Omalizumab (Xolair^®) was added to the list of treatments for chronic spontaneous urticaria in 2017. The following year saw the publication of international and Japanese Dermatological Association guidelines giving detailed instructions for omalizumab use in chronic spontaneous urticaria treatment. However, no studies in Japan have yet analyzed the effects of this drug on. The medial records of 105 patients who received omalizumab 300 mg / month for chronic spontaneous urticaria between June 2017 and March 2021 at Tokyo Medical University Hospital were retrospectively analyzed. The cohort consisted of 23 males and 82 females with the average age of 45.4 ± 16.0 years. The duration of symptoms was 46.9 ± 99.4 months. Only patients with 16 points on the urticaria control test at three months after treatment initiation were considered to have completed the treatment. The average number of completed treatments was 6.4 ± 4.1. Nine patients experienced a recurrence; of these, seven discontinued omalizumab treatment after six or fewer doses. The patients with a recurrence improved after resuming omalizumab administration, and five of these patients completed the treatment. Omalizumab has fewer adverse effects than cyclosporine. In 2018, the criteria for facilities permitted to use the drug were broadened to “allow the use of omalizumab by allergologists and dermatologists at the relevant facility or in coordination with neighboring medical institutions to treat asthma, anaphylaxis, and other adverse effects.” Omalizumab is effective against severe chronic spontaneous urticaria; its use it therefore expected to become widespread among dermatologists.

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Objective: We investigated a novel Janus kinase inhibitor, 0.5% delgocitinib ointment, in adult patients with atopic dermatitis. The efficacy was evaluated by body region and sign, and the safety by body region. Methods: A Japanese phase III study of delgocitinib ointment, in adult patients with moderate to severe atopic dermatitis, was comprised of 2 parts; part 1 lasted 4 weeks and consisted of a placebo-controlled, double-blind, comparative study (N = 158); part 2 continued over 24 weeks and was an uncontrolled, open-label, continuous administration study (N = 126). The efficacy by body region and sign was analyzed by the Eczema Area and Severity Index (EASI) score in part 1, and the safety by body region was analyzed throughout parts 1 and 2. Results: For all the body regions evaluated, including head and neck, upper extremities, trunk, and lower extremities, EASI score changes by body region were significantly greater in the delgocitinib group than those in the placebo group (all p < 0.0001) in part 1. The change in EASI scores by sign was significantly greater in the delgocitinib group than that in the placebo group for erythema, edema/papulation, excoriation, and lichenification (all p < 0.0001). The incidence of adverse drug reactions was 5 in 5 patients (4.7%) in the delgocitinib group and 2 in 1 patient (1.9%) in the placebo group in part 1, and there was no difference in the incidence of adverse drug reactions by body region in parts 1 and 2. Conclusions: Delgocitinib ointment was effective in moderate to severe atopic dermatitis in adult Japanese patients, irrespective of the body region and sign of the disease. Delgocitinib ointment was well tolerated for up to 28 weeks, regardless of the body region of application.

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Ozenoxacin lotion (Zebiax^® Lotion 2%) is a topical quinolone antimicrobial agent approved for the treatment of acne accompanied by suppurative inflammation and superficial skin infections in September 2015. The safety and efficacy were evaluated in the drug use-results survey (observation period: until 7 days after the start date of use) starting in April 2016 for superficial skin infections in clinical practice. Although 4 adverse drug reactions were observed in 4 out of 310 cases (1.29%) in the safety analysis set, all of these reactions were non-serious and developed in patients with impetigo contagiosa aged younger than 13 years who were not included in domestic clinical studies. The adverse reactions included 1 event each of contact dermatitis, application site irritation, application site pain and application site eczema. With regard to the clinical effect, the rate of "markedly effective" and "effective" (efficacy rate) is 67.9% (209/308) of all the cases and the efficacy rate by disease was 53.1% (85/160) for folliculitis, 76.5% (13/17) for purulent periporitis and 84.7% (111/131) for impetigo contagiosa. The efficacy rate in patients aged younger than 13 years was 80.4% (115/143). These results indicate that this drug is useful in superficial skin infections in real clinical settings and also the effectiveness was confirmed on purulent periporitis and impetigo contagiosa that have not been investigated in the domestic clinical studies. It was indicated that by using this drug with caution against irritation in the applied sites, it may become a useful treatment option also in patients aged younger than 13 years.

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