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Guselkumab appears to be safe and effective in the treatment of patients with HS, who do not respond to adalimumab and other systemic therapies. Guselkumab can be used in patients with comorbid Crohn's disease.

Aim: To examine the association between serum levels and effectiveness of omalizumab in patients with chronic spontaneous urticaria (CSU), and explore patient-specific factors associated with omalizumab pharmacokinetics. Methods: Patients with CSU, who were refractory to high-dose antihistamines and who initiated treatment with omalizumab (300 mg every four weeks) were eligible for the study. Treatment was evaluated every 4 week during 12 weeks of treatment with urticaria activity score in the past week (UAS7) as primary outcome and urticaria control test (UCT), Chronic Urticaria Quality of Life Questionnaire (CU QoL) and dermatology life quality index (DLQI) as secondary outcomes. Serum drug level of omalizumab was measured before (trough level) and at day seven (peak level) after each injection. Results: A total of 23 patients were included. After 12 weeks of treatment with omalizumab, an improvement of 16.8 UAS7 points (95% CI 10.8-22.8), pConclusion: In patients with CSU initiating treatment with omalizumab, a higher BMI predicts lower peak concentrations of omalizumab during treatment, whereas lower trough concentrations of omalizumab are associated with a poorer response on UAS7 and other patient reported outcomes.

Background: cold urticaria (ColdU), that is, the occurrence of wheals or angioedema in response to cold exposure, is classified into typical and atypical forms. The diagnosis of typical ColdU relies on whealing in response to local cold stimulation testing (CST). It can also manifest with cold-induced anaphylaxis (ColdA). We aimed to determine risk factors for ColdA in typical ColdU. Methods: an international, cross-sectional study COLD-CE was carried out at 32 urticaria centers of reference and excellence (UCAREs). Detailed history was taken and CST with an ice cube and/or TempTest(R) performed. ColdA was defined as an acute cold-induced involvement of the skin and/or visible mucosal tissue and at least one of: cardiovascular manifestations, difficulty breathing, or gastrointestinal symptoms. Results: of 551 ColdU patients, 75% (n = 412) had a positive CST and ColdA occurred in 37% (n = 151) of the latter. Cold-induced generalized wheals, angioedema, acral swelling, oropharyngeal/laryngeal symptoms, and itch of earlobes were identified as signs/symptoms of severe disease. ColdA was most commonly provoked by complete cold water immersion and ColdA caused by cold air was more common in countries with a warmer climate. Ten percent (n = 40) of typical ColdU patients had a concomitant chronic spontaneous urticaria (CSU). They had a lower frequency of ColdA than those without CSU (4% vs. 39%, p = .003). We identified the following risk factors for cardiovascular manifestations: previous systemic reaction to a Hymenoptera sting, angioedema, oropharyngeal/laryngeal symptoms, and itchy earlobes. Conclusion: coldA is common in typical ColdU. High-risk patients require education about their condition and how to use an adrenaline autoinjector., GA(2)LEN UCARE Network

Hidradenitis suppurativa (HS) has a substantial impact on patients’ lives. We identified factors associated with decreased quality of life (QoL) in patients with HS. Consecutive newly referred patients with HS attending a tertiary referral centre for HS were evaluated with the dermatology life quality index (DLQI). Clinical evaluation was performed according to the Hurley stage. Furthermore, disease duration, number of boils in the past month, boil-associated pain score, overall disease-related distress score, smoking status, employment status and comorbidities were recorded. A total of 339 patients with a mean age of 39.4 years were included; 218 (64.3%) females and 121 (35.7%) males. Of these, 96 (28.3%) had Hurley stage I, whereas 195 (57.5%) and 48 (14.2%) had Hurley II and III, respectively. The mean BMI was 29.0 (SD 7.1) kg/m2 and 75.2% of patients were current or former smokers. The mean overall DLQI score was 11.9 (SD 7.6). After mutual adjustment for clinical characteristics a significant difference in mean overall DLQI score was observed between severity groups (8.6 vs. 12.6 vs. 16.1, adjusted p 60 years, respectively), employment status (11.0 vs. 14.6, adjusted p = 0.003, for employed and unemployed, respectively), presence of boils in the preceding month (8.3 vs. 13.6, adjusted p = 0.001, for no boils and presence of boils, respectively), higher overall disease-related distress score (6.3 vs. 13.9, adjusted p

We aimed to explore the association of key clinical characteristics with disease severity in atopic dermatitis (AD) and its relation to components of the atopic march in a large hospital cohort. Outpatients with AD referred to the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark, between January 2012 and December 2017, were compared based on disease severity (SCORAD); mild ( 50). A total of 470 AD patients were included: 122 small children ( 15 years of age). A significant difference between severity groups in small children was observed for FLG mutation carrier status (16.7 vs. 30.2 vs. 60.0% mutation carriers among patients with mild, moderate and severe AD, respectively, p = 0.012) and self-rated health (3.2 vs. 2.7 vs. 2.8 with 4 being excellent health, p = 0.022). A significant difference between severity groups in adults was observed for male sex (24.4 vs. 39.8 vs. 52.9%, p = 0.003), serum total IgE (577 vs. 1269 vs. 2379 × 103 IU/L, p

Background: Treatment of atopic dermatitis (AD) may be challenging, therefore some patients seek complementary and alternative medications (CAM). We determined prevalence and predictors for CAM use in a hospital cohort of AD patients. Material and Methods: Between January 1, 2012, and December 31, 2017, AD patients referred to the dermatological outpatient clinic at Bispebjerg Hospital were included in the study. Information on CAM use, demographics and disease characteristics were obtained by questionnaire, and associations were determined by χ2 and t test separately for children (< 16 years) and adults (≥16 years). Results: In total 441 filled in the questionnaire on AD, and 433 patients responded to the questions about CAM use: 198 children and 235 adults. A total of 137 (31.6%) had used one or more CAM. CAM use in children was significantly associated with prior use of ≥2 conventional treatments (p = 0.047) and topical calcineurin inhibitors (p = 0.021), a higher number of affected eczema sites (p < 0.001) including more frequent affection of the face and extremities, a higher SCORAD score (p = 0.045), and low mean overall self-rated health (p = 0.003). CAM use in adults was significantly associated with lower age of onset of AD (p = 0.004), comorbid allergic rhinoconjunctivitis (p = 0.039), frequent use of moisturizing cream (p = 0.024), facial and neck eczema (p = 0.005) and high educational level (p = 0.043). Conclusion: CAM use is frequent in both children and adult AD patients. CAM users are characterized by long disease duration, a significant disease burden and by having a longer education. The high prevalence of CAM may indicate that patients’ expectations regarding treatment of AD are not redeemed in the conventional health care system.

Background: A growing body of evidence links various biomarkers to atopic dermatitis (AD). Still, little is known about the association of specific biomarkers to disease characteristics and severity in AD. Objective: To explore the relationship between various immunological markers in the serum and disease severity in a hospital cohort of AD patients. Methods: Outpatients with AD referred to the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark, were divided into groups based on disease severity (SCORAD). Serum levels of a preselected panel of immunoinflammatory biomarkers were tested for association with disease characteristics. Two machine learning models were developed to predict SCORAD from the measured biomarkers. Results: A total of 160 patients with AD were included; 53 (33.1%) with mild, 73 (45.6%) with moderate, and 34 (21.3%) with severe disease. Mean age was 29.2 years (range 6–70 years) and 84 (52.5%) were females. Numerous biomarkers showed a statistically significant correlation with SCORAD, with the strongest correlations seen for CCL17/thymus and activation-regulated chemokine (chemokine ligand-17/TARC) and CCL27/cutaneous T cell-attracting-chemokine (CTACK; Spearman R of 0.50 and 0.43, respectively, p < 0.001). Extrinsic AD patients were more likely to have higher mean SCORAD (p < 0.001), CCL17 (p < 0.001), CCL26/eotaxin-3 (p < 0.001), and eosinophil count (p < 0.001) than intrinsic AD patients. Predictive models for SCORAD identified CCL17, CCL27, serum total IgE, IL-33, and IL-5 as the most important predictors for SCORAD, but with weaker associations than single cytokines. Conclusions: Specific immunoinflammatory biomarkers in the serum, mainly of the Th2 pathway, are correlated with disease severity in patients with AD. Predictive models identified biomarkers associated with disease severity but this finding warrants further investigation.

We explored differences between lesional and non-lesional skin and anatomical variation in epidermal biomarker levels using stratum corneum (SC) tape strips in adult patients with atopic dermatitis (AD). SC tape strips from three distinct anatomical locations (upper extremity, trunk and lower extremity) and serum samples were collected from 25 adult patients with AD (mean age 34.8 years). Inflammatory cytokines in tape strips and serum, natural moisturizing factor (NMF), skin pH and trans-epidermal water loss (TEWL) were measured. Disease severity was assessed using SCORing of Atopic Dermatitis (SCORAD) scores, respectively, global (overall) and local (lesion specific based on objective signs) SCORAD. A clear differentiation between serum and epidermal biomarker levels was observed. Furthermore, a strong intrasample correlation between biomarker expression was observed.

To examine the effectiveness of omalizumab on disease activity and quality of life in patients with cholinergic urticaria (CholU). Further, a systematic review of the literature was performed to identify all studies of use of omalizumab in CholU. A total of 23 patients (63.9%) were refractory to updosed non-sedating antihistamines and initiated omalizumab in the observation period. Among these, an improvement of 10.8 UAS7 points (4.6-17.0), P = .002, was seen at 6 months follow up. DLQI and disease bother score VAS also improved significantly from before initiating treatment with omalizumab to follow-up; 7.0 points (3.6-10.3), P < .001 and 3.1 points (1.5-4.8), P = .001, respectively. The overall mean drug survival time for omalizumab (discontinued due to any cause) was 30.6 months (22.2-39.0). A total of five patients (21.7%) reported suspected side effects (headache, muscle pain, fatigue and injection site reactions) during treatment with omalizumab until 6 months follow-up. The systematic literature review identified 58 additional antihistamine refractory patients with CholU treated with omalizumab. The available studies reported that omalizumab is effective in patients with CholU and improves their disease-related quality of life. Omalizumab is safe, reduces disease activity and improves disease-related quality of life in patients with CholU.

Dupilumab is a recombinant complete human monoclonal antibody modulating the signaling of interleukin-4 and interleukin-13 pathways and has been approved for the treatment of moderate/severe atopic dermatitis. Here, we present three cases of prurigo nodularis treated off-label with dupilumab, and a review of the existing literature. All patients in this study had longstanding severe disease and had tried multiple treatment modalities. They were treated with dupilumab at an initial dose of 600 mg subcutaneously, followed by 300 mg every 2 weeks. Systematic literature searches were performed to identify literature describing the evaluation of the effect of treatment with dupilumab in prurigo nodularis. The physician's assessment of the patients revealed a good or excellent response to the treatment with dupilumab. Patients were evaluated after treatment for 4 and 7 months. Treatment was generally well-tolerated; one in three patients reported dry eyes. Four studies with a total of 11 patients (range: 1-4) were identified by the literature search. Complete response was noted in all 11 patients. Treatment with dupilumab appears to be safe and well-tolerated with clinical benefit in recalcitrant prurigo nodularis. Larger randomized and controlled trials using validated outcome measures are needed before dupilumab could be applied in clinical settings.

To examine the effectiveness of omalizumab (anti-IgE) on symptoms and disease-related quality of life in chronic spontaneous urticaria (CSU) and to identify possible patient-specific factors associated with response to omalizumab in patients with antihistamine refractory CSU.Six months prospective trial of omalizumab 300 mg every 4 weeks among patients with CSU from a dermatological university department. The primary outcome was the urticaria activity score in the past week (UAS7) at 3 months.A total of 117 patients (39 men and 78 women) with a mean age of 42 years were included. The mean baseline UAS7 score was 29.3 points (SD = 10.8), which improved to 11.9 points (SD = 12.9) at 3 months follow-up, difference = 17.4 points (95% CI: 14.8-19.9), P 0.0001. Other patient-reported outcomes (PROs) also improved significantly during 3 months of treatment. No significant further improvement was seen between three and 6 months follow-up. None of the following patient-specific factors: sex, age, age of onset of CSU, symptom duration, presence of chronic inducible urticaria (CINDU), comorbidities, positive urticaria HR test, smoking, ethnicity, angio-oedema, serum total IgE level, CRP, leucocytes, absolute neutrophil count or previous treatment with prednisolone or montelukast were significantly associated with response to omalizumab at 3 months, P 0.05 for all comparisons. Previous treatment with traditional immunosuppressant drugs (azathioprine, cyclosporine or methotrexate) was associated with poorer treatment response to omalizumab at 3 months, P 0.001. A strong correlation was seen between different patient-reported outcomes (PROs) at baseline and 3 months follow-up. Fifteen patients (12.8%) reported side-effects of the treatment.Omalizumab is a highly effective therapy for antihistamine refractory CSU with treatment effects similar to those observed in randomized controlled trials. Validated PROs to assess disease activity, disease control and impairment of quality of life are valuable tools in the clinical management of CSU. Identification of patient-specific predictors of effect and safety of omalizumab in CSU is still warranted.

Knowledge of effectiveness and safety of the nonbiologic, nonantihistamine treatments used for chronic urticaria is important as in some cases the principal guideline-recommended drug; omalizumab, has limited effect, side effects or is too expensive or unavailable. Herein, we systematically review the evidence for the use of the nonbiologic treatments in antihistamine-refractory chronic urticaria.We performed a systematic review of the literature using PubMed and Webofscience and identified studies that reported use of one or more of the nonbiological, nonantihistamine treatment options for chronic urticaria. The studies were evaluated based on study design, number of patients, effect of treatment and safety.We identified 118 studies or case series with 13 different treatments (azathioprine, chloroquine, colchicine, cyclosporine, dapsone, intravenous immunoglobulin (IVIG), methotrexate, montelukast, mycophenolate mofetil, plasmapheresis, sulfasalazine, tranexamic acid and ultraviolet light (UV) A, UVB) totaling 1682 patients. There was a paucity of controlled trials for most of the treatments reviewed albeit the strongest evidence in favor of a beneficial effect in chronic urticaria was, apart from montelukast and cyclosporine, seen for UV therapy and dapsone followed by IVIG.The treatment options reviewed should be seen as potential alternatives in treatment-resistant chronic urticaria where guideline-based selections have failed. However, larger controlled trials are warranted to advance the level of evidence, possibly supporting some treatments' future recommendation in selected patients.

Introduction Omalizumab, has been used for almost two decades, mainly in allergic asthma and chronic spontaneous urticaria for which it is highly beneficial. Smaller studies have evaluated the effects of omalizumab in atopic dermatitis (AD). Current treatments options, such as cyclosporine and azathioprine have limited effect on AD and numerous side effects. The recently introduced biologic dupilumab (anti-IL4) shows promising results, however with conjunctivitis as a prevalent side effect. We evaluate the current evidence for the use of omalizumab in AD. Evidence acquisition Systematic literature searches were performed in PubMed, Web of Science, Embase and Clinicaltrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD. Evidence synthesis Thirty-four studies (12 single case studies, 15 case series, 5 prospective studies and 2 small pilot randomized placebo-controlled trials [RCTs]), including a total of 214 patients with median of 3, ranging from 1-35 patients were identified. A total of 169 patients (79.0%) experienced a beneficial effect from treatment, ranging from little to complete response, whereas 45 patients (21.0%) reported no or negative effect from omalizumab treatment. Conclusions Omalizumab is a safe and well-tolerated treatment with some clinical benefit in AD patients. However, the lack of larger RCTs and possible publication bias limit the recommendation of omalizumab for use in clinical practice for AD. Newer and more effective treatments exist and should be prioritized.

Psoriasis (PsO) is one of the most common chronic inflammatory skin diseases with a world prevalence of 2%-4%. The increasing knowledge of the mechanisms driving PsO has raised focus on existing links to metabolic syndrome and type 2 diabetes (T2D). We reviewed the existing literature of the prevalence and risk of T2D in patients with PsO. The studies reviewed were mainly large retrospective cohort and case-control studies, showing an increased prevalence of T2D in PsO patients compared to controls, particularly in late onset (type 2) PsO. T2D prevalence did not correlate to patient age or severity of PsO in the reviewed studies. Conclusively, T2D was found to be more prevalent in patients with PsO compared to the background population. Several mechanisms involved in lipid transportation seem to be upregulated in PsO patients. Physicians play a key role concerning information about known comorbidity and promotion of early prophylaxis in patients with PsO.

Omalizumab is a recombinant humanized monoclonal antibody targeting the high-affinity Fc receptor of IgE, registered for the treatment of chronic spontaneous urticaria and severe allergic asthma. We present a case series of nine patients with atopic dermatitis (AD) treated off-label with omalizumab and a systematic review of the existing literature. Patients were selected consecutively from a tertiary dermatological referral center during a 5-year period. All patients were treated with omalizumab at a starting dose of 300 mg subcutaneously every 4 weeks. Systematic literature searches were performed in PubMed, Web of Science, EMBASE, and ClinicalTrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD. Based on physicians' assessment, 50% of our patients had a good or excellent response to treatment with omalizumab; a further 12.5% had a moderate response, while 37.5% experienced no response or deterioration of symptoms during treatment. Treatment was generally well tolerated. Twenty-six studies with a median of four patients each (range 1-21), comprising 174 patients, were included in the systematic review. Summed over all studies, a total of 129 patients (74.1%) experienced a beneficial effect of treatment ranging from little to complete response. Omalizumab appears to be a safe and well tolerated, however expensive, treatment with some clinical benefit in patients with severe recalcitrant AD. Recommendation for use in clinical practice awaits evidence from larger randomized controlled trials.

Background Management of moderate-to-severe atopic dermatitis (AD) frequently requires treatment with systemic therapies. Dupilumab is the first biological agent approved for treatment of moderate-to-severe AD. Although promising results have appeared in clinical trials, real-life data on efficacy and safety are lacking. Objectives To assess effectiveness and safety of treatment with dupilumab in the real-life clinical setting at a Danish tertiary referral centre. Methods All patients with AD treated with dupilumab from October 2017 to October 2018 at Bispebjerg Hospital, Denmark, were included in the study. Patients were evaluated three times: at treatment initiation and at 1 and 3 months after first dupilumab injection. At each visit, disease activity was assessed by severity score (Eczema Area and Severity Index, EASI), patient-reported outcomes (Dermatology Life Quality Index, DLQI, pruritus and sleep score) and serological markers [immunoglobulin (Ig)E, eosinophil count and lactate dehydrogenase (LDH)]. Results A total of 43 patients were included in the study. The mean reduction in EASI score from baseline was 19.6 points (72.4%) at 1-month and 22.6 points (76.7%) at 3-month follow-up. EASI, DLQI, pruritus score, sleep score, IgE and LDH were all statistically significantly reduced between baseline and 1- and 3-month follow-up. Mean reductions in EASI score and LDH at 3-month follow-up were significantly correlated (P = 0.003). One patient (2.3%) discontinued treatment due to side-effects, and seven patients (18.4%) developed conjunctivitis during the study period. Conclusion The effectiveness and safety of dupilumab treatment in a real-life clinical setting are comparable to that of phase 3 clinical trials. LDH is suggested as a potential serological marker predictive of treatment response.