Tildrakizumab in Combination With Topical Halcinonide 0.1% Ointment for Treating Moderate to Severe Plaque Psoriasis.

BACKGROUND: This prospective, open-label study evaluated the effectiveness and safety of tildrakizumab plus topical halcinonide ointment in psoriasis patients. METHODS: Adults (age greater than or equal to 18 years) with moderate to severe plaque psoriasis (body surface area [BSA] greater than or equal to 10%, physician's global assessment [PGA] greater than or equal to 3, psoriasis area severity index [PASI] greater than or equal to 12) received tildrakizumab (100 mg; s.c.) at weeks 0, 4, and 16. Patients with BSA >3% at week 16 received additional halcinonide 0.1% twice daily for 4 weeks (week 20) and were followed for another 4 weeks (week 24); those with BSA less than or equal to 3% were followed to week 24. RESULTS: Twenty-five patients were enrolled (mean age 52.6 years; 68% male). The proportion of all patients achieving BSA less than or equal to 3% was 52.2% at week 16, 73.7% at week 20 (after 4 weeks of adjunctive halcinonide in patients with BSA >3% at week 16), and 84.2% at week 24 (4 weeks after halcinonide discontinuation). PASI 75 was attained in 60.9% of all patients at week 16, and 73.7% at weeks 20 and 24. In patients adding halcinonide, improvements from baseline in mean BSA, PGA, and PGA x BSA increased from week 16 (55%, 29%, and 64%, respectively) to week 20 (78%, 51%, and 88%, respectively), and were maintained through week 24. Quality of life improved with tildrakizumab monotherapy and further with adjunctive halcinonide. Adverse events (AEs) were infrequent. No serious AEs or discontinuations due to AEs were noted. CONCLUSION: Tildrakizumab plus topical halcinonide ointment is safe and effective in controlling psoriasis for patients inadequately responding to tildrakizumab monotherapy.Bagel J, Novak K, Nelson E. Tildrakizumab in combination with topical halcinonide 0.1% ointment for treating moderate to severe plaque psoriasis. J Drugs Dermatol. 2023;22(8):766-772. doi:10.36849/JDD.6830.

Adjunctive Use of Halobetasol Propionate-Tazarotene in Biologic-Experienced Patients With Psoriasis.

Not all patients with psoriasis achieve a satisfactory response to their initial biologic monotherapy. Switching to a new biologic may be associated with new safety issues and additional costs. In this study, we assessed the effectiveness and safety of adjunctive halobetasol propionate (HP) 0.01%-tazarotene (TAZ) 0.045% lotion in adult patients with moderate to severe plaque psoriasis who had been receiving biologic monotherapy for 24 weeks or more but had inadequate responses. All participants received HP-TAZ lotion once daily for 8 weeks, then once every other day for 4 weeks, in addition to their ongoing biologics. This real-world study demonstrated that HP-TAZ lotion adjunctive to ongoing biologics is safe and effective and potentially a more economical alternative to switching biologics for patients with psoriasis with inadequate responses to biologic monotherapy.

Adjunctive Use of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Patients With Psoriasis Treated With Ixekizumab.

OBJECTIVE: To examine the effectiveness and safety of adjunctive treatment with calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adult patients with chronic plaque psoriasis who have localized residual plaques after ≥24 weeks of treatment with ixekizumab biologic therapy. METHODS: This study was a prospective, open-label, single-arm study of adult patients with moderate-to-severe chronic plaque psoriasis who had suboptimal response after ≥24 weeks of treatment with ixekizumab (residual 3–8% body surface area [BSA] involvement). All patients continued treatment with ixekizumab and received once-daily Cal/BD foam for 4 weeks, followed by every other day for weeks 8 to 12. The primary endpoint was treat-to-target BSA ≤1% at week 4. Additional endpoints included the Physician’s Global Assessment (PGA) score, PGA×BSA, and the patient-reported Dermatology Life Quality Index (DLQI). Safety evaluations included assessments of adverse events (AEs) and local skin reactions. RESULTS: Among 25 enrolled patients, 36% were female, and the mean age was 50 years. After 4 weeks of daily Cal/BD foam, 56% of patients achieved the treat-to-target goal of ≤1% BSA. Mean % BSA involvement, mean PGA score, and composite PGA×BSA score decreased 4 weeks after the addition of Cal/BD foam. Improvements in disease severity outcomes were maintained after reducing Cal/BD dosing frequency. Cal/BD was generally safe and well-tolerated, with no serious AEs reported. CONCLUSION: In real-world clinical practice, for patients with moderate-to-severe plaque psoriasis who had residual plaques following ≥24 weeks of ixekizumab monotherapy, adjunctive treatment with Cal/BD foam was associated with notable and sustained improvements in disease control. J Drugs Dermatol. 2022;21(3): 235-240. doi:10.36849/JDD.6396.

A Retrospective Review of Patients' Response to Biologic Therapy for Psoriasis.

BACKGROUND: Biologic treatments have taken the forefront in treating moderate-to-severe psoriasis. Although numerous randomized, controlled trials have demonstrated the efficacy of these agents, there is limited data suggesting that clinical trial outcomes are reproducible in real-world patients. OBJECTIVE: Obtain real-world evidence for the use of biologics that target different segments of the immune system in patients with moderate-to-severe psoriasis. METHODS: A retrospective chart review was conducted for 100 patients who initiated biologic therapy and had a follow-up visit within a 4- to 12-month period. Efficacy assessments included body surface area (BSA), Physician’s Global Assessment (PGA) scores, composite BSA×PGA scores, and the National Psoriasis Foundation (NPF) Treat to Target (TTT) goal of ≤1% BSA. RESULTS: Biologic treatment led to notable reductions in BSA, PGA, and BSA×PGA relative to baseline, with the majority (67.0%) of the population achieving NPF TTT goals at follow-up. Disease improvements were observed in all patients, regardless of baseline body weight, prior experience with biologics, or the specific immune target of the prescribed biologic. CONCLUSION: Long-term biologic therapy demonstrated effectiveness in treating patients with moderate-to-severe psoriasis. J Drugs Dermatol. 20(4):442-449. doi:10.36849/JDD.2021.5823Visit the Psoriasis Resource Center for more.

Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Adjunctive Use of Calcipotriene/Betamethasone Dipropionate Foam in a Real-World Setting Curtails the Cost of Biologics Without Reducing Efficacy in Psoriasis.

INTRODUCTION: Although the efficacy of monotherapy with biologics for psoriasis is well established, many patients fail to achieve complete plaque clearance from their initial biologic treatment alone. Adjunctive treatment with topical calcipotriene plus betamethasone dipropionate (Cal/BD) foam may offer substantial clinical benefit and potential cost savings. METHODS: We conducted a 16-week, open-label, single-arm study of adjunctive therapy with Cal/BD foam in subjects who had been treated with etanercept or adalimumab for ≥ 24 weeks but had not obtained a satisfactory treatment response. Assessments included affected body surface area (BSA), Physician's Global Assessment (PGA) of disease severity, BSA × PGA, National Psoriasis Foundation (NPF) Treat to Target status, and likelihood of the physician to switch biologics. In parallel, a cost analysis was performed to compare the cost of switching to a different biologic versus adding Cal/BD foam to the original biologic. RESULTS: Four weeks of daily adjunctive treatment with Cal/BD foam led to notable reductions in BSA, PGA, and BSA × PGA relative to baseline. Additionally, by week 4, > 75% of subjects achieved NPF Treat to Target status, and the likelihood of the investigator to switch biologics decreased from 90.0% at baseline to 7.1%. The improved efficacy was maintained throughout the additional 12 weeks of maintenance Cal/BD foam application. The pharmacoeconomic evaluation demonstrated that adjuvant use of Cal/BD foam led to cost savings compared with switching biologic treatments. LIMITATIONS: Due to the nature of the open-label study lacking a vehicle-treated control, no statistical comparison can be made. CONCLUSIONS: The results of this study demonstrate that the addition of Cal/BD foam to plaque psoriasis patients who still have significant disease activity despite being on stable biologic therapy improves treatment outcomes to the point where switching to a more expensive biologic therapy is a less suitable treatment option.

A Prospective, Open-Label Study Evaluating Adjunctive Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Psoriasis Patients With Inadequate Response to Biologic Therapy.

OBJECTIVE: To assess the effectiveness and safety of combining calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam with biologic therapies for patients with plaque psoriasis who have not obtained an adequate response with biologic therapy. METHODS: This was a prospective, open-label, single-arm study of patients with chronic plaque-type psoriasis (body surface area [BSA] ≤5%) who were being treated with biologic agents for ≥24 weeks. All patients received once-daily Cal/BD foam for 4 weeks, followed by twice-weekly use on consecutive days for 12 weeks (maintenance regimen). The end points were assessed at weeks 4 and 16, and included the Physician's Global Assessment (PGA), BSA, PGA×BSA, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM)-9. Safety evaluations included assessments of local skin reactions and adverse events (AEs). RESULTS: Enrolled were 25 patients (18 men and 7 women; mean age, 53 ± 11 years). Patients had significant disease activity despite being on stable biologic therapy (median values: BSA, 3%; PGA, 3; PGA×BSA, 8). At weeks 4 and 16 versus baseline, adjunctive therapy with Cal/BD foam significantly improved PGA score (1 vs 1 vs 3; P less than .01), BSA involvement (1% vs 1% vs 3%; P less than .01), and PGA×BSA measure (1 vs 1 vs 8; P less than .01). Most patients achieved treat-to-target criteria for BSA ≤1% and PGA ≤1 at week 4 (both 76%) and week 16 (both 68%) versus 12% and 4%, respectively, at baseline. Quality of life was improved at both weeks 4 and 16, with high treatment satisfaction. Overall, adjunctive Cal/BD foam was safe and well-tolerated, with no serious AEs. CONCLUSIONS: Adjunctive therapy with Cal/BD foam was associated with an improvement of every measure of disease activity in patients with inadequate response to biologics, an effect that was maintained throughout the study. The majority of patients achieved treat-to-target goals. J Drugs Dermatol. 2018;17(8):845-850.

An Open-label, Observational Study Evaluating Desoximetasone Topical Spray 0.25% in Patients with Scalp Psoriasis.

Objective: The goal of this study was to evaluate efficacy and safety of desoximetasone spray 0.25%, a topical corticosteroid, in the management of scalp and body psoriasis. Design: This was an open-label, observational study. Participants: Twenty adults aged 18 years or older with chronic scalp psoriasis present on at least 30 percent of the scalp surface area and an Investigator Global Assessment (IGA) scale score of scalp disease of at least 2 on a scale of 0 to 4 were included in the study. Measurements: Study spray was applied twice daily for four weeks, followed by 12 weeks of twice-daily application for two consecutive days weekly. Results: At Week 4, the mean Physician Global Assessment (PGA) scale score had decreased 54.8 percent, from moderate disease to almost clear. Body surface area (BSA) had decreased by 51.2 percent, BSA × PGA had decreased by 63 percent, and scalp IGA had decreased by 64.5 percent from moderate to almost clear. Additionally, mean Psoriasis Scalp Severity Index (PSSI) score was 27.3±10.0 at baseline and decreased 82.4 percent to 4.8±5.2 and scalp surface area (SSA) was reduced by 70.7 percent at Week 4. The initial Scalp Index score was a mean of 65.7±15.0 at baseline and was reduced by 44.3 percent and 40.8 percent at Weeks 4 and 16, respectively. The initial response was maintained after a change to twice-weekly, twice-daily dosing, with a 48.4-percent decrease in PGA, a 17.1-percent decrease in BSA, a 31.5-percent decrease in BSA × PGA, a 51.6-percent decrease in scalp IGA, a 63.4 percent decrease in PSSI, and a 42.3-percent decrease in SSA seen at Week 16. Minimal adverse events were experienced by seven subjects. Conclusion: Desoximetasone spray 0.25% produced rapid improvements in PGA, BSA, BSA×PGA, scalp IGA, PSSI, SSA.

Apremilast and Narrowband Ultraviolet-B Combination Therapy for Treating Moderate-to-Severe Plaque Psoriasis.

BACKGROUND: Combining narrowband UVB (NB-UVB) phototherapy with biologics has been shown to enhance the therapeutic response of plaque psoriasis patients. The objective of this study was to evaluate the effectiveness of apremilast combined with NB-UVB in patients with moderate to severe plaque psoriasis. METHODS: This was a 12-week, open-label study of 29 patients diagnosed with moderate to severe psoriasis. Patients received apremilast 30 mg twice daily, and increasing doses of NB-UVB (310-312 nm) 3 times per week for 12 weeks. RESULTS: Twenty-two of 29 patients (76%) completed the 12-week apremilast and NB-UVB combination therapy; 73% (16 of 22 completers) achieved a PASI 75 response at week 12. Mean scores for PASI, VAS pain, VAS itch, DLQI, and PGA improved by 77%, 77%, 69%, 70%, and 67%, respectively, at week 12. The most commonly reported adverse events (AEs) were mild and moderate first-degree burns related to NB-UVB (n=11 [38%] patients). A second-degree NB-UVB burn was reported (likely due to an underlying photosensitivity) and was considered a serious AE. CONCLUSION: The combination of apremilast with NB-UVB was effective for the treatment of moderate to severe plaque psoriasis, without any unexpected safety signals. Apremilast combined with NB-UVB provided a high treatment response in patients with moderate to severe plaque psoriasis, and may be an option for patients to enhance a patient's initial therapeutic response.

J Drugs Dermatol. 2017;16(10):957-962.

Psychiatric comorbidity in depressed HIV-infected individuals: common and clinically consequential.

OBJECTIVE: To report on the prevalence of psychiatric comorbidity and its association with illness severity in depressed HIV patients. METHODS: As part of a multi-site randomized controlled trial of depression treatment for HIV patients, 304 participants meeting criteria for current Major Depressive Disorder (MDD) were assessed for other mood, anxiety and substance use disorders with the Mini-International Neuropsychiatric Interview, a structured psychiatric diagnostic interview. We also assessed baseline adherence, risk, and health measures. RESULTS: Complicated depressive illness was common. Only 18% of participants experienced MDD with no comorbid psychiatric diagnoses; 49% had comorbid dysthymia, 62% had ≥1 comorbid anxiety disorder, and 28% had a comorbid substance use disorder. Self-reported antiretroviral adherence did not differ by the presence of psychiatric comorbidity. However, psychiatric comorbidity was associated with worse physical health and functioning: compared to those with MDD alone, individuals with ≥1 comorbidity reported more HIV symptoms (5.1 vs. 4.1, P=.01), and worse mental health-related quality of life on the SF-12 (29 vs. 35, P<.01). CONCLUSION: For HIV patients with MDD, chronic depression and psychiatric comorbidity are strikingly common, and this complexity is associated with greater HIV disease severity and worse quality of life. Appreciating this comorbidity can help clinicians better target those at risk of harder-to-treat HIV disease, and underscores the challenge of treating depression in this population.

Using high-fidelity simulation to develop nurse-physician teams.

BACKGROUND: This study was undertaken to determine whether interdisciplinary high-fidelity simulation training improves group cohesion in nurse-physician teams. In addition, perceptions of collaboration and satisfaction with patient care decisions were measured in nurse-physician participants. METHODS: Clinical scenarios relevant to the general surgical urology inpatient unit were conducted in an interdisciplinary high-fidelity simulation center. Participants included physicians and staff nurses. RESULTS: Participants reported a positive shift in group cohesion over time. In addition, the results suggested a positive shift in perceptions of collaboration and satisfaction with patient care decisions over time. The youngest participants (Millennial Generation, born in the 1980s and 1990s) showed the most significant growth in response to the training. CONCLUSION: This study provides evidence of benefits of high-fidelity simulation that extend beyond the training. Simulation training may be a strategy to build and strengthen relationships across nurse-physician teams. In addition, this type of training may positively affect collaboration and satisfaction with patient care decisions. When data were analyzed by generational grouping, the most significant growth occurred in the Millennial Generation participants. These influences need to be explored further.