International Dermatology Outcome Measures (IDEOM): Report from the 2020 Annual Meeting.

BACKGROUND: The International Dermatology Outcome Measures (IDEOM) initiative is a non-profit organization that aims to develop evidence-based outcome measurements to evaluate the impact of treatments for patients with dermatological disease. IDEOM includes all key stakeholders in dermatology (patient, physician, industry, insurer, and government) during the process of developing such outcome measurements. SUMMARY: Here, we provide an update of IDEOM activities that were presented at the 2020 IDEOM Virtual Annual Meeting (October 23-24, 2020). During the meeting, multiple IDEOM workgroups (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) shared their progress to date, as well as future directions in developing and validating Patient-Reported Outcome Measures. Updates on demonstrating efficacy in clinicals trials by the US Food and Drug Administration are also summarized. KEY MESSAGES: In this report, we summarize the work presented by each IDEOM workgroup (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) at the 2020 IDEOM Virtual Annual Meeting.

Current Concepts in Acne Pathogenesis: Pathways to Inflammation.

Acne is a disease of pilosebaceous inflammation. Pivotal in pathogenesis are the roles of hormones (insulin, insulin-like growth factor-1, androgens), Propionibacterium acnes, lipogenesis, and a proinflammatory lipid profile. Innate immune responses are induced through interaction with toll-like receptors and inflammasome activation initially and subsequently through adaptive immune activation. These insights into pathogenic inflammatory pathways can translate into novel therapeutic approaches for acne. Semin Cutan Med Surg 37(supp3):S60-S62 ©2018 published by Frontline Medical Communication.

Advances in Acne and Rosacea Therapy.

New topical therapies have demonstrated efficacy in patients with moderate or severe acne who might otherwise have required therapy with systemic antibiotics or isotretinoin. Increasing knowledge about the pathogenesis of acne has facilitated the development of therapies with novel modes of action. New and investigational therapies also are available or in development for the treatment of both the papulopustular and erythematous manifestations of rosacea. Semin Cutan Med Surg 37(supp3):S63-S66 © 2018 published by Frontline Medical Communications.

Treating Acne in Adult Women.

Acne can persist into adulthood or erupt de novo at any point after adolescence. Adult acne is more common in women than in men. Considerations for treating acne in adult women include childbearing potential, pregnancy, lactation, and concomitant skin conditions. Semin Cutan Med Surg 37(supp3):S67-S70 © 2018 published by Frontline Medical Communications.

Treating Acne in Patients With Skin of Color.

Patients with skin of color are more likely to develop acne and postinflammatory hyperpigmentation (PIH). Many therapies for acne have demonstrated efficacy in darker skin types and in the treatment of PIH. Semin Cutan Med Surg 37(supp3):S71-S73 © 2018 published by Frontline Medical Communications.

Quality appraisal of acne clinical practice guidelines, 2008-2013.

BACKGROUND: Acne vulgaris is a common chronic disease, and evidence-based clinical practice guidelines (CPGs) can provide credible treatment information. METHOD: A literature search for acne CPGs published between January 2008 and September 2013 was conducted. Two reviewers independently applied the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. METHODological quality was evaluated by ranking in AGREE II domains and the highest number of items scoring above the neutral threshold score. RESULTS: Four CPGs fulfilled the selection criteria, and the highest ranked were the European and Malaysian. Highest scores achieved by the former were for scope/purpose, stakeholder involvement, and rigor of development and by the latter were for scope/purpose, clarity of presentation, and applicability. Applicability was the lowest scoring of all domains for all CPGs. CONCLUSION: European and Malaysian acne CPGs were ranked highest for methodological quality and may serve to inform clinical practice and guideline adaptation.

Biologic therapy in psoriasis: perspectives on associated risks and patient management.

BACKGROUND: Previous publications have described practical considerations for initiating biologic therapy in psoriasis patients. However, most publications have focused on anti-tumor necrosis factor (TNF) therapy. OBJECTIVE: To create an evidence-based, practical tool that provides guidance on patient management for all biologics currently approved in Canada and the United States. METHODS: Psoriasis publications regarding safety issues in the initiation or monitoring of adalimumab, alefacept, etanercept, infliximab, or ustekinumab therapy were identified through a PubMed search. Phase III trials and open-label extensions (regardless of indication) and relevant guidelines from Health Canada were used to compile this review. RESULTS: Although these biologic agents have demonstrated efficacy in patients with psoriasis and are generally considered safe and well tolerated, rare but serious safety issues (ie, demyelination, infection, tuberculosis, malignancy, lymphoma, cardiovascular outcomes, hepatitis, pregnancy, surgery, and vaccination) have been observed. Attention to specific aspects of patient management (ie, prescreening requirements, symptoms to watch for, appropriate treatment, and referrals) is required to mitigate risk. CONCLUSION: Much of the evidence regarding the long-term safety of these agents has been based on experience in other patient populations. However, it does serve to guide us in understanding the risks that may impact the management of psoriasis patients.

Development and validation of a Scale for Acne Scar Severity (SCAR-S) of the face and trunk.

BACKGROUND: scarring is an important component of overall acne severity, but there are no global scales for its evaluation inclusive of the face and trunk. OBJECTIVE: our objective was to develop a global scale for acne scar severity inclusive of the trunk and the face. METHODS: a six-category global severity scale (SCAR-S) was developed for assessment of acne scarring at each of the face, chest, and back. We evaluated SCAR-S against acne severity and patient-reported scar severity. RESULTS: of 973 subjects, 73% reported acne scarring. Self-assessment of scarring was associated with facial SCAR-S and overall SCAR-S scores (p < .001, r = .31 and .30, respectively). Acne scarring was observed at the face in 87%, the back in 51%, and the chest in 38%. Clinically relevant scarring (mild or greater) at each of these regions was 55%, 24%, and 14%, respectively. Acne severity correlated with SCAR-S (p < .001) for the back (r = .612), the chest (r = .548), and the face (r = .514). Acne duration correlated with patient-reported severity of scarring (r = .244) and overall SCAR-S scores (r = .152). Clinically relevant scarring increased with acne duration. CONCLUSION: SCAR-S is a practical, validated, global system for acne scar evaluation and is clinically relevant in overall severity grading of acne.

Effect of quality of life impact and clinical severity on adherence to topical acne treatment.

BACKGROUND: Topical medications are the most commonly prescribed treatments for acne patients. However, adherence to these treatments and possible associations with clinical severity and quality of life (QoL) impact are unclear. PURPOSE: We evaluated the association between sociodemographic factors, clinical severity, and QoL impact and adherence to topical acne treatments. METHODS: This was an observational study of acne patients referred for usual care to community-based dermatologists. Adherence was assessed with questionnaires after 2 months of acne therapy. The associations of adherence with factors of interest were evaluated by chi-square analysis and Spearman rank correlation. RESULTS: In 152 acne patients treated with topical medications, low adherence was observed in 26%, medium in 49%, and high in 24%. Age, gender, duration of acne, education level, third-party drug plan coverage, smoking history, recreational drug use, ingestion of alcohol, and number of prescribed topical agents were not significantly associated with adherence. Adherence was significantly positively correlated with QoL impact (r = .24, p = .003), with the role-emotional and self-perception domains having the highest correlations. In contrast, adherence was weakly negatively correlated with facial acne severity (r = -.16, p = .047). LIMITATIONS: This study focused on facial acne, and adherence was based on patient reporting. CONCLUSIONS: Adherence to topical acne therapy increases with impact on QoL but decreases with increasing acne severity.

Divergence of demographic factors associated with clinical severity compared with quality of life impact in acne.

BACKGROUND: Previous smaller studies suggest that age, gender, and duration of acne may individually be associated with clinical acne severity and quality of life (QoL) impact. OBJECTIVE: Our purpose was to concurrently evaluate the association of demographic factors with clinical acne severity and with QoL impact. METHODS: Clinical acne severity was assessed using the Investigators Global Assessment, whereas QoL impact was evaluated by the patient-completed Acne-QoL. These outcomes were correlated with sociodemographic variables, including age, gender, and duration of acne. RESULTS: In 862 acne patients, clinical severity was associated with younger age, male gender, and shorter acne duration (1-5 years). In contrast, greater impact on QoL was associated with older age, female gender, and longer acne duration (> 5 years). CONCLUSIONS: Clinical and QoL measures each differentiate between groups of patients most severely affected by acne. Our findings reinforce the imperative for clinicians to use both measures for comprehensive patient management. LIMITATIONS: Study limitations include referral population of acne patients and the restriction of outcome measures to facial acne.

Development and validation of a comprehensive acne severity scale.

BACKGROUND: Although more than 25 acne grading systems exist, only 2 are inclusive of truncal acne. There is neither a gold standard nor a consistently used standardized system. PURPOSE: Our purpose was to develop and validate an acne grading system incorporating severity at the face, chest, and back. METHODS: We developed a comprehensive acne severity scale (CASS) by modifying a preexisting facial acne scale, the Investigator Global Assessment, to include truncal acne. The validity and responsiveness of CASS grades were correlated with Leeds scores at baseline and after 6 months of standard acne treatment. RESULTS: Spearman correlations were significant between Leeds and CASS grades for the face (0.823), chest (0.854), and back (0.872), respectively (p < .001). After 6 months of therapy, changes in these scores were also significantly correlated (p < .001) at all three sites. CONCLUSION: Concurrent validity of CASS is demonstrated by a very strong correlation with Leeds grading. CASS is simpler to use than the Leeds system and more appropriate for translation of research trial results to clinical practice.

Efficacy of imiquimod as an adjunct to cryotherapy for actinic keratoses.

BACKGROUND: Cryotherapy is the standard of care for clinically apparent (target) actinic keratoses (AKs). Topical imiquimod may reduce initially inapparent or subclinical AKs. OBJECTIVE: We evaluated the potential of topical imiquimod to decrease subclinical AKs after cryotherapy of target AKs. METHODS: A randomized trial of imiquimod or vehicle twice weekly for 8 weeks following 3- to 5-second cryotherapy of target AKs within a 50 cm(2) field at the face or scalp was conducted. Efficacy outcomes included clearance of target, subclinical, and total AKs and proportions clear of AKs. Subjects with residual AKs were offered cryotherapy and open-label imiquimod twice weekly for 8 weeks. RESULTS: Sixty-three subjects completed the randomized phase. At 12 weeks, target AK clearance was similar for imiquimod and vehicle (79% vs 76%), but fewer total AKs were noted for imiquimod (78 vs 116). This was due to a progressive reduction in subclinical AKs with imiquimod compared with a progressive increase with vehicle. More subjects treated with imiquimod achieved clearance of subclinical (58% vs 34%; p = .06) and total (23% vs 9%; p = .21) AKs. CONCLUSION: Imiquimod postcryotherapy may increase clearance of subclinical and total AKs and proportions of subjects clear at 3 months. These findings require confirmation in larger controlled trials powered for statistical significance.

Reliability of dermatologists in acne lesion counts and global assessments.

BACKGROUND: There is a paucity of data on the reliability of dermatologists in acne lesion counting and global severity assessments. The effects of training and practice on reliability are also uncertain. The objective of this study was to determine the reliability of these outcome measurements when performed by trained dermatologists. METHODS: Eleven dermatologists were divided into two groups that evaluated the same six acne subjects twice on the same day. A training session was provided either after (group A) or before (group B) the first patient evaluation sessions. Reliability of raters in lesion counting and global severity assessment was determined by calculation of intraclass correlation coefficients (ICCs). ICC values close to 1.0 indicate excellent reliability, whereas values less than 0.75 are considered unacceptable. RESULTS: Intrarater ICCs ranged from 0.37 to 0.99 for noninflammatory lesions, 0.26 to 0.97 for inflammatory lesions, and 0.56 to 0.83 for global assessments for group A (trained after); corresponding values for group B (trained before) were 0.84 to 0.98, 0.61 to 0.95, and 0.43 to 0.91. ICC values >or= 0.75 for all three outcome parameters were observed in one of six group A and three of five group B raters. Interrater ICCs for groups A and B after the first evaluation session were 0.17 versus 0.68 for noninflammatory counts, 0.84 versus 0.72 for inflammatory counts, and 0.71 versus 0.65 for global assessments, respectively. Corresponding values after session 2 were 0.79 and 0.77 for noninflammatory, 0.81 and 0.90 for inflammatory, and 0.61 and 0.77 for global assessments. CONCLUSION: Dermatologists tended to be reliable in acne lesion counting but somewhat less so in global assessments. Training tended to improve group reliability in noninflammatory lesion counts and increased the proportion of raters with good reliability in all three outcome measures. Practice enhanced reliability in all outcome measurements.