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Table 2 AEs in the DB Period and the OLE (Safety Analysis Set)

From: Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study

 

Placebo

Quarterly fremanezumab

Monthly fremanezumab

AE, n (%)

DB period (n = 277)

OLEa (n = 262)

DB period (n = 276)

OLEa (n = 271)

DB period (n = 285)

OLEa (n = 274)

Any AE

134 (48)

137 (52)

151 (55)

149 (55)

129 (45)

155 (57)

Any SAEb, c

4 (1)

9 (3)

2 (< 1)

7 (3)

4 (1)

7 (3)

Treatment-related AE

55 (20)

41 (16)

57 (21)

47 (17)

55 (19)

56 (20)

Protocol-defined AE of special interestd

2 (<1)

4 (2)

3 (1)

2 (<1)

3 (1)

9 (3)

Death

0

0

0

0

0

0

AE leading to discontinuatione, f

3 (1)

4 (2)

1 (<1)

1 (<1)

4 (1)

2 (<1)

Cardiovascular AEs

3 (1)

3 (1)

2 (<1)

1 (<1)

4 (1)

4 (1)

 Extrasystoles

0

2 (<1)

0

0

0

0

 Palpitations

2 (<1)

1 (<1)

1 (<1)

0

2 (<1)

1 (<1)

 Atrial fibrillation

0

0

0

1 (<1)

1 (<1)

0

 Supraventricular tachycardia

0

0

1 (<1)

0

0

0

 Tachycardia

0

1 (<1)

0

0

1 (<1)

1 (<1)

 Bradycardia

1 (<1)

0

0

0

0

0

 Left bundle branch block

0

0

0

0

0

1 (<1)

 Coronary artery disease

0

0

0

0

0

1 (<1)g

  1. AE adverse event, DB double-blind, OLE open-label extension, SAE serious adverse event, AST aspartate aminotransferase, ALT alanine aminotransferase, ULN upper limit of normal, INR international normalized ratio
  2. aAll patients in the OLE received fremanezumab 225 mg monthly
  3. bDB period: thoracic vertebral fracture, uterine leiomyoma, vulval cancer, hypoesthesia, and metrorrhagia in the placebo group; atrial fibrillation, cholelithiasis, clavicle fracture, foot fracture, respiratory fume inhalation, rib fracture, road traffic accident, back pain, nephrolithiasis, and vocal cord thickening in the fremanezumab groups
  4. cOLE: retinal tear, anal polyp, acute cholecystitis, cholelithiasis, anaphylactic reaction, diverticulitis, abnormal INR, angiomyxoma, intracranial aneurysm, multiple sclerosis, optic neuritis, nephrolithiasis, renal colic, dysmenorrhea, endometriosis, menometrorrhagia, and menorrhagia in the fremanezumab groups
  5. dOphthalmic-related AEs of at least moderate severity, events of possible drug-induced liver injury (AST or ALT ≥3 ULN, total bilirubin ≥2 ULN or INR >1.5), Hy’s law events, or events of anaphylaxis and severe hypersensitivity reactions
  6. eDB period: chest discomfort, injection-site pain, and vulval cancer in the placebo group; palpitations, fatigue, cholelithiasis, road traffic accidents, and temporal arteritis in the fremanezumab groups
  7. fOLE: upper abdominal pain, nausea, injection-site reactions, breast cancer, dizziness, headache, oropharyngeal pain, and hyperhidrosis in the placebo group; injection-site reactions, depressed mood, and asthma in the fremanezumab groups
  8. gPatient experienced a non-serious event of coronary artery disease on day 211 of the study. The event was considered not related to study treatment by the investigator and was considered likely due to chronic pre-existing disease. The event was ongoing at the time of the last visit
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The Journal of Headache and Pain

ISSN: 1129-2377

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