Background To our knowledge, there are no large multicenter studies concerning frontal fibrosing alopecia (FFA) that could give clues about its pathogenesis and best treatment. Objective We sought to ...describe the epidemiology, comorbidities, clinical presentation, diagnostic findings, and therapeutic choices in a large series of patients with FFA. Methods This retrospective multicenter study included patients given the diagnosis of FFA. Clinical severity was classified based on the recession of the frontotemporal hairline. Results In all, 355 patients (343 women 49 premenopausal and 12 men) with a mean age of 61 years (range 23-86) were included. Early menopause was detected in 49 patients (14%), whereas 46 (13%) had undergone hysterectomy. Severe FFA was observed in 131 patients (37%). Independent factors associated with severe FFA after multivariate analysis were: eyelash loss, facial papules, and body hair involvement. Eyebrow loss as the initial clinical presentation was associated with mild forms. Antiandrogens such as finasteride and dutasteride were used in 111 patients (31%), with improvement in 52 (47%) and stabilization in 59 (53%). Limitations The retrospective design is a limitation. Conclusions Eyelash loss, facial papules, and body hair involvement were associated with severe FFA. Antiandrogens were the most useful treatment.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Cutaneous squamous cell carcinoma (cSCC) is the second most common skin cancer and its incidence is rising. The prognosis is mostly good but patients with high‐risk cSCC have a greater risk of ...recurrence and death. The aim of the present study was to conduct a systematic review analyzing the prevalence, predictors and prognostic utility of sentinel lymph node (SLN) involvement in cSCC. We performed a published work search in Ovid MEDLINE and reviewed the reference lists of selected studies. Based on the 23 studies included in the systematic review, the proportion of patients with cSCC and positive SLN biopsy findings was 8% (95% confidence interval, 5.1–10.8%; I2= 44.51%). We found no studies reporting on predictors of SLN involvement in cSCC or on the prognostic utility of this finding following adjustment for confounders. The rate of positive SLN in cSCC is less than previously reported. Criteria for recommending SLN biopsy as a staging tool for cSCC vary considerably from study to study, and none of the studies were large enough to reliably identify predictors of SLN positivity. No randomized controlled trials have yet analyzed whether SLN biopsy may improve the prognosis of cSCC. More studies are required on the prognostic value of SLN positivity and the associated risk factors in cSCC.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background
Studies are required before incorporating egg oral immunotherapy (OIT) into clinical practice. The Spanish Society of Pediatric Allergy, Asthma and Clinical Immunology (SEICAP) conducted a ...multicenter, randomized controlled study assessing the effectiveness and safety of the OIT using pasteurized egg white (PEW) in egg‐allergic children.
Methods
One hundred and one egg‐allergic children (6‐9 years) were randomized for 1 year: 25 to an egg‐free‐diet (CG) and 76 to OIT (target dose 3.3 g PEW proteins), PI (30% weekly plus 5% daily increments) or PII (only 30% weekly increments) buildup patterns. Egg skin prick test, sIgE and sIgG4 serum levels, PEW double‐blind placebo‐controlled food challenge (DBPCFC), and dosing adverse reactions (DARs) were evaluated in all patients from inclusion (T0) until completing 1 year of follow‐up (T12). At T12, egg‐allergic control patients could start OIT. The effectiveness and safety of OIT and the effect of the buildup pattern were analyzed.
Results
At T12, 4/25 (16.0%) CG patients passed the PEW DBPCFC vs 64/76 (84.2%) OIT that reached total desensitization (P = 0.000); 12 egg‐allergic control patients started OIT. Finally, 72/88 (81.81%) patients reached total desensitization, 96.15% PI vs 75.80% on PII (P = 0.01). Induction period (121.12 ± 91.43, median 98.00 days) was longer in patients on PII buildup pattern, and those with allergic asthma, minor threshold dose, or higher egg sIgE (P < 0.05). Most patients (89.06%) developed DARs: 74.53% were mild; 21.90% moderate; and 3.5% requiring adrenaline‐treatment. Moderate reactions and those requiring adrenaline were more frequent in patients with allergic asthma, PII pattern, or higher egg sIgE serum antibody levels (P < 0.05).
Conclusions
PEW OIT is an effective treatment for children with persistent egg allergy. A 30% weekly plus 5% daily increment pattern could be more effective and safer than one with only 30% weekly increments.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Background
It is unknown which are the most suitable maintenance pattern and egg consumption to maintain the desensitization state after ending the oral immunotherapy (OIT). This multicenter, ...randomized, controlled trial compared two OIT maintenance patterns with pasteurized egg white (PEW), evaluating the egg consumption effect on the desensitization state after ending the OIT.
Methods
One hundred and one children with confirmed egg allergy were randomized: 25 to an egg‐free diet (CG) and 76 to an OIT year with PEW and two maintenance patterns, 38 patients to daily 3.3 g proteins (AG) and 38 to every two days (BG). PEW challenge (DBPCFC), adverse reactions, and immune markers were assessed at baseline, at the end of the OIT, and at 6 and 12 months later on ad libitum egg consumption (T0, T12, T18, and T24). A questionnaire evaluated the egg consumption at T18.
Results
At T12, 64 of 76 (84.21%) OIT patients had reached total desensitization (32 AG and 32 BG) vs 4 of 25 (16.00%) CG who passed the PEW DBPCFC. Thirty (93.75%) AG vs 25 (78.12%) BG patients completed an OIT year. At T18, 27 of 29 (93.1%) AG vs 20 of 24 (83.3%) BG passed the PEW DBPCFC, 96% consuming at least two egg servings/week. At T24, 97.43% OIT patients passed the challenge. Most patients had adverse reactions, more frequent in the BG patients; frequency and severity of reactions decreased through the study. PEW skin prick test wheal and sIgE antibody serum levels similarly decreased in AG or BG, but AG patients had greater increase in PEW sIgG4 (P < 0.05).
Conclusions
Daily OIT maintenance achieves better adherence, effectiveness, and safety. Two egg servings/week ensure maintained desensitization after the end of an OIT year.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Background
Psoriasis is a chronic immune-mediated inflammatory systemic disease with skin manifestations characterized by erythematous, scaly, itchy and/or painful plaques resulting from ...hyperproliferation of keratinocytes. Certolizumab pegol CZP, a PEGylated antigen binding fragment of a humanized monoclonal antibody against TNF-alpha, is approved for the treatment of moderate-to-severe plaque psoriasis. Patients with psoriasis present clinical and molecular variability, affecting response to treatment. Herein, we utilized an
in silico
approach to model the effects of CZP in a virtual population (vPop) with moderate-to-severe psoriasis. Our proof-of-concept study aims to assess the performance of our model in generating a vPop and defining CZP response variability based on patient profiles.
Methods
We built a quantitative systems pharmacology (QSP) model of a clinical trial-like vPop with moderate-to-severe psoriasis treated with two dosing schemes of CZP (200 mg and 400 mg, both every two weeks for 16 weeks, starting with a loading dose of CZP 400 mg at weeks 0, 2, and 4). We applied different modelling approaches: (i) an algorithm to generate vPop according to reference population values and comorbidity frequencies in real-world populations; (ii) physiologically based pharmacokinetic (PBPK) models of CZP dosing schemes in each virtual patient; and (iii) systems biology-based models of the mechanism of action (MoA) of the drug.
Results
The combination of our different modelling approaches yielded a vPop distribution and a PBPK model that aligned with existing literature. Our systems biology and QSP models reproduced known biological and clinical activity, presenting outcomes correlating with clinical efficacy measures. We identified distinct clusters of virtual patients based on their psoriasis-related protein predicted activity when treated with CZP, which could help unravel differences in drug efficacy in diverse subpopulations. Moreover, our models revealed clusters of MoA solutions irrespective of the dosing regimen employed.
Conclusion
Our study provided patient specific QSP models that reproduced clinical and molecular efficacy features, supporting the use of computational methods as modelling strategy to explore drug response variability. This might shed light on the differences in drug efficacy in diverse subpopulations, especially useful in complex diseases such as psoriasis, through the generation of mechanistically based hypotheses.
Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the follicular unit characterized by recurrent, painful, skin lesions including inflammatory nodules, abscesses, tunnels, and ...mutilating scarring. Intralesional corticosteroids injection (ICI) for HS has received little attention in the scientific literature. We evaluate the clinical response of ICI in acute and chronic HS lesions and aim to identify new applications of ultrasound-assisted procedures in HS management.
An observational, retrospective, multicenter study of HS patients treated with ICI was conducted from January 1 to August 1, 2015. We collected 98 HS patients. A total of 135 individual lesions were infiltrated, including non-inflammatory nodules, inflammatory nodules abscesses and fistulous tracts.
Complete response was reached in 95 lesions (70.37%), 34 showed partial response (25.19%) and 6 (4.44%) were non-response. A total of 105 individual lesions underwent sonographic scan before ICI.
Clinical experience supported the use of ICI for individual lesions. Our results showed that ICI is a useful treatment to control in acute and recalcitrant HS lesions. Response rates improve significantly if lesions are previously evaluated with HFUS.
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DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Background
Hidradenitis suppurativa (HS) is a chronic, inflammatory, debilitating skin disease. HS is difficult‐to‐treat, and a multifaceted treatment approach is recommended to achieve adequate ...clinical response. A greater understanding of HS treatment could help identify unmet clinical needs.
Objectives
To evaluate disease characteristics and treatment patterns in a real‐world population of patients with HS in Spain.
Methods
This retrospective analysis utilised data collected from the Adelphi HS Disease Specific Programme between November 2020 and April 2021. Dermatologists completed patient record forms (PRFs) for consulting HS patients. Outcomes included disease severity, HS clinical signs, quality of life measures, medical treatments and previous surgeries.
Results
Overall, 53 dermatologists completed 332 PRFs, each representing one patient with HS. Based on physician‐judged disease severity at sampling, 73.8%, 22.9% and 3.3% of patients were classified as mild, moderate or severe, respectively. Overall, patients presented with 2.8±2.7 (mean±SD) HS symptoms, which increased with worsening disease severity. The most frequently reported symptoms were ‘inflammation/redness of HS lesions/abscess’ (45.9%), general pain/discomfort (39.9%) and pain on sitting (32.3%). Overall, patients reported a mean±SD Dermatology Life Quality Index score of 4.7±4.8, which increased with worsening disease severity (mild, 3.9±4.3; moderate, 8.7±5.1; moderate to severe, 9.0±5.1). When asked what effect HS had on everyday activities, a large proportion of patients reported that HS sometimes or greatly affected personal appearance/self‐confidence (66.0%), mood (60.2%), close personal relationships (60.4%), motivation (38.3%), leisure activities (43.0%) and feelings about the future (33.6%). At the time of HS diagnosis, the most frequently prescribed treatment regimens were topicals (70.7%), antibiotics (57.6%) and antiseptics (32.2%). At the time of sampling, the most common treatment regimens were biologics (43.8%), topicals (34.9%) and antibiotics (32.2%). The mean±SD number of surgical interventions was 0.6±0.8; incision and drainage (31.3%), local or limited excision (13.0%), and wide surgical excision of all hair‐bearing skin (9.9%) were the most common surgeries.
Conclusions
These real‐world data suggest a high disease burden in patients with HS in Spain. Patients received multiple treatments, and a notable proportion underwent surgery. More data are needed to define optimal HS management strategies.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background
The oral anti‐janus kinase 1 inhibitor upadacitinib has shown a good efficacy–safety profile in the treatment of moderate‐to‐severe atopic dermatitis (AD) in clinical trials; however, few ...data from real clinical practice have been published so far.
Objectives
To evaluate the efficacy and safety of upadactinib in clinical practice.
Methods
An observational and multicentric study was conducted. Inclusion criteria consisted of patients who had previously received upadacitinib in the clinical trial M19‐850 and continued treatment with upadacitinib (15 mg or 30 mg) under daily clinical practice conditions for 12 months. Demographic data, characteristics of AD, treatment response and adverse events were recorded. Preliminary results at 24‐week follow‐up are herein presented.
Results
A total of 26 patients (61.54% males, mean age: 35.58 years) were included in the study; of these, 92.31% received upadacitinib 30 mg at baseline. At 24 weeks, mean values of Eczema Area and Severity Index and body surface area were 2.26 and 2.37%, respectively, 82.35% of the patients reached the Investigator's Global Assessment 0/1 and the mean value of peak pruritus numerical rating scale was 1.74. Adverse events were present in 19.23% of the cases, causing one definitive treatment interruption (due to herpes zoster) and two temporary treatment discontinuations (due to temporary elevation of creatine kinase).
Conclusions
These data support the maintenance of the efficacy of upadacitinib at 24‐week posttrial follow‐up, with no unexpected safety concerns. More real‐world data are needed to confirm these results.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
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