PMID- 37522351 OWN - NLM STAT- MEDLINE DCOM- 20231222 LR - 20231222 IS - 1365-2133 (Electronic) IS - 0007-0963 (Linking) VI - 190 IP - 1 DP - 2023 Dec 20 TI - Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: results from a phase III, randomized, double-blind, placebo-controlled, multicentre study. PG - 20-28 LID - 10.1093/bjd/ljad268 [doi] AB - BACKGROUND: Atopic dermatitis (AD) is a chronic, inflammatory skin condition affecting up to one-quarter of children. Uncontrolled pruritus associated with childhood AD, and the accompanying scratching, negatively impacts quality of life (QoL), sleep and development. The humanized monoclonal antibody nemolizumab, used concomitantly with topical agents, was shown to reduce pruritus and improve QoL in patients with AD aged >/= 13 years. However, data relating to its efficacy and safety in younger children (aged < 13 years) have been lacking. OBJECTIVES: To evaluate the efficacy and safety of nemolizumab, administered concomitantly with topical agents, in Japanese paediatric patients (aged 6-12 years) with AD and inadequately controlled moderate-to-severe pruritus. METHODS: This was a randomized, placebo-controlled, double-blind, parallel-group, multicentre, 16-week, phase III study. Patients aged >/= 6 and < 13 years, with confirmed AD, and an inadequate pruritic response despite treatment with topical agents and oral antihistamines were randomly assigned (1 : 1) to receive nemolizumab 30 mg or placebo every 4 weeks (Q4W). The primary efficacy endpoint was the change in the weekly mean 5-level itch score from baseline to week 16; secondary efficacy endpoints were related to pruritus, indicators for AD and QoL. Safety was assessed via adverse events (AEs) and laboratory test results. RESULTS: In total, 89 patients were enrolled, received either nemolizumab 30 mg (n = 45) or placebo (n = 44) Q4W, and completed the study. The mean patient age was 9.1 (SD 1.9) years, and mean duration of AD was 8.5 (2.7) years. The change in 5-level itch score from baseline to week 16 showed a statistically significant difference in the nemolizumab treatment group (-1.3) compared with placebo (-0.5; least-squares mean difference -0.8, 95% confidence interval -1.1 to -0.5; P < 0.0001). Improvements with nemolizumab were observed from the second day of administration. Secondary endpoints were in favour of nemolizumab. No AEs resulted in discontinuation, and the overall safety profile in patients aged 6-12 years was comparable with that in older patients (aged >/= 13 years) with AD. CONCLUSIONS: Nemolizumab is a potential new treatment option for paediatric patients with AD whose pruritus has not been sufficiently improved with topical treatments and antihistamines. CI - (c) The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. FAU - Igarashi, Atsuyuki AU - Igarashi A AUID- ORCID: 0000-0002-5903-3187 AD - Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan. FAU - Katsunuma, Toshio AU - Katsunuma T AUID- ORCID: 0000-0003-2646-3006 AD - Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan. FAU - Matsumura, Takayo AU - Matsumura T AUID- ORCID: 0000-0002-0986-8469 AD - Clinical Development Department, Maruho Co. Ltd, Kyoto, Japan. FAU - Komazaki, Hiroshi AU - Komazaki H AUID- ORCID: 0000-0002-0426-1553 AD - Clinical Development Department, Maruho Co. Ltd, Kyoto, Japan. CN - Nemolizumab-JP04 Study Group LA - eng GR - Maruho Co. Ltd/ GR - Chugai Pharmaceutical Co. Ltd/ PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - England TA - Br J Dermatol JT - The British journal of dermatology JID - 0004041 RN - GN465U8B72 (nemolizumab) RN - 0 (Histamine Antagonists) SB - IM CIN - Br J Dermatol. 2023 Sep 02;:. PMID: 37658936 CIN - Br J Dermatol. 2023 Dec 20;190(1):e2. PMID: 38124526 MH - Humans MH - Child MH - Aged MH - *Dermatitis, Atopic/complications/drug therapy MH - Quality of Life MH - Injections, Subcutaneous MH - Pruritus/etiology/complications MH - Histamine Antagonists/therapeutic use MH - Double-Blind Method MH - Treatment Outcome MH - Severity of Illness Index COIS- Conflicts of interest A.I. reports receiving grants and honoraria from Maruho Co. Ltd; and honoraria from AbbVie, Eli Lilly Japan, Japan Tobacco Inc., LEO Pharma, Novartis, Sanofi and Torii Pharmaceutical Co. Ltd. T.K. reports receiving grants and honoraria from Maruho Co. Ltd; grants from Grafa Laboratories; and honoraria from AbbVie, AstraZeneca, Kyorin Pharmaceutical Co. Ltd, Mitsubishi Tanabe Pharma, Sanofi, Taiho Pharma, Teijin and Torii Pharmaceutical Co. Ltd. T.M. and H.K. are employees of Maruho Co. Ltd. FIR - Takahashi, Hidetoshi IR - Takahashi H FIR - Miura, Katsushi IR - Miura K FIR - Horino, Satoshi IR - Horino S FIR - Yoshihara, Shigemi IR - Yoshihara S FIR - Maeda, Shozo IR - Maeda S FIR - Akashi, Masayuki IR - Akashi M FIR - Hamahata, Yuko IR - Hamahata Y FIR - Nezu, Yoko IR - Nezu Y FIR - Masuda, Kei IR - Masuda K FIR - Shirakawa, Seigo IR - Shirakawa S FIR - Katsunuma, Toshio IR - Katsunuma T FIR - Ohya, Yukihiro IR - Ohya Y FIR - Yanagida, Noriyuki IR - Yanagida N FIR - Tadaki, Hiromi IR - Tadaki H FIR - Fukuzawa, Masao IR - Fukuzawa M FIR - Kaneko, Hideo IR - Kaneko H FIR - Takahashi, Kazuhiro IR - Takahashi K FIR - Funato, Michinori IR - Funato M FIR - Futamura, Masaki IR - Futamura M FIR - Kodera, Masanari IR - Kodera M FIR - Takasato, Yoshihiro IR - Takasato Y FIR - Fujisawa, Takao IR - Fujisawa T FIR - Kume, Akihiro IR - Kume A FIR - Taketani, Takeshi IR - Taketani T FIR - Murakami, Youko IR - Murakami Y FIR - Wakatsuki, Masatoshi IR - Wakatsuki M FIR - Igawa, Satomi IR - Igawa S FIR - Tomiita, Minako IR - Tomiita M FIR - Suzuki, Shuichi IR - Suzuki S FIR - Narita, Masami IR - Narita M FIR - Yoshida, Koichi IR - Yoshida K FIR - Kondo, Yasuto IR - Kondo Y FIR - Kiyomasu, Takahiro IR - Kiyomasu T FIR - Takemura, Yutaka IR - Takemura Y FIR - Manki, Akira IR - Manki A FIR - Hide, Michihiro IR - Hide M FIR - Tanaka, Akio IR - Tanaka A FIR - Tezuka, Junichiro IR - Tezuka J FIR - Ikeda, Masanori IR - Ikeda M FIR - Yamaide, Fumiya IR - Yamaide F FIR - Nakano, Taiji IR - Nakano T EDAT- 2023/07/31 13:08 MHDA- 2023/12/22 06:42 CRDT- 2023/07/31 06:34 PHST- 2023/05/17 00:00 [received] PHST- 2023/07/24 00:00 [revised] PHST- 2023/07/25 00:00 [accepted] PHST- 2023/12/22 06:42 [medline] PHST- 2023/07/31 13:08 [pubmed] PHST- 2023/07/31 06:34 [entrez] AID - 7233858 [pii] AID - 10.1093/bjd/ljad268 [doi] PST - ppublish SO - Br J Dermatol. 2023 Dec 20;190(1):20-28. doi: 10.1093/bjd/ljad268.