{"id":7825,"date":"2024-03-11T07:46:16","date_gmt":"2024-03-11T06:46:16","guid":{"rendered":"https:\/\/shams-alyaoum.com\/en\/?p=7825"},"modified":"2024-03-11T07:46:23","modified_gmt":"2024-03-11T06:46:23","slug":"galderma-aad-2024-new-data-demonstrate-the-long-term-efficacy-of-nemolizumab-in-prurigo-nodularis-and-its-durability-in-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/shams-alyaoum.com\/en\/galderma-aad-2024-new-data-demonstrate-the-long-term-efficacy-of-nemolizumab-in-prurigo-nodularis-and-its-durability-in-atopic-dermatitis\/","title":{"rendered":"Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis"},"content":{"rendered":"<div class=\"printarea\">\n<ul class=\"bwlistdisc\">\n<li>Nemolizumab is a first-in-class investigational monoclonal antibody designed to provide relief from itch by targeting IL-31<\/li>\n<li>One-year data from an interim analysis of the OLYMPIA long-term extension (LTE) study show that more than 80% of nemolizumab-treated patients with prurigo nodularis experienced improvement in itch and more than 60% achieved clear or almost-clear skin<sup>1<\/sup><\/li>\n<li>Results from the phase III ARCADIA clinical trials in atopic dermatitis show that nemolizumab-treated patients who responded at 16 weeks maintained skin and itch responses through to week 48, even when dosing was reduced from every four to every eight weeks<sup>2<\/sup><\/li>\n<li>These new data build on results from the phase III OLYMPIA and ARCADIA clinical trial programs and demonstrate nemolizumab\u2019s long-term and long-lasting benefit in prurigo nodularis and atopic dermatitis, respectively<sup>1-5<\/sup><\/li>\n<\/ul>\n<div class=\"content content-justify \">\n<p>&nbsp;<\/p>\n<p>(<a href=\"http:\/\/www.businesswire.com\/\">BUSINESS WIRE<\/a>)&#8211;Galderma today announced new data demonstrating nemolizumab\u2019s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.<sup>1<\/sup>\u00a0Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).<sup>2<\/sup>\u00a0These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.<\/p>\n<table class=\"bwtablemarginb bwblockalignc\" cellspacing=\"0\">\n<tbody>\n<tr>\n<td class=\"bwvertalignt bwrowaltcolor0 bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\u201cWe\u2019re excited to see the evidence base for nemolizumab continue to<br \/>\nbuild and strengthen for these debilitating diseases, where symptoms<br \/>\nsuch as intense itch can put a significant burden on quality of life.<br \/>\nHaving already demonstrated nemolizumab\u2019s efficacy and rapid onset<br \/>\nof action, these new results show its long-term benefit and durability of<br \/>\nresponse in prurigo nodularis and atopic dermatitis, respectively.\u201d<\/p>\n<p class=\"bwalignc bwcellpmargin\"><b>BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.<\/b><br \/>\n<b>GLOBAL HEAD OF R&amp;D<\/b><br \/>\n<b>GALDERMA<\/b><\/p>\n<p class=\"bwalignc bwcellpmargin\">\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Building on the results of\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.galderma.com%2Fnews%2Fgalderma-eadv-2023-phase-iii-trials-demonstrate-nemolizumabs-efficacy-and-rapid-onset-action&amp;esheet=53907380&amp;newsitemid=20240310697617&amp;lan=en-US&amp;anchor=OLYMPIA+1&amp;index=1&amp;md5=af26d03ce9fb3a5f1a5131fb56385d8f\" rel=\"nofollow\" shape=\"rect\">OLYMPIA 1<\/a>\u00a0and\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.galderma.com%2Fnews%2Fgalderma-phase-iii-data-published-new-england-journal-medicine-full-olympia-2-trial-results&amp;esheet=53907380&amp;newsitemid=20240310697617&amp;lan=en-US&amp;anchor=OLYMPIA+2&amp;index=2&amp;md5=3bc759664afc43ddb33be4f9602771b0\" rel=\"nofollow\" shape=\"rect\">OLYMPIA 2<\/a>, the OLYMPIA open-label LTE study is an ongoing 184-week trial to evaluate the long-term efficacy and safety of nemolizumab monotherapy (without topical corticosteroids) in patients with moderate to severe prurigo nodularis who had received nemolizumab in phase II and III lead-in trials as well as those who had previously received placebo (nemolizumab-na\u00efve).<sup>1,4,5<\/sup><\/p>\n<p>Results from an interim analysis of the OLYMPIA LTE study demonstrated that nemolizumab treatment provided continuous improvement in skin lesions and itch up to week 52:<sup>1<\/sup><\/p>\n<ul class=\"bwlistdisc\">\n<li>69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-na\u00efve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator\u2019s Global Assessment (IGA) score<\/li>\n<li>89% of those who had received continuous nemolizumab treatment and 83% of nemolizumab-na\u00efve patients achieved a significant response on itch intensity as measured by an at least four-point improvement on the peak-pruritus numerical rating scale (PP-NRS)<\/li>\n<\/ul>\n<p>Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).<sup>1<\/sup><\/p>\n<p>Results also reinforced nemolizumab\u2019s rapid onset of action, with nemolizumab-na\u00efve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week four, consistent with the continuous-nemolizumab cohort. No new safety signals were observed.<sup>1<\/sup><\/p>\n<p>Galderma also presented results from an analysis of maintenance data from two pivotal phase III trials of nemolizumab (administered with background topical corticosteroid therapy or topical calcineurin inhibitors) in adolescent and adult patients with moderate to severe atopic dermatitis (<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.galderma.com%2Fnews%2Fgalderma-eadv-2023-phase-iii-trials-demonstrate-nemolizumabs-efficacy-and-rapid-onset-action&amp;esheet=53907380&amp;newsitemid=20240310697617&amp;lan=en-US&amp;anchor=ARCADIA+1+and+ARCADIA+2&amp;index=3&amp;md5=62632f0b47efca3d27664e7e1c0d31f6\" rel=\"nofollow\" shape=\"rect\">ARCADIA 1 and ARCADIA 2<\/a>).<sup>2,3<\/sup><\/p>\n<p>Out of the patients who had clinical responses to skin lesions* at week 16 in ARCADIA 1 and 2, the majority maintained skin and itch responses at week 48 when receiving nemolizumab Q4W or Q8W in the maintenance phase:<sup>2<\/sup><\/p>\n<ul class=\"bwlistdisc\">\n<li>62% of those receiving nemolizumab Q4W and 60% of those receiving nemolizumab Q8W maintained clearance or almost-clearance of skin lesions, when assessed using the IGA score, compared to 50% receiving placebo<\/li>\n<li>The Eczema Area and Severity Index (EASI)-75 score was also maintained in 76% of those receiving nemolizumab\u2014both Q4W and Q8W\u2014compared to 64% receiving a placebo<\/li>\n<li>Itch response, as measured by an at least four-point improvement in weekly average PP-NRS score, was similarly maintained in the majority of patients receiving nemolizumab\u2014both Q4W and Q8W\u2014compared to placebo<\/li>\n<\/ul>\n<p><i>*Defined as patients who achieved an IGA score of clear (0) or almost-clear (1), or a 75% or greater improvement in the EASI score<\/i><\/p>\n<p>Response in sleep and quality of life, as measured by the SD-NRS and DLQI scales, respectively, were also well maintained.<sup>2<\/sup>\u00a0The safety profile was consistent across treatment arms and most treatment-related adverse events were non-serious and mild\/moderate in intensity.<sup>2<\/sup><\/p>\n<p>The U.S. Food and Drug Administration (FDA) and European Medicines Agency accepted filing submissions for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024. Nemolizumab was also granted U.S. FDA Priority Review for prurigo nodularis. Further submissions to regulatory authorities in additional countries are planned in 2024.<\/p>\n<p><b>About prurigo nodularis<\/b><br \/>\nPrurigo nodularis is a chronic, debilitating and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.<sup>6-8<\/sup>\u00a0Prurigo nodularis is an underrecognized and underdiagnosed skin disease.<sup>7,9<\/sup><\/p>\n<p><b>About atopic dermatitis<\/b><br \/>\nAtopic dermatitis is a common, chronic and flaring inflammatory skin disease characterized by persistent itch and recurrent skin lesions.<sup>10,11<\/sup>\u00a0It impacts more than 230 million people worldwide and is the most common inflammatory skin disease.<sup>10<\/sup><\/p>\n<p><b>About the OLYMPIA LTE study<\/b><br \/>\nOLYMPIA-LTE is a 184-week open-label study designed to evaluate the long-term efficacy and safety of nemolizumab in patients with moderate to severe prurigo nodularis.<sup>1<\/sup>\u00a0The study includes eligible patients with prurigo nodularis from phase II and phase III lead-in studies, including those who received nemolizumab and those who had previously received placebo (nemolizumab-na\u00efve). The study is ongoing.<sup>1<\/sup><\/p>\n<p><b>About the ARCADIA phase III clinical trial program<\/b><br \/>\nThe ARCADIA program included two identically designed, pivotal phase III clinical trials which enrolled more than 1,700 patients: ARCADIA 1 and ARCADIA 2.<sup>12,13<\/sup>\u00a0These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroid therapy or topical calcineurin inhibitors).<sup>12,13\u00a0<\/sup>The trials were conducted in adolescent (12 years and over) and adult patients with moderate to severe atopic dermatitis for an initial treatment phase of 16 weeks, followed by a maintenance treatment phase for up to 48 weeks.<sup>12,13\u00a0<\/sup>The two phase III ARCADIA trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab rapidly and significantly improves itch, skin lesions and sleep disturbance in patients with moderate to severe atopic dermatitis.<sup>3<\/sup><\/p>\n<p><b>About nemolizumab<\/b><br \/>\nNemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except in Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis. Nemolizumab is under regulatory review for the treatment of patients with prurigo nodularis and moderate to severe atopic dermatitis by the U.S. Food and Drug Administration and European Medicines Agency. Galderma has not received regulatory approval for nemolizumab for any indication in any country to date.<\/p>\n<p><b>About Galderma<\/b><br \/>\nGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body\u2019s largest organ\u2014the skin\u2014meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information:\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.galderma.com%2F&amp;esheet=53907380&amp;newsitemid=20240310697617&amp;lan=en-US&amp;anchor=www.galderma.com.&amp;index=4&amp;md5=2bd3775381bbb7a7b8d7a811d0eaebc8\" rel=\"nofollow\" shape=\"rect\">www.galderma.com.<\/a><\/p>\n<p><b>References:<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li>Kwatra, S, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: an interim analysis. Late-breaking abstract presented at AAD 2024.<\/li>\n<li>Silverberg, J, et al. Maintenance of efficacy and safety with nemolizumab at Week 48: results from two global phase III pivotal studies (ARCADIA 1 and ARCADIA 2) in patients with moderate-to-severe atopic dermatitis\u200b. Late-breaking abstract presented at AAD 2024<\/li>\n<li>Silverberg J, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented at EADV 2023<\/li>\n<li>St\u00e4nder S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1). Late-breaking abstract presented at EADV 2023.<\/li>\n<li>Kwatra SG, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis.\u00a0<i>N Engl J Med<\/i>. 2023;389:1579-89. DOI: 10.1056\/NEJMoa2301333<\/li>\n<li>Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo.\u00a0<i>J Eur Acad Dermatol Venereol<\/i>. 2018;32(7):1059-1065. doi:10.1111\/jdv.14570<\/li>\n<li>Huang AH, et al. Prurigo nodularis: epidemiology and clinical features.\u00a0<i>J Am Acad Dermatol<\/i>. 2020;83(6):1559-1565. doi:10.1016\/j.jaad.2020.04.183<\/li>\n<li>St\u00e4nder S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis.\u00a0<i>Itch<\/i>. 2020;5(4):e42. doi:10.1097\/itx.0000000000000042<\/li>\n<li>Kwatra SG, et al. Patient journey and the burden of systemic comorbidities and sequalae in prurigo nodularis.\u00a0<i>J Drugs Dermatol<\/i>. 2023;22(12): 12-14. doi:10.36849\/JDD.SF365502<\/li>\n<li>Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016\/S0140-6736(20)31286-1<\/li>\n<li>St\u00e4nder S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056\/NEJMra2023911<\/li>\n<li>ClinicalTrials.Gov. Efficacy &amp; Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online:\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03989349&amp;esheet=53907380&amp;newsitemid=20240310697617&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03989349&amp;index=5&amp;md5=3fbabfeb38c4dd9f398ec9b79d5b6ef8\" rel=\"nofollow\" shape=\"rect\">https:\/\/clinicaltrials.gov\/study\/NCT03989349<\/a>. Last accessed February 2024<\/li>\n<li>ClinicalTrials.Gov. Efficacy &amp; Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online:\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03985943&amp;esheet=53907380&amp;newsitemid=20240310697617&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03985943&amp;index=6&amp;md5=78f087bf3f5ccd3ff78e6d753d175373\" rel=\"nofollow\" shape=\"rect\">https:\/\/clinicaltrials.gov\/study\/NCT03985943<\/a>\u00a0Last accessed February 2024<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<\/div>\n<div class=\"permalink\"><\/div>\n<div>\n<h3>Contacts<\/h3>\n<div class=\"content\">\n<div class=\"hd\">\n<p class=\"c epi-chromeHeader\"><b>For further information:<\/b><br \/>\nChristian Marcoux, M.Sc.<br \/>\nChief Communications Officer<br \/>\n<a href=\"mailto:christian.marcoux@galderma.com\" rel=\"nofollow\" shape=\"rect\">christian.marcoux@galderma.com<\/a><br \/>\n+41 76 315 26 50<\/p>\n<p>S\u00e9bastien Cros<br \/>\nCorporate Communications Director<br \/>\n<a href=\"mailto:sebastien.cros@galderma.com\" rel=\"nofollow\" shape=\"rect\">sebastien.cros@galderma.com<\/a><br \/>\n+41 79 529 59 85<\/p>\n<p>Emil Ivanov<br \/>\nHead of Strategy, Investor Relations, and ESG<br \/>\n<a href=\"mailto:emil.ivanov@galderma.com\" rel=\"nofollow\" shape=\"rect\">emil.ivanov@galderma.com<\/a><br \/>\n+41 21 642 78 12<\/p>\n<p>Jessica Cohen<br \/>\nInvestor Relations and Strategy Director<br \/>\n<a href=\"mailto:jessica.cohen@galderma.com\" rel=\"nofollow\" shape=\"rect\">jessica.cohen@galderma.com<\/a><br \/>\n+41 21 642 76 43<\/p>\n<\/div>\n<div id=\"bwContactsFoot\" class=\"ft\">\n<div class=\"c\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"row\"><\/div>\n<\/div>\n<div class=\"post_footer\">\n<div class=\"row\">\n<div class=\"col-md-6 post-box-previous-container \">\n<div class=\"footer-post-next-title\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nemolizumab is a first-in-class investigational monoclonal antibody designed to provide relief from itch by targeting IL-31 One-year data from an interim analysis of the OLYMPIA long-term extension (LTE) study show that more than 80% of nemolizumab-treated patients with prurigo nodularis experienced improvement in itch and more than 60% achieved clear or almost-clear skin1 Results from &hellip;<\/p>\n","protected":false},"author":1,"featured_media":7826,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28,17],"tags":[1228,1226,1227],"class_list":["post-7825","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-economy","tag-arcadia","tag-nemolizumab","tag-www-galderma-com"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - 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