Late-Breaking Abstracts of the 2017 International Headache                     Congress

Piero, Vittorio Di; Lucchese, Franco; Farihah, Khaliq; Uribe, Nelson Barrientos; Geppetti, P.; Michele, Viana; Nappi, Giuseppe; Chiriac, Ecaterina; Brighina, Filippo; Lago, Cristina Perez; Marfil, Alejandro; Tassorelli, Giorgio Sandrini And Cristina; Figueroa, Marıa De Lourdes; Valerio, Maffey; Maggioni, Ferdinando; Iannacchero, Rosario; Jurno, Mauro Eduardo; Grazia, S. Della; Carlos, Bordini

doi:10.1177/0333102417732504

Cited by 6 publications

(8 citation statements)

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“…23 Efficacy results from this study confirmed those reported in phase 2 studies, 17,18 and the treatment duration was twice as long in this study (6 months vs 3 months). These results were replicated in a similarly designed study (EVOLVE-2) 29 in which 915 patients were randomized and received at least 1 dose of IP.…”

Section: Discussionmentioning

confidence: 76%

Evaluation of Galcanezumab for the Prevention of Episodic Migraine

et al. 2018

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IMPORTANCE Migraine is a disabling neurological disease characterized by severe headache attacks. Treatment options reduce migraine frequency for many patients, but adverse effects lead to discontinuation in many patients. OBJECTIVE To demonstrate that galcanezumab is superior to placebo in the prevention of episodic migraine with or without aura. DESIGN, SETTING, AND PARTICIPANTS The EVOLVE-1 (Evaluation of LY2951742 in the Prevention of Episodic Migraine 1) trial was a double-blind, randomized, placebo-controlled (January 11, 2016, to March 22, 2017) trial comparing galcanezumab (120 mg and 240 mg) vs placebo. Patients received treatments once monthly for 6 months (subcutaneous injection via prefilled syringe) and were followed up for 5 months after their last injection. It was a multicenter, clinic-based study involving 90 sites in North America. Participants in the study were adults (aged 18 to 65 years) with at least a 1-year history of migraine, 4 to 14 migraine headache days per month and a mean of at least 2 migraine attacks per month within the past 3 months, and were diagnosed prior to age 50 years. During the study, no other preventive medications were allowed. A total of 1671 patients were assessed; 809 did not meet study entry or baseline criteria, and 858 were included in the intent-to-treat population. INTERVENTIONS Patients were randomized (2:1:1) to monthly placebo, galcanezumab, 120 mg, and galcanezumab, 240 mg. MAIN OUTCOMES AND MEASURES The primary outcome was overall mean change from baseline in the number of monthly migraine headache days during the treatment period. Secondary measures included at least 50%, at least 75%, and 100% reduction in monthly migraine headache days, migraine headache days with acute medication use, and scores from the Migraine-Specific Quality of Life questionnaire, Patient Global Impression of Severity, and Migraine Disability Assessment. Treatment-emergent adverse events and serious adverse events were reported. RESULTS Of the 1671 patients assessed, 858 (mean age, 40.7 years; 718 women [83.7%]) met study entry criteria and received at least 1 dose of investigational product. The primary objective was met for both galcanezumab doses; treatment with galcanezumab significantly reduced monthly migraine headache days (both P < .001) by 4.7 days (120 mg) and 4.6 days (240 mg) compared with placebo (2.8 days). All key secondary objectives were also significant after multiplicity adjustment. There were no meaningful differences between 120-mg and 240-mg doses of galcanezumab on measures of efficacy. Completion rate during treatment was high (81.9%; n = 718), and the incidence of discontinuation owing to adverse events was less than 5% across all treatment groups. CONCLUSIONS AND RELEVANCE Galcanezumab 120-mg and 240-mg monthly injections provided clinical benefits and improved functioning. The incidence rate of adverse events was low, demonstrating the favorable tolerability profile of galcanezumab.

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Section: Discussionmentioning

confidence: 76%

Evaluation of Galcanezumab for the Prevention of Episodic Migraine

et al. 2018

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“…In addition, the placebo response rate for 2‐hour MBS freedom (42%) was substantially higher than that for 2‐hour pain freedom (14%) in this trial,5 as has been observed in other trials,6, 7 which may increase the number of trial participants necessary to show freedom for both endpoints. Further work is required to elucidate if this concordance rate is maintained across trials.…”

Section: Discussionsupporting

confidence: 47%

Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post‐Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial

Dodick

Tepper

Friedman³

et al. 2018

Headache

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ObjectiveTo better understand the utility of using pain freedom and most bothersome headache‐associated symptom (MBS) freedom as co‐primary endpoints in clinical trials of acute migraine interventions.BackgroundAdhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co‐primary endpoints per recently issued guidance by the US Food and Drug Administration. In this trial, the proportion of patients treated with ADAM zolmitriptan 3.8 mg, who were pain‐free and MBS‐free at 2 hours post‐dose, was significantly higher than for placebo.MethodsWe undertook a post‐hoc analysis of data from the ZOTRIP trial to examine how the outcomes from this trial compare to what might have been achieved using the conventional co‐primary endpoints of pain relief, nausea, photophobia, and phonophobia.ResultsOf the 159 patients treated with ADAM zolmitriptan 3.8 mg or placebo, prospectively designated MBS were photophobia (n = 79), phonophobia (n = 43), and nausea (n = 37). Two‐hour pain free rates in those with photophobia as the MBS were 36% for ADAM zolmitriptan 3.8 mg and 14% for placebo (P = .02). Corresponding rates for those with phonophobia as the MBS were 14% and 41% (P = .05). For those whose MBS was nausea, corresponding values were 56% and 16%, respectively (P = .01). Two‐hour freedom from the MBS for active drug vs placebo were 67% vs 35% (P < .01) for photophobia, 55% vs 43% (P = .45) for phonophobia, and 89% vs 58% for nausea (P = .04). MBS freedom but not pain freedom was achieved in 28%. Only 1 patient (1%) achieved pain freedom, but not MBS freedom. The proportion with both pain and MBS freedom was highest (56%) among those whose MBS was nausea.ConclusionIn this study, the use of MBS was feasible and seemed to compare favorably to the previously required 4 co‐primary endpoints.

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“…Galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, belongs to a novel class of molecules specifically designed for migraine prevention, unlike currently available preventives. 31 In two phase 2 32 , 33 and three phase 3 studies, 34 – 36 treatment with galcanezumab versus placebo led to significant reductions in the number of migraine headache days (MHDs) per month in people with episodic and chronic migraine. Another measure of successful migraine preventive treatment is the reduction of acute medication use for migraine.…”

Section: Introductionmentioning

confidence: 99%

“…In phase 3 studies in patients with episodic and chronic migraine, treatment with galcanezumab led to significant reductions in number of MHDs with acute medication use per month. 34 – 36 Study CGAJ was a 12-month, open-label study, part of the phase 3 development program for migraine prevention. People with episodic or chronic migraine were included in the study and were assigned to one of two treatment arms, galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg. 37 Study CGAJ was designed to have fewer clinical research site visits, and patients were allowed to self-administer galcanezumab monthly while collecting outcome measures such as the Patient Satisfaction with Medication Questionnaire–Modified (PSMQ-M) questionnaire, HCRU, and acute medication use for migraine or headache.…”

Section: Introductionmentioning

confidence: 99%

Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine

Ford¹,

Foster²,

Stauffer³

et al. 2018

PPA

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BackgroundEffects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine.MethodsPatients with episodic (78.9%) or chronic migraine (21.1%) were evaluated in the CGAJ study, an open-label study with 12-month treatment period. Galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg was administered subcutaneously once a month during treatment period. A self-rated scale, Patient Satisfaction with Medication Questionnaire–Modified (PSMQ-M), was used to measure satisfaction levels. Participants reported HCRU for the previous 6 months at baseline and that which occurred since the patient’s last study visit during treatment period. Acute headache medication use for migraine or headache for the past month was self-reported by participants at baseline and at each monthly visit during treatment period.ResultsAt Months 1, 6, and 12, at least 69% of patients treated with galcanezumab responded positively for overall satisfaction, preference over prior treatments, and less impact from side effects. There were within-group reductions from baseline in migraine-specific HCRU (per 100 person-years) with galcanezumab for health care professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), and hospital admissions (3.7 to 0.4) during treatment period. Statistically significant reductions in HCRU were observed for some events. There were significant within-group reductions from baseline in mean number of days/month with acute headache medication use for migraine or headache at each monthly visit during treatment period (overall change: −5.1 for galcanezumab 120 mg/240 mg; p<0.001).ConclusionResults from this long-term, open-label study suggest that treatment with galcanezumab is likely to lead to high patient satisfaction with treatment as well as meaningful reductions in migraine-specific HCRU and acute headache medication use in people with migraine.

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Late-Breaking Abstracts of the 2017 International Headache Congress

Cited by 6 publications

References 0 publications

Evaluation of Galcanezumab for the Prevention of Episodic Migraine

Evaluation of Galcanezumab for the Prevention of Episodic Migraine

Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post‐Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial

Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine

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