USEFULNESS OF RUPATADINE FOR PRURITUS OF PATIENTS WITH ATOPIC DERMATITIS

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  • Hide Michihiro
    Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University
  • Hirata Kazuya
    Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation
  • Komorita Naruyasu
    Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation
  • Kubo Hajime
    Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation
  • Suzuki Takamasa
    Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.
  • Tanaka Ayaka
    Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.
  • Aoki Hiroshi
    Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.

Bibliographic Information

Other Title
  • アトピー性皮膚炎患者のそう痒に対するルパタジンの長期有用性
  • アトピー性皮膚炎患者のそう痒に対するルパタジンの長期有用性 : 皮膚疾患に伴うそう痒を有する患者を対象にした国内第Ⅲ相臨床試験のpost hoc解析
  • アトピーセイ ヒフエン カンジャ ノ ソウ ヨウ ニ タイスル ルパタジン ノ チョウキ ユウヨウセイ : ヒフ シッカン ニ トモナウ ソウ ヨウ オ ユウスル カンジャ オ タイショウ ニ シタ コクナイ ダイ Ⅲ ソウ リンショウ シケン ノ post hoc カイセキ
  • —POST HOC ANALYSIS OF PHASE III CLINICAL TRIAL FOR JAPANESE PATIENTS WITH PRURITUS ASSOCIATED WITH SKIN DISEASES—
  • ―皮膚疾患に伴うそう痒を有する患者を対象にした国内第III相臨床試験のpost hoc解析―

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<p>Background: Histamine H1 receptor antagonists (antihistamines) are recommended as adjunctive therapy for atopic dermatitis (AD). However, their long-term usefulness and the effect of updosing have not been clarified.</p><p>Purpose: To analyzed the long-term usefulness and the effect of updosing of rupatadine, a second generation antihistamine, for patients with AD.</p><p>Methods: Efficacy and safety of rupatadine were evaluated in 66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases.</p><p>Results: The mean score at baseline total pruritus score (TPS) was 4.682. It decreased to 3.885 at 2 weeks, and 2.376 at 52 weeks by rupatadine administration. The change (of one week after baseline TPS) was significant. Baseline TPS of dose escalation groups, either after 2 weeks or after week 4, were higher than those of 10mg maintenance dose cases, but no significant difference was shown in the change from baseline TPS among the groups at 52 weeks. The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.</p><p>Conclusion: These results suggest the long-term usefulness of rupatadine for pruritus in AD.</p>

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