Erenumab now available for migraine treatment
The monoclonal antibody erenumab (Pasurta®), a calcitonin gene-related peptide (CGRP) receptor antagonist, is now available locally for the treatment of migraine.
Administered as a once-monthly subcutaneous injection, erenumab is currently indicated for the treatment of migraine in adults who have experienced four or more migraine days in a month.
“[Erenumab] is reported to reduce migraine episodes by 50 percent and has consistently shown to be effective in preventing migraine and bringing relief from the grip of this disease,” said Patrik Grande, Novartis Malaysia managing director and country president. “The launch … is our commitment to reimagine medicines for patients who live with this condition every day of their lives.”
Grande referred to the LIBERTY study, a randomized, double-blind placebo-controlled phase 3b clinical trial of erenumab in patients with difficult-to-treat episodic migraine. Enrolled participants (n=246, age 18–65 years) had a history of episodic migraine with or without aura for at least 12 months, had migraine for 4 to 14 days per month prior to screening, and had been treated unsuccessfully with two-to-four preventative treatments. [Lancet 2018;392:2280–2287]
Patients were randomized to either two injections of erenumab 70 mg (n=121) or placebo (n=125) every 4 weeks for a 12-week period. At week 12, 30 percent of patients on erenumab had a ≥50 percent reduction in average monthly migraine days (MMD), compared to 17 percent on placebo (odds ratio 2.7 [95% CI 1.4–5.2]; p=0.002).
Speaking at the recent launch of erenumab in Kuala Lumpur, Dr Julia Shahnaz Merican, consultant neurologist and headache specialist, highlighted an interim analysis from a phase II open-label extension study of erenumab, which found that 65, 42 and 26 percent of patients (n=383) achieved a ≥50, ≥75 and 100 percent reduction in MMD, respectively, at week 64 of treatment. [Neurology 2017;89:1237–1243]
“One-in-four migraine patients were migraine-free by week 64, while two-in-three patients experienced at least a 50 percent reduction in MMD,” said Shahnaz, who added that erenumab has also demonstrated a safety profile comparable to placebo. [Lancet Neurol 2017;16(6):425–434]
Erenumab is a monoclonal antibody targeting the CGRP receptor, which has been identified as a key component of the migraine pain pathway. CGRP is a sensory neurotransmitter peptide widely distributed in the central and peripheral nervous systems.
When released by the trigeminovascular system, CGRP has a strong vasodilatory effect on cranial blood vessels and causes mast cell degranulation, both of which contribute to neurogenic inflammation, with subsequent attacks of pain, nausea and hypersensitivity. [Headache 2013;53(8):1230–1244; Nat Rev Neurol 2018;14(6):338–350]
Migraine is a chronic neurological disease defined by recurrent attacks of headache often associated with nausea and vomiting, with possible involvement of photophobia and phonophobia. It is known to primarily affect adults between 25 and 55 years—with prevalence in women being three times that of men—and has been identified as the second most common cause of disability worldwide in individuals under 50 years of age. [Headache 2001;41:646–657; Lancet 2017;390(10100):1211–1259]
While little recent population data exists on migraine prevalence in Malaysia, a 1996 community-based study reported a 9 percent prevalence of individuals experiencing migraine in the previous year, based on International Headache Society (IHS) diagnostic criteria. [Headache 1996;36:379–384]