BSA Involvement Research Articles

Role of Koebner phenomenon in predicting the clinical profile and course of vitiligo

Background: Koebner phenomenon (KP) is a clinical indicator of disease activity in vitiligo. Few studies have suggested that it may also be used to predict the clinical profile, prognosis, and response to therapy. Aims: To compare the clinical characteristics of vitiligo patients with different types of KP in an Indian population. Methods: A prospective longitudinal observational study was conducted from January to November 2016. Classification of KP was done according to the Vitiligo European Task Force guidelines into KP1-by history and KP2-by clinical examination (2A: lesions on friction areas and 2B: trauma-induced lesions). Results: Of the total 160 patients, KP was observed in 102 (63.8%) cases. Type 1 KP was seen in 43 (26.9%), type 2A in 87 (54.4%), and type 2B in 34 (21.3%) cases. Patients with KP1 and KP2B had an earlier age of presentation and disease onset, while those with KP2A had a higher age of presentation and disease onset. Incidence of other autoimmune disorders, higher BSA involvement and requirement of betamethasone oral mini pulse therapy were significantly higher in cases with KP1 and KP2A, while significantly elevated anti-thyroid peroxidase levels were seen in cases with KP2A. Also, lesser treatment response was noted among cases with KP1 and KP2A. Conclusion: KP is associated with increased disease activity and more extensive involvement of vitiligo. Type 2A KP was associated with a higher incidence of other autoimmune disorders, more extensive disease, and the use of systemic steroids for treatment, which were not seen in KP2B. Thus, these groups might define two different subsets of patients.

Deucravacitinib in Moderate Plaque Psoriasis: Efficacy in the Phase 3 POETYK PSO-1 and PSO-2 Trials

Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, was efficacious and well tolerated in adults with moderate to severe plaque psoriasis in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials. We report clinical efficacy of deucravacitinib in the patient subgroup from these trials with baseline plaque psoriasis of moderate severity.
 Methods: PSO-1 and PSO-2 randomized patients with moderate to severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA involvement ≥10% at baseline) 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Placebo patients crossed over to deucravacitinib at Week 16 in both trials. In PSO-1, deucravacitinib-treated patients received continuous deucravacitinib through Week 52. In PSO-2, PASI 75 responders at Week 24 on deucravacitinib were rerandomized to placebo or deucravacitinib (1:1) through Week 52. In patients meeting criteria for plaque psoriasis of moderate severity, defined as sPGA 3 and BSA 10%-15% at baseline, in the pooled PSO-1/PSO-2 trials, PSO-1 alone, and the PSO-1 placebo crossover population, deucravacitinib efficacy vs placebo was evaluated by PASI 75, PASI 90, and sPGA 0/1 (clear/almost clear) responses (nonresponder imputation) and PASI change from baseline (mBOCF). The Clopper-Pearson method was used to calculate 95% CIs.
 Results: PSO-1/PSO-2 moderate psoriasis subgroup PASI 75 response rates were higher with deucravacitinib vs placebo at Week 16 (49.1% [95% CI, 42.5%-55.7%] vs 11.7% [95% CI%, 5.9%-17.4%]) and continued to increase through Week 24 (63.8% [95% CI, 57.5%-70.1%]). PSO-1 PASI 75 response rates were higher with deucravacitinib vs placebo at Week 16 (54.1% [95% CI, 42.1%-65.7%] vs 12.0% [95% CI, 4.5%-24.3%]), Week 24, and were sustained until Week 52. Week 52 PASI 75 response rates for deucravacitinib and placebo crossover groups were comparable (74.3% [95% CI, 62.8%-83.8%] and 67.4% [95% CI, 51.5%-80.9%], respectively). PASI 90 and sPGA 0/1 response rates and change from baseline PASI followed similar patterns, with marked improvement vs placebo at Week 16; peak responses were observed at Week 24 and sustained through Week 52. Efficacy results were comparable to those previously reported for moderate to severe psoriasis.
 Conclusion: Deucravacitinib efficacy was confirmed in moderate plaque psoriasis and was consistent with published data in the PSO-1 and PSO-2 overall study population with moderate to severe plaque psoriasis.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Factors Associated with Persistent Efficacy of Abrocitinib without Flare: A Multivariable Analysis of the JADE-REGIMEN Study

Introduction: JADE REGIMEN (NCT03627767) was conducted to evaluate the feasibility of continual, reduced dose or withdrawal of abrocitinib after induction of response in patients with moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated patient factors associated with a higher probability of persistent clinical response with abrocitinib, without flare, during a 40-week maintenance period.Methods: Data were analyzed from patients who responded to abrocitinib 200 mg induction therapy (12 weeks) and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo in the maintenance period (40 weeks). A multivariable logistic regression model with fixed and random effects was fit to determine factors associated with not experiencing flare by week 52. Fixed effects (factors) considered were randomly allocated treatment, age (<18 vs ≥18 years), race, weight, prior use of systemic agents, AD duration, onset of response in induction (early vs late), Investigator’s Global Assessment score at randomization, body surface area (BSA, ≤50% vs >50%) at baseline, and percentage change in Eczema Area and Severity Index (EASI) at randomization. Backward elimination and stepwise model selection procedures were applied with entry and exit criteria based on a P value threshold of 5%.Results:1233 patients received abrocitinib 200 mg in the induction period. By week 12, 798 (64.7%) achieved a response and were randomly assigned to receive maintenance treatment for 40 weeks. In total, 356 patients (44.6%) experienced a protocol-defined flare: 16.5% (200 mg), 39.6% (100 mg), and 77.5% (placebo). After model selection, the analysis identified continuation of treatment with abrocitinib 200 mg (odds ratio [OR], 19.51; 95% CI, 11.28-33.75) or reduced-dose abrocitinib 100 mg (5.27; 3.29-8.46) as the greatest predictors of not experiencing flare during maintenance. Not having previously used systemic agents (OR, 1.53; 95% CI, 1.09-2.14), lower baseline BSA (1.55; 1.10-2.17), and greater percentage reduction of EASI during induction (1.35; 1.15-1.59) were also associated with not experiencing flare.Conclusions: Multivariable analysis of JADE REGIMEN indicated that maintenance treatment with abrocitinib in patients with AD reduced the risk for flare in a dose-dependent manner. Other factors associated with maintaining response to treatment without flare included no previous exposure to systemic agents, lower extent of BSA involvement at baseline, and greater percent change in EASI during induction. These findings may assist clinicians with abrocitinib dosing decisions in the future.

43569 BSA and special area involvement informs psoriasis disease severity in a real-world population: patient characteristics and treatment patterns

43569 BSA and special area involvement informs psoriasis disease severity in a real-world population: patient characteristics and treatment patterns

Influences of vitiligo-associated characteristics on the occurrence of diabetes mellitus: Interactive analysis of a cross-sectional study.

The risk of diabetes mellitus (DM) in vitiligo patients is higher than that in non-vitiligo population. Our goal was to explore the influencing factors for DM in vitiligo patients. A matched-pair design of 107 cases with DM and 428 controls without DM was conducted among vitiligo patients in Xijing hospital from January 2010 to October 2021. The baseline characteristics of patients were analysed based on standard descriptive statistics. The vitiligo-associated characteristics were analysed by logistic regression to identify influencing factors of DM. Interaction analysis was performed to explore the additive interactions between vitiligo-associated characteristics and baseline characteristics. After adjustment for the baseline characteristics, the severity of vitiligo [odds ratio (OR) = 2.47, 95% confidence interval (CI): 1.47-4.14] and onset age of vitiligo (OR = 0.98, 95% CI: 0.97-0.99) had a significant correlation with occurrence of DM. The severity of vitiligo had additive interaction with family history of diabetes [relative excess risk due to interaction (RERI) = 132.51 (95% CI: 5.51-1100.20), attributable proportion (AP) = 0.91 (95% CI: 0.17-0.95), synergy index (S) = 11.53 (95% CI: 1.32-100.5)] and with smoking history [RERI = 6.54 (95% CI: 0.67-19.83), AP = 0.64 (95% CI: 0.04-0.80), S = 3.48 (95% CI: 1.17-10.36)]. Earlier onset age of vitiligo and greater BSA involvement might be two independent risk factors for DM in vitiligo patients. Interaction assessment identified the severity of vitiligo as additive interaction factors with diabetes family history and with smoking history for the DM occurrence.

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials

Introduction: Tyrosine kinase 2 (TYK2), an intracellular kinase, mediates signaling of cytokines (IL-23 and Type I interferons) involved in psoriasis pathogenesis. Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Deucravacitinib was significantly more efficacious than placebo or apremilast and was well tolerated in the phase 3 POETYK PSO-1 and PSO-2 trials. We evaluated changes in lipid parameters in these trials.
 Methods: PSO-1 (NCT03624127) and PSO-2 (NCT03611751) were 52-week, double-blind trials conducted globally. Patients with moderate to severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA involvement ≥10%) were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. This analysis evaluated serum lipids in patients taking placebo, deucravacitinib, or apremilast during Weeks 0-16 and those taking deucravacitinib continuously during Weeks 0-52 in PSO-1 and PSO-2. Mean changes in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels are reported, as are shifts from baseline in CTCAE v5 severity grade of hypercholesterolemia and hypertriglyceridemia.
 Results: 666 and 1020 patients were randomized in PSO-1 and PSO-2, respectively. Mean baseline levels of total cholesterol, HDL cholesterol, and LDL cholesterol were comparable between treatment groups. Mean changes from baseline to Week 16 were small; none was clinically meaningful. Worsening of hypercholesterolemia grade from baseline was observed with similar frequencies among patients receiving placebo, deucravacitinib, and apremilast (10.6%, 11.7%, and 8.4%, respectively); nearly all shifts were 1 grade, and there was no grade ≥3 event. Baseline triglyceride levels were near the upper limit of normal (150 mg/dL) across treatment groups. A 10.3 mg/dL increase in mean triglycerides from baseline to Week 16 was observed with deucravacitinib, but worsening in hypertriglyceridemia >1 grade from baseline was rare (1.2%) and comparable to placebo (1.4%). Most deucravacitinib-treated patients maintained the same or shifted to a lower grade of hypertriglyceridemia from baseline to Week 16. Among patients treated with deucravacitinib continuously for 52 weeks, mean changes in total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were small. Shifts in >1 grade from baseline for hypercholesterolemia and hypertriglyceridemia were uncommon (0.2% and 1.9%, respectively). No patient discontinued deucravacitinib due to a lipid-related adverse event.
 Conclusion: There were no meaningful changes in total cholesterol, HDL cholesterol, and LDL cholesterol levels with deucravacitinib treatment. Minimal increases in mean triglyceride levels from baseline to Weeks 16 and 52 were accompanied by very few worsening shifts >1 grade.

34820 Real-world treat-to-target skin clearance with risankizumab in patients with moderate to severe psoriasis from the CorEvitas Psoriasis Registry

Objective: Risankizumab is efficacious in the treatment of plaque psoriasis, with a reported 73%–75% of patients receiving risankizumab vs 2%–5% receiving placebo achieving Psoriasis Area Severity Index ≥90% improvement at week 16. This analysis assessed real-world effectiveness of risankizumab in achieving National Psoriasis Foundation (NPF)-defined treatment targets. Methods: CorEvitas’ Psoriasis Registry is an independent, prospective, observational cohort of patients ≥18 years diagnosed with psoriasis by a dermatologist and recruited from practices in US and Canada. Adult patients with moderate-to-severe plaque psoriasis (Investigator’s Global Assessment ≥3) at baseline, who initiated risankizumab at baseline visit and had persistent use at 12-month ( ± 3 months) follow-up were included. The achievement of NPF-defined target response (body surface area [BSA] ≤1%) or acceptable response (BSA ≤3% or BSA improvement ≥75% from baseline) at 12 months after initiation was assessed (3). Results: Among 137 patients, mean (SD) age was 48.7 (14.0) years, 59.9% were male, and mean (SD) psoriasis duration was 15.3 (13.0) years at baseline. Mean (SD) BSA involvement was 13.8% (12.8%) and 62.0% of patients had prior biologic use at baseline. At 12 months (n = 136), 70.4% of patients achieved NPF-defined target and 90.4% achieved NPF-defined acceptable response. NPF-defined target and acceptable responses were achieved by 80% and 94% of biologic-naive patients (n = 52) and 64% and 88% of biologic-experienced patients (n = 85), respectively, at 12 months. Conclusion: Persistent 12-month risankizumab use was highly effective in achieving NPF-defined patient-centered treatment targets among patients with moderate-to-severe psoriasis in a real-world setting.

740 Cyclosporine in Stevens Johnson Syndrome & Toxic Epidermal Necrolysis: Experience from a Tertiary Care Center

IntroductionStevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are rare severe cutaneous adverse reactions associated with high morbidity and mortality, however, there lacks an established treatment protocol. Treatment with intravenous immunoglobulin (IVIg) has demonstrated mixed success rates in improving mortality. More recently, cyclosporine (CsA) has been found to have a promising role in management of SJS/TEN owing to its potent anti-apoptotic activity. We present 3 patients with SJS/TEN treated in our burn unit with CsA; all of them demonstrated clinical improvement.MethodsWe conducted a retrospective analysis of patients who were hospitalized with the diagnosis of SJS/TEN in a specialized burn center in the year 2020. Data regarding clinical factors, causative agent(s), disease severity, treatment received, and outcome were collected on chart review. SCORTEN and ABCD-10 prognostic scores were calculated for each patient at the time of admission. All patients were evaluated by a dermatologist and started on CsA at a dosage of 5 mg/kg daily given in 2 divided doses. Predicted mortality rate was compared with observed mortality rate to assess treatment outcomes.ResultsA total of 3 patients were identified with a mean age of 48.33 ± 16.50. All patients had TEN with an average initial BSA involvement of 56.67 ± 20.21 and peak BSA involvement of 63.33 ± 25.17. Lamotrigine was the presumptive causative drug in each case with an average duration of time from starting the medication to symptom onset of 19.3 days. Patients received CsA on average 7 days after symptom onset. Most of our patients had oral (100%), ocular (100%), genital (100%), and esophageal (33.3%) involvement during hospitalization. The observed mortality rate of 0% was lower than that predicted by SCORTEN (12.2% to 32.4%) and ABCD-10 (5.4% to 12.3%). No patients developed complications during admission. All patients had minimal wound care needs on discharge as most of the involved areas were healed by then.ConclusionsOur study sheds light on a possible beneficial role of cyclosporine for the treatment of SJS/TEN and reinforces the necessity of further prospective studies to solidify treatment guidelines.

736 Intravenous Immunoglobulin in Stevens-Johnson Syndrome & Toxic Epidermal Necrolysis: Experience from a Tertiary Care Center

IntroductionStevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are rare severe cutaneous adverse reactions associated with high morbidity and mortality, however, there lacks an established treatment protocol. Treatment with intravenous immunoglobulin (IVIg) has demonstrated mixed success rates in improving mortality. It has been suggested that early intervention with IVIg in SJS/TEN patients may lead to a reduction in observed mortality rate when compared to the predicted rate. We present 24 patients with SJS/TEN treated in our burn unit with IVIg.MethodsWe conducted a retrospective analysis of patients who were hospitalized with the diagnosis of SJS/TEN in a specialized burn center over the years 2011-2020. Data regarding clinical factors, causative agent(s), disease severity, treatment received, and outcome were collected on chart review. SCORTEN and ABCD-10 prognostic scores were calculated for each patient at the time of admission. All patients were started on IVIg at the recommendation of dermatology. A standardized mortality ratio was obtained to compare the actual number of deaths to the predicted number based on SCORTEN and ABCD-10 formulas.ResultsA total of 24 patients were identified with a mean age of 49.8 ± 18.1 years. Most of the patients, i.e., 18 out of 24 had TEN, and 6 patients had SJS/TEN overlap with an overall average initial BSA involvement of 42.7% ± 25.3. Among the suspected drugs, sulfonamide antibiotics (41.7%) was the major predicted culprit. All patients were started on IVIg, 3 of which were treated in combination with corticosteroids. Most of our patients (23/24) received IVIg within 2 days of admission, but on average 11 ± 27 days (range: 2-135) after symptom onset. Many patients (10/24) experienced complications during hospital admission, such as: acute respiratory distress syndrome (8/24), sepsis (6/24), and anemia (2/24). There was no statistically significant difference in the overall observed mortality of 4 patients (16.7%) and the predicted overall mortality of 6.4 patients (26.7%) by the SCORTEN formula [standardized mortality ratio = 0.63; 95% confidence intervals, 0.17-1.61; P = 0.48], and the predicted overall mortality of 3.6 patients (15%) by the ABCD-10 formula [standardized mortality ratio = 1.12; 95% confidence intervals, 0.30-2.86; P = 0.96].ConclusionsThe findings of the present study do not support the clinical benefits of IVIg for SJS/TEN overlap and TEN patients.

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

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. 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. 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. 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.

Impact of chronic and recurrent dermatophytosis on quality of life and psychologic morbidity-a cross-sectional study.

Chronic and recurrent dermatophytosis is adversely effecting the psychosocial well-being of patients. To assess the impact of chronic and recurrent dermatophytosis on quality of life and psychological well-being of patients. We performed a cross-sectional study on patients of chronic and recurrent dermatophytosis aged >12years. Clinical diagnosis was done, followed by appropriate investigations when required. The patients were made to fill up the questionnaires on Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, and Perceived Stress Scale in English and local languages. The responses were coded with 4-point Likert scale. Statistical analysis was done using MedCal® V.125.0. Data of 123 patients were analyzed. Mean DLQI score was 21.4±5.6 and main domain affected was "symptoms and feelings." CRD had an "extremely large effect" on QoL (DLQI score 21-30) in 55.3% patients. Mean HADS-A(anxiety) score was 10.1±3.6, and mean HADS-D(depression) score of participants was 7.8±3.2. Mean perceived stress scale (PSS) score was 18.8±4.3. Involvement of >1site was a risk factor for higher DLQI score suggestive of "extremely large impact" on QoL (OR 34.02,95% CI 5.7-203.2,p=0.0001), higher/worsened HADS-A score (OR 5.4, 95% CI 1.2-22.9, p=0.02), and higher/worsened PSS score (OR 6.1, 95% CI 1.1-34.1, p=0.04). Persistent disease >1year (OR 11.5, 95% CI 1.9-67.8, p=0.007) and male gender (OR 0.3, 95% CI 0.1-0.8, p=0.01) were significant risk factors for anxiety while BSA involvement >10% was a significant risk factor for moderate to severe perceived stress(OR 13.9, 95% CI 1.5-130.7, p=0.02). Chronic and recurrent dermatophytosis requires a multidisciplinary approach involving psychiatrists, to reduce the psychological burden.

Epidemiologic features and burden of atopic dermatitis in adolescent and adult patients: A cross-sectional multicenter study

BackgroundAtopic dermatitis (AD) is considered as one of the most frequent chronic skin conditions. Previous AD epidemiologic studies have been mainly retrospective and/or have been performed through surveys instead of in-person visits. Epidemiological studies concerning AD in Latin American countries are scarce. ObjectiveTo describe sociodemographic and clinical features and the economic burden of AD on children and adult patients in Colombia through in-person visits. MethodsThis was a cross-sectional study of 212 patients that included sociodemographic and clinimetric data. The diagnostic criteria of Hanifin and Rajka was used and data relating to disease distribution, disease severity (through the BSA: Body surface area; EASI: Eczema Area and Severity Index; SCORAD: Scoring Atopic Dermatitis), Fitzpatrick's skin phototypes, personal and familiar history of allergic diseases, previous treatments, and personal history of comorbidities, was collected. ResultsPatient age range was 12–76, and 52.8% were female. Disease distribution was mainly flexural (19.6%). Early age start, Denni-Morgan fold, and infections tendency were more frequent in adolescents compared to adults. Mean age of diagnosis was 12 years old, AD diagnosis was made mostly by a dermatologist, 48.1% (102 patients) reported alcohol consumption, and 59% of consumers were heavy drinkers. Comorbidities found were: chronic rhinitis (68.9%) food allergy (32.5%), allergic conjunctivitis (29.7%), and asthma (28.8%). Around 81% earned less than $896 US dollars and 59% invested 6–30% of their monthly budget yearly, and 40% had work or school absenteeism. Mean scores of BSA, EASI, and SCORAD involvement were 32.6, 13.7, and 42.4, respectively. ConclusionsThis study adds well-supported data through an in-depth clinical and economical characterization of Colombian adolescents and adult patients with atopic dermatitis and shows its high impact and burden on patients and their families. It also contributes to understand the burden of AD in Latin America.

Epidemiology of Burn-Related Morbidity and Mortality in Patients Over 80 Years of Age.

Burns cause greater morbidity and mortality in older patients owing to the physiological changes and functional status declines with age. We sought to characterize the epidemiology of burn injuries in the patient population aged over 80 years. A retrospective analysis of all patients aged >80 years admitted to a tertiary burn center in Brazil over a 10-year period was conducted. Multiple parameters including comorbidities, BSA burned, intensive care unit (ICU) admissions, inhalation injury, and revised Baux score were analyzed to assess association with mortality. Twenty-six patients were identified. The overall mortality rate was 42.3%. The mortality rate increased with the TBSA, with 100% mortality at >20% total BSA involvement (P < .001). Inhalation injury occurred in 3 (11.5%) patients, all of whom suffered mortality (P < .001). ICU admission was necessary for 14 (53.8%) patients, out of which 11 (78.6%) did not survive (P < .001). The revised Baux score had a significant impact on the mortality, with higher values among patients who did not survive (89.2 ± 6.2 vs 110.7 ± 17.9, P < .001). Burns cause high mortality in the octogenarian and nonagenarian populations. It is important to stratify patients at high risk, institute prompt treatment and discuss goals of care early on for optimal patient outcomes.

Study of clinical profile of dermatophytosis in a tertiary care center as per ECTODERM guidelines

Background: Dermatophytic infections are one of the most common skin infections encountered by dermatologists. A recent increase in incidence has been seen over the last few years with substantial change in the clinical profile of patients. Recently a group of dermatology experts published Expert Consensus on The Management of Dermatophytosis in India (ECTODERM India). The group agreed upon various definitions with respect to current dermatophytosis epidemic as well as gave recommendations for investigations and management. Clinical profile of dermatophytosis was done in present study on the basis of definitions agreed upon by ECTODERM consensus group. Aims and Objective: To assess the clinical profile, prevalence and severity of dermatophytic infection in study population. Materials and Methods: Cross-sectional observational study was conducted at out-patient department of Dermatology in, Sharda hospital, Greater Noida. A total of 317 patients presenting with clinical diagnosis of dermatophytosis were included in the study. Results: A total of 317 patients were recruited in the study, out of which 213 were males (67.2%). The most common age group presenting with superficial dermatophytosis was 21-30 years. Majority of the patient presented with chronic dermatophytosis with duration more than 6 months (76.6%) while more than 3 lesions of tinea were observed in 76.6% cases. 191 patients (60%) had moderate to severe involvement with more than 3% of BSA involved. Family members presenting with similar complaints were seen in 39% cases. Majority of patients (76 %) studies had received previous treatment topical, systemic or both. 62 patients presented with recurrence of disease within 6 weeks of complete antifungal treatment (19.6%). Conclusion: Our study concludes that dermatophytosis still remain a challenging issue for dermatologists. Chronicity of infection, moderate to severe BSA involvement and involvement of family members in a good proportion of our study cases were the main findings of our study.

Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6Years of Age and Older.

IntroductionIn phase III trials in adolescents and children with atopic dermatitis (AD), dupilumab significantly decreased global disease severity. However, the effects of dupilumab on the extent and signs of AD across different anatomical regions were not reported. Here we characterize the efficacy of dupilumab in improving the extent and signs of AD across four different anatomical regions in children and adolescents.MethodsA post hoc subset analysis was performed using data from two randomized, double-blind, placebo-controlled, international multicenter, phase III trials of dupilumab therapy in adolescents aged ≥ 12 to < 18 years with moderate-to-severe AD and children aged ≥ 6 to < 12 years with severe AD. Endpoints included mean percentage change in Eczema Area and Severity Index (EASI) signs (erythema, edema/papulation, excoriation, lichenification) and extent of AD (measured by percentage of body surface area [% BSA] involvement) from baseline to week 16 across four anatomical regions (head and neck, trunk, upper extremities, lower extremities).ResultsDupilumab improved both the extent and severity of AD signs across the four anatomical regions. Improvements were shown to be similar across the four anatomical regions for % BSA involvement and for reduction in EASI signs. Improvements in all signs were seen early, within the first 4 weeks of treatment, and were sustained through week 16, across all regions.ConclusionsIn pediatric patients 6 years of age and older, treatment with dupilumab resulted in rapid and consistent improvement in the extent and signs of AD across all anatomical regions.ClinicalTrials.gov IdentifiersLIBERTY AD ADOL (NCT03054428) and LIBERTY AD PEDS (NCT03345914). Does dupilumab provide improvement in atopic dermatitis across all anatomical regions in children and adolescents? (MP4 48,385 kb) Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-021-00568-y.

POS1042 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 (TYK2) INHIBITOR, COMPARED WITH PLACEBO AND APREMILAST IN MODERATE TO SEVERE PLAQUE PSORIASIS: RESULTS FROM THE PHASE 3 POETYK PSO-1 STUDY

Background:Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates interleukin (IL)-23, IL-12, and interferon (IFN)α/β signaling. Deucravacitinib is a novel, oral, selective inhibitor of TYK2 acting via binding to the TYK2 regulatory domain.1 Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo in patients with moderate to severe plaque psoriasis or active psoriatic arthritis.2,3 No herpes zoster infections, opportunistic infections, thromboembolic events, or hematologic or lipid abnormalities characteristic of Janus kinase (JAK) 1−3 inhibitors were reported in the Phase 2 trials.2,3Objectives:To compare the efficacy and safety of deucravacitinib versus placebo and apremilast in plaque psoriasis.Methods:This Phase 3, double-blinded, 52-week study (NCT03624127) randomized patients with moderate to severe plaque psoriasis (BSA ≥10%, PASI ≥12, sPGA ≥3) to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily (2:1:1). Patients receiving placebo were switched to deucravacitinib at Week 16; apremilast-treated patients not achieving PASI 50 at Week 24 were switched to deucravacitinib. Coprimary endpoints were PASI 75 and sPGA 0/1 response versus placebo at Week 16. Key secondary endpoints included superiority versus apremilast, assessed via multiple measures.Results:666 patients were randomized. Demographic and baseline disease characteristics were balanced across groups; mean age was 46.1 years, mean disease duration was 17.3 years, 18.2% of patients had psoriatic arthritis at baseline, and 38.9% had previously used biologic therapy. Mean BSA involvement at baseline was 26.3%, mean PASI was 21.4, and the percentage with severe sPGA (score=4) at baseline was 21.2%. Significantly greater proportions of patients in the deucravacitinib versus placebo and apremilast arms achieved PASI 75 (58.7% vs 12.7% vs 35.1%, respectively; P&lt;0.0001) and sPGA 0/1 (53.6% vs 7.2% vs 32.1%, respectively; P&lt;0.0001) response at Week 16 (Figure 1). Deucravacitinib was also superior to apremilast at Week 24, with 69.0% versus 38.1% of patients achieving PASI 75 and 58.4% versus 31.0% achieving sPGA 0/1 (P&lt;0.0001 for both). In addition, DLQI 0/1 responses at Week 16 were significantly higher with deucravacitinib versus placebo and apremilast, demonstrating improved quality of life (40.7% vs 10.6% vs 28.6%, respectively; Figure 1). During the 16-week, placebo-controlled period, the most common AEs (≥5% in any arm) were nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea (Table 1). Frequencies of SAEs and treatment discontinuations due to AEs were low (Table 1).Table 1.Summary of adverse events (AEs) through Week 16Patients, n (%)Deucravacitinibn=332Placebon=165Apremilastn=168Any AEs176 (53.0)70 (42.4)93 (55.4)Severe AEs5 (1.5)7 (4.2)5 (3.0)Serious AEs7 (2.1)9 (5.5)4 (2.4)AEs leading to treatment discontinuation6 (1.8)7 (4.2)10 (6.0)Most common AEs (≥5% in any arm) Nasopharyngitis21 (6.3)7 (4.2)14 (8.3) Upper respiratory tract infection21 (6.3)6 (3.6)3 (1.8) Headache16 (4.8)5 (3.0)17 (10.1) Diarrhea13 (3.9)6 (3.6)17 (10.1) Nausea7 (2.1)4 (2.4)19 (11.3)Conclusion:Deucravacitinib demonstrated superiority versus placebo and apremilast across multiple efficacy endpoints in patients with moderate to severe plaque psoriasis, and was generally well tolerated. Overall, the efficacy and safety profile of deucravacitinib was consistent with that observed in the Phase 2 plaque psoriasis and psoriatic arthritis trials.2,3

P195 Efficacy of ixekizumab versus adalimumab in psoriatic arthritis (PsA) patients with and without moderate-to-severe psoriasis: 52-week results from a multicentre, randomised open-label study

P195 Efficacy of ixekizumab versus adalimumab in psoriatic arthritis (PsA) patients with and without moderate-to-severe psoriasis: 52-week results from a multicentre, randomised open-label study

OP0228 EFFICACY AND SAFETY OF IXEKIZUMAB VERSUS ADALIMUMAB (SPIRIT-H2H) WITH AND WITHOUT CONCOMITANT CONVENTIONAL SYNTHETIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (DMARD) IN BIOLOGIC DMARD-NAÏVE PATIENTS WITH PSORIATIC ARTHRITIS: 52-WEEK RESULTS

Background:Ixekizumab (IXE), a high-affinity monoclonal antibody selectively targeting IL-17A, was superior to adalimumab (ADA) at Week (Wk) 24 for simultaneous achievement of ACR50 and 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI 100) (primary endpoint) in patients (pts) with active PsA from SPIRIT-H2H1. SPIRIT-H2H had two major secondary endpoints and achieved both: noninferiority of IXE to ADA for ACR50 at Wk 24, and superiority of IXE to ADA for PASI 100 at Wk 24.Objectives:To determine how concomitant conventional synthetic DMARD (csDMARD) use affects safety and efficacy of IXE and ADA in prespecified subgroups defined by biologic monotherapy, concomitant MTX use, and concomitant csDMARD use through Wk 52 in SPIRIT-H2H.Methods:SPIRIT-H2H (NCT03151551) was a 52-week, multicentre, randomised, open-label, assessor-blinded, parallel-group study evaluating the efficacy and safety of IXE versus ADA in adults with PsA and naïve to biologic DMARDs. Patients were required to have active PsA fulfilling Classification for Psoriatic Arthritis (CASPAR) criteria and ≥3/68 tender and ≥3/66 swollen joints, ≥3% plaque psoriasis BSA involvement, no prior treatment with bDMARDs, and with prior inadequate response to ≥1 csDMARD (but not necessarily current treatment with csDMARDs). Randomization (1:1) was stratified by concomitant use of csDMARD and the presence/absence of moderate to severe PsO (baseline: BSA≥10% + PASI≥12, + static Physician’s Global Assessment≥3). Patients (N=566) received IXE/ADA through 52 wks according to the labelled dose dependent on presence/absence of moderate-to-severe PsO. In this prespecified subgroup analysis by presence or absence of csDMARDs, efficacy outcomes through wk 52 were compared between IXE and ADA using logistic regression models and Fisher’s exact tests. Missing data were imputed using non-responder imputation.Results:At baseline, 167 of 283 IXE-treated patients and 169 of 283 ADA-treated patients had concomitant MTX use. Of these, 9.0% (15/167) and 7.1% (12/169) treated with IXE and ADA, respectively, were taking an additional csDMARD (sulfasalazine, cyclosporine, or leflunomide). A significantly greater proportion of patients on IXE versus ADA achieved the primary endpoint or PASI 100 when used as monotherapy or in combination with csDMARD (Figure 1A and 1C). At Wk 52, the proportion of patients achieving ACR50 was not statistically different between IXE and ADA, regardless of monotherapy or concomitant csDMARD use (Figure 1B). A significantly higher proportion of patients achieved MDA on IXE compared to ADA in the monotherapy subgroup (49% vs 33%), while the response rates were similar in both combination subgroups (Figure 1D). These data support consistent ACR50, PASI 100, and MDA response for IXE across all three subgroups. Frequencies of adverse events were similar across the three subgroups for IXE and ADA (Figure 2).Conclusion:As with prior studies,2,3consistent efficacy across multiple PsA disease-specific endpoints was observed with IXE in SPIRIT-H2H, regardless of whether IXE was taken as monotherapy or in combination with MTX or another csDMARD. No unexpected safety signals were found for either agent.

Association Between Quality of Life and Improvement in Psoriasis Severity and Extent in Pediatric Patients

Treatment of psoriasis is associated with improved quality of life (QOL) in those with the disease. However, in daily clinical practice, the association between the degree of psoriasis clearance and QOL has not been studied to date, especially in the pediatric population. To identify the association between the degree of psoriasis improvement (as measured by the Psoriasis Area Severity Index [PASI] and body surface area [BSA] response) and QOL (as measured by the Children's Dermatology Life Quality Index [CDLQI]) in pediatric psoriasis, and to assess the association of treatment type with QOL, independent of psoriasis improvement. Data used in this single-center cohort study were extracted from the Child-CAPTURE (Continuous Assessment of Psoriasis Treatment Use Registry), a prospective, observational, daily clinical practice cohort of all children (aged <18 years) with a psoriasis diagnosis who attended the outpatient clinic of the Department of Dermatology at the Radboud University Medical Center in Nijmegen, the Netherlands, between September 3, 2008, and May 4, 2018. All records of treatment episodes with CDLQI, PASI, and BSA scores were included in the analysis. Patients were treated according to daily clinical care. Treatments were clustered into topical, dithranol, conventional systemic, and biological treatments. Because of low numbers of UV-B phototherapy, this treatment was not assessed. Primary outcomes were mean change of CDLQI scores per PASI and BSA response categories (0 to <50, 50 to <75, 75 to <90, and ≥90) and mean CDLQI change per treatment categories. In total, 319 patients (median [interquartile range] age, 10.0 [7.0] years; 183 female [57.4%]) were analyzed for PASI score improvement (399 treatment episodes) and improvement in BSA involvement (366 treatment episodes). The greatest improvements in CDLQI scores were seen in the PASI ≥90 response category, with an estimated marginal mean change in CDLQI score of -6.6 (95% CI, -7.5 to -5.7). The greatest improvements in CDLQI scores were also observed in the BSA ≥90 response category, with an estimated marginal mean change in CDLQI score of -6.8 (95% CI, -7.5 to -6.1). Systemic treatment demonstrated a greater degree of improvement of CDLQI compared with topical treatment, independent of PASI response categories. This cohort study in a real-world setting found that the greatest improvements in QOL were associated with PASI 90 or greater, a decrease in BSA involvement of 90% or greater, and systemic treatments. These findings suggest that reaching PASI 90 or greater and decreasing BSA involvement by at least 90% may be clinically meaningful treatment goals that will help pediatric patients with psoriasis reach optimal QOL.

Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial

Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Patients were randomized 1:1 to 40mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P < .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. Patients with less than 5% BSA involvement were not eligible for enrollment. After 26weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.