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Table 2 Patient clinical outcomes

From: Calcitonin gene related peptide monoclonal antibody treats headache in patients with active idiopathic intracranial hypertension

 

P1

P2

P3

P4

P5

P6

P7

Mean (SD)

MmsHD change at 3 months

− 3

− 6

− 9

− 9

− 2

− 6

− 4

− 5.6 (2.8)

p = 0.002

MmsHD change at relapse

− 5

− 13

− 6

− 13

− 7

− 10

− 6

−8.6 (3.4)

p < 0.001

MHD change at 3 months

− 20

0

− 18

− 12

− 15

−16

− 4

−12.1 (7.4)

p = 0.028

MHD change at relapse

− 22

0

0

−15

− 10

− 24

− 5

− 10.9 (9.9)

p = 0.043

Headache severity (NRS) change at 3 months

2

−0.9

0.2

−2.6

0.1

0.1

−1.7

−0.4 (1.5)

p = 0.497

Headache severity (NRS) change at relapse

2.7

−1.4

−0.8

−2.7

− 1.8

− 0.4

−2.4

− 1.0 (1.8)

p = 0.253

Monthly analgesic days change at 3 months

3

−1

− 6

− 18

0

− 4

−9

− 5.0 (7.0)

p = 0.107

Monthly analgesic days change at relapse

0

0

−5

−18

−7

1

−10

−5.6 (6.9)

p = 0.075

HIT-6 score change at 3 months

− 5

−11

− 4

− 13

1

− 8

2

− 5.4 (5.7)

p = 0.045

HIT-6 score change at relapse

− 5

− 13

−4

−3

0

−18

− 2

−6.4 (6.6)

p = 0.041

Frisén grade at relapse (worst eye)

4

2

3

1

1

1

1

1.9 (1.2)

OCT global average RNFL thickness at relapse worst eye (μm) a

326 b

140 b

174 b

132 c

116 c

151 c

202 c

177.3 (71.4)

p = 0.043

BMI at relapse

31.3

48.5

38.7

38

44.6

36.7

30.5

38.3 (6.5)

p = 0.025

BMI change

0.3

2.3

3.5

0.7

2.5

7.3

1.7

2.6 (2.3)

IIH characteristics at relapse

B, T, V

B, T

B, T, V

B, D, T

B, D, T

B, D, T

B, T

 

Side effects

 

CO

 

HT, I

I

CO, MC

  
  1. Clinical outcomes and changes compared to erenumab initiation and the 30-day pre-treatment period *, p values indicate changes from erenumab initiation and the 30-day pre-treatment period
  2. aHeidelberg Engineering SPECTRALIS, Heidelberg, Germany
  3. bAt 6 months since commencing erenumab
  4. cAt 12 months since commencing erenumab
  5. Abbreviations: P Patient, IIH Idiopathic intracranial hypertension, MmsHD Monthly moderate/severe days, MHD Monthly headache days, NRS Numeric Rating Scale (0 = no pain to 10 = worst imaginable pain), HIT-6 Headache impact test-6, BMI Body mass index, B Blurred vision, D Double vision, T Tinnitus, V Visual obscurations, OCT Optical coherence tomography, RNFL Retinal nerve fiber layer, CO Constipation, HT Hair thinning, I Itch, MC Muscle cramps