663 (OC baseline), n = 245 (OC week 52), n = 465 (LOCF); p < 0.001 versus baseline for PASI < 3 and PASI < 5, using OC and LOCF, McNemar’s test. LOCF, last observation carried forward; OC, observed cases; PASI, Psoriasis Area and Severity Index

Fig. 3

a Physician’s Global Assessment of nail psoriasis. Patients presenting with nail disease at baseline (nail PGA > 0 at visit 1) n = 247 (OC baseline), n = 95 (OC week 52), n = 178 (LOCF); p < 0.001 versus baseline, using OC and LOCF, McNemar’s test. b Physician’s Global Assessment of nail psoriasis—distribution of nail severity grades. Patients presenting with nail disease at baseline (nail PGA > 0 at visit 1), n = 247 (OC baseline), n = 95 (OC week 52) in red on the left, n = 178 (LOCF) in blue on the right, p < 0.001 for clear or mild nail disease versus baseline, McNemar’s test. c Physician’s Global Assessment of palmoplantar psoriasis. n = 205 (OC baseline), n = 82 (OC week 52), n = 140 (LOCF); p < 0.001 versus baseline, using OC and LOCF, McNemar’s test. d Physician’s Global Assessment of palmoplantar psoriasis—distribution of degrees of severity of palmoplantar psoriasis. Patients presenting with palmoplantar disease at baseline (PP-PGA > 0 at baseline), n = 205 (OC baseline), n = 82 (OC week 52) in red on the left, n = 140 (LOCF) in blue on the right, p < 0.001 for clear or almost clear versus baseline, McNemar’s test. LOCF, last observation carried forward; PP-PGA, palmoplantar Physician Global Assessment

Fig. 3

a Physician’s Global Assessment of nail psoriasis. Patients presenting with nail disease at baseline (nail PGA > 0 at visit 1) n = 247 (OC baseline), n = 95 (OC week 52), n = 178 (LOCF); p < 0.001 versus baseline, using OC and LOCF, McNemar’s test. b Physician’s Global Assessment of nail psoriasis—distribution of nail severity grades. Patients presenting with nail disease at baseline (nail PGA > 0 at visit 1), n = 247 (OC baseline), n = 95 (OC week 52) in red on the left, n = 178 (LOCF) in blue on the right, p < 0.001 for clear or mild nail disease versus baseline, McNemar’s test. c Physician’s Global Assessment of palmoplantar psoriasis. n = 205 (OC baseline), n = 82 (OC week 52), n = 140 (LOCF); p < 0.001 versus baseline, using OC and LOCF, McNemar’s test. d Physician’s Global Assessment of palmoplantar psoriasis—distribution of degrees of severity of palmoplantar psoriasis. Patients presenting with palmoplantar disease at baseline (PP-PGA > 0 at baseline), n = 205 (OC baseline), n = 82 (OC week 52) in red on the left, n = 140 (LOCF) in blue on the right, p < 0.001 for clear or almost clear versus baseline, McNemar’s test. LOCF, last observation carried forward; PP-PGA, palmoplantar Physician Global Assessment

Fig. 4

Physician’s Global Assessment of scalp psoriasis scalp-PGA 0/1 (clear or almost clear). n = 675 (OC baseline), n = 253 (OC week 52), n = 452 (LOCF); p < 0.001 versus baseline, using OC and LOCF, McNemar’s test. LOCF, last observation carried forward; OC, observed cases; PGA, Physician Global Assessment