Topical Corticosteroids Group Research Articles

Safety and efficacy of Pimecrolimus in atopic dermatitis among Chinese infants: a sub-group analysis of a five-year open-label study

IntroductionAtopic dermatitis (AD) exhibits difference in immune polarization between Caucasians and Asian races due to which an evaluation of the efficacy and safety of Pimecrolimus (PIM) in Asian population is called for. The current study addresses the need via a sub-group analysis of the PETITE study (NCT00120523) to evaluate the safety and efficacy of PIM in Chinese infants.Materials and methodsPatients with AD (≥3 months–<12 months of age) were randomized in a 1:1 ratio to either PIM 1% cream or topical corticosteroids (TCS). The primary endpoint was safety. The secondary endpoint was efficacy.Results120 patients were randomized to either PIM 1% or TCS (n = 61 for PIM, n = 59 for TCS). The most often reported adverse events were reported by similar proportions of patients treated with PIM or TCS. There was a progressive increase in overall IGA treatment success in infants treated with PIM (82.9%, p < .05, 95% CI: 70.4, 95.3) after 26 weeks which was comparable to the TCS group (88.5%, p < .05, 95% CI: 79.8, 97.1).ConclusionPIM showed an early and sustained efficacy in the Chinese sub-population with a substantial corticosteroid-sparing effect in patients with AD.

Immunological Changes of Basophil Hyperreactivity to Sweat in Patients With Well-Controlled Atopic Dermatitis.

BackgroundSweat aggravates atopic dermatitis (AD). In patients with AD, type-I hypersensitivity to sweat may be shown by histamine release from patients’ basophils in response to the semi-purified sweat antigen (QR), and the presence of specific immunoglobulin E (IgE) binding to MGL_1304, the component of QR. However, there has been no information on the immunological changes of type-I hypersensitivity to the sweat antigen in patients with well-controlled AD using topical corticosteroids (TCSs) and/or biologics as treatments.MethodHistamine-releasing tests using patients’ basophils and QR and the detection of serum IgE against MGL_1304 and mite allergen Der f 1 were performed in patients with AD who were well controlled by topical TCS with/without dupilumab for 53–96 weeks.ResultsIn total, 14 patients were enrolled. Seven patients received TCS therapy alone (TCS group), and seven patients received TCS with dupilumab therapy (dupilumab group). In all participants, the level of specific IgE against MGL_1304 decreased after treatments, but histamine release from basophils in response to QR did not show a statistically significant reduction; rather, it increased. In the dupilumab group, all changes in histamine release induced by QR (increase), the IgE level against MGL_1304 (decrease), and that against Der f 1 (decrease) were statistically significant, whereas the TCS group showed no significant change in any of them.ConclusionThe well-controlled condition for 53–96 weeks resulted in no reduction of the hyperreactivity of basophils against in patients with AD, even with the treatment with dupilumab. This study suggests persistent basophil hyperreactivity to sweat antigen over a year or longer.

Real-world efficacy of proactive maintenance treatment with delgocitinib ointment twice weekly in adult patients with atopic dermatitis.

Previous studies have shown the efficacy of delgocitinib (DEL) ointment, a topical Janus kinase inhibitor, against atopic dermatitis (AD). However, there is no available information regarding the efficacy of DEL ointment in maintaining remission. Data of patients with AD who received remission maintenance therapy twice weekly with DEL or topical corticosteroid (TCS) on the affected skin of each upper limb were extracted from the medical records. Efficacy was assessed based on changes in pruritus numerical rating scale (NRS) score, stratum corneum hydration (SCH), erythema index (EI). Of 25 patients, four patients (16%) had eczema flare-ups on the TCS side and eight patients (32%) on the DEL side. The extent of change in each parameter between TCS- and DEL-treated areas of the skin did not differ significantly. The mean changes in the NRS and EI showed a slight improvement on the side treated with TCS and were slightly worse on the side treated with DEL. However, the SCH of the DEL group was maintained, while that of the TCS group worsened. TCS is more likely to be effective than DEL in terms of remission maintenance therapy. However, topical DEL is as effective as topical steroid in the maintenance therapy of AD in dry skin patients.

Лікування алергічного риніту в дітей: стара проблема, нові рішення

У статті розглядається проблема алергічного риніту в дітей. Приділено увагу питанням лікування цієї патології. Підкреслено, що найбільш типовим і найпроблемнішим проявом алергічного риніту є набряк слизової оболонки носа, який блокує носове дихання. Для полегшення цього симптому патогенетично обґрунтованим є призначення препарату групи топічних кортикостероїдів, наприклад препарату вітчизняного виробництва під торговою назвою Форінекс. Наведені дані ефективності використання Форінексу в дітей 6–14 років з алергічним ринітом середньої тяжкості.

Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial

Systemic therapies are typically combined with topical corticosteroids for the management of moderate-to-severe atopic dermatitis. Upadacitinib is an oral Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, or tyrosine kinase 2 that is being tested for atopic dermatitis. We aimed to assess the efficacy and safety of upadacitinib plus topical corticosteroids compared with placebo for the treatment of moderate-to-severe atopic dermatitis. In this randomised, double-blind, placebo-controlled, phase 3 trial (AD Up) adults (aged 18-75 years) and adolescents (aged 12-17 years) with chronic atopic dermatitis that was moderate to severe (≥10% of body surface area affected, Eczema Area and Severity Index [EASI] score of ≥16, validated Investigator's Global Assessment for atopic dermatitis [vIGA-AD] score of ≥3, and weekly average Worst Pruritus Numerical Rating Scale score of ≥4 at baseline) were enrolled at 171 clinical centres across 22 countries in the Asia-Pacific region, Europe, the Middle East, North America, and Oceania. Patients were randomly assigned (1:1:1) to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, all in combination with topical corticosteroids for 16 weeks. Randomisation was done using an interactive response technology system, stratified by baseline disease severity, geographical region, and age. Study investigators, study site personnel, and patients were masked to study treatment. The coprimary endpoints were the proportion of patients who had achieved at least a 75% reduction in EASI score from baseline (EASI-75) and the proportion of patients who had achieved a vIGA-AD response (defined as a vIGA-AD score of 0 [clear] or 1 [almost clear] with ≥2 grades of improvement from baseline) at week 16. Efficacy was analysed in the intention-to-treat population and safety was analysed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03568318, and is active, but not recruiting. Between Aug 9, 2018, and Dec 20, 2019, 901 patients were randomly assigned to receive upadacitinib 15 mg plus topical corticosteroids (n=300), upadacitinib 30 mg plus topical corticosteroids (n=297), or placebo plus topical corticosteroids (n=304). At week 16, the proportion of patients who had achieved EASI-75 was significantly higher in the upadacitinib 15 mg plus topical corticosteroid group (194 [65%] of 300 patients) and the upadacitinib 30 mg plus topical corticosteroids group (229 [77%] of 297 patients) than the placebo group (80 [26%] of 304 patients; adjusted difference in EASI-75 response rate vs placebo, 38·1% [95% CI 30·8-45·4] for the upadacitinib 15 mg group and 50·6% [43·8-57·4] for the upadacitinib 30 mg group; p<0·0001 for both doses). The proportion of patients who had achieved a vIGA-AD response at week 16 was significantly higher in the upadacitinib 15 mg plus topical corticosteroid group (119 [40%] patients) and upadacitinib 30 mg plus topical corticosteroid group (174 [59%] patients) than the placebo group (33 [11%] patients; adjusted difference in vIGA-AD response vs placebo, 28·5% [22·1-34·9] for the upadacitinib 15 mg group and 47·6% [41·1-54·0] for the upadacitinib 30 mg group; p<0·0001 for both doses). During the double-blind period, upadacitinib 15 and 30 mg were well tolerated in combination with topical corticosteroids. The most frequently reported treatment-emergent adverse events (≥5% in any treatment group) were acne, nasopharyngitis, upper respiratory tract infection, oral herpes, elevation of blood creatine phosphokinase levels, headache, and atopic dermatitis. The incidence of acne was higher in the upadacitinib 15 mg (30 [10%] of 300 patients) and upadacitinib 30 mg (41 [14%] of 297 patients) groups than the placebo group (six [2%] of 304 patients). The incidence of adverse events leading to discontinuation of study drug (four [1%] patients in the upadacitinib 15 mg plus topical corticosteroids group, four [1%] patients in the upadacitinib 30 mg plus topical corticosteroids group, and seven [2%] patients in the placebo plus topical corticosteroids group) and serious adverse events (seven [2%] patients, four [1%] patients, and nine [3%] patients) were similar among treatment groups. No deaths were reported in any treatment group. Upadacitinib plus topical corticosteroids was well tolerated and superior to placebo plus topical corticosteroids. Upadacitinib as combination therapy had a positive benefit-risk profile in adults and adolescents with moderate-to-severe atopic dermatitis. AbbVie.

CLINICAL PROFILES OF VITILIGO WITH NARROWBAND UVB AND TOPICAL CORTICOSTEROID THERAPY AT DR. SOETOMO HOSPITAL

Background: Vitiligo is a depigmenting disorder that causes a loss of melanocytes in the epidermis. Treatment preferences are based on the characteristics of the vitiligo lesions. Purpose: This study evaluates the clinical profiles of vitiligo treated with narrowband UVB (NB-UVB) and topical corticosteroid therapy in Dr. Soetomo Hospital in 2017. Methods: This study is a retrospective study that uses data from the medical records of vitiligo patients who were treated with NB-UVB and topical corticosteroids in Dr. Soetomo Hospital in 2017. The dependent variable was vitiligo treated with NB-UVB radiation or topical corticosteroids, while the independent variables were disease onset, precipitating factor, duration, stability, amount, affected area, location, and type of vitiligo. Results: Thirty-seven patients (19 females) were included, four of whom had been treated with NB-UVB and 33 with topical corticosteroids. In the NB-UVB group, 75% had stable lesions, 50% had a single lesion, 50% had multiple lesions, 75% had an affected area &lt;10cm2, 40% had lesions around their face, 40% had lesions on their extremities, and 75% had focal vitiligo. In the topical corticosteroids group, 76% had active lesions, 82% had multiple lesions, 82% had an affected area &lt;10 cm2, 28% had lesions around their upper extremities, 28% had lesions around their lower extremities, and 46% had segmental vitiligo. Conclusion: Treatment preference in Dr. Soetomo Hospital 2017 was indicated by the patients’ clinical profiles.

Пимекролимус в лечении атопического дерматита у детей. Вопросы безопасности и эффективности. Опыт пятилетнего применения

A growth in the incidence rate for atopic dermatitis (AD) in infants has been observed for this decade. Early formation of AD (at the age of 3-6 months) is observed in 45% of infants, and in 60% of infants - during the first year of life. As many as 65% of children (by the age of 7) and 74% of children (by the age of 16) suffering from AD have a spontaneous remission of the disease. As many as 20-43% of children suffering from AD further develop bronchial asthma, and the incidence rate of allergic rhinitis is twice as high. In spite of the fact that topical corticosteroids (TCS) are prescribed frequently enough, there is a need in the non-hormonal therapy due to poor compliance with the TCS treatment regimen in connection with side effects. Treatment of AD is often complicated by the colonization with Staphylococcus aureus and inefficacy of the external therapy with topical corticosteroids because many patients with AD have a high level of IgE against the superantigen of Staphylococcus. 1% pimecrolimus cream (PIM) and TCS were compared in a long-term large-scale study involving younger children suffering from mild to moderate AD. Materials and methods. The five-year open-label study involved 2,418 children, who were randomized into groups receiving PIM (n = 1205; in case of an aggravation - short-term administration of TCS) or TCS (n = 1213). The main goal of the study was to compare the safety of these two methods of treatment; an auxiliary goal was to confirm the long-term efficacy of PIM. Treatment was considered to be successful if the score based on the IGA scale was 0 (clean skin) or 1 (almost clean). Results. The effect in both groups of the drugs - PIM and TCS - was fast, and the success of treatment was recorded for &gt;50% of patients by Week 3. In both groups, treatment was determined to be successful after 5 years in &gt;85% of patients, and treatment of manifestations of AD on the face was efficient in 95% of all subjects. In the PIM group, the need in steroids was considerably lower than in the TCS group (7 days of administration vs. 178 days in the TCS group). In both groups, there were adverse events similar by their nature and frequency, and no disorders of humoral or cellular immunity were revealed. Conclusions. The long-term administration of PIM in case of mild to moderate AD in children was revealed to be safe and had no effect on the immune system. When PIM was used, the need in corticosteroids was considerably reduced (steroid-preserving effect). These data confirm that PIM is as efficient as TCS and can be used as the first-line therapy for mild to moderate AD in infants and younger children.

Is topical corticosteroid necessary in traumatic hyphema?

To compare the outcomes in the management of traumatic hyphema treated with topical corticosteroid plus supportive therapy versus only supportive therapy. In this retrospective study, 206 patients were divided into two groups; group I, 98 eyes were treated with topical corticosteroid 12 × 1 and supportive therapy including bed rest, keeping the head elevated (45 degrees), and hydration. In group II, 108 eyes were treated with only supportive therapy. Hyphema size, initial and final visual acuities and intraocular pressure, time to hyphema clearance, and incidence of rebleeding were evaluated. The time needed for hyphema resorption in the two groups were 60.25 ± 33.9 and 62.3 ± 28.9 hours respectively (P=0.62). There was no significant difference in rebleeding rate between the topical corticosteroid group (4.01%) and non-steroid group (6.48%) (P=0.67). The initial and final visual acuities were similar in the two groups (P=0.86). In Groups I and II, the average intraocular pressures were 19.7 ± 8.01 and 14.2 ± 10.2 mmHg respectively. The difference between the two groups was statistically significant (P=0.04). Patients who were treated with topical corticosteroids were no less likely to experience a rebleed or a poor visual outcome than those treated with supportive therapy alone. Supportive therapy alone may be convenient and cost-effective management strategy in uncomplicated traumatic hyphema.

Efficacy of intranasal steroid spray (mometasone furoate) on treatment of patients with seasonal allergic rhinitis: Comparison with oral corticosteroids

Intranasal corticosteroids are effective for allergic rhinitis and broadly used in daily clinical practice. Systemic oral corticosteroids are also known to be effective for treatment of allergic rhinitis. These topical and systemic corticosteroids are both effective formulations for allergic rhinitis, and both drugs have some side effects. When treatment formulations for allergic rhinitis are selected based on side effects, topical corticosteroids are more commonly selected than systemic steroids. Systemic corticosteroids, on the other hand, have traditionally been believed to have higher and more instantaneous therapeutic effects than those of topical corticosteroids. However, there have been few reports of direct comparisons between topical corticosteroid and systemic corticosteroid efficacy. The purpose of this study was to evaluate the subjective outcomes of nasal symptom management using topical intranasal corticosteroid therapy or systemic oral corticosteroid therapy in patients with seasonal allergic rhinitis. We compared the efficacy of mometasone furoate nasal spray (MFNS) to betamethasone oral tablets (BOT) for the treatment of patients with seasonal allergic rhinitis. In an open label study, patients with seasonal allergic rhinitis who had intermediate-to-severe symptoms and who visited the hospital without prior treatment were allocated to 1 of 3 treatment groups (noncorticosteroid group, topical corticosteroid group, and oral corticosteroid group). Evaluation was conducted using allergy diaries that consisted of patient questionnaires. The Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) was used in this study. Compared to only loratazine nonsteroid therapy, both MFNS 200μg once daily and BOT 0.25mg twice daily significantly reduced the total and individual symptom scores for sneezing, nasal obstruction, watery nasal discharge, and nasal itching (P<0.05). Scores for itching of the eyes were reduced slightly more in the MFNS group than in the noncorticosteriod treatment group, but the difference was not significant. MFNS and BOT have virtually equivalent effects on nasal symptoms in patients with seasonal allergies. Our study was the first direct comparison between an intranasal corticosteroid spray and a systemic oral corticosteroid for seasonal allergic rhinitis. No significant differences were found in the therapeutic effects of the topical and systemic corticosteroids tested, suggesting that topical corticosteroids are expected to sufficiently improve nasal symptoms without administration of oral corticosteroids. Treatment with intranasal corticosteroid spray is more strongly recommended than treatment with systemic corticoid steroids, due to the side effects associated with each treatment.

Long‐term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids in adults with moderate to severe atopic dermatitis

OBJECTIVE: This randomized, double‐blind, multi‐centre study compared the long‐term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids (TCS) in 658 adults with moderate–severe atopic dermatitis (AD).METHODS: Patients applied either pimecrolimus or TCS (i.e. 0.1% triamcinolone acetonide cream and/or 1% hydrocortisone acetate cream) twice daily to all affected areas until complete clearance or for up to 1 year. The study was approved by the institutional review board or ethics committee at each centre.RESULTS: A majority of patients treated with either pimecrolimus or TCS used the drug on a continuous basis over 1 year. In patients who had >30% of the body surface involved by AD, the incidence rate of all skin infections was significantly lower in the pimecrolimus group than in the TCS group (95% CI of the treatment difference: −25.3% to −3.4%). The most frequent application site reaction was burning (25.9% of patients on pimecrolimus and 10.9% on TCS), which was transient and mild–moderate in most cases. Three TCS‐treated patients reported skin striae. There were no treatment‐related serious or clinically significant systemic adverse events. Efficacy was better in patients on continuous TCS therapy, although patients completing the study were similarly well‐controlled in both groups. About 42% of the pimecrolimus‐treated patients were maintained for 1 year without TCS.CONCLUSION: Pimecrolimus demonstrated a favourable safety profile when used to treat adult patients with moderate–severe AD for up to 1 year. A significant proportion of patients could be maintained without TCS for a year.