Fremanezumab

Fremanezumab, humanizirano, monoklonsko IgG2 protutijelo na peptid povezan s kalcitoninskim genom, razvijen je za specifičnu profilaktičku terapiju migrene. Peptid povezan s kalcitoninskim genom je vazoaktivni neuropeptid uključen u nocicepciju i patogenezu migrene. Cilj je rada prikazati rezultate publiciranih kliničkih ispitivanja faze III, učinkovitosti, sigurnosti i podnošljivosti primjene fremanezumaba u specifičnoj profilaktičkoj terapiji epizodne (EM) i kronične (KM) migrene u odraslih bolesnika. Rezultati publiciranih kliničkih ispitivanja ukazuju na učinkovitost, sigurnost primjene te dobru podnošljivost fremanezumaba, supkutano 225 mg mjesečno i 675 mg tromjesečno, u specifičnoj profilaktičkoj terapiji odraslih, inače zdravih bolesnika s ≥ 4 dana migrene mjesečno. Učinkovitost fremanezumaba održana je tijekom 12 mjeseci primjene. Učinkovitost fremanezumaba pokazana je i u bolesnika s EM-om i KM-om prethodno neuspješno liječenih s 2 do 4 klase lijekova za nespecifičnu oralnu profilaktičku terapiju. Česte nuspojave javljale su se samo lokalno na mjestu primjene – induracija, bol i eritem. European Headache Federation preporučuje primjenu fremanezumaba u bolesnika s EM-om i KM-om neuspješno liječenih s ≥ 2 lijeka za nespecifičnu oralnu profilaktičku terapiju. Daljnje praćenje kliničkih rezultata primjene fremanezumaba u heterogenoj općoj populaciji bolesnika s migrenom nužno je za odgovore o održanoj učinkovitosti i sigurnosti dugotrajne primjene u profilaktičkoj terapiji.Fremanezumab is a humanized, monoclonal IgG2 antibody directed against calcitonin gene-related peptide, developed for specific prophylactic therapy of migraines. The calcitonin gene-related peptide is a vasoactive neuropeptide involved in the nociception and pathogenesis of the migraine. The aim of this study is to present the results of published phase III clinical trials of the efficacy, safety and tolerability of fremanezumab in specific prophylactic therapy of episodic (EM) and chronic (CM) migraine in adult patients. The results of published clinical trials point to the efficacy, safety and good tolerability of fremanezumab, subcutaneously 225 mg per month and 675 mg quarterly in specific prophylactic therapy of otherwise healthy adult patients with ≥4 days of migraine per month. The efficacy of fremanezumab was maintained throughout 12 months of administration. Its efficacy has also been exhibited in patients with prior unsuccessfully treated EM and CM with 2 to 4 classes of non-specific oral prophylactic therapy. Frequent side effects appeared only locally in situ - induration, pain and erythema. The European Headache Federation recommends the use of fremanezumab in patients with EM and CM with ≥2 non-specific oral prophylactic therapy drugs who had previously been treated unsuccessfully. Further monitoring of the clinical results of fremanezumab in a heterogeneous general population of migraine patients is pertinent in order to show the continued efficacy and safety of long-term use in prophylactic therapy