fumaric-acid and apremilast

Although the inclusion of patients' preferences and needs is essential for therapy adherence, the assessment of patient-reported outcome measures in clinical trials is often neglected. Therefore, the aim of this study was to quantify several patient-reported outcome measures in psoriasis patients undergoing systemic therapy in a real-life clinical setting.. This clinical trial has been designed as a prospective, multiarm study to investigate the treatment satisfaction, adherence to therapy, quality of life (QoL), and clinical response in a real-life clinical setting during the initial 6 months of treatment with apremilast, methotrexate, and fumaric acids in 80 patients suffering from plaque psoriasis.. The treatment satisfaction for the three systemic therapies was rated 'sufficient' with a mean (±SD) Treatment Satisfaction Questionnaire for Medication (TSQM) score of 275.0 (±62.7). Most potential for improvement was seen in the 'effectiveness' domain (54.3 ± 21.5). The highest treatment satisfaction level in all four domains (convenience, effectiveness, global satisfaction, and side-effects) was seen in the methotrexate group with a mean TSQM score of 306.3 ± 50.9, followed by apremilast (267.1 ± 61.6) and fumaric acids (254.9 ± 65.0;. This real-life study demonstrates that an adequate assessment of antipsoriatic drugs by PASI-reduction alone is not sufficient and underlines the importance of patient-reported outcome measures not only in clinical trials, but also for improved patient care.

Topics: Dermatologic Agents; Humans; Methotrexate; Patient Reported Outcome Measures; Prospective Studies; Psoriasis; Quality of Life; Severity of Illness Index; Treatment Outcome

Plaque psoriasis has significant impact on patients' quality of life. Topical therapy is considered the treatment mainstay for mild-to-moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability and therapeutic options; particularly decisions on transition from topical to non-biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions.. To compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non-biologic systemic treatments based on aggregated patient characteristics and treatment outcomes.. Individual data from four Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching-adjusted indirect comparisons. Literature review identified non-biologic systemic treatment trials where methods, populations and outcomes align with Cal/BD foam trials. Of 3090 screened publications, four studies of apremilast, methotrexate, acitretin or fumaric acid esters (FAE) were included.. After baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P < 0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P < 0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 vs. 12 weeks of methotrexate (50.8% vs. 33.5%; P < 0.001) or acitretin (50.9% vs. 31.7%; P = 0.009), and comparable response to FAE (42.4% vs. 47.0%; P = 0.451).. Despite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate or acitretin, and comparable efficacy to FAE.

Topics: Acitretin; Administration, Cutaneous; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Esters; Female; Fumarates; Humans; Male; Methotrexate; Middle Aged; Psoriasis; Thalidomide; Treatment Outcome