Systemic Cyclosporine Research Articles

Risk Factors Associated with Weight Gain during Treatment with Dupilumab among Patients with Moderate to Severe Atopic Dermatitis.

This cohort study used prospectively collected data from the Swedish national quality registry, SwedAD, to investigate weight gain as a possible side effect of dupilumab treatment for atopic dermatitis. Patients on dupilumab were compared with patients on other systemic medications, e.g., methotrexate, cyclosporine, or Janus kinase inhibitors, and possible risk factors for weight change during treatment with dupilumab were analysed. All patients aged 18 years or above, included in SwedAD between March 2018 and April 2023, who initiated systemic treatment at or after inclusion and had data on weight at baseline and at least 1 follow-up weight measurement were included (n = 157). After 2 years on dupilumab, patients had a mean weight gain of 1.6 kg (p = 0.007, 95% confidence interval [CI] 0.4-2.7). In the multivariable analysis, controlling for age at start, sex, asthma, and body mass index at start, dupilumab was associated with higher weight gain than other systemic treatments (3.3 kg, p = 0.005 [95% CI1.0-5.6]). Asthma was associated with weight loss; male sex tended to be associated with weight gain.

Investigation of the Prevalence and Treatment of Atopic Dermatitis in South Korea Using a Large National Dataset.

Updated reports on the population-based analysis of atopic dermatitis (AD) in Korea are rare. This study aimed to investigate the nationwide prevalence and systemic medication prescription trends of AD in Korea. Based on the Korean National Health Insurance database, the prevalence of AD and systemic medication prescription trends in patients with AD were analyzed according to age groups and regional districts from 2010 to 2015. The prevalence of AD was the highest among patients aged 0-1 year (18.6%-24.5%), decreasing rapidly with increasing age (<2% in patients aged ≥20 years). From 2010 to 2015, the prevalence of AD decreased in children but increased slightly in adolescents and adults. In 2015, the proportion of systemic steroid prescriptions increased from 11.2% in the 0-9 years age group to 41.1% in the 50-59 years age group, while that of systemic antibiotic prescriptions gradually decreased from 6.2% in the 0-9 years age group to 1.8% in the 80-89 years age group. The proportion of systemic steroid prescriptions by region remained consistently high in Gyeongbuk (34.2%- 34.9%) and low in Daejeon (20.2%-22.5%). The annual proportion of systemic cyclosporine prescriptions increased significantly from 0.6% in 2010 to 1.2% in 2015, with the highest rates observed in patients in their 30s (1.5%-2.4%), followed by those in their 20s (1.3%-2.3%) and 40s (1.1%-2.0%). From 2010 to 2015, the prevalence of AD decreased in children but increased slightly in adolescents and adults. Approximately one-fourth of the patients with AD were prescribed systemic steroids, and the percentage of cyclosporine prescriptions doubled during the study period.

Ocular Manifestation of Granulomatosis with Polyangiitis Presenting as Serous Retinal Detachment: A Case Report

Background: Ocular involvement is relatively common in granulomatosis with polyangiitis (GPA); however, choroidal involvement is rare. We present a case of serous retinal detachment resulting from choroidal involvement in GPA. Case presentation: A 55-year-old male presented to our clinic with bilateral eye redness and pain. Ocular examination revealed bilateral conjunctival injection, and dilation of the episcleral and scleral vessels. Slit-lamp examination revealed anterior chamber cells. Optical coherence tomography (OCT) confirmed serous retinal detachment (SRD) in the left eye. The patient had recently been diagnosed with GPA following a lung biopsy and had received immunosuppressive therapy, including systemic steroids, cyclosporine, mycophenolate mofetil, and rituximab. Five weeks after treatment, the clinical symptoms of the patient, including SRD, improved with alleviation of systemic symptoms. However, tapering systemic steroids and immunosuppressants and discontinuing rituximab led to disease reactivation. OCT demonstrated a recurrence of subretinal fluid, which had previously resolved, and slit-lamp examination showed mild bilateral engorged scleral vessels. Conclusions: Choroidal involvement can present as SRD and may indicate disease activity in patients with GPA.

Toxic epidermal necrolysis associated with phenytoin in a 6-year-old child: a case report

Toxic epidermal necrolysis (TEN) is a severe mucocutaneous syndrome often triggered by adverse drug reactions, characterized by extensive skin detachment. We present a rare case of a 6-year-old boy developing TEN associated with phenytoin use for post-bacterial meningitis seizures. The patient initially presented with fever, epigastric pain, oral ulcers, and skin rashes, later progressing to extensive skin peeling. Phenytoin was promptly discontinued. The SCORTEN score indicated a mortality rate of 35.3%. Informed consent was taken by parents. The patient received supportive care, including IV fluids, antibiotics, and topical treatments. The patient exhibited a positive response to early initiation of systemic steroids (Dexamethasone) and cyclosporine, leading to a successful recovery within 15 days. This case underscores the importance of recognizing and managing drug induced TEN promptly, especially in pediatric populations, and highlights potential immunopathologic pathways and genetic predispositions to the condition.

Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia: A Retrospective, Real-Life Analysis in a Tertiary Center in Germany.

Background: Lichen planopilaris (LPP) is an inflammatory cicatricial alopecia characterized by an irreversible destruction of the hair follicle resulting in its permeant destruction. The clinical presentation of LPP is a progressive patchy scarring alopecia. A variety of systemic agents is used to treat LPP with varying success. The aim of this retrospective, real-life analysis was to evaluate the treatment of hydroxychloroquine for LPP. Method: In this retrospective, single-center study, we analyzed 110 patients with LPP and frontal fibrosing alopecia (FFA) who received treatment over a 12-month period from March 2014 to March 2021 at the Department of Dermatology, University of Mainz Medical Center. Patient records were analyzed for response to treatment, co-morbidities, disease progression-free survival (DPFS), and safety. Clinical parameters associated with treatment response were determined with Cox regression modelling and logistic regression. Results: Overall, 77 of 110 patients were treated with a systemic agent. There was a clear association between LPP and the occurrence of Hashimoto thyroiditis. Topical treatment with corticosteroids did not improve clinical symptoms in the majority of patients (15 out of 101). In 71% of patients treated with systemic cyclosporine A and 62% of patients treated with hydroxychloroquine, we observed a significant resolution of the inflammatory process, which correlated with a robust durable clinical response (p < 0.001). Toxicity was observed in 17% (n = 9) of patients receiving systemic treatment with hydroxychloroquine and correlated with the duration of systemic treatment (p < 0.001). Treatment discontinuation was associated with a flare-up of clinical symptoms (29%), which required the re-initiation of second-line therapy in 13 out of 51 patients. Overall, the initiation of second-line treatment, either hydroxychloroquine or Cyclosporine A (CsA), yielded positive results, especially in the patient cohort treated with hydroxychloroquine (overall response rate, ORR = 100%), who showed disease progression during CsA or retinoids. Conclusions: Our results from this contemporary cohort of patients with LPP and FFA indicate that hydroxychloroquine and cyclosporine are effective systemic agents in decreasing clinical symptoms. However, our data also show that the discontinuation of treatment is often associated with the exacerbation of clinical symptoms. Response rates to second-line treatment were especially favorable in the patient cohort with hydroxychloroquine.

A Non-Interventional, Multicenter Study to Characterize the Socio-Demographics, Clinical Characteristics, and Management of Generalized Pustular Psoriasis Patients in Spain: IMPULSE Study.

Generalized pustular psoriasis (GPP) is a chronic, rare, and potentially life-threatening skin condition characterized by flares comprising widespread sterile pustules and systemic inflammation. Both the rarity and heterogeneity of the disease have made GPP classification and standardization of clinical criteria challenging. Before the approval of spesolimab (IL-36R antibody) in 2022, there were no approved treatments in the USA or Europe for GPP flares. Treatment for GPP has amounted to off-label use of medicines approved to treat plaque psoriasis. Our aim was to describe the sociodemographics, clinical characteristics, and treatment patterns of patients with GPP in Spain. Non-interventional, descriptive, multi-center, retrospective chart review of patients diagnosed with GPP in Spain. 56 patients (50% women) were included, with a mean (standard deviation, SD) age at diagnosis of 53.7 (20.5) and a mean (SD) time of follow-up of 3.7 (3.1) years. In 80% of patients, GPP diagnosis was associated with a flare and 67.3% had known risk factors for GPP (such as previous diagnosis or family history of plaque psoriasis, comorbidities, smoking or stress). Hypertension and plaque psoriasis were the most frequent comorbidities (44.6% each). The number of GPP flares per patient-year was 0.55 with (range 0-4) a mean (SD) body surface area involvement of 21.3% (19.1). The most frequent manifestations of GPP flares were pustules (88.5%), erythema (76.9%), and scaling (76.9%). Additionally, 65.4% of patients had plaque psoriasis, 53.8% had unspecified skin lesions, and 30.8% experienced pain. The treatments used for GPP flares were off-label conventional systemic drugs (75%), mostly corticosteroids, cyclosporine, and acitretin. In the periods between flares, off-label biologics were used in 56.5% of patients. During the study period, 9 patients (16.1%) had at least one complication and 5 of them required hospitalization. This is the first multicenter study in Spanish GPP patients. Most patients were in their fifties, with personal or family history of plaque psoriasis, stress, smoking and a wide range of comorbidities and complications. Even though the number of flares per patient/year was 0.55, there was variability between patients. Both off-label conventional systemics and off-label biologics were used for flare management without a clear treatment pattern.

Systemic Treatment With Cyclosporine A in Children With Severe Vernal Keratoconjunctivitis.

To report our experience with systemic cyclosporine as a treatment for severe vernal keratoconjunctivitis (VKC) in pediatric patients who did not respond to previous treatments. We analyzed the medical records of 6 patients, aged 4 to 15 years, with severe VKC treated with systemic cyclosporine for VKC at Shamir Medical Center in Zerifin, Israel, between the years 2000 and 2023. The average treatment duration was 18 months. In all patients, previous treatments with antihistamines, mast cells stabilizers, topical steroids and topical cyclosporine, and systemic steroids did not result in sufficient improvement. The severity of inflammation was evaluated during clinical examinations and the patients' subjective assessment of their quality of life. In all 6 patients, signs and symptoms showed significant improvement within 2 to 4 weeks of initiating systemic cyclosporine treatment. All patients were able to discontinue regular steroids use and reported a significant improvement in their quality of life. No significant side effects were observed in any of the patients. Systemic cyclosporine is a safe and effective treatment for severe VKC. It is a steroid-sparing treatment that allows good quality of life, while keeping the disease latent.

Macrophage Activation Syndrome in Children: Update on Diagnosis and Treatment.

Macrophage activation syndrome (MAS) is potentially fatal; so, early diagnosis and timely treatment are essential. However, detecting MAS is sometimes challenging because its principal features can be observed in other pediatric diseases that cause severe inflammation. Cytokine storm due to immune dysregulation represents the clinical and laboratory features of MAS that are included in the diagnostic criteria. Most cases of MAS occur as an underlying condition worsens and progresses. Therefore, a patient with autoimmune or autoinflammatory disease who shows unexplained clinical deterioration despite appropriate management should be considered at high risk for MAS (i.e., occult MAS). The basic principles of treatment are control of triggering factors, supportive care, and relief of hyperinflammation. Systemic steroids and cyclosporine A are frequently used as a first-line treatment. For the treatment of refractory MAS, cytokine-specific biologic agents such as anakinra have recently become preferred over traditional immunosuppressive agents such as etoposide. MAS might be underrecognized in pediatric patients with infectious and inflammatory diseases due to its diverse clinical presentations. Clinical suspicion of MAS is of the utmost importance for early recognition of the disease.

The treatment journey of children with moderate to severe atopic dermatitis in Türkiye: unmet needs.

Atopic dermatitis (AD) substantially burdens individuals, families, and healthcare systems. We aimed to document the treatment journey of pediatric patients with moderate-to-severe AD in a referral center based in our country. This retrospective study reviewed patients aged 1-18 years diagnosed with AD, seeking systemic treatment recommendations from the "pediatric allergy and dermatology multidisciplinary team meeting". Over the 14-month study period, 30 (12.5%) of 240 AD patients were evaluated in the pediatric dermato-allergy team meetings. The median age of the patients was 13.66 years (Q1-Q3: 7.94-17.27), of whom 60% were male. The median annual healthcare visits for AD were 4 (Q1-Q3: 1.00-8.75). Among the study group, 70% were sensitized to aeroallergens, and admission markers included total IgE (median: 1980 IU/mL, Q1-Q3: 794.50-5446), and eosinophil counts (median: 650, Q1-Q3: 275-1275). All patients utilized intermittent and/or continuous topical corticosteroids (CS), with 56.6% employing short-term/long-term topical tacrolimus. Over the past two years, systemic CSs were utilized in 93.3% of the patients, whereas 57.1% received more than one course. Approximately 43.3% of the patients agreed to receive systemic cyclosporine treatment, with only 30.8% benefiting and 3.3% reporting adverse effects (hypertrichosis and cellulitis). Three patients self-funded dupilumab, all benefiting without adverse effects. Omalizumab, mycophenolate mofetil and narrow-band ultraviolet (UV) treatments were used in one patient each, with limited benefit observed. Health insurance did not grant approval for a Janus kinase inhibitor for one patient. Managing moderate to severe AD is complex and costly, considering disease heterogeneity, comorbidities, care pathways, and health system challenges. Addressing the unmet needs should be a priority in Türkiye's healthcare systems.

Pustular Psoriasis of Pregnancy Successfully Managed with Steroid and Cyclosporine – A Case Report

Pustular psoriasis of pregnancy is a well-known dermatosis of pregnancy. Erythematous plaques with pustular rings and central erosions affecting the intertriginous regions are one of the most common presentations. It can be severe during pregnancy and may impact both the mother and the foetus if not treated. It typically disappears quickly after birth, but there is a chance of recurrence with increased severity in consecutive pregnancies. Systemic corticosteroids are the treatment of choice in generalised pustular psoriasis of pregnancy (GPPP). Cyclosporine also plays a role in the management. We present a case of GPPP in a 30-year-old woman who was treated with systemic corticosteroids and cyclosporine with an uneventful childbirth and a normal foetus.

Evaluation of the Factors Influencing Mortality in Patients with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Multicenter Study of 166 Patients.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening acute mucocutaneous disorders usually triggered by drugs. In this study, we aimed to evaluate the factors affecting mortality in patients with SJS-TEN. Our study is a retrospective cohort study, analyzing data collected from a total of 12 tertiary care centers between April 2012 and April 2022. The study included 59 males and 107 females, a total of 166 patients, with an average age of 50.91 ± 21.25years. Disease classification was TEN in 50% of cases, SJS in 33.1%, and SJS-TEN overlap in 16.9%. The average SCORTEN within the first 24h was 2.44 ± 1.42. Supportive care was provided to 99.4% of patients. The most commonly used systemic immunomodulatory treatments were systemic steroids (84.3%), IVIG (intravenous immunoglobulin) (49.3%), and cyclosporine (38.6%). Plasmapheresis was administered to five patients. While 66.3% of patients were discharged, 24.1% resulted in exitus. Our comparative analysis of survivors and deceased patients found no effect of systemic steroids, IVIG, and cyclosporine treatments on mortality. Univariate analysis revealed that the SCORTEN scores on days 1 and 3 as well as the rates of detachment at the onset and during follow-up were significantly higher in deceased patients compared to survivors. The rates of fever, positive blood cultures, and systemic antibiotic use were higher in deceased patients compared to survivors. The presence of comorbidities, diabetes, and malignancy were significantly more common in deceased patients. Multivariate regression analysis indicated that over SCORTEN 2, the mortality risk exponentially rose with each SCORTEN increment, culminating in an 84-fold increase in mortality at SCORTEN 5-6 (odds ratio [95% confidence interval]: 13.902-507.537, p < 0.001) compared to SCORTEN 0-1. Additionally, the utilization of plasmapheresis was associated with a 22-fold increase in mortality (odds ratio [95% confidence interval]: 1.96-247.2, p = 0.012). Our study found that a high SCORTEN score within the first 24h and the use of plasmapheresis were related to increased mortality, while systemic steroids, IVIG, and cyclosporine treatments had no impact on mortality. We believe that data gathered from one of the most comprehensive studies which we conducted on SJS-TEN will enrich the literature, although additional research is warranted.

Clinical Characteristics and Treatment Outcomes of Prurigo Nodularis: A Retrospective Study.

Prurigo nodularis (PN) is a complex chronic skin disease characterized by severe pruritic nodules. PN is often associated with mental health disorders and chronic medical comorbidities. Until recently, PN treatment has been challenging and difficult. This study aims to describe the demographic, clinical characteristics, and comorbidities associated with PN. Also, we aim to describe the effectiveness of systemic therapies, including methotrexate, cyclosporine, and narrow band ultraviolet (NB-UVB) in adult patients with PN. This is a retrospective chart review of adult patients diagnosed with PN at Hamilton Health Science Center and/or McMaster University in Hamilton, Ontario, between 2015 and 2023. The study included 81 patients (57% female). The mean age was 52.8 years, and the mean age of PN diagnosis was 50 years. Reported symptoms included: itching (100%), dry skin (53%), pain (17%), and burning sensation (5%). Lower and upper extremities were the most common areas involved in 93% and 69%, respectively. Mental health disorders were present in 79% of patients, with depression (58%) and anxiety (52%) being the most common. Atopic dermatitis was the most common skin comorbidity noted. Treatments used included cyclosporine, and NB-UVB, and MTX, which resulted in significant improvement of pruritus in 38%, 35%, and 31% of patients, respectively, at week 16. PN is associated with increased risk of mental health disorders and other medical comorbidities. Cyclosporine, methotrexate, and NB-UVB therapy may be effective treatment options, however clinicians must consider the potential short- and long-term adverse effects of these treatments.

Treatment With Upadacitinib in Refractory Prurigo Nodularis: A Prospective Cohort Study.

Prurigo nodularis (PN) is a chronic neuroinflammatory dermatosis with severe pruritus that has limited efficacy in various conventional treatments. This study investigated the outcomes of upadacitinib treatment in patients with refractory PN. A prospective study was conducted to screen for potential chronic infections prior to treatment. Upadacitinib was administered at a daily dose of 15 mg for 24 weeks, and the treatment response was assessed using the itch Numeric Rating Scale (NRS), investigator's Global Assessment (IGA), and Dermatology Life Quality Index (DLQI). Adverse events were monitored at each visit. Ten patients, with an average age of 48.8 years, were included in the study. All participants were treated with systemic cyclosporine before receiving upadacitinib, which yielded limited responses. At baseline, the mean prurigo severity scores assessed using the IGA, DLQI, and itch NRS were 3.4, 17.8, and 8.1, respectively; after 24 weeks of treatment, these scores significantly reduced to 1.0, 0.6, and 0.8, respectively. No severe adverse effects were observed. In conclusion, upadacitinib could be considered an alternative therapeutic option with good tolerability for refractory PN.

Therapeutic response of oral chronic graft-versus-host disease to topical corticosteroids according to the 2014 National Institutes of Health (USA) consensus criteria.

Chronic graft-versus-host-disease (cGVHD) is a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The oral cavity is one of the most frequently affected anatomic sites and is affected in 70% of all patients who develop cGVHD. The objective of this study was to determine the therapeutic response to topical corticosteroids and clinical outcome of patients with oral cGVHD using the 2014 NIH consensus criteria. The oral manifestations of cGVHD were collected at the first and the follow-up (FU) visits after the therapeutic treatment of oral GVHD. The FU intervals were: FU0, first visit; FU1, 0-1 month; FU2, 1-3 months; FU3, 3-6 months; FU4, 6-9 months; and FU5, 9-12 months. The oral cGVHD activity was assessed using the NIH modification of the Schubert Oral Mucosa Rating Scale (OMRS) and Thongprasom sign score. The functional impact was assessed by the organ-specific severity score. Fourteen patients (93.3%) at FU0 were being treated with at least one form of systemic immunosuppressive therapy, i.e., prednisolone, cyclosporin, and tacrolimus. The OMRS was reduced between FU0 and FU3 (p < 0.001), FU0 and FU4 (p < 0.001), and FU0 and FU5 (p = 0.004). The organ-specific severity scores were also reduced between FU0 and FU4 (p = 0.016), and FU0 and FU5 (p = 0.001). There was no significant difference in the highest Thongprasom sign score between all follow-up intervals (FU0-FU5) (p = 0.201). One patient (6.7%) at FU4 and three patients (20.0%) at FU5 did not receive topical corticosteroid therapy for oral cGVHD. The oral cGVHD lesions and functional impacts improved within 6 months and 9 months, respectively. However, most of the patients required topical corticosteroid therapy for more than 1 year to control their symptoms and lesions.

Association of vitiligo and metabolic syndrome: a case control study

Background: Vitiligo is an acquired disorder of depigmentation which involves skin and mucous membranes characterized by development of well-defined white macules on skin, mucosa and overlying hair of the skin can be involved. Systemic nature of the vitiligo might lead to insulin resistance metabolic profile abnormalities. Objective was to study the association between vitiligo and metabolic syndrome. Methods: The study was done in department of dermatology, venereology and leprosy of Dr. R. P. Government Medical College Kangra (Tanda), Himachal Pradesh. The study included 150 cases and 150 controls. Cases: age above 18 years with a diagnosis of vitiligo were included in the study. Pregnant and lactating women were excluded. Patients who had used medications that could affect the metabolic status (like systemic steroid therapy or cyclosporine or on hormonal replacement therapy). Patients already on lipid lowering agents and antidiabetic drugs. The case group was further subdivided into three subgroups according to VIDA score (group A: 1-0, group B: 1-2 and group C: 3-4). Controls: those visiting outdoor patient department and admitted for minor day care procedures Clinical details of patients were recorded regarding age, sex, smoking/alcohol consumption. General physical examination includes height, weight, body mass index, waist circumference, blood pressure. All the patients and controls were subjected to following tests: fasting blood sugar (FBS), cholesterol (CHOL), triglyceride (TAG), low density lipoprotein (LDL), high density lipoprotein (HDL), very low-density lipoprotein (VLDL), fasting serum insulin level (FSIL). Venous samples were taken after 12 hours of fasting. The participants were screened for metabolic syndrome as per national cholesterol education program adult treatment panel III (NCEP ATP III). Metabolic syndrome rates were compared between case and control groups. Results: The mean age was 35.82±12.9 years among cases and 36.97±11.76 years among controls. The M/F ratio of cases being (1:1.6) and controls (1:1). The mean duration of vitiligo was 117.8±105.5 months. Metabolic syndrome was significantly prevalent amid vitiligo cases 74 (49.3%) as compared to controls 23 (15.3%) with OR (95% CI) =5.37 (3.1-9.3). Metabolic syndrome was more frequent in VIDA subgroup 3{71 (47.3%)} and was statistically significant (p≤0.001). Conclusions: The study found association of metabolic syndrome among vitiligo patients. In addition, the study also found that in non-segmental vitiligo, frequency of metabolic syndrome was higher as compared to another pattern. Furthermore, frequency of metabolic syndrome increased as activity of vitiligo increased in the study.

Disease burden and treatment satisfaction in patients with prurigo nodularis in Japan.

Prurigo nodularis (PN) is a chronic inflammatory skin disorder with a high disease burden. In this cross-sectional, web-based survey, Global Questions (GQ), the Numerical Rating Scales (NRS) for pruritus, burning sensation and sleep disturbance, the Short-Form-8 (SF-8) Health Survey, Dermatology Life Quality Index (DLQI), Patient Health Questionnaire 9 (PHQ-9), Work Productivity and Activity Impairment (WPAI), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) scores were used to assess the current disease burden and treatment satisfaction among patients with PN in Japan. In total, 97 patients were included (55.7% male, median age 51 years, median duration of PN 36 months). Based on GQ scores, 35.1% of patients had mild disease, 50.5% moderate, and 14.4% severe disease. Disease burden increased as the severity of PN increased, as indicated by worsening of pruritus NRS scores and quality of life (DLQI, PHQ-9, WPAI presenteeism, work productivity loss, and activity impairment scores). Patients with comorbid atopic dermatitis (AD) also had more intense pruritus than those without AD. Mean ± standard deviation TSQM-9 scores for effectiveness, convenience, and global satisfaction were 54.7 ± 18.1%, 62.4 ± 15.2%, and 57.4 ± 15.9%, respectively. TSQM-9 scores were lowest in patients receiving the most intensive guideline-directed treatment (i.e., topical corticosteroids + systemic oral corticosteroids or cyclosporine), highlighting an unmet need for more effective treatment options for patients with PN. In summary, Japanese patients with PN reported increased disease burden and reduced treatment satisfaction with increased disease severity, despite the use of guideline-recommended therapies.

Real‐life case‐series experience with tralokinumab in patients with severe atopic dermatitis

AbstractAtopic dermatitis (AD) is an inflammatory chronic recurrent skin condition that causes recurrent, itching eczematous lesions with a great impact on the quality of life of patients. We describe a case series of five adult patients with severe AD (Eczema Area Severity Index [EASI] ≥24) treated with tralokinumab. Tralokinumab is a monoclonal antibody that specifically binds IL‐13 with high affinity, blocking the interaction of IL‐13 with its specific receptors and neutralising its biological activity. Tralokinumab was recently approved for the treatment of moderate‐to‐severe AD in adults. In these patients, several conventional topical and systemic treatments (such as UV‐B phototherapy, systemic cyclosporine and dupilumab) had been previously tried. Three patients reported severe conjunctivitis during the previous treatment with dupilumab and one patient had not a good clinical response to dupilumab, as this treatment was stopped. Therefore, treatment with tralokinumab as a subcutaneous injection at an initial dose of 600 mg followed by 300 mg administered every other week was started. The severity of AD was assessed at baseline, Week 12 and Week 20 using several clinical scores (EASI, SCOring Atopic Dermatitis, Itch score, Dermatology Life Quality Index). All patients achieved clinical remission with a significant clinical improvement of itching and eczema in all body areas, assessed with several clinical scores; furthermore, no adverse events were reported during the observation period. During the treatment with tralokinumab, one patient was also infected by the SARS‐CoV‐2 virus, reporting mild clinical symptoms of the upper respiratory tract. These symptoms spontaneously resolved in 2 days with no medications. Although additional real‐world data are certainly required about the efficacy and safety of tralokinumab, the prospects of new drugs for the long‐term treatment of moderate‐to‐severe AD represent a great opportunity for these patients, which had very few therapeutic options until now.

A Rare Case of Lyell Syndrome Secondary to Ofloxacin Eye Drops

Abstract Lyell syndrome or toxic epidermal necrolysis (TEN) is a severe mucocutaneous adverse drug reaction characterized by generalized erythema and widespread epidermal necrosis resulting in its detachment. If not appropriately intervened, it may result in sepsis, multiorgan failure, and death. TEN secondary to topical drugs is very rare and only a few cases have been documented so far. Here, we report a case of a 10-year-old child who presented with features of TEN following administration of ofloxacin eye drops, which is commonly prescribed in ophthalmic practice for conjunctival inflammation. She was treated in the pediatric intensive care unit with systemic corticosteroids, cyclosporine, intravenous immunoglobulin, and other supportive therapy including collagen dressing, and showed complete recovery. This case report highlights the need for awareness among physicians regarding serious adverse events caused by topical drugs and a multidisciplinary approach which paves the road for recovery.

The Clinical Characteristics of Patients With Pyoderma Gangrenosum in a Tertiary Referral Hospital: A Retrospective Cohort Study.

Since pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis, epidemiological and clinical data on the disease are scarce. In this single-center retrospective study, we aim to evaluate the clinical characteristics, underlying systemic associations and treatment modalities in patients with PG in a university hospital between 2014 and 2022. It is known that PG most commonly affects the lower extremities, but extracutaneous involvement should also be kept in mind. PG is usually associated with various comorbidities that share a similar inflammatory pathogenesis with the disease. The prevalence of PG-related comorbidities varies in different studies, arthritis and solid organ malignancies were observed most frequently in the current study. Non-PG-related comorbidities including diabetes mellitus, hypertension and peripheral vascular disease can adversely affect wound healing and limit treatment options; therefore, a holistic approach to patients with PG is crucial. Consistent with literature, the mainstay of treatment for PG is systemic corticosteroids and cyclosporine. However, the implementation of biologic agents in treatment-resistant patients is an increasingly important issue in the literature. Antitumor necrosis factors (anti-TNFs) are the most commonly preferred biological therapies, and these agents seem to have paved the way for a paradigm shift in the treatment of PG. In the present study, a relatively high per cent of (23.3%) patients treated with anti-TNFs, most commonly infliximab (87.5%). Recurrence was observed in 46.7% of our patients in the follow-up period and the relapse rate was found to be higher in patients using multiple systemic agents compared to those using single agents (64.7% vs 23.1%, P < .05). In conclusion, we emphasize that early diagnosis and treatment by considering the patient's comorbidities are important in preventing complications, and biologic treatments seem particularly promising in treatment-resistant patients.

Upadacitinib for moderate-to-severe atopic dermatitis: stratified analysis from three randomized phase 3 trials by key baseline characteristics.

Atopic dermatitis (AD) is a heterogeneous inflammatory skin disease with different clinical phenotypes based on factors such as age, race, comorbidities, and clinical signs and symptoms. The effect of these factors on therapeutic responses in AD has only been scarcely studied and not for upadacitinib. Currently, there is no biomarker predicting response to upadacitinib. Evaluate the efficacy of the oral Janus kinase inhibitor upadacitinib across patient subgroups (baseline demographics, disease characteristics, and prior treatment) in patients with moderate-to-severe AD. Data from phase 3 studies (Measure Up 1, Measure Up 2, and AD Up) were utilized for this post hoc analysis. Adults and adolescents with moderate-to-severe AD were randomized to receive once daily oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo; patients enrolled in the AD Up study received concomitant topical corticosteroids. Data from the Measure Up 1 and Measure Up 2 studies were integrated. A total of 2584 patients were randomized. A consistently greater proportion of patients achieved at least 75% improvement in the Eczema Area and Severity Index, a 0 or 1 on the validated Investigator Global Assessment for Atopic Dermatitis, and improvement in itch (including an achievement of a reduction of ≥4; and score of 0/1 in Worst Pruritus Numerical Rating Scale) with upadacitinib compared with placebo at week 16, regardless of age, sex, race, body mass index, AD severity, body surface area involvement, history of atopic comorbidities or asthma, or previous exposure to systemic therapy or cyclosporin. Upadacitinib had consistently high skin clearance rates and itch efficacy across subgroups of patients with moderate-to-severe AD through week 16. These results support upadacitinib as a suitable treatment option in a variety of patients. ClinicalTrials.gov Identifiers: NCT03569293 (Measure Up 1), NCT03607422 (Measure Up 2), and NCT03568318 (AD Up).