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May 07, 2019; 92 (19) ArticleOpen Access

Erenumab in chronic migraine

Patient-reported outcomes in a randomized double-blind study

Richard B. Lipton, Stewart J. Tepper, Uwe Reuter, Stephen Silberstein, Walter F. Stewart, Jon Nilsen, Dean K. Leonardi, Pooja Desai, Sunfa Cheng, Daniel D. Mikol, Robert Lenz
First published April 17, 2019, DOI: https://doi.org/10.1212/WNL.0000000000007452
Richard B. Lipton
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Stewart J. Tepper
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Uwe Reuter
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Stephen Silberstein
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Walter F. Stewart
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Jon Nilsen
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Dean K. Leonardi
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Pooja Desai
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Sunfa Cheng
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Daniel D. Mikol
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Robert Lenz
From the Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, New York; Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA; Sutter Health (W.F.S.), Walnut Creek, CA; and Amgen Inc. (J.N., D.K.L., P.D., S.C., D.D.M., R.L.), Thousand Oaks, CA.
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Citation
Erenumab in chronic migraine
Patient-reported outcomes in a randomized double-blind study
Richard B. Lipton, Stewart J. Tepper, Uwe Reuter, Stephen Silberstein, Walter F. Stewart, Jon Nilsen, Dean K. Leonardi, Pooja Desai, Sunfa Cheng, Daniel D. Mikol, Robert Lenz
Neurology May 2019, 92 (19) e2250-e2260; DOI: 10.1212/WNL.0000000000007452

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    Figure 1 Change in Migraine-Specific Quality-of-Life Questionnaire (MSQ) scores from baseline over 3 months

    Least-squares (LS) mean changes from baseline in (A) MSQ–role function-restrictive (MSQ-RFR), (B) MSQ–role function-preventive (MSQ-RFP), and (C) MSQ–emotional functioning (MSQ-EF) scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.05, except for MSQ-RFP at month 2: erenumab 70 mg, p = 0.051, and erenumab 140 mg, p = 0.061. MID = minimally important difference.

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    Figure 2 Change in Headache Impact Test–6 (HIT-6) total score from baseline over 3 months

    Least-squares (LS) mean changes from baseline in HIT-6 scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.05. MID = minimally important difference.

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    Figure 3 Change in Migraine Disability Assessment (MIDAS) scores from baseline to month 3

    Least-squares (LS) mean changes from baseline in (A) MIDAS total, (B) absenteeism, and (C) presenteeism scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.05.

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    Figure 4 Scatterplots of correlation between change in migraine days and change in patient-reported outcome scores

    (A) Migraine-Specific Quality-of-Life Questionnaire–role function-restrictive (MSQ-RFR), (B) Migraine-Specific Quality-of-Life Questionnaire–role function-preventive (MSQ-RFP), (C) Migraine-Specific Quality-of-Life Questionnaire–emotional functioning (MSQ-EF), (D) Headache Impact Test–6 (HIT-6), and (E) Migraine Disability Assessment (MIDAS).

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    Figure 5 Change in Patient-Reported Outcomes Measurement Information System (PROMIS) scores from baseline over 3 months

    Least-squares (LS) mean changes from baseline in PROMIS scores among participants with chronic migraine who were assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo every month. The error bars represent 95% confidence intervals (CIs). Figure based on the efficacy analysis set. All p values ≤0.01, except for erenumab 70 mg at month 1, p = 0.082.

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