{"id":334126,"date":"2020-06-01T01:00:00","date_gmt":"2020-05-31T23:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/now-also-available-as-a-patient-friendly-ready-to-use-pen\/"},"modified":"2020-06-01T01:00:00","modified_gmt":"2020-05-31T23:00:00","slug":"now-also-available-as-a-patient-friendly-ready-to-use-pen","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/now-also-available-as-a-patient-friendly-ready-to-use-pen\/","title":{"rendered":"Now also available as a patient-friendly ready-to-use pen"},"content":{"rendered":"<p><strong>The device, which was recently approved by Swissmedic, enables psoriasis sufferers to self-administer the biologic in single doses. It is currently the only IL23 inhibitor available in Switzerland in the form of a patient-controlled injector.  <\/strong><\/p>\n<p> <!--more--> <\/p>\n<p>The new TREMFYA\u00ae <sup>prefabricated<\/sup> pen [1] is not an autoinjector as with other biologics in the therapy of moderate to severe plaque psoriasis. The innovative design of the TREMFYA\u00ae <sup>prefabricated<\/sup> pen allows patients to control the intensity and pressure of their injection themselves. In the ORION study, nearly 99% of patients reported a successful first injection [2]. In addition, the pre-filled pen includes a safety system to protect the needle after use. Even after three injections, patients in the study continued to rate the use of the <sup>TREMFYA\u00ae<\/sup> pen as positive [2].  &nbsp;<\/p>\n<h2 id=\"convincingly-simple-handling\">Convincingly simple handling<\/h2>\n<p>Psoriasis patients sometimes have difficulty with self-administered forms of treatment due to a number of factors. In the randomized phase III ORION trial [2] conducted at multiple study sites, patients&#8217; subjective assessment in this regard was evaluated using a validated questionnaire (Self-Injection Assessment Questionnaire, SIAQ) [3]. This involved assessing patients&#8217; experiences with the TREMFYA\u00ae <sup>prefabricated<\/sup> pen at weeks 0, 4, and 12 on a scale of 0 (&#8220;worst&#8221;) to 10 (&#8220;best&#8221;) using the following six criteria:<\/p>\n<ul>\n<li>Sensations regarding injections<\/li>\n<li>Self-image, self-confidence<\/li>\n<li>Pain and skin reactions during or after injection<\/li>\n<li>Ease of use of the device<\/li>\n<li>Satisfaction with self-injection<\/li>\n<\/ul>\n<p>The mean score for the criterion &#8220;satisfaction with self-injection&#8221; in the study was 9.18 points (10=&#8221;very satisfied&#8221;) and the mean score for &#8220;ease of use&#8221; was 9.24&nbsp; points (10=&#8221;very easy&#8221;) [2].<\/p>\n<h2 id=\"\">&nbsp;<\/h2>\n<h2 id=\"-2\"><img fetchpriority=\"high\" decoding=\"async\" class=\" size-full wp-image-13337\" alt=\"\" src=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2020\/06\/fertigpen_dp1_s37.jpg\" style=\"height:452px; width:600px\" width=\"1100\" height=\"829\"><\/h2>\n<h2 id=\"-3\">&nbsp;<\/h2>\n<h2 id=\"good-efficacy-and-safety\">Good efficacy and safety<\/h2>\n<p>In the ORION study efficacy and safety review, a significantly greater proportion of study participants achieved clearance of IGA0 or IGA1 (81% vs. 0%) and a PASI 90 response rate (76% vs. 0%), respectively, at week 16 in the TREMFYA\u00ae <sup>pre-cast<\/sup> group compared to placebo. The proportion of participants achieving a PASI100 response at week 16 was also significantly higher in the TREMFYA\u00ae <sup>pre-cast<\/sup> group than in the placebo group (50% vs. 0%). The majority of injection site reactions with the TREMFYA\u00ae prefabricated pen were mild and transient in nature [2].<\/p>\n<p>Already in summer 2018, <sup>TREMFYA\u00ae<\/sup> (guselkumab) in conventional administration form had received marketing authorization in Switzerland for the treatment of adult patients with moderate to severe plaque psoriasis and inadequate response to other systemic therapies or PUVA [1]. Guselkumab was generally well tolerated by patients with psoriasis during clinical development [4\u20136]. Also, over the open-label period of 4 years, no new safety signals were identified with the use of this fully human monoclonal antibody [7].<\/p>\n<h2 id=\"the-most-important-in-a-nutshell\">The most important in a nutshell<\/h2>\n<ul>\n<li>The TREMFA\u00ae <sup>prefabricated<\/sup> pen is a patient-controlled injector.&nbsp; It is currently the only IL23 inhibitor in Switzerland in this administration form.<\/li>\n<li>In the Self-Injection Assessment Questionnaire (SIAQ), the criterion &#8220;ease of use&#8221; was assessed with an average of 9.24 points (maximum: 10 points) [2].<\/li>\n<li>In the ORION trial, a significantly higher proportion of patients in the TREMFYA\u00ae <sup>pre-cast<\/sup> group achieved IGA1 or IGA0 (81% vs. 0%) and PASI90 or PASI100 (76% vs. 0%), respectively, at week 16 after baseline compared to placebo [2].<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Literature:<\/p>\n<ol>\n<li><sup>Tremfya\u00ae<\/sup> Technical Information, as of 09\/2019 available at www.swissmedicinfo.ch.<\/li>\n<li>Ferris LK, et al: Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatol Treat 2019: 1-8. doi:10.1080\/09546634.2019.1587145<\/li>\n<li>Keininger D, Coteur G: Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ) Health and Quality of Life Outcomes 2011; 9, Article number 2.<\/li>\n<li>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<li>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<li>Langley RG, 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<li>Griffiths CE, et al: Fall Clinical Dermatology Conference. Oct, 2019; Las Vegas, USA<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><em>DERMATOLOGIE PRAXIS 2020; 30(1): 37 (published 2\/24\/20, ahead of print).<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The device, which was recently approved by Swissmedic, enables psoriasis sufferers to self-administer the biologic in single doses. It is currently the only IL23 inhibitor available in Switzerland in the&hellip;<\/p>\n","protected":false},"author":7,"featured_media":94898,"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":[18157,14032,25270,23439],"powerkit_post_featured":[],"class_list":["post-334126","post","type-post","status-publish","format-standard","has-post-thumbnail","category-dermatology-and-venereology","category-market-medicine","category-rx-en","category-studies","tag-guselkumab-en","tag-psoriasis-en-2","tag-readypen","tag-tremfya-en","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-04-22 09:19:14","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":334130,"slug":"nouveau-un-stylo-pret-a-lemploi-facile-a-utiliser","post_title":"Nouveau : un stylo pr\u00eat \u00e0 l'emploi facile \u00e0 utiliser","href":"https:\/\/medizinonline.com\/fr\/nouveau-un-stylo-pret-a-lemploi-facile-a-utiliser\/"},"it_IT":{"locale":"it_IT","id":334144,"slug":"ora-e-disponibile-anche-come-penna-pronta-alluso-per-il-paziente","post_title":"Ora \u00e8 disponibile anche come penna pronta all'uso per il paziente.","href":"https:\/\/medizinonline.com\/it\/ora-e-disponibile-anche-come-penna-pronta-alluso-per-il-paziente\/"},"pt_PT":{"locale":"pt_PT","id":334153,"slug":"agora-tambem-disponivel-como-uma-caneta-pronta-a-usar-amiga-do-paciente","post_title":"Agora tamb\u00e9m dispon\u00edvel como uma caneta pronta a usar amiga do paciente","href":"https:\/\/medizinonline.com\/pt-pt\/agora-tambem-disponivel-como-uma-caneta-pronta-a-usar-amiga-do-paciente\/"},"es_ES":{"locale":"es_ES","id":334163,"slug":"ahora-tambien-disponible-como-boligrafo-listo-para-usar-facil-de-usar-por-el-paciente","post_title":"Ahora tambi\u00e9n disponible como bol\u00edgrafo listo para usar, f\u00e1cil de usar por el paciente","href":"https:\/\/medizinonline.com\/es\/ahora-tambien-disponible-como-boligrafo-listo-para-usar-facil-de-usar-por-el-paciente\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/334126","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=334126"}],"version-history":[{"count":0,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/334126\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/94898"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=334126"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=334126"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=334126"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=334126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}