calcipotriene and apremilast

Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.

Topics: Administration, Cutaneous; Aerosols; Betamethasone; Biological Products; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Humans; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Thalidomide; Treatment Outcome

To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.. A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.. 28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.. In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.

Topics: Administration, Cutaneous; Administration, Oral; Adult; Aerosols; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Pruritus; Psoriasis; Quality of Life; Severity of Illness Index; Thalidomide; Treatment Outcome; Visual Analog Scale

About 20% of patients taking apremilast alone obtain PASI 75 by week 8. This single-center, pilot study aimed to determine whether add-on topical therapy with calcipotriene/betamethasone dipropionate (C/BD) could improve responses of partial apremilast responders by week 12.. Adults (≥18 years of age) with moderate to severe plaque psoriasis (baseline PGA ≥3, BSA affected ≥10%, PASI ≥12) took oral apremilast (30 mg twice daily) for 8 weeks. Patients who achieved between PASI 25–74 at week 8 used add-on, daily topical C/BD (.005%/.064%) foam up to week 12; those with <PASI 25 at week 8 were discontinued.. Of 50 patients enrolled, 26 achieved PASI 25−74 and 8 PASI 75 at week 8. At week 12, 29 achieved PASI 75, and 24 at week 16. Of the week-8 partial responders, 21/26 achieved PASI 75 at week 12 on combination therapy and 15 maintained PASI 75 through week 16 on apremilast alone (4 did not maintain; 2 lost to follow up). In partial responders, mean PGA and BSA affected improved by 30% and 33% on apremilast, respectively, and by 67% and 86% at week 12 on the combination therapy, respectively. The most commonly reported adverse events (AEs; >5% occurrence) were headache (14%), diarrhea (10%), and nausea (8%); majority were mild. No related serious AEs occurred.. We show that most week-8 partial apremilast responders can achieve PASI 75 at week 12 with combination C/BD topical therapy, and maintain PASI 75 through week 16 with apremilast monotherapy. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5435.

Topics: Administration, Cutaneous; Adult; Aerosols; Aged; Betamethasone; Calcitriol; Diarrhea; Drug Combinations; Drug Therapy, Combination; Female; Headache; Humans; Male; Middle Aged; Nausea; Pilot Projects; Psoriasis; Severity of Illness Index; Thalidomide; Treatment Outcome; Young Adult

Even in light of significant recent therapeutic advancements, many patients with psoriasis will use a combination of treatments at some point in the disease course. Despite the frequency with which combinations are used in clinical practice, there are few large-scale, randomized controlled trials investigating the use of various combination therapies in psoriasis. Twice-weekly maintenance application of topical Cal/BD aerosolized foam has recently been shown to prolong time to remission and is associated with fewer relapses in patients initially treated with standard dosing of the formulation. Data from a small number of pilot studies suggest potential benefits from the combined used topical Cal/BD foam with oral apremilast. This pilot study assesses the effect of twice-weekly maintenance doses of Cal/BD foam after 4 weeks of standard once-daily treatment in combination with apremilast. The combination of apremilast plus Cal/BD achieved the primary endpoint, with 95% of subjects rated clear or almost clear on PGA at week 4. Subject’s global assessment scores showed similar improvement to PGA scores at week 4 (47% of subjects clear or almost clear). Ten subjects (53%) achieved PASI 75 at week 4, and 12 (63%) achieved PASI 75 at week 16. Maintenance dosing of Cal/BD foam in combination with apremilast is safe and effective for the management of moderate psoriasis. J Drugs Dermatol. 2022;21(4):381-386. doi:10.36849/JDD.6622.

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Pilot Projects; Psoriasis; Thalidomide; Treatment Outcome

Topics: Administration, Oral; Aged; Betamethasone; Calcitriol; Cyclosporine; Dermatologic Agents; Drug Combinations; Drug Resistance; Female; Gels; Humans; Male; Middle Aged; Nail Diseases; Ointments; Psoriasis; Severity of Illness Index; Thalidomide; 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

Stacey Croney, Clinical Nurse Lead Dermatology, Medway NHS Foundation Trust, Kent discusses the care of patients with psoriasis, including the latest drug treatments.

Topics: Acitretin; Administration, Cutaneous; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Cyclosporine; Dermatologic Agents; Disease Management; Emollients; Humans; Immunosuppressive Agents; Keratolytic Agents; Methotrexate; Phototherapy; Psoriasis; Thalidomide