Mark W. Green, MD, FAAN

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1 Mark W. Green, MD, FAAN Professor of Neurology, Anesthesiology, and Rehabilitation Medicine Director of Headache and Pain Medicine Icahn School of Medicine at Mt Sinai New York

2 Pain-sensitive structures Portions of the Meninges Basal Dura Mater Venous Sinuses and tributaries Neural Structures Trigeminal Cranial Nerves Glossopharyngeal Nerves Vagus Nerves Scalp and superficial Structures Vascular Structures Dural Arteries Carotid / Vertebral Arteries Proximal portions of the cerebral vessels in the head

3 Why is the pain of migraine pulsatile?

4 Cortical Spreading Depression AA NO CGRP K+ Meninges Sphenopalatine ganglion Trigeminal nerve Trigeminal ganglion Pain Adapted from; Bolay H et al. Nat Med Superior salivatory nucleus Trigeminal nucleus

5 Peripheral and central sensitization Sensitization of trigeminovascular neurons in nucleus caudalis mediates cutaneous allodynia and muscle tenderness

6 Presumed Chronic Migraine Pathophysiology: Activation of Trigeminovascular System In response to noxious stimuli CGRP and substance P are released, causing additional dilation, inflammation, and pain in meningeal vessels 1 Irritation of the meninges is transmitted by trigeminal afferent fibers via the trigeminal ganglion to the brainstem (trigeminal nucleus caudalis) CGRP = calcitonin gene related peptide. 1. Pietrobon D, Neuroscientist. 2005;11:

7 Chronic migraine ICDH-3 A. Headache (tension-type-like and/or migraine-like)on 15 days per month for > 3 months and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B- D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura C. On 8 days per month for > 3 months, fulfilling any of the following3 : 1. criteria C and D for 1.1 Migraine without aura 2. criteria B and C for 1.2 Migraine with aura 3. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis

8 Prevalence of Chronic Migraine Chronic migraine is the most common form of chronic daily headache in headache specialty clinics 1 Approximately 2%* of the global population suffers from chronic migraine 2 Chronic migraine prevalence estimates are 2.5 to 6.5 times higher in women (1.7% 4.0%) than in men (0.6% 0.7%) 2 * According to broad criteria (migraine with 15 headache days/month). 1. Dodick D. N Engl J Med 2006;354: Natoli J et al. Cephalalgia. 2010;30(5):

9 There is colocalization of SNAP 25 in cranial dura Pericranially injected BoNT/A is taken up by local sensory nerve endings, axonally transported to the trigeminal ganglion and trancytosed to dural afferents BoNT/A (like sumatriptan) reduces dural neurogenic inflammation and inhibits release of CGRP levels in dura BoNT/A may prevent neurogenic inflammation by suppressing transmission by CGRP Lackovic Z et al. Activity of botulinum toxin A in cranial dura: implications for treatment of migraine and other headaches. Brit J Pharm Dec 19, 2015.

10 Peripheral innervation of dura Lidocaine/bupivacaine anesthetizes dura 5 day old mice: stained for peripherin and CGRP Cross skull and issue collaterals to dura and arachnoid Most anterior third of skull, others occipital

11 Hypothetical mechanism of extracranial nerve block in migraine BTX-A BTX-A

12 Getting insurance approval You have to try and fail on medications not FDA approved for chronic migraine Seizure meds: topiramate has positive data Hypertensive meds: propranolol ineffective Antidepressants

13 Migraine is meningitis Throbbing pain, neck tight, light and sound sensitivity, increase pain with exertion Neurogenic inflammation

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15 Effects of BoNT/A on the number of migraine days per month according to type of headache (study I and II combined)

16 OnabotulinumtoxinA Two prospective, placebo controlled, randomized clinical trials indicated improvement in chronic migraine 155 units given over 31 injection sites 40 additional units discretionary Frontalis, glabellar, temporalis, suboccipitalis, cervical paraspinous, and trapezius muscle distributions

17 Please see see Important Safety Information, including Boxed Warning, throughout on slides this deck. Injection Sites: Corrugator and Procerus 5 Units BOTOX at each site (0.1 ml injected) Procerus: 5 Units in 1 site Corrugator: 10 Units divided in 2 sites 18 BOTOX (onabotulinumtoxina) Prescribing Information. Allergan, Inc., 2011.

18 Please see see Important Safety Information, including Boxed Warning, throughout on slides this deck. Injection Sites: Frontalis Region 5 Units BOTOX at each site (0.1 ml injected) Frontalis: 20 Units divided in 4 sites 19 BOTOX (onabotulinumtoxina) Prescribing Information. Allergan, Inc., 2011.

19 Please see Important Safety Information, including Boxed Warning, throughout this deck. Injection Sites: Temporalis 5 Units BOTOX at each site (0.1 ml injected) Having the patient clench teeth will produce a palpable anterior bulge to the temporalis muscle, directing the anterior injection site Temporalis: 40 Units divided in 8 sites 20 BOTOX (onabotulinumtoxina) Prescribing Information. Allergan, Inc., 2011.

20 Please see see Important Safety Information, including Boxed Warning, throughout on slides this deck. Injection Sites: Occipitalis 5 Units BOTOX at each site (0.1 ml injected) Occipitalis: 30 Units divided in 6 sites Nuchal ridge 21 BOTOX (onabotulinumtoxina) Prescribing Information. Allergan, Inc., 2011.

21 Please see see Important Safety Information, including Boxed Warning, throughout on slides this deck. Injection Sites: Cervical Paraspinal Muscle Group and Trapezius 5 Units BOTOX at each site (0.1 ml injected) Trapezius: 30 Units divided in 6 sites Cervical paraspinal muscle group: 20 Units divided in 4 sites 22 BOTOX (onabotulinumtoxina) Prescribing Information. Allergan, Inc., 2011.

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23 PREEMPT Pooled Analysis: ~70% of Patients Achieved 50% Reduction in Headache Days at 56 Weeks Change in Headache Days: Primary Endpoint Week Headache Days/28 Days (Mean Headache Change Days/28 From Baseline) Days p<0.001 Double-Blind Phase Week 24 Primary Endpoint BOTOX Placebo p<0.001 p<0.001 p<0.001 p<0.001 p<0.001 p<0.001 p=0.008 p=0.01 p=0.007 p=0.047 p=0.019 p=0.011 p=0.019 Open Label Phase Mean ± standard error. The double blind phase included 688 subjects in the BOTOX group and 696 in the placebo group. Headache days at baseline: 19.9 BOTOX group vs 19.8 placebo group, p= Aurora SK et al. Presented at IHC

24 Pooled Efficacy of BOTOX at Week 24 (Primary Time Point) Endpoint, Mean Change From Baseline BOTOX (n=688) Placebo (n=696) p Value* Frequency of HA days <0.001 Frequency of migraine days <0.001 Frequency of moderate/severe HA days <0.001 Total cumulative HA hours on HA days <0.001 % Patients with severe ( 60) HIT-6 score <0.001 Total HIT-6 score <0.001 Frequency of HA episodes Frequency of migraine episodes Frequency of acute HA pain medication intake (all categories) Frequency of triptan use <0.001 BOTOX was statistically significantly more effective than placebo in reducing mean frequency of headache days at every visit in the doubleblind phase starting at the first post treatment study visit (Week 4) HA = headache; HIT = Headache Impact Test. Dodick DW et al. Headache. 2010;50:

25 Labeling of trigeminal ganglion neurons using neurofilament, peripherin, CGRP and VR1 immunostaining Neurofilament - myelinated (A, A, A ) and unmyelinated (C) nerve fibers Found in sensory, motor, and autonomic neurons Peripherin - thinly-myelinated (A ) and unmyelinated (C) nerve fibers Found in sensory, motor, and autonomic neurons CGRP unmyelinated (C), peptidergic pain fibers Found in sensory, motor, and autonomic neurons (TRPV1) unmyelinated (C) fibers, peptidergic pain fibers found in sensory neurons alone

26 Immunostained cell bodies in the trigeminal ganglion

27 Neurofilament-positive fibers in the periosteum Muscle Bone Bone bottom

28 Peripherin-positive fibers in the periosteum

29 CGRP-positive fibers in the galea and periosteum bottom

30 TRPV1-positive fibers in the galea and periosteum

31 Neurofilament-positive fibers in the parietal bone Galea aponeurotica Periosteum Parietal bone Bone Cortex bottom

32 Peripherin-positive fiber running longitudinally in the frontal bone Skin Bone Back Front Cerebral cortex

33 CGRP-positive fiber in the temporal bone Temporal bone Dermis

34 TRPV1-positive fiber in the temporal bone

35 Nociceptive fibers crossing the bone

36 Neurofilament-positive fibers crossing the bone Dermis Parietal bone Cortex

37 Peripherin-positive fibers crossing the bone Dermis Parietal bone Cortex Bottom

38 CGRP-positive fibers crossing the bone Dermis Parietal bone Cortex

39 Nociceptive fibers extending between bone and dura

40 Peripherin-positive fibers crossing the bone Bottom

41 Neurofilament-positive fibers extending between bone and dura Dermis Temporal bone Dura Cortex

42 Peripherin-positive fiber extending between bone and dura Rhinal Fissure Dura Cortex Ethmoid bone

43 CGRP-positive fiber extending between bone and dura Dermis Parietal bone Dura Cortex

44 Fibers running between dura and pia

45 Nociceptive fibers passing through sutures of the skull

46 Fibers passing through the sutures Neurofilament fibers in the squamos suture Peripherin fibers in the superior sagittal suture

47 San Antonio military treatment facility; allows injection paradigm through discretion (including obtxa, ibtxa, or rbtxb 5 receiving PREEMPT paradigm: 2 superior, 3 moderate 163 others: 63 superior, 87 moderate, 13 ineffective Grogan P et al. To PREEMPT or Not to PREEMPT: Is there an Ideal Botulinum Toxin Injection Strategy for Migraine Prevention? Neurology April 5, 2016 Vol 86 #16 Supp P2.213.

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49 Safety and Efficacy of BoNT in Chronic Migraine AAN QSS: 2016 OnaBoNT-A is established as safe and effective for increasing the number of headache-free days in CM (2 Class I studies) and probably effective for improvement in health-related quality of life (1 Class I study). Simpson DM et al. Neurology 2016 Published online before print, doi: / dx. doi. org/ / WNL Slide 50

50 BoNT in Chronic Migraine AAN QSS: 2016 Clinical Context Although the reduction of headache days with onabont-a was statistically superior to placebo in 2 Class I studies, the magnitude of the difference is small (approximately 15% reduction BoNT vs placebo). Simpson DM et al. Neurology 2016 Published online before print, doi: / dx. doi. org/ / WNL Slide 51

51 BoNT in Episodic Migraine QSS 2016 AAN QSS: Evidence-based review Conclusions and recommendations : 3 class I 1 Results: no difference, BoNT vs placebo QSS conclusion: probably ineffective QSS recommendation: should not be offered 1. Simpson DM et al. Neurology 2016 Published online before print, doi: / dx. doi. org/ / WNL

52 BoNT in Tension-Type Headache AAN QSS 2016 AAN QSS: Evidence-based review Conclusions and recommendations : 2 class I 1, Results: no difference, BoNT vs placebo QSS conclusion: probably ineffective QSS recommendation: should not be offered 1. Schulte-Mattler et al. Pain 2004;109: Silberstein S et al. Cephalagia 2006;26: Padberg M et al. Cephalalgia 2004;24: Simpson DM et al. Neurology 2016 Published online before print, doi: / dx. doi. org/ / WNL

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