\n| Placebo: 12%<\/td>\n | Placebo: 12%<\/td>\n | Placebo: 30%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Patients with clear\/almost clear hands at the end of treatment were followed up for a further 24 weeks. During that period, no active drug treatment for CHE was allowed. Relapse<\/span> was defined as the 75% of the initial total injury<\/span> symptom<\/span> Punctuation.<\/p>\nIn this analysis, the majority of responders who received 10 mg and 30 mg of alitretinoin did not relapse at the end of the follow-up period.<\/p>\n Relapse rates * at the end of follow-up<\/p>\n \n\n\n| Alitretinoin<\/th>\n | Placebo<\/th>\n<\/tr>\n | \n| <\/td>\n | 10mg<\/td>\n | 30mg<\/td>\n | <\/td>\n<\/tr>\n | \n| N = 418<\/td>\n | N = 409<\/td>\n | N = 205<\/td>\n<\/tr>\n | \n| responders<\/td>\n | 115 (100%)<\/td>\n | 195 (100%)<\/td>\n | 34 (100%)<\/td>\n<\/tr>\n | \n| no relapse<\/td>\n | 81 (70,4%)<\/td>\n | 122 (62,6%)<\/td>\n | 19 (55,9%)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n * Corresponds to a calculation of the last observation carried forward (LOCF)<\/p>\n <\/span>Study 2<\/span><\/h3>\nA follow-up study (the second phase 3 study) investigated the efficacy and safety of a second course of treatment in both patients who previously responded to treatment and then relapsed (Cohort A) and in patients who did not respond to therapy (Cohort A). B). Cohort A patients were randomized to the same dose of alitretinoin they received during initial treatment or to placebo in a 2:1 ratio.<\/p>\n The 80% of the relapsing patients in Cohort A, who received repeated treatment with 30 mg alitretinoin, achieved clear\/almost clear hands vs. the 8% in the placebo group (p < 0.001).<\/p>\n The 48% of Cohort A relapsers who withdrew on alitretinoin 10 mg achieved clear\/almost clear hands vs. 10% in the placebo group (p = 0.1).<\/p>\n <\/span>Alitretinoin gel<\/span> 0.1% for Kaposi sarcoma<\/span>
\n<\/span><\/h2>\nThe US FDA-approved alitretinoin gel (Panretin\u00ae; Ligand Pharmaceuticals USA) for the treatment of cutaneous<\/span> lesions in Kaposi's sarcoma (KS) in 1999. Since then, the drug has been approved in Europe and Canada.<\/p>\nTwo multicenter, prospective, randomized, double-blind<\/span>, vehicle-controlled studies evaluated the efficacy of alitretinoin gel in patients with AIDS-related KS skin lesions.<\/p>\nIn both studies, the primary efficacy endpoint was cutaneous KS tumor<\/span> response rate after 12 weeks of study drug treatment.<\/p>\nKS tumor response rate was assessed by evaluating 3 to 8 KS index lesions according to modified AIDS Clinical Trials Group (ACTG) response criteria applied to topical therapy (i.e., evaluation of reductions in height and area of index lesions only; progressive<\/span> disease was scored only in treated index lesions and not in non-index lesions and new lesions).<\/p>\nThe FDA reviewed photographs of lesions in patients considered responders based on modified ACTG criteria for a cosmetically beneficial response, defined as at least 50% improvement in appearance compared to base<\/span>, in at least 50% of the index lesions and maintained for at least 3 weeks.<\/p>\nA global evaluation by the doctors was also performed. It considered all of the patient's treated lesions (index and other) compared to baseline. In this evaluation, patients with at least 50% improvement in KS lesions were considered responders.<\/p>\n <\/span>Study 1<\/span><\/h3>\nA total of 268 patients were admitted from centers in the US and Canada.<\/p>\n Patients were treated topically three to four times daily with alitretinoin gel or a corresponding vehicle gel for a minimum of 12 weeks.<\/p>\n Responses to alitretinoin gel were observed in both treatment-na\u00efve patients and patients with systemic<\/span> and\/or topical treatment of KS.<\/p>\n\n\nPrimary efficacy parameters \u2013 study 1<\/caption>\n<\/tbody>\n\n\n| Parameter<\/th>\n | Alitretinoin gel (n = 134)<\/th>\n | Vehicle gel (n = 134)<\/th>\n<\/tr>\n | \n| Modified ACTG response (index lesions)<\/td>\n | 34% (partial response)
1% (complete response)<\/td>\n | 16% (partial response)
p = 0.0012<\/td>\n<\/tr>\n | \n| Physicians' global assessment (all lesions treated)<\/td>\n | 19% (partial response)<\/td>\n | 4% (partial response)
P = 0.00014<\/td>\n<\/tr>\n | \n| Beneficial response photographs (index lesions only)<\/td>\n | 15%<\/td>\n | 4%
p = 0.0026<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/span>Study 2<\/span><\/h3>\nStudy 2 was an international study with a planned enrollment of 270 patients.<\/p>\n The study was stopped early due to positive interim results in the initial data set of 82 patients.<\/p>\n Patients were treated topically twice daily with alitretinoin gel or a corresponding vehicle for 12 weeks.<\/p>\n Responses to alitretinoin gel were observed in both treatment-na\u00efve patients and patients with prior systemic and\/or topical treatment with KS.<\/p>\n \n\nPrimary efficacy parameters \u2013 study 2<\/caption>\n<\/tbody>\n\n\n| Parameter<\/th>\n | Alitretinoin gel (n = 36)<\/th>\n | Vehicle gel (n = 46)<\/th>\n<\/tr>\n | \n| Modified ACTG response (index lesions)<\/td>\n | 36% (partial response)<\/td>\n | 7% (partial response)<\/td>\n<\/tr>\n | \n| Physicians' global assessment (all lesions treated)<\/td>\n | 47% (partial response)<\/td>\n | 11% (partial response)<\/td>\n<\/tr>\n | \n| Beneficial response photographs (index lesions only)<\/td>\n | 19%<\/td>\n | 2%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n In both studies, responses occurred in patients with a wide range of baseline CD4+ lymphocyte<\/span> counts, including patients with CD4+ lymphocyte counts less than 50 cells\/mm3. Almost all patients received concomitant<\/span> Combination antiretroviral therapy.<\/p>\n\nNew Zealand approved data sheets are the official source of information for these prescription drugs, including approved uses and risk information. See the New Zealand individual data sheet on the Medsafe website.<\/span><\/em><\/div>\n<\/section>\n<\/div>\n<\/section>","protected":false},"excerpt":{"rendered":" Alitretino\u00edna oral para mano eczema Toctino\u00ae (alitretino\u00edna oral) es comercializado por los laboratorios Stiefel (Reino Unido) y est\u00e1 aprobado para el tratamiento del eccema de manos en el Reino Unido,…<\/p>","protected":false},"author":8,"featured_media":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","format":"standard","meta":{"footnotes":""},"categories":[204],"tags":[],"class_list":["post-16561","wiki","type-wiki","status-publish","format-standard","category-glosario-definiciones"],"_links":{"self":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki\/16561","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki"}],"about":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/types\/wiki"}],"author":[{"embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/comments?post=16561"}],"version-history":[{"count":0,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki\/16561\/revisions"}],"wp:attachment":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/media?parent=16561"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/categories?post=16561"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/tags?post=16561"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}} | | | |