Table 5.

ISRs following mirikizumab administered with either prefilled syringe or autoinjector

Participants with event, n (%)	Study AMBW (mirikizumab 200 mg)		Study AMBX (mirikizumab 300 mg)
	PFS (N = 120)	Autoinjector (N = 120)	PFS (N = 117)	Autoinjector (N = 120)
Participants with any ISRa	10 (8.3)	11 (9.2)	2 (1.7)	12 (10.0)
Number of ISRs	30	33	3	34
Erythema
Noticeable but very mild redness	3 (10)	5 (15.2)	0 (0)	8 (23.5)
Clearly red	2 (6.7)	0 (0)	0 (0)	0 (0)
Bright red	2 (6.7)	0 (0)	0 (0)	0 (0)
Dark with ulceration, or necrosis	0 (0)	0 (0)	0 (0)	0 (0)
Pruritus
Mild	3 (10)	0 (0)	0 (0)	7 (20.6)
Moderate	2 (6.7)	0 (0)	0 (0)	0 (0)
Severe	0 (0)	0 (0)	0 (0)	0 (0)
Induration
Barely noticeable	2 (6.7)	4 (12.1)	0 (0)	2 (5.9)
Slight	0 (0)	0 (0)	0 (0)	0 (0)
Moderate	0 (0)	0 (0)	1 (33.3)	0 (0)
Severe	0 (0)	0 (0)	0 (0)	0 (0)
Edema
Mild	2 (6.7)	2 (6.1)	0 (0)	4 (11.8)
Moderate	1 (3.3)	0 (0)	0 (0)	0 (0)
Severe	0 (0)	0 (0)	0 (0)	0 (0)
Painb	7 (5.8)	11 (9.2)c	2 (1.7)	7 (5.8)

ISR injection-site reaction, PFS prefilled syringe, VAS visual analog scale

^aISRs that triggered further assessment (AMBW, n = 21; AMBX, n = 14)

^bOverall data for left or right side of body (arm, thigh, or abdomen)

^cTwo (1.7%) participants self-reported a VAS pain score > 70 mm. Additional information on erythema, edema, pain, induration, and pruritis was collected for each ISR reported, regardless of the type of ISR reported as the TEAE, with each positive response in any category counted as an event; thus, more than one event could be counted for each TEAE. Pain categories are defined as follows: no pain, VAS pain score = 0; mild pain, VAS pain score > 0 and ≤ 30; moderate pain, VAS pain score > 30 and ≤ 70; severe pain = VAS pain score > 70