Dermatologists' Perspectives on Biosimilars.

BACKGROUND: Biosimilars are biologic agents the Food and Drug Administration (FDA) has deemed to have no clinical difference from their reference biologics. In dermatology,  biosimilars are approved for the treatment of psoriasis and hidradenitis suppurativa. Although dermatologists are high prescribers of biologics, they are more reluctant to prescribe biosimilars than other specialists. This survey-based study sought to characterize dermatologists’ current perspectives on biosimilars.  Methods: A 27-question survey was distributed via email to dermatologists between September and October of 2022.  Results: Twenty percent of respondents would not prescribe a biosimilar for an FDA-approved indication. When asked about the greatest barriers to biosimilar adoption, 61% had concerns about biosimilar safety and efficacy, 24% reported uncertainty about state laws for interchangeability and substitutions, and 20% had concerns about biosimilar safety without concerns about efficacy. Thirty-five percent of respondents felt moderately or extremely knowledgeable about biosimilar interchangeability.  Conclusion: Biosimilars are safe and effective for treating approved dermatological conditions and may lower patient costs compared to their reference products. Patients are not always offered biosimilar therapy as an option, which may be due to unfamiliarity among dermatologists.  This survey suggests a need for more research and educational initiatives, such as modules and workshops that focus on biosimilar safety, efficacy, and interchangeability guidelines. J Drugs Dermatol. 2024;23(4):doi:10.36849/JDD.7755.

Outcomes in Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Patients Treated With a Medicine-Led Multidisciplinary Approach.

Patients with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have traditionally been treated in burn centers. Our burn center's approach differs by admitting these patients to a medicine service, with support from the burn team. The aim of this study was to determine whether SJS/TEN patients cared for with our system, with burn involvement but not burn admission, demonstrate equivalent outcomes. We conducted a retrospective review of all SJS/TEN patients admitted to the medicine service at a single academic medical center from 2009 to 2021. Outcome measures such as mortality, length of ICU stay, and total length of hospitalization were collected. The Severity-of-Illness Score for Toxic Epidermal Necrolysis (SCORTEN) was used to calculate expected mortality rates within the cohort. The observed mortality rates were then compared to the expected mortality rates. One hundred and twenty-six patients who were admitted for SJS/TEN were included (70 SJS, 40 SJS/TEN overlap, 16 TEN). The mortality rate for the entire cohort was 10.32% as compared to a 22.33% expected mortality rate (P = .010). The observed and expected mortality rates for SJS, SJS/TEN overlap, and TEN subgroups were 1.43% observed versus 10.22% expected (P = .029), 20.00% observed versus 35.83% expected (P = .133), and 25.00% observed version 44.06% expected (P = .264), respectively. Mortality rates in SJS/TEN patients admitted to medicine units are equivalent or decreased as compared to SCORTEN-predicted mortality rates. Admission of SJS/TEN patients to a medicine unit is appropriate providing there is burn team involvement in their care.

Choosing Systemic Agents for Psoriasis.

Treatment options for moderate-to-severe psoriasis depend on drug efficacy and safety, patient preferences, comorbidities, and cost-no drug dominates across all dimensions. Interleukin (IL)-17 inhibitors may be preferred for fast-acting treatment, while the 3-month schedule of risankizumab, ustekinumab, or tildrakizumab may be attractive for patients who prioritize fewer injections. Phototherapy is suitable for patients who wish to avoid systemic agents or when cost is a concern. For patients with poor adherence, infliximab or tildrakizumab may be well suited as they require in-office administration. Dermatologists can educate patients on available therapies to find a regimen best suited to their needs.

Understanding the Medical Dictionary for Regulatory Activities (MedDRA) reporting of herpes simplex virus (HSV) adverse events in atopic dermatitis clinical trials.

Drug efficacy is best evaluated by randomized, controlled, double-blind clinical trials; however, safety is harder to assess. The Medical Dictionary for Regulatory Activities (MedDRA) is used to track and categorize adverse events (AE) during clinical trials. Recent atopic dermatitis (AD) clinical trials were reviewed to illustrate how an understanding of MedDRA may be helpful when evaluating the rates and nature of adverse events related to herpes simplex virus (HSV) infection. All completed AD clinical trials (excluding phase I studies) with results on clinicaltrials.gov (01/01/2018-01/31/2023) were queried in January 2023. MedDRA version, preferred term (PT) for AEs captured as "HSV", PTs for other AEs possibly related to HSV, frequency thresholds for reporting non-serious AEs, and route of treatment were recorded. Of the 46 clinical trials, 17 had PTs for AEs captured as "HSV". Among all studies, 11 different versions of MedDRA were utilized, from versions 10 to 24.1. In all studies, PTs for AEs captured as "HSV" were listed in the Infections and Infestations system organ class (SOC) classification of MedDRA. PTs varied from "herpes simplex", "herpes virus infection", "herpes ophthalmic", "ophthalmic herpes simplex", "nasal herpes", "oral herpes", "herpes dermatitis", "eczema herpeticum", "genital herpes simplex", and "genital herpes." While one clinical trial of dupilumab (NCT03359356) simply reported the PT "oral herpes" as an AE, a clinical trial of DS107 (NCT03817190) reported the PTs "oral herpes", "herpes simplex", and "herpes virus infection" separately. In the DS107 clinical trial, it is unclear if the same adverse event was reported under multiple PTs or if multiple HSV-related AEs occurred. Although the definition of HSV is unchanged from 2018 to 2023 and there are few changes between MedDRA versions, coding for HSV is complex. HSV events can be reported in different ways, which may impact the interpretation of a drug's safety profile.

JAK1 inhibitors for the treatment of atopic dermatitis: a focus on pharmacokinetic considerations.

INTRODUCTION: Atopic dermatitis (AD) is associated with reduced quality of life, depression, and anxiety, making efficacious and safe treatments a priority. We will focus on the safety, efficacy, and pharmacokinetics of JAK1 inhibitors used in the treatment of AD. AREAS COVERED: In this review, the pharmacodynamics, pharmacokinetics, safety, and efficacy of JAK1 inhibitors for the treatment of atopic dermatitis are discussed. The data was obtained by searching ClinicalTrials.gov, PubMed, and Google Scholar. Articles between January 2012 and March 2023 were considered for inclusion. EXPERT OPINION: Given the rare, but serious black box warnings with JAK inhibitors, patients and providers may be weary of initiating treatment. In these instances, clinicians may weigh the risks and benefits of treatment with this class. Risk is relative, and while there are risks to treating AD with JAK inhibitors, there are also risks to untreated or undertreated AD, including infection and impairments in mental, physical, and psychosocial function. While JAK1 inhibitors appear to be safe, they were only recently approved for AD in January 2022, and more long-term safety data is needed. We expect to see additional FDA approval of these drugs, new formulations, and more safety and efficacy data in the future.

Efficacy, Convenience, and Safety of Calcipotriene-Betamethasone Dipropionate Cream in Skin of Color Patients With Plaque Psoriasis.

BACKGROUND: Psoriasis affects diverse racial and ethnic groups. In July 2021, the US Food and Drug Administration approved calcipotriene/betamethasone dipropionate (CAL/BDP) 0.005%/0.065% cream to treat plaque psoriasis in adults. The efficacy and safety of CAL/BDP in patients with skin of color (SOC) who have psoriasis is not well characterized. METHOD: A post hoc analysis of phase 3 clinical trial data (NCT03308799) was conducted to assess the efficacy, convenience, and safety of CAL/BDP cream versus CAL/BDP topical solution and vehicle cream in people with Fitzpatrick skin types IV to VI.   Results: This study included 784 participants, 280 (35.7%) of whom had Fitzpatrick skin types IV to VI. Patients treated with CAL/BDP cream had greater disease improvement, treatment convenience scores, and overall satisfaction than those treated with CAL/BDP topical solution in the subgroup with skin types IV to VI and the total study population.  Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms.  Conclusion: Psoriasis is associated with a greater physical and psychosocial impact in patients with SOC. While many effective topical therapies exist, it may be helpful to conduct separate analyses of patients with SOC to assess the efficacy and safety of treatment in this population. This sub-analysis of phase 3 clinical trial data supports the efficacy and safety of CAL/BDP cream in the treatment of plaque psoriasis in patients with SOC. CAL/BDP cream also had greater convenience, formula acceptability, and overall satisfaction in both the subgroup with SOC and the total trial population, which may improve adherence to topical therapy and treatment outcomes for people with SOC who have psoriasis. Kontzias CL, Curcio A, Gorodokin B, et al. Efficacy, convenience, and safety of calcipotriene-betamethasone dipropionate cream in skin of color patients with plaque psoriasis. J Drugs Dermatol. 2023;22(7):668-672. doi:10.36849/JDD.7497.

Patient Preferences in Topical Psoriasis Treatment.

BACKGROUND: Psoriasis is a common inflammatory skin condition that varies in severity. Most patients have limited disease amenable to topical treatment; however, poor treatment adherence limits efficacy. The purpose of this study was to assess patients’ psoriasis treatment experience, expectations, and preferences. METHOD: The National Psoriasis Foundation conducted a 17-question survey in March 2022 assessing psoriasis severity, bothersome signs and symptoms, current treatment modalities, frequency of topical therapy use, and vehicle preferences. Statistical analysis of the qualitative data was performed using descriptive analysis and calculations of relative frequencies. RESULTS: Most participants self-reported moderate psoriasis (83.9%). The most common bothersome symptoms were scaly appearance (78.8%), bleeding/oozing (60%), itch (55%), and flaking (37.4%). For treatment, 72.5% of participants disclosed using oral medication, while 8% used topical treatment alone. Most participants (76%) reported using topical therapy at least once weekly. Nearly 80% of participants said they would allow 2 weeks for a medication to become effective before considering discontinuation. Participants preferred water-based creams (75.7%), followed by oil-based foam (70.8%), gel (48.7%), solution (42.8%), lotion (21.2%), non-oil-based foam (17.5%), ointment (16.5%), and spray (6.3%). The formulation attributes rated most important were application feel (55.2%), non-staining (49.9%), quick absorption (46.7%), non-sticky texture (39.7%), ease of application (28.5%), no unpleasant smell (22.4%), non-greasy (16.8%), works quickly (14.1%), absent sting or burn (10%), no adverse skin reaction (9.7%), and once daily treatment (6.8%). If participants did not like a topical treatment's formulation, most (74.7%) said they would continue to use the medication for a week before discontinuation. CONCLUSION: Topical treatments continue to be a mainstay of psoriasis treatment. Patients expect to see rapid improvement with topical treatment; otherwise, they report that they will discontinue treatment. The characteristics of psoriasis treatment vehicles also affect patients’ reported willingness to use treatment and may be an important consideration in treatment planning. J Drugs Dermatol. 2023;22(4): doi:10.36849/JDD.7372 Citation: Curcio A, Kontzias C, Gorodokin B, et al. Patient preferences in topical psoriasis treatment. J Drugs Dermatol. 2023;22(4):326-329. doi:10.36849/JDD.7372.