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. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-022-00714-0.

Efficacy and Safety of Dimethyl Fumarate in Patients with Moderate-to-Severe Plaque Psoriasis: Results from a 52-Week Open-Label Phase IV Clinical Trial (DIMESKIN 1)

“…Overall, our results are also in accordance with recent real-world data in the use of DMF showing good effectiveness and safety in routine practice [ 40 – 42 ].…”

Efficacy and Safety of Dimethyl Fumarate in Patients with Moderate-to-Severe Plaque Psoriasis: DIMESKIN-2, a Multicentre Single-Arm Phase IIIb Study

“…Given that a high proportion of psoriasis patients (particularly those with moderate-severe disease) are burdened with co-morbidities as well as psoriasis lesions in difficult-to-treat areas (e.g., scalp, nails, genitals etc. ), recent evidence suggests that DMF can also be effective in these cases [ 42 , 43 ], allowing dermatologists to offer this treatment in these difficult-to-treat patients.…”

Real-world use of dimehtyl fumarate in patients with plaque psoriasis: a Delphi-based expert consensus

“…2 Observational studies confirm the efficacy and safety of DMF. 11,12 Although clinical data with DMF are still scarce, several studies (including real-life observational studies) suggest that long-term treatment with FAEs is safe and beneficial (both as monotherapy and in combination with other therapies) and is characterized by high drug survival rates. [13][14][15] In the European S3-Guidelines, FAEs are recommended for the induction and long-term treatment of psoriasis vulgaris.…”

“…5 Once the individual maintenance dose has been achieved, DMF offers the advantage of a long-term therapy characterized by sustained efficacy, an acceptable safety profile and excellent drug survival. [13][14][15]20 Based on clinical experience and the results of observational studies, most patients require daily maintenance doses of DMF in the range of 240-480 mg. 11,12 In the prospective interim analysis of the SKILL study, the DMF maintenance dose at week 52 was in the range of 120-480 mg in 75% of the study population and <120 mg in 10%. 12 DMF is a slow-acting drug that may require several weeks before a meaningful clinical effect is experienced, and side effects are common during the first period of drug exposure.…”

“…[13][14][15]20 Based on clinical experience and the results of observational studies, most patients require daily maintenance doses of DMF in the range of 240-480 mg. 11,12 In the prospective interim analysis of the SKILL study, the DMF maintenance dose at week 52 was in the range of 120-480 mg in 75% of the study population and <120 mg in 10%. 12 DMF is a slow-acting drug that may require several weeks before a meaningful clinical effect is experienced, and side effects are common during the first period of drug exposure. These facts need to be clearly communicated to the patient before treatment initiation.…”