{"id":334998,"date":"2020-01-13T01:00:00","date_gmt":"2020-01-13T00:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/high-response-rate-maintained-over-4-years\/"},"modified":"2020-01-13T01:00:00","modified_gmt":"2020-01-13T00:00:00","slug":"high-response-rate-maintained-over-4-years","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/high-response-rate-maintained-over-4-years\/","title":{"rendered":"High response rate maintained over 4 years"},"content":{"rendered":"

Recently presented long-term data from the VOYAGE 1 Phase III clinical trial demonstrate that 84% of patients continued to achieve PASI-90 at 204 weeks.<\/strong><\/p>\n

<\/p>\n

The monoclonal antibody guselkumab (TREMFYA\u00ae<\/sup>) has been approved in Switzerland since 2018 in adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy [1]. In the pivotal VOYAGE 1 trial (n=837), guselkumab was shown to be significantly superior to adalimumab and placebo in all primary endpoints (PASI-90 response) and key secondary endpoints (IGA 0\/1, PASI-75 response).<\/p>\n

Sustained high efficacy and tolerability<\/h2>\n

Four-year data from the open-label phase of the multicenter, randomized, double-blind VOYAGE 1 study are now available and were presented at the 39th Fall Clinical Dermatology Conference in Las Vegas (USA) [2]: The proportion of patients with PASI 90 remained continuously stable until week 204: 8 out of 10 patients showed a PASI-90 response under guselkumab over this time period (Fig. 1).<\/strong> 82% of patients receiving TREMFYA\u00ae<\/sup> (guselkumab) in the combined group of patients initially randomized to the guselkumab or placebo condition with a switch to guselkumab at week 16 achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) at week 204. In addition, an IGA score of 0 (lesion-free) or 1 (nearly lesion-free) was measurable at this measurement time point.<\/p>\n

 <\/p>\n

\"\"<\/p>\n

 <\/p>\n

Guselkumab (TREMFYA\u00ae<\/sup>) is the first approved all-human monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor [1]. This substance thus blocks the release of these inflammatory cytokines, which are involved in the formation of plaques in psoriasis.  TREMFYA\u00ae<\/sup> was generally well tolerated by patients with psoriasis during clinical development [3\u20135]. Also, no new safety signals were identified over the open-label period of 4 years [2].<\/p>\n

VOYAGE 1 Phase III Follow-up Study<\/h2>\n

Subjects were randomly assigned at baseline to placebo, guselkumab, or adalimumab conditions. The placebo-controlled treatment phase lasted from week 0 to 16, after which patients in the placebo condition were switched to guselkumab until week 48, and a comparison was made with the active substance adalimumab (weeks 0-48). Study participants were randomized to guselkumab at week 0, and those who switched from placebo to guselkumab at week 16 received guselkumab at week 48, 8 weeks apart. From week 52, all participants received guselkumab. Efficacy was assessed using the Psoriasis Area and Severity Index (PASI75\/90\/100) and IGA scores (0=lesion-free, 1=almost lesion-free). Missing data were calculated using the following methods: NRI (“Non-Responder Imputation Rules”), TFR (“Treatment Failure”) and OBS (“As Observed”).<\/p>\n

Source: Janssen-Cilag AG   <\/em><\/p>\n

 <\/p>\n

Literature:<\/p>\n

    \n
  1. Technical Information Tremfya\u00ae<\/sup>, 02\/2019, www.swissmedicinfo.ch, last accessed 24 Oct 2019.<\/li>\n
  2. Griffiths CE, et al: Maintenance of response with up to 4 years of continuous guselkumab treatment: results from the VOYAGE 1 phase 3 trial. Falls Clinical Dermatology Conference. Oct, 2019; Las Vegas, USA.<\/li>\n
  3. Blauvelt A, et al: Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017; 76(3): 405-417.<\/li>\n
  4. Reich K, et al: Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017; 76(3): 418-431.<\/li>\n
  5. Langley R, et al: Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2018; 178(1): 114-123.<\/li>\n<\/ol>\n

     <\/p>\n

    DERMATOLOGIE PRAXIS 2019; 29(6): 31 (published 8\/12\/19, ahead of print).<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Recently presented long-term data from the VOYAGE 1 Phase III clinical trial demonstrate that 84% of patients continued to achieve PASI-90 at 204 weeks.<\/p>\n","protected":false},"author":7,"featured_media":93400,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Guselkumab ","footnotes":""},"category":[11340,11530,11548,11503],"tags":[14032,26569],"powerkit_post_featured":[],"class_list":["post-334998","post","type-post","status-publish","format-standard","has-post-thumbnail","category-dermatology-and-venereology","category-market-medicine","category-rx-en","category-studies","tag-psoriasis-en-2","tag-risankizumab-en","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-06-20 20:06:24","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":334902,"slug":"maintien-dun-taux-de-reponse-eleve-pendant-4-ans","post_title":"Maintien d'un taux de r\u00e9ponse \u00e9lev\u00e9 pendant 4 ans","href":"https:\/\/medizinonline.com\/fr\/maintien-dun-taux-de-reponse-eleve-pendant-4-ans\/"},"it_IT":{"locale":"it_IT","id":334906,"slug":"alto-tasso-di-risposta-mantenuto-per-4-anni","post_title":"Alto tasso di risposta mantenuto per 4 anni","href":"https:\/\/medizinonline.com\/it\/alto-tasso-di-risposta-mantenuto-per-4-anni\/"},"pt_PT":{"locale":"pt_PT","id":335003,"slug":"elevada-taxa-de-resposta-mantida-ao-longo-de-4-anos","post_title":"Elevada taxa de resposta mantida ao longo de 4 anos","href":"https:\/\/medizinonline.com\/pt-pt\/elevada-taxa-de-resposta-mantida-ao-longo-de-4-anos\/"},"es_ES":{"locale":"es_ES","id":334967,"slug":"alto-indice-de-respuesta-mantenido-durante-4-anos","post_title":"Alto \u00edndice de respuesta mantenido durante 4 a\u00f1os","href":"https:\/\/medizinonline.com\/es\/alto-indice-de-respuesta-mantenido-durante-4-anos\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/334998","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=334998"}],"version-history":[{"count":0,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/334998\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/93400"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=334998"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=334998"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=334998"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=334998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}