Nemolizumab plus topical agents in patients with atopic dermatitis (AD) and moderate-to-severe pruritus provide improvement in pruritus and signs of AD for up to 68 weeks: results from two phase III, long-term studies.

BACKGROUND: Interleukin (IL)-31 affects the inflammatory response, is involved in epidermal barrier disruption in atopic dermatitis (AD) and plays a key role in pruritus. Nemolizumab, a humanized monoclonal antibody against IL-31 receptor A, reduced pruritus in patients with AD after a 16-week administration period. OBJECTIVES: To examine the long-term effectiveness and safety of nemolizumab in patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus. METHODS: In two long-term phase III studies, nemolizumab 60 mg every 4 weeks (Q4W) was administered subcutaneously, concomitantly with topical treatments. Study-JP01 patients received double-blind nemolizumab or placebo for 16 weeks, and then entered a 52-week extension period in which all patients received nemolizumab (nemolizumab/nemolizumab and placebo/nemolizumab groups). Study-JP02 patients received nemolizumab for 52 weeks. Both studies included an 8-week follow-up period. RESULTS: Study-JP01 nemolizumab/nemolizumab and placebo/nemolizumab, and Study-JP02 nemolizumab groups comprised 143, 72 and 88 patients, respectively. In the nemolizumab/nemolizumab group, there were clinically meaningful improvements from the start of treatment to week 68 in the pruritus visual analogue scale (66% decrease) and Eczema Area and Severity Index (78% decrease). Quality of life (QoL) indicators improved after the first nemolizumab dose; improvements were maintained during the follow-up period. The long-term safety profile was consistent with previous studies, with no unexpected late-onset adverse events. CONCLUSIONS: Nemolizumab 60 mg Q4W with concomitant topical treatments in patients with AD and inadequately controlled moderate-to-severe pruritus produced a continuous improvement in pruritus, signs of AD, and QoL for up to 68 weeks, with a favourable safety profile.

[Parasomnia associated with abnormal REM sleep in the aged].

Three aged patients (age 63-78 years) had 3-15-year histories of abnormal behaviors during nocturnal sleep. These three patients presented no other psychiatric problems. Polysomnographic recordings were carried out from 1-3 nights after adaptation. The patients were simultaneously monitored via a video system during the recording period. Various nocturnal behaviors, including laughing, weeping, the shaking of arms and getting up were detected during these recordings. These behaviors appeared exclusively during REM periods which were associated with a large amount of abnormal REM sleep lacking muscle atonia (d-STREM with EMG). NREM sleep architecture was intact and %SWS was within the normal limits per age for all the patients. The patients, manifesting such abnormal behaviors during sleep, could be aroused completely with awakening stimuli, and could recall in detail their unpleasant dreams. Two of the three were treated with clonazepam (0.5-1 mg/day) which immediately decreased the abnormal behaviors during sleep. Polysomnographic studies after the treatment showed a marked decrease in the d-STREM with EMG. The above results indicate that these abnormal behavior during nocturnal sleep were closely linked to d-STREM with EMG. And the administration of clonazepam not only led to an amelioration in the abnormal behaviors but also in the polysomnographic pathology. It is concluded that parasomnia in the aged is characterized by behavioral manifestations of the dreaming due to dysfunctions of the muscle atonia system.