Brodalumab: 5-Year US Pharmacovigilance Report.

INTRODUCTION: Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Although the US prescribing information for brodalumab includes a boxed warning regarding suicidal ideation and behavior, no causal association has been demonstrated. Here, we summarize 5 years of pharmacovigilance data, from August 15, 2017, through August 14, 2022, reported to Ortho Dermatologics by US patients and healthcare providers. METHODS: Prevalence of the most common adverse events (AEs) listed in the brodalumab package insert (incidence ≥ 1%) and AEs of special interest are described. Brodalumab exposure was estimated as the time from the first to last prescription-dispensing authorization dates. Data were collected from 4744 patients in the USA, with an estimated exposure of 5815 patient-years. RESULTS: Over 5 years, 11 cases of adjudicated major adverse cardiovascular events were reported (0.23 events/100 patients), a rate lower than that experienced by patients in the international Psoriasis Longitudinal Assessment and Registry. There were 106 serious infections. No serious fungal infections were reported. There were 40 confirmed and 2 suspected COVID-19 cases, with no new COVID-19-related deaths. Of 49 reported malignancies among 42 patients, 3 were deemed possibly related to brodalumab. No completed suicides and no new suicidal attempts were reported. CONCLUSION: Five-year pharmacovigilance data are consistent with the established safety profile reported in long-term clinical trials and previous pharmacovigilance reports, with no new safety signals.

Brodalumab is an injectable treatment approved for moderate-to-severe plaque psoriasis in adults who lacked response to previous treatments. In the USA, brodalumab is only available under a Risk Evaluation and Mitigation Strategy for increased suicidality risks; however, findings from 5 years of real-world safety data have demonstrated a lack of association. In this report, we discuss safety findings reported by US patients and healthcare providers for 4744 patients treated with brodalumab over 5 years. Joint pain (known as arthralgia) was the most common safety finding, with 122 cases reported over 5 years. Other safety findings of interest across 5 years included 106 serious infections (defined as prolonged infections or infections requiring treatment), 54 cases of depression, 49 cases of cancer (in 42 patients), 40 confirmed cases of COVID-19, and 11 cases of major cardiovascular events (such as stroke or heart attack). No completed suicides occurred throughout 5 years, and no new suicidal attempts were reported in year 5. In indirect comparisons with safety data from patients with psoriasis receiving or eligible to receive similar treatments, brodalumab was not associated with an increased risk of serious infection, cancer, major cardiovascular events, or inflammatory bowel disease. Taken together, these data are consistent with safety findings from long-term clinical trials and previous safety reports of brodalumab.

Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity.

INTRODUCTION: Skin involvement in patients with psoriatic arthritis (PsA) worsens the severity and burden of disease. Ixekizumab (IXE), a selective interleukin (IL)-17A antagonist, was compared to placebo (PBO) in the SPIRIT-P1 (NCT01695239) and SPIRIT-P2 (NCT02349295) studies in patients with PsA and evidence of plaque psoriasis. This post hoc analysis reports musculoskeletal, skin, and nail outcomes through week 24 in patients from SPIRIT-P1 and SPIRIT-P2, stratified by mild, moderate, or psoriasis at baseline. METHODS: This post hoc analysis pooled patients from SPIRIT-P1 and SPIRIT-P2 who were randomly assigned to PBO or IXE 80 mg every 4 weeks (Q4W) or every 2 weeks (Q2W). Efficacy outcomes were analyzed through week 24 by baseline psoriasis severity, defined by percent body surface area (BSA) affected; mild = BSA < 3%, moderate = 3% ≤ BSA ≤ 10%, severe = BSA > 10%. The primary outcomes assessed were the proportion of patients achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 responses. Secondary outcomes included musculoskeletal, disease activity, skin and nail, and health-related quality-of-life measures. RESULTS: Similar proportions of patients achieved ACR20/ACR50/ACR70 over time across all severity subgroups and treatment arms. More than one-third of IXE-treated patients achieved ACR20 at week 4, or ACR50 at week 24, with no significant differences according to psoriasis severity at baseline. Disease activity outcomes were similar through week 24 with both IXEQ4W and IXEQ2W, regardless of psoriasis severity at baseline. There were no significant differences over 24 weeks in the proportions of IXE-treated patients with mild, moderate, or severe baseline psoriasis who achieved Minimal Disease Activity (MDA). Across all severity subgroups, IXE demonstrated Psoriasis Area Severity Index 100 response as early as week 4, and approximately one-third of IXE-treated patients achieved total skin clearance at week 24. CONCLUSION: IXE demonstrated rapid and consistent efficacy in joint, skin, and nail for patients with PsA, regardless of baseline psoriasis severity. TRIAL REGISTRATION: SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295).

Deucravacitinib in moderate-to-severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO-1 and PSO-2).

BACKGROUND: Two phase 3 trials, POETYK PSO-1 and PSO-2, previously established the efficacy and overall safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in plaque psoriasis. OBJECTIVES: To further assess the safety of deucravacitinib over 52 weeks in the pooled population from these two trials. METHODS: Pooled safety data were evaluated from PSO-1 and PSO-2 in which patients with moderate-to-severe plaque psoriasis were randomized 1:2:1 to receive oral placebo, deucravacitinib or apremilast. RESULTS: A total of 1683 patients were included in the pooled analysis. Adverse event (AE) incidence rates were similar in each treatment group, serious AEs were low and balanced across groups, and discontinuation rates were lower with deucravacitinib versus placebo or apremilast. No new safety signals emerged with longer deucravacitinib treatment. Exposure-adjusted incidence rates of AEs of interest with placebo, deucravacitinib and apremilast, respectively, were as follows: serious infections (0.8/100 person-years [PY], 1.7/100 PY, and 1.8/100 PY), major adverse cardiovascular events (1.2/100 PY, 0.3/100 PY, and 0.9/100 PY), venous thromboembolic events (0, 0.2/100 PY, and 0), malignancies (0, 1.0/100 PY and 0.9/100 PY), herpes zoster (0.4/100 PY, 0.8/100 PY, and 0), acne (0.4/100 PY, 2.9/100 PY, and 0) and folliculitis (0, 2.8/100 PY, and 0.9/100 PY). No clinically meaningful changes from baseline in mean levels, or shifts from baseline to CTCAE grade ≥3 abnormalities, were reported in laboratory parameters with deucravacitinib. CONCLUSIONS: Deucravacitinib was well-tolerated with acceptable safety over 52 weeks in patients with psoriasis.

Comparing Cosmetic Outcomes of Straight-Line Versus W-Plasty Techniques for Linear Postauricular Wound Closure: A Randomized Evaluator Blind Split-Scar Trial.

BACKGROUND: Surgeons' opinions vary on the cosmetic outcome of straight-line (SL) versus broken-line (W-plasty) closure methods. To date, no studies have compared the 2 techniques in the split-scar design model that resolves the confounding individual patient factors that affects the scar outcome. OBJECTIVE: Compare outcomes and wound cosmesis with SL versus W-plasty closure techniques. METHODS: This clinical trial was conducted with 50 linear surgical wounds randomized to SL closure on half and W-plasty on the other half. At 3 months, patients and 2 masked observers evaluated each scar using the Patient and Observer Scar Assessment Scale (Patient Observer Scar Assessment Scale [POSAS]). RESULTS: The mean (SD) sum of the POSAS observer component scores were 16.6 (6.18) for the SL side and 15.5 (6.37) for the W-plasty side ( p = .49). The mean (SD) sum of the POSAS patient scores were 14.4 (6.8) in SL and 15.1 (8.2) in W-plasty ( p = .59). The mean (SD) complications were 0.08 (0.06) for SL and 0.02 (0.14) for W-plasty ( p = .18). CONCLUSION: No statistically significant difference in wound cosmesis or complications was noted between SL versus W-plasty closure techniques. Surgeons may want to consider whether the extra time involved in placing zigzag W-plasty lines is worthwhile.

Evaluating Treatment Choice in Patients with Moderate to Severe Psoriasis in the United States: Results from a US Patient Survey.

INTRODUCTION: While multiple treatments are available for moderate to severe psoriasis, patient preferences are rarely systematically studied. This study aims to identify factors associated with choice of a new once-daily oral psoriasis treatment, elicit patient views on treatment characteristics, and rank treatment characteristics by importance. METHODS: This noninterventional, cross-sectional survey study, conducted from December 2021 to June 2022, recruited US adults with moderate to severe psoriasis. Demographics, clinical characteristics, and perspectives on psoriasis treatment were collected. Factors associated with the choice of a new oral treatment were identified using multivariable logistic regression analysis. Treatment characteristics and reasons for treatment choice were ranked using bivariate comparisons. RESULTS: The study included 882 participants [mean (standard deviation; SD) age, 45.7 (12.8) years; female, 67.7%; White, 74.9%]; 92.7% were currently receiving treatment [mean (SD) duration, 2.9 (4.8) years]. Half of participants rated their psoriasis symptoms over the past week as mild, very mild, or nonexistent; 36.5% as moderate; and 12.7% as severe or very severe. Most (66.5%) indicated willingness to start a new oral treatment; 65.0% indicated that the new oral treatment would cause less anxiety than injections/infusions. Participants were significantly more likely to start the new oral treatment if they were currently receiving a tumor necrosis factor inhibitor [odds ratio (OR): 2.1, 95% confidence interval (CI): 1.4-3.1] or ustekinumab (OR: 2.7, 95% CI: 1.6-5.0) versus apremilast (P < 0.001) or if they reported mild (OR: 3.2, 95% CI: 2.0-4.9), moderate (OR: 5.0, 95% CI: 3.1-8.2), or severe (OR: 7.6, 95% CI: 3.9-15.0) psoriasis symptoms compared with those who reported no symptoms in the past week (P < 0.001). CONCLUSION: Most participants indicated willingness to start a new once-daily oral treatment, viewing it as less anxiety provoking than injections/infusions. Current treatment and psoriasis severity affected participants' willingness to start a new oral treatment.

Patients with psoriasis have multiple treatment options available to them. We surveyed 882 adults with moderate to severe psoriasis in the US to assess their perspectives and the values placed on treatment characteristics that are most important to them when making treatment-related decisions. Participants were assigned to one of five groups based on their psoriasis treatment at the time of the survey: (1) apremilast (oral), (2) a tumor necrosis factor inhibitor (TNFi) treatment (injectable), (3) ustekinumab (injectable), (4) a topical therapy or phototherapy, or (5) over-the-counter medications or participants who were untreated (this group included those who were not currently using a psoriasis treatment). The extent of skin clearance associated with a drug, how a drug is taken, and a drug's safety profile were among the top-ranked treatment characteristics that are important to survey participants when they choose a psoriasis treatment. Most participants (66.5%) were willing to start a new oral treatment, with 65.0% indicating that the new oral treatment would cause less anxiety than injections or infusions. Participants were more willing to switch to a new oral psoriasis treatment if they were currently receiving an injectable treatment, such as ustekinumab or a TNFi, compared with those who were already taking an oral treatment. These findings suggest that, when prescribing treatments for psoriasis, health care providers should consider the treatment characteristics that are important to their patients and consider that patients generally prefer an oral versus injectable drug.

International Dermatology Outcome Measures (IDEOM) - Report from the 2022 Annual Meeting.

BACKGROUND: The International Dermatology Outcome Measures (IDEOM) is a non-profit organization dedicated to the advancement of evidence-based, consensus-driven outcome measures in dermatological diseases. Researchers and stakeholders from various backgrounds collaborate to develop these objective benchmark metrics to further advance treatment and management of dermatological conditions. SUMMARY: The 2022 IDEOM Annual Meeting was held on June 17-18, 2022. Leaders and stakeholders from the hidradenitis suppurativa, acne, vitiligo, actinic keratosis, alopecia areata, itch, cutaneous lymphoma, and psoriatic disease workgroups discussed the progress of their respective outcome-measures research. This report summarizes each workgroup's updates from 2022 and their next steps as established during the 2022 IDEOM Annual Meeting. J Drugs Dermatol. 2023;22(12):1153-1159 doi:10.36849/JDD.7615.

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis.

INTRODUCTION: Deucravacitinib, a newly approved oral medication for the treatment of patients with moderate to severe plaque psoriasis, demonstrated efficacy versus apremilast and placebo in two phase 3 randomized controlled trials (RCTs). A systematic review and network meta-analysis (NMA) indirectly compared deucravacitinib with other relevant systemic biologic/nonbiologic treatments. METHODS: Online databases were searched for RCTs published through October 2021. Eligible studies were head-to-head comparisons between systemic therapies and/or placebo reporting 50%, 75%, 90%, or 100% improvement in Psoriasis Area and Severity Index (PASI) from baseline in adults with moderate to severe plaque psoriasis. Comparisons included tumor necrosis factor inhibitors, interleukin (IL)-17, IL-23, and IL 12/23 inhibitors, and systemic nonbiologics. A multinomial Bayesian NMA was used to derive estimates of the relative efficacy of deucravacitinib and other systemic therapies. Response probabilities for each treatment and corresponding 95% credible intervals (CrIs) for achieving a PASI response were calculated over short-, mid-, and long-term follow-up (weeks 10-16, 24-28, and 44-60). RESULTS: The NMA included 47 RCTs. Deucravacitinib showed the highest PASI 75 response rates among nonbiologic systemic therapies across time points. Deucravacitinib PASI 75 response rate (95% CrI) over short-term follow-up was 54.1% (46.5-61.6), within the range of first-generation biologics (etanercept, 39.7% [31.6-48.3]; infliximab, 79.0% [74.0-83.5]). At mid-term follow-up, deucravacitinib PASI 75 increased to 63.3% (58.0-68.4). At long-term follow-up, deucravacitinib PASI 75 was 65.9% (58.0-73.4), comparable to first-generation biologics adalimumab (62.8%; 55.3-69.6) and ustekinumab (68.0%; 64.6-71.5). CONCLUSIONS: Patients receiving deucravacitinib were more likely to achieve PASI 75 response versus apremilast and methotrexate across all time points. The long-term PASI 75 response rate for deucravacitinib was similar to those of adalimumab and ustekinumab. The approval of deucravacitinib offers patients the choice of an oral therapy with long-term efficacy similar to that of some biologics.

Report of the Skin Research Workgroups From the IDEOM Breakout at the GRAPPA 2022 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) organization presented an update on its progress related to patient-centered outcome measures for psoriasis (PsO) and psoriatic arthritis (PsA) at the 2022 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). The Musculoskeletal (MSK) Symptoms working group presented an update on the development of the IDEOM Musculoskeletal Questionnaire (IDEOM MSK-Q). The IDEOM MSK-Q is a patient-reported outcome measure intended to capture MSK symptoms and describe their intensity and impact on health-related quality of life in patients with psoriatic disease. IDEOM also presented the progress of the integration of the Psoriasis Epidemiology Screening Tool (PEST) and Psoriatic Arthritis Impact of Disease (PsAID) questionnaires into the Epic electronic health record system. This will allow for automated PsA screening and symptom measurement in the hopes of improving disease detection and treat-to-target strategies. The Treatment Satisfaction working group discussed the development of the DermSat-7, a 7-item treatment satisfaction questionnaire specific for dermatological conditions. The DermSat-7 is currently being validated in a multicenter study of patients with PsO.

Sociodemographic and clinical characteristics associated with multiple biologic failure in psoriasis: A 2015-2022 prospective cohort analysis of the CorEvitas psoriasis registry.

BACKGROUND: Psoriasis patients with poor therapeutic response to multiple biologic agents are not well-characterized. OBJECTIVE: To describe the characteristics associated with development of multiple biologic failure (MBF) versus good clinical response (GR) to the first biologic. METHODS: This prospective cohort analysis evaluated patients in the multicenter CorEvitas Psoriasis Registry who initiated their first biologic between 2015 and 2020 and were followed for ≥24 months. Multivariable logistic regression identified sociodemographic, clinical, and patient-reported outcomes that differed between MBF (discontinued ≥2 biologics of different classes, each used for ≥90 days, due to inadequate efficacy) and GR (continued use of first biologic for ≥2 years) patients. RESULTS: One thousand thirty-nine patients were analyzed (490 GR [47.2%], 65 MBF [6.3%]). Female sex, shorter psoriasis duration, earlier year of biologic initiation, prior nonbiologic systemic therapy use, history of hyperlipidemia, and Medicaid insurance were significantly associated with MBF, though the latter 2 variables exhibited wider confidence intervals, indicating a lower level of support. The first-to-second biologic sequence most observed with MBF was Tumor necrosis factor-α inhibitor to IL-17 inhibitor use. LIMITATIONS: Biologic adherence between visits was not evaluated. CONCLUSION: Approximately 6% of psoriasis patients met MBF criteria. The results identify characteristics associated with MBF that may distinguish patients warranting more frequent follow-up.

Interleukin (IL)-17 Versus IL-23 Inhibitors: Which Is Better to Treat Patients With Moderate-to-Severe Psoriasis and Mild Psoriatic Arthritis in Dermatology Clinics?

Interleukin (IL)-17 and IL-23 inhibitors are both approved for the treatment of moderate-to-severe plaque psoriasis (PsO), as well as psoriatic arthritis (PsA). In the absence of head-to-head studies, it is not clear which agent is better suited to treat patients with moderate-to-severe PsO and mild PsA. During the 2022 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) conference, Dr. April Armstrong and Dr. Joseph Merola debated which of these 2 biologic classes should be used in this patient population. Armstrong argued in favor of IL-17 inhibition, whereas Merola presented reasons for IL-23 inhibition. An overview of their main arguments is described in this manuscript.

Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2022 Annual Meeting.

The 2022 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held from July 14 to 17, 2022, in New York City, New York, USA, and was attended by 420 rheumatologists, dermatologists, basic scientists, allied health professionals, patient research partners, and industry partners from 31 countries. A GRAPPA executive retreat, a Trainee Symposium, and the Patient Research Partners Network meeting were held prior to the annual meeting. Presentations included updates in basic research, focusing on biomarkers, personalization of treatments, and the promise of single-cell omics, elucidating the pathogenesis of psoriatic disease (PsD). Presentations also highlighted guttate and plaque psoriasis (PsO), the impact of coronavirus disease 2019 (COVID-19) and its treatments on patients with PsD globally, and the effects of sex and gender in PsD. Reports of ongoing projects included an update on the recently published treatment recommendations, educational initiatives, and the Diagnostic Ultrasound Enthesitis Tool (DUET) study. A session on early identification of psoriatic arthritis (PsA) among patients with PsO included an update on PsA screening tools. Debates were held on whether early intervention for PsO will reduce PsA, whether interleukin (IL)-17 or IL-23 inhibition is a better treatment for PsO and PsA, similarities and differences between axial PsA and axial spondyloarthritis with PsO, and data affecting the understanding of guttate and plaque PsO. Reports from the International Dermatology Outcome Measures (IDEOM) and Young GRAPPiAns concurrent sessions were presented in addition to reports of several other partner groups. Here, we highlight features of the annual meeting and introduce the manuscripts published together as a meeting report.

Patient Perspectives on Psoriatic Disease Burden: Results from the Global Psoriasis and Beyond Survey.

BACKGROUND: Patients' understanding of the systemic nature of psoriatic disease (PsD) remains insufficiently explored. OBJECTIVES: The objective of this study was to assess patients' understanding of PsD, associated comorbidities, disease burden, and relationships with healthcare professionals (HCPs). METHODS: Psoriasis and Beyond was a cross-sectional, quantitative online survey conducted in patients with a self-reported, physician-given diagnosis of moderate to severe psoriasis (body surface area [BSA] >5% to <10%, affecting sensitive and/or prominent body parts or BSA ≥10%) at its worst, with/without psoriatic arthritis (PsA). Patients were recruited through online panels by the Institut de Publique Sondage d'Opinion Secteur (Ipsos SA) and patient advocacy groups. RESULTS: Overall, 4,978 respondents with psoriasis completed the online survey from 20 countries across Australia, Asia, Europe, and the Americas; 30% of patients also reported having concomitant PsA. Overall, 69% of patients with psoriasis had heard that their disease was part of a systemic disease, and 60% had heard of the term "psoriatic disease." Despite this, recognition of common manifestations and comorbidities associated with PsD was low. Among psoriasis-only patients (n = 3,490), 38% screened positive using the Psoriasis Epidemiology Screening Tool (PEST), indicative of potential PsA. Overall, 48% of patients reported that their disease had a very large to extremely large effect on quality of life (QoL; Dermatology Life Quality Index [DLQI] score, 11-30); only 13% of patients reported no impact of the disease on QoL (DLQI, 0-1). Most patients had experienced stigma and discrimination (82%) and a negative impact on relationships (81%) in their lives. Overall, 59% of patients were not involved in deciding their treatment goals: 58% of all treated patients (n = 4,757) and 64% of treated patients with concomitant PsA (n = 1,409) were satisfied with their current treatment. CONCLUSIONS: These results highlight that patients may not fully understand the systemic nature of their disease, were frequently uninvolved in deciding treatment goals, and were often not satisfied with their current treatment. Increasing patients' participation in their care can facilitate shared decision-making between patients and HCPs, which may result in better treatment adherence and patient outcomes. Furthermore, these data indicate that policies should be implemented to protect against stigma and discrimination, which are commonly experienced by patients with psoriasis.

Demographic and Clinical Factors Associated with Patient-Reported Remission in Psoriatic Arthritis.

INTRODUCTION: Achievement of remission in psoriatic arthritis is a key goal for patients and clinicians, yet definitions of remission may vary. Previous efforts have utilized multidomain measures such as minimal disease activity that assess the status of joints, skin, and function to determine current level of psoriatic arthritis (PsA) disease activity. The goal of this study is to identify factors associated with patient-reported psoriatic arthritis remission. METHODS: The National Psoriasis Foundation conducted a cross-sectional study using an online survey of a random stratified sample of 1570 individuals with psoriatic disease in the USA. Participants were asked about a provider diagnosis of psoriasis and/or psoriatic arthritis, comorbid conditions, and psoriatic arthritis impact and disease activity, and demographic questions. All participants reporting a physician-given diagnosis of psoriatic arthritis were asked if they felt their psoriatic arthritis was in remission ("Do you feel your psoriatic arthritis is in remission?" Yes/No/Unsure) and, if so, length of remission. Individuals with psoriasis and psoriatic arthritis reporting a body surface area impacted by psoriasis 3% or less were asked if they felt their psoriasis was in remission. Psoriatic arthritis disease activity and impact was assessed using the nine-question Psoriatic Arthritis Impact of Disease (PsAID-9) instrument and a global PsA-related quality of life question. PsAID-9 scores ≤ 4 were used to indicate acceptable disease state. Multivariate logistic regression was used to identify factors associated with patient-perceived PsA remission. RESULTS: Of 834 participants with PsA, including 76 (4.8%) with PsA without skin involvement ever, 144 (17.3%) felt their psoriatic arthritis was in remission, with an average remission duration of 43 months. Of those in remission, 116 (78.4%) reported currently using a treatment for their PsA, with most (75.7%) reporting using a biologic therapy for their PsA in the past 12 months. Multivariate logistic regression revealed that patient-perceived psoriatic arthritis remission was independently associated with experiencing acceptable disease state (PsAID-9 ≤ 4), perception of psoriasis remission, lower impact of PsA on global quality of life, and non-white race. Age, sex, body mass index, or biologic use in the last 12 months were not associated with patient-reported PsA remission. CONCLUSION: Overall, patient perception of PsA remission was most strongly associated with patient-reported psoriasis remission.

Development of a core outcome set for basal cell carcinoma.

BACKGROUND: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. OBJECTIVE: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. METHODS: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. RESULTS: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. LIMITATIONS: English-speaking patients and professionals rated outcomes extracted from English language studies. CONCLUSION: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.

Report of the Skin Research Working Groups from the GRAPPA 2021 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) initiative presented an update on their progress related to instruments for psoriasis (PsO) and psoriatic arthritis (PsA) patient-centered outcome measures at the 2021 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). The Treatment Satisfaction working group presented the development of a 7-item treatment satisfaction questionnaire specific for dermatological conditions. The group is beginning by assessing the validity and reliability of the instrument in PsO patient populations, with the ultimate goal of validating it for use in multiple dermatological diseases. The Musculoskeletal Symptoms working group discussed how implementation of a screening measurement tool in patients with PsO can help identify unknown diagnoses of PsA or prevent worsening of symptoms.

Proceedings of the 2021 GRAPPA-Collaborative Research Network (CRN) Meeting.

At the 2021 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Collaborative Research Network (CRN) annual meeting, the GRAPPA-CRN group presented a number of project updates, including a pilot investigator-initiated study to evaluate liquid and tissue biomarkers associated with axial involvement in psoriatic arthritis (PsA). The GRAPPA-CRN session updated progress made with 3 parallel international research initiatives based on 3 previously defined unmet needs in PsA. The Health Initiatives in Psoriasis and PsOriatic arthritis ConsoRTium European States (HIPPOCRATES) is a European research consortium formed to address unmet clinical needs in PsA. The Preventing Arthritis in a multicenter Psoriasis At-Risk Population (PAMPA) is a US-based organization that has defined consensus terminology for preclinical phases of PsA and is interested in the transition process from psoriasis to PsA. An overview of the Accelerating Medicines Partnership Autoimmune and Immune-Mediated Diseases (AMP AIM) program 2.0, a consortium including GRAPPA-CRN members that addressed these 3 unmet needs in PsA, was also presented.

2021 GRAPPA Trainee Symposium: A Summary of Oral and Poster Presentations.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) held a trainee symposium at its 2021 virtual meeting. Dermatology and rheumatology trainees presented their work on psoriasis and psoriatic arthritis (PsA). This report briefly reviews 5 oral presentations: prediction of cardiovascular events in psoriatic disease (PsD), correlation between spine abnormalities and clinical findings, biomechanical stress as a trigger for PsA, differences in DNA methylation among twins with PsD, and critical proteins associated with induction of PsD. In addition, we highlight 22 posters broadly discussing clinical and molecular implications of PsD.

Interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial.

BACKGROUND: Surgical reconstructions following Mohs micrographic surgery and standard surgical excisions are often closed with two layers of sutures: a deep subcuticular layer and a superficial cuticular layer. Some surgeons feel the need to place many deep sutures in order to reduce tension on cuticular sutures, as they believe this may decrease incidence of track marks and dehiscence, and lead to better cosmetic outcomes. However, others feel that a higher number of subcuticular sutures increases the risk of a suture reaction, which leads to patient anxiety and poorer wound cosmesis. To our knowledge, there are no studies published on the effect of subcuticular suture spacing on wound cosmesis. OBJECTIVES: To determine whether suturing with 1-cm interval subcuticular sutures results in better cosmetic outcomes than suturing with 2-cm interval subcuticular sutures. METHODS: Fifty patients were enrolled in a randomized clinical trial using a split-wound model, where half of the wound was repaired with sutures spaced 2 cm apart and the other half was repaired with sutures spaced 1 cm apart (ClinicalTrials.gov identifier NCT03327922). Both the evaluators and patients were blinded as to which side received which treatment. The scar was evaluated 3 months post-surgery by two blinded observers and the patients themselves using the Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment instrument. RESULTS: The total mean POSAS score for observers for the sides that received 1-cm interval subcuticular sutures and the sides that received 2-cm interval subcuticular sutures did not differ significantly at 3 months (P = 0·34). There was also no significant difference in the patient assessment scale score between the two sides at 3 months (P = 0·084). CONCLUSIONS: We found that 1-cm suture spacing was not significantly associated with improved overall cosmetic outcome compared with 2-cm suture spacing when evaluated by blinded observers or the patients themselves. Our results support the use of either interval. What is already known about this topic? Surgeons have differing opinions on the ideal frequency of subcuticular sutures for optimizing cosmetic outcomes and minimizing suture reactions. The effect of subcuticular suture spacing on wound cosmesis has not been previously explored in the literature. What does this study add? There was no significant difference in cosmetic outcome between 1-cm suture spacing and 2-cm suture spacing when evaluated by blinded observers and patients. Dermatology surgeons can use 2-cm suture spacing for increased efficiency, without significantly different cosmetic outcomes, detected by blinded observers and patients.