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The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response.
Brandes, Jan Lewis; Diener, Hans-Christoph; Dolezil, David; Freeman, Marshall C; McAllister, Peter J; Winner, Paul; Klatt, Jan; Cheng, Sunfa; Zhang, Feng; Wen, Shihua; Ritter, Shannon; Lenz, Robert A; Mikol, Daniel D.
Afiliação
  • Brandes JL; Nashville Neuroscience Group, NUMC, Vanderbilt University, Department of Neurology, Nashville, TN, USA.
  • Diener HC; Faculty of Medicine, University Duisburg-Essen, Essen, Germany.
  • Dolezil D; Prague Headache Center, DADO MEDICAL s.r.o., Prague, Czech Republic.
  • Freeman MC; Headache Wellness Center, Greensboro, NC, USA.
  • McAllister PJ; New England Institute for Neurology and Headache, Stamford, CT, USA.
  • Winner P; Palm Beach Headache Center, West Palm Beach, FL, USA.
  • Klatt J; Novartis Pharma AG, Basel, Switzerland.
  • Cheng S; Amgen Inc., Thousand Oaks, CA, USA.
  • Zhang F; Amgen Inc., Thousand Oaks, CA, USA.
  • Wen S; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Ritter S; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Lenz RA; Amgen Inc., Thousand Oaks, CA, USA.
  • Mikol DD; Amgen Inc., Thousand Oaks, CA, USA.
Cephalalgia ; 40(1): 28-38, 2020 01.
Article em En | MEDLINE | ID: mdl-31816249
ABSTRACT

OBJECTIVE:

To assess the efficacy of erenumab across the spectrum of response thresholds (≥50%, ≥75%, 100%) based on monthly migraine days (MMD) reduction in patients with chronic migraine from a 12-week, randomized study (NCT02066415).

METHODS:

Patients (n = 667) received (322) placebo or erenumab 70/140 mg once-monthly. The proportion of patients achieving a given response threshold was assessed. A post-hoc analysis was conducted to contextualize the actual treatment benefit in subgroups of patients achieving (or not) specified response thresholds. Outcome measures included MMD, acute migraine-specific medication treatment days (MSMD) and disability.

RESULTS:

The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds. At month 3, 39.9% and 41.2% of patients on erenumab 70 and 140 mg, respectively, achieved ≥50% response versus placebo (23.5%). Similarly, at month 3, 17.0% and 20.9% of patients on erenumab 70 and 140 mg, respectively, achieved ≥75% response versus placebo (7.8%). Compared with the overall erenumab-treated population (change in MMD -6.6 [both 70 and 140 mg]), ≥50% responders showed MMD reductions of -12.2/-12.5 for 70 mg/140 mg versus -2.6/-2.2 for those not achieving ≥50% response. ≥75% responders showed MMD reductions of -13.9/-14.8 for 70 mg/140 mg versus -5.0/-4.3 for those not achieving ≥75% response. Relative improvements in MSMD and disability were observed in responders versus overall erenumab-treated population.

CONCLUSION:

For erenumab-treated patients achieving ≥50% response, the actual reduction in MMD was almost twice that of the overall population. These findings provide context for setting realistic expectations regarding actual treatment benefit experienced by patients responding to treatment.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Internacionalidade / Anticorpos Monoclonais Humanizados / Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina / Transtornos de Enxaqueca Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Cephalalgia Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Internacionalidade / Anticorpos Monoclonais Humanizados / Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina / Transtornos de Enxaqueca Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Cephalalgia Ano de publicação: 2020 Tipo de documento: Article