Factors Associated With A History Of Failure And Switching Migraine Prophylaxis Treatment: An Analysis Of Clinical Practice Data From The United States, Germany, France, And Japan

Pike, James; Mutebi, Alex; Shah, Neel; Jackson, James; Cotton, S; Desai, PR; Sapra, Sandhya

doi:10.1016/j.jval.2016.03.213

Cited by 8 publications

(7 citation statements)

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“…The risk of medication overuse headache and associated disability is particularly high among patients with chronic migraine (12,13). When stratified by frequency of headache days in a month, migraine-related disability levels are consistently greater among patients with a history of failure and switches to several migraine preventives when compared to patients on their first preventive treatment (14). Therefore, patients with chronic migraine who have failed prior preventive treatments for efficacy reasons, safety/tolerability reasons, or both, are an important subgroup with high unmet need and in whom it is important to understand therapeutic effects of novel preventive treatment options.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure

et al. 2019

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Background Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed. Study design/methods REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score. Results Treatment with galcanezumab versus placebo resulted in significant improvements ( p < 0.01) in overall reduction (Months 1–3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: −5.35 (0.71); galcanezumab 240 mg: −2.77 (0.66); placebo: −1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: −5.53 (0.60), galcanezumab 240 mg: −3.53 (0.59); placebo: −2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures. Conclusion Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome. Clinicaltrials.gov identifier number NCT02614261.

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Section: Introductionmentioning

confidence: 99%

Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure

et al. 2019

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“…In regard to patients’ preferences for preventive treatment, the ideal scenario is access to medications that possess high efficacy, have fewer side effects, and with lower dosing frequency. 17 Studies show that the current migraine preventive options are underutilized 18 and are associated with high discontinuation rates due to tolerability issues and lack of efficacy. 19 – 22 In the US, nearly 50% and 80% of people with migraine who are prescribed a preventive medication discontinue it 60–90 days after initiation and are no longer on therapy 12 months after initiation, respectively.…”

Section: Introductionmentioning

confidence: 99%

“… 20 , 23 , 24 A large proportion of preventive medication users often have a history either of prior medication failures or of switching treatments. 17 , 21 As a result, there is a high risk of patients not achieving meaningful reductions in headache with currently available preventives. This leads to many people with migraine relying solely on acute medications for managing the disease.…”

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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“…Notably, significant differences in HRQoL and disability were observed across groups, with the greatest impact of disease in patients with the highest number of preventive lines. Other research has shown an association between cycling through preventive treatment and headache frequency and comorbidities; 31 the present extensive analyses of PRO measures provide complementary insight into the effects of having failed previous treatment lines in patients with migraine. The full complexity of these findings is unknown, as it relates to migraine disease severity, adverse effects of treatment regimens, the sequence of medical/treatment/life events, and other physical/psychological factors that likely play a role in these observed outcomes.…”

Section: Discussionmentioning

confidence: 74%

Patient-Reported Outcomes for Migraine in the US and Europe: Burden Associated with Multiple Preventive Treatment Failures

Ford¹,

Nichols²,

Ye³

et al. 2021

CEOR

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Purpose: To evaluate patient-reported outcomes (PROs) among patients with migraine, including those who were preventive-naïve and preventive-treated. Methods: This was a point-in-time, real-world study of patients with migraine in the US and EU5 (France, Germany, Spain, Italy, and UK) and their physicians using data from the Adelphi Migraine Disease Specific Programme (DSP™). Physicians completed patient record forms (PRFs) for the next nine consulting patients with migraine plus a tenth patient, who did not need to be consecutive, for whom prior preventive migraine treatments had failed at least once, in order to achieve oversampling of such patients. Patients were given self-completion (PSC) forms that included the Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ), Migraine Disability Assessment Scale (MIDAS), and Work Productivity and Activity Impairment (WPAI) questionnaire. Populations of interest included preventive-naïve and preventive-treated patients defined by the number of treatment lines (1-2 or 3+ preventive regimens). Continuous variables were compared using t-test or ANOVA if normally distributed and Mann-Whitney if not. Chi-squared was used for categorical variables. Results: During August-December 2017, 615 physicians (359 PCPs, 256 neurologists) completed PRFs for 5785 patients (71% female; mean age 40 (±14) years; 65% in full-or part-time employment). Of these, 2798 completed a PSC (preventive-naïve/1-2/3+ preventive lines, n=1707/1034/57). Preventive-treated patients had a greater patient-reported burden across multiple measures versus preventive-naïve patients. Preventive-treated patients had lower MSQ scores indicating greater functional impairment, higher MIDAS scores indicating greater migraine-associated disability, and higher WPAI scores indicating greater overall work and activity impairment than preventive-naïve patients. The magnitude of difference was greatest for the 3+ preventive-treatments cohort. Patterns were similar in the US and EU5. Conclusion: Among patients with migraine who are preventive-treated, including those with multiple lines of therapy, there remain considerable unmet needs in terms of restoring patient function.

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Factors Associated With A History Of Failure And Switching Migraine Prophylaxis Treatment: An Analysis Of Clinical Practice Data From The United States, Germany, France, And Japan

Cited by 8 publications

References 0 publications

Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure

Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure

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

Patient-Reported Outcomes for Migraine in the US and Europe: Burden Associated with Multiple Preventive Treatment Failures

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