FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Rothrock, John F.; Adams, Aubrey Manack; Lipton, Richard B.; Silberstein, Stephen D.; Jo, Esther; Zhao, Xiang; Blumenfeld, Andrew

doi:10.1111/head.13653

Cited by 75 publications

(97 citation statements)

References 29 publications

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“…55% (OnaBoNT-A). Such rate of discontinuation is quite high but in line with recent data from the pharmacological arm of the FORWARD trial [32]. Interestingly, in the present study, the adherence dropped mostly at the time of the latest follow-up (12 months).…”

Section: Discussionsupporting

confidence: 92%

A Propensity Score Matching study on the effect of OnabotulinumtoxinA alone versus Short-Term Psychodynamic Psychotherapy plus drug-of-choice as preventive therapy in Chronic Migraine: effects and predictive factors.

Alessiani¹,

Petolicchio²,

Sanctis³

et al. 2020

Preprint

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Background: Chronic migraine (CM) is an ensemble disorder in which pain, comorbidities, and medication overuse headache (MOH) interact to determine the degree of disability. No data support the choice of a monotherapy rather than a multidisciplinary preventive approach. The aim of this study is testing the superiority of multidisciplinary approach, i.e. Short-term Psychodynamic Psychotherapy (STPP) plus drug of choice, vs. monotherapy, i.e. OnabotulinumtoxinA. Methods: We consecutively recorded data from CM patients who underwent STPP or OnaBoNT-A, with a 3-month follow-up schedule. Headache days and analgesics intake were monitored as primary outcome measures to determine the benefit. Propensity score matching (PSM) was used to eliminate discrepancies between groups. Discriminant function analysis was used to pinpoint predictive factors associated to the clinical response. Results: 96 patients with CM (64% with MOH) were treated with STPP and 54 (59% with MOH) with OnaBoNT-A. At baseline, OnaBoNT-A patients had more failed preventive therapies, more years of illness and chronicity, and were older, while STPP patients were more depressed and had an higher HIT-6 (p<0.001). Both STPP and OnaBoNT-A patients showed a significant reduction of headache days (STPP: -14 vs. OnaBoNT-A:-14.3) and analgesics intake (STPP: -12,3 vs. OnaBoNT-A -13.5 pills/month), respectively. MOH diminished more in STPP, adherence was higher in OnaBoNT-A. Results were confirmed after that PSM balanced the two groups for all these variables that resulted different (but age). DFA predicts responders in pooled and OnaBoNT-A group. Conclusions: OnaBoNT-A monotherapy produced similar results of a multidisciplinary approach with psychotherapy plus medication. STPP provided a better short term response but short- and long-term adherence was higher in OnaBoNT-A.

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Section: Discussionsupporting

confidence: 92%

A Propensity Score Matching study on the effect of OnabotulinumtoxinA alone versus Short-Term Psychodynamic Psychotherapy plus drug-of-choice as preventive therapy in Chronic Migraine: effects and predictive factors.

Alessiani¹,

Petolicchio²,

Sanctis³

et al. 2020

Preprint

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“…In the primary analysis of the FORWARD study, a significantly higher proportion of patients randomized to onabotulinumtoxinA experienced ≥50% reduction in headache frequency at week 32 (primary endpoint) compared with those randomized to topiramate (40% [56/140] vs 12% [17/142], respectively; adjusted OR, 4.9 [95% CI, 2.7-9.1]; P < .001). 22 OnabotulinumtoxinA was superior to topiramate in meeting secondary endpoints including frequency of headache days per 28-day period and proportion of patients with ≥70% decrease in headache days. 22 AEs were reported by 48% (105/220) of onabotulinumtoxinA and 79% (112/142) of topiramate patients.…”

Section: Resultsmentioning

confidence: 94%

“…Of patients randomized to topiramate, 28 (19.7%) completed their initial treatment and 80 (56.3%) discontinued topiramate and switched to onabotulinumtoxinA. 22 …”

Section: Resultsmentioning

confidence: 99%

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Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Blumenfeld

Patel²,

Turner³

et al. 2020

J Prim Care Community Health

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Introduction/Objective: Chronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated efficacy (treatment benefit under ideal conditions) for the prevention of headaches in people with CM in clinical trials, but real-world studies suggest markedly different clinical effectiveness (treatment benefit based on a blend of efficacy and tolerability). This study sought to evaluate patient-reported outcomes (PROs) of onabotulinumtoxinA versus topiramate immediate release for people with CM. Methods: FORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ). Results: A total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate ( P < .001). Improvements in depression over time were observed via larger changes in PHQ-9 scores with onabotulinumtoxinA than topiramate ( P < .001). Work productivity assessed via WPAI:SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P = .024) and Activity Impairment ( P < .001) domains. Results from the FIMQ also revealed a larger reduction from baseline with onabotulinumtoxinA vs topiramate ( P < .0001). Conclusion: OnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM. Trial Registration: ClinicalTrials.gov: NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579

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Diagnosis and Management of Headache

Robbins

2021

JAMA

116

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IMPORTANCE Approximately 90% of people in the US experience headache during their lifetime. Migraine is the second leading cause of years lived with disability worldwide.OBSERVATIONS Primary headache disorders are defined as headaches that are unrelated to an underlying medical condition and are categorized into 4 groups: migraine, tension-type headache, trigeminal autonomic cephalalgias, and other primary headache disorders. Studies evaluating prevalence in more than 100 000 people reported that tension-type headache affected 38% of the population, while migraine affected 12% and was the most disabling. Secondary headache disorders are defined as headaches due to an underlying medical condition and are classified according to whether they are due to vascular, neoplastic, infectious, or intracranial pressure/volume causes. Patients presenting with headache should be evaluated to determine whether their headache is most likely a primary or a secondary headache disorder. They should be evaluated for symptoms or signs that suggest an urgent medical problem such as an abrupt onset, neurologic signs, age 50 years and older, presence of cancer or immunosuppression, and provocation by physical activities or postural changes. Acute migraine treatment includes acetaminophen, nonsteroidal anti-inflammatory drugs, and combination products that include caffeine. Patients not responsive to these treatments may require migraine-specific treatments including triptans (5-HT 1B/D agonists), which eliminate pain in 20% to 30% of patients by 2 hours, but are accompanied by adverse effects such as transient flushing, tightness, or tingling in the upper body in 25% of patients. Patients with or at high risk for cardiovascular disease should avoid triptans because of vasoconstrictive properties. Acute treatments with gepants, antagonists to receptors for the inflammatory neuropeptide calcitonin gene-related peptide, such as rimegepant or ubrogepant, can eliminate headache symptoms for 2 hours in 20% of patients but have adverse effects of nausea and dry mouth in 1% to 4% of patients. A 5-HT 1F agonist, lasmiditan, is also available for acute migraine treatment and appears safe in patients with cardiovascular risk factors. Preventive treatments include antihypertensives, antiepileptics, antidepressants, calcitonin gene-related peptide monoclonal antibodies, and onabotulinumtoxinA, which reduce migraine by 1 to 3 days per month relative to placebo.CONCLUSIONS AND RELEVANCE Headache disorders affect approximately 90% of people during their lifetime. Among primary headache disorders, migraine is most debilitating and can be treated acutely with analgesics, nonsteroidal anti-inflammatory drugs, triptans, gepants, and lasmiditan.

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FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Cited by 75 publications

References 29 publications

A Propensity Score Matching study on the effect of OnabotulinumtoxinA alone versus Short-Term Psychodynamic Psychotherapy plus drug-of-choice as preventive therapy in Chronic Migraine: effects and predictive factors.

A Propensity Score Matching study on the effect of OnabotulinumtoxinA alone versus Short-Term Psychodynamic Psychotherapy plus drug-of-choice as preventive therapy in Chronic Migraine: effects and predictive factors.

Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Diagnosis and Management of Headache

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