Safety of Rimegepant in Patients Using Preventive Migraine Medications: A Subgroup Analysis of a Long-Term, Open-Label Study Conducted in the United States

Figures & data

Table 1 Demographics, Migraine History, and Exposure to Rimegepant

	Using Preventives (N = 243)	Not Using Preventives (N = 1557)	Total (N = 1800)
Age, years
Mean (SD)	45.5 (13.0)	42.7 (12.0)	43.1 (12.2)
Median (min, max)	45.8 (18, 84)	42.6 (18, 77)	43.0 (18, 84)
Sex, n (%)
Female	225 (92.6)	1384 (88.9)	1609 (89.4)
Male	18 (7.4)	173 (11.1)	191 (10.6)
Race, n (%)
White	207 (85.2)	1268 (81.4)	1475 (81.9)
Black or African American	23 (9.5)	227 (14.6)	250 (13.9)
Other^a	13 (5.3)	62 (4.0)	75 (4.2)
BMI, kg/m^2
Mean (SD)	29.0 (6.6)	29.5 (7.6)	29.4 (7.5)
Median (min, max)	27.6 (17.7, 56.4)	28.1 (14.7, 73.7)	28.0 (14.7, 73.7)
Primary migraine type, n (%)^b
Without aura	171 (70.4)	1029 (66.1)	1200 (66.7)
With aura	72 (29.6)	528 (33.9)	600 (33.3)
Number of moderate or severe migraine attacks per month^b
Mean (SD)	7.1 (3.2)	6.7 (3.1)	6.7 (3.1)
Median (min, max)	7.0 (2, 14)	6.0 (2, 14)	6.0 (2, 14)
Duration of untreated migraine attacks, hours^b
Mean (SD)	36.9 (23.3)	33.4 (22.1)	33.9 (22.3)
Median (min, max)	36.0 (4, 72)	24.0 (4, 72)	24.0 (4, 72)
Time on rimegepant 75 mg, weeks
Mean (SD)	33.2 (19.8)	34.0 (19.1)	33.9 (19.2)
Median (min, max)	47.0 (0.1, 54.6)	47.3 (0.1, 55.3)	47.3 (0.1, 55.3)
Number of rimegepant 75 mg tablets taken per 4 weeks
Mean (SD)	7.8 (4.5)	7.7 (4.7)	7.7 (4.6)
Median (min, max)	6.5 (0.3, 26.0)	6.4 (0.2, 27.6)	6.5 (0.2, 27.6)
Cumulative number of rimegepant 75 mg tablets taken during the study
Mean (SD)	61.8 (48.3)	62.3 (48.4)	62.2 (48.4)
Median (min, max)	49.0 (1.0, 339.0)	50.0 (1.0, 359.0)	50.0 (1.0, 359.0)

Notes: ^aIncludes American Indian or Alaska Native, Asian, Multiple, and Native Hawaiian or Other Pacific Islander. ^bHistorical data assessed at screening.

Abbreviations: BMI, body mass index; SD, standard deviation.

Table 2 Most Common (>3%) Preventive Migraine Medications Used During Treatment with Rimegepant^a

N (%) of Participants^b
Any preventive medication	243 (100)
Topiramate	64 (26.3)
Amitriptyline	24 (9.9)
Botulinum toxin type A	19 (7.8)
Erenumab-aooe	13 (5.3)
Magnesium	14 (5.8)
Propranolol	12 (4.9)
Nortriptyline	11 (4.5)
Metoprolol	11 (4.5)

Notes: ^aNon-study medications were recorded on the case report form. Investigators were required to indicate on the form whether the medication was a prophylactic migraine medication (yes or no). ^bPercentages based on the 243 participants who used preventive medications.

Table 3 Summary of On-Treatment AEs

n (%) of Participants	Using Preventives (N = 243)	Not Using Preventives (N = 1557)	Total (N = 1800)
Any AE	167 (68.7)	921 (59.2)	1088 (60.4)
Severe AE	16 (6.6)	63 (4.0)	79 (4.4)
Serious AE	11 (4.5)	36 (2.3)	47 (2.6)
Discontinued treatment due to AE	11 (4.5)	37 (2.4)	48 (2.7)
Most common AEs^a
Upper respiratory tract infection	18 (7.4)	140 (9.0)	158 (8.8)
Nasopharyngitis	19 (7.8)	103 (6.6)	122 (6.8)
Sinusitis	17 (7.0)	75 (4.8)	92 (5.1)
Urinary tract infection	13 (5.3)	56 (3.6)	69 (3.8)
Influenza	7 (2.9)	52 (3.3)	59 (3.3)
Back pain	13 (5.3)	43 (2.8)	56 (3.1)
Bronchitis	11 (4.5)	42 (2.7)	53 (2.9)
Nausea	8 (3.3)	43 (2.8)	51 (2.8)
Dizziness	8 (3.3)	34 (2.2)	42 (2.3)
Arthralgia	5 (2.1)	31 (2.0)	36 (2.0)
Most common serious AEs^b
Appendicitis	1 (0.4)	2 (0.1)	3 (0.2)
Osteoarthritis	1 (0.4)	2 (0.1)	3 (0.2)
Pulmonary embolism	1 (0.4)	2 (0.1)	3 (0.2)
Accidental overdose	0	3 (0.2)	3 (0.2)
Constipation	0	2 (0.1)	2 (0.1)
Sepsis	0	2 (0.1)	2 (0.1)
Pneumonia	0	2 (0.1)	2 (0.1)
Most common AEs leading to discontinuation^b
Dizziness	1 (0.4)	4 (0.3)	5 (0.3)
Anxiety	2 (0.8)	0	2 (0.1)
Depression	0	2 (0.1)	2 (0.1)
Suicidal ideation	0	2 (0.1)	2 (0.1)
Alanine aminotransferase increased	0	3 (0.2)	3 (0.2)
Aspartate aminotransferase increased	0	3 (0.2)	3 (0.2)
Blood creatine phosphokinase increased	0	2 (0.1)	2 (0.1)
Hot flush	0	2 (0.1)	2 (0.1)
Constipation	0	2 (0.1)	2 (0.1)
Arthralgia	0	2 (0.1)	2 (0.1)
Vertigo	0	2 (0.1)	2 (0.1)

Notes: ^aOccurring in ≥2% of all treated participants. ^bOccurring in >1 participant in any cohort.

Abbreviation: AE, adverse event.

Table 4 Summary of On-Treatment AEs Classified as Related to Rimegepant^a

n (%) of Participants	Using Preventives (N = 243)	Not Using Preventives (N = 1557)	Total (N = 1800)
Any AE	54 (22.2)	306 (19.7)	360 (20.0)
Severe AE	6 (2.5)	12 (0.8)	18 (1.0)
Serious AE	4 (1.6)	6 (0.4)	10 (0.6)
Most common AEs^b
Dizziness	3 (1.2)	24 (1.5)	27 (1.5)
Nausea	2 (0.8)	21 (1.3)	23 (1.3)
Constipation	2 (0.8)	18 (1.2)	20 (1.1)
Somnolence	4 (1.6)	15 (1.0)	19 (1.1)
All serious AEs^c
Cellulitis	1 (0.4)	0	1 (0.1)
Deep vein thrombosis	1 (0.4)	0	1 (0.1)
Headache	0	1 (0.1)	1 (0.1)
Hemiplegic migraine	0	1 (0.1)	1 (0.1)
Invasive ductal breast carcinoma	1 (0.4)	0	1 (0.1)
Suicidal ideation	0	1 (0.1)	1 (0.1)
Migraine	0	1 (0.1)	1 (0.1)
Colitis ischemic	1 (0.4)	0	1 (0.1)
Constipation	0	1 (0.1)	1 (0.1)
Nephrolithiasis	0	1 (0.1)	1 (0.1)

Notes: ^aTreatment-related AEs represent AEs that were considered by site investigators to have study drug relationship of “unlikely related”, “possibly related”, “related”, or not reported. ^bOccurring in ≥ 1% of all treated participants. ^cAll serious treatment-related AEs were deemed “unlikely related” to rimegepant by site investigators except for colitis ischemic, which was deemed “possibly related” to rimegepant.

Abbreviation: AE, adverse event.

Table 5 Summary of On-Treatment Grade 3 to 4 Clinical Laboratory Test Abnormalities Occurring in ≥1% of All Treated Participants

Grade 3 to 4 Abnormality, Number of Participants with Abnormality/Number of Participants with Data (%)	Using Preventives (N = 243)	Not Using Preventives (N = 1557)	Total (N = 1800)
LDL cholesterol (fasting)^a	2/93 (2.2)	25/720 (3.5)	27/813 (3.3)
LDL cholesterol	6/214 (2.8)	42/1332 (3.2)	48/1546 (3.1)
LDL cholesterol (non-fasting)	4/143 (2.8)	19/760 (2.5)	23/903 (2.5)
Creatine kinase	3/238 (1.3)	26/1492 (1.7)	29/1730 (1.7)
Urine glucose	0/180	12/1048 (1.1)	12/1228 (1.0)

Note: ^aFasting for ≥8 hours.

Abbreviation: LDL, low-density lipoprotein.