Background Tralokinumab, a fully human immunoglobulin G4 monoclonal antibody that specifically binds to the interleukin-13 cytokine with high affinity, effectively reduces moderate-to-severe atopic dermatitis when given every 2 weeks. The incidence of conjunctivitis is elevated compared to placebo, but severity and etiology have not been examined. Objective To analyze conjunctivitis data recorded in five randomized, placebo-controlled trials of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Methods Overall, 2285 adults with atopic dermatitis were studied up to 16 weeks. Cochran-Mantel-Haenszel weights were applied to calculate adjusted adverse-event incidences. Results Incidence of conjunctivitis was higher (7.5%) with tralokinumab compared to placebo (3.2%). Most events were mild or moderate in severity and 78.6% and 73.9% of events resolved during the trial in the tralokinumab and placebo groups, respectively. Two (1.4%) events led to permanent discontinuation of tralokinumab. An increased incidence of conjunctivitis, regardless of treatment group, was associated with more severe baseline atopic dermatitis, and history of allergic conjunctivitis/atopic keratoconjunctivitis, as well as the number of atopic comorbidities. Limitation This analysis reports events up to Week 16 only, with limited confirmation of conjunctivitis and its etiology by an ophthalmologist and insufficient reporting of ophthalmic treatments. Conclusions Treatment with tralokinumab was associated with increased incidence of conjunctivitis compared to placebo, but these cases were mostly mild and transient.
Amenamevir is a potent helicase–primase inhibitor and a novel class of antiviral agent other than nucleoside compounds, such as aciclovir, valaciclovir and famciclovir. This study is the first randomized, double‐blind, valaciclovir‐controlled phase 3 study to evaluate the efficacy and safety of amenamevir in Japanese patients with herpes zoster when treated within 72 h after onset of rash. A total of 751 patients were randomly assigned to receive either amenamevir 400 mg or 200 mg p.o. once daily or valaciclovir 1000 mg three times daily (daily dose, 3000 mg) for 7 days. The primary efficacy end‐point was the proportion of cessation of new lesion formation by day 4 (“day 4 cessation proportion”). The day 4 cessation proportions for amenamevir 400 and 200 mg and valaciclovir were 81.1% (197/243), 69.6% (172/247) and 75.1% (184/245), respectively. Non‐inferiority of amenamevir 400 mg to valaciclovir was confirmed by a closed testing procedure. Days to cessation of new lesion formation, complete crusting, healing, pain resolution and virus disappearance were evaluated as secondary end‐points. No significant differences were observed in any of the treatment groups. Amenamevir 400 and 200 mg were well tolerated as well as valaciclovir. The proportions of patients who experienced drug‐related adverse events were 10.0% (25/249), 10.7% (27/252) and 12.0% (30/249) with amenamevir 400 and 200 mg and valaciclovir, respectively. In conclusion, amenamevir 400 mg appears to be effective and well tolerated for treatment of herpes zoster in immunocompetent Japanese patients.
DOI: 10.1111/bjd.13377 DEAR EDITOR, Recent studies have shown that adherence to treatment is an important factor for good therapeutic outcome in various chronic disorders such as hypertension and diabe-tes.1,2 In dermatology, patient nonadherence to therapy is also very problematic and has been associated with poor therapeu-tic outcomes in common skin diseases.3–5 Although there is no ‘gold standard ’ to measure medication adherence, an eight-item self-reported scale called the Morisky Medication Adherence Scale-8 (MMAS-8) has been developed by Morisky et al.1 MMAS-8 originally targeted oral medication for hyper-tensive patients, but it is now applied to measure medication adherence in a wide range of disorders such as diabetes and osteoporosis.2,6 However, there are no reports of studies investigating dermatological adherence using this scale. There