. 2023 Jul 17;10(5):1255–1276. doi: 10.1007/s40744-023-00576-8

Table 5.

Safety outcomes by sex and age < 65 and ≥ 65 years among patients with PsA and RA (all tofacitinib)

PsA	Age < 65 years 13,453 PY			Age ≥ 65 years 7253 PY			Female sex 14,331 PY			Male sex 6375 PY
PsA	N	%^a	RR^b	N	%^a	RR^b	N	%^a	RR^b	N	%^a	RR^b
Case reports	3299			965			3468			1338
AEs	10,198		75.80	3505		48.32	11,455		79.93	3770		59.14
SAEs	1130	11.08	8.40	555	15.83	7.65	1402	12.24	9.78	530	14.06	8.31
AESIs^c
Serious infections	284	2.78	2.11	114	3.25	1.57	312	2.72	2.18	113	3.00	1.77
HZ (serious and nonserious)	46	0.45	0.34	25	0.71	0.34	59	0.52	0.41	21	0.56	0.33
Cardiovascular events^d	31	0.30	0.23	23	0.66	0.32	38	0.33	0.27	27	0.72	0.42
Malignancies (excluding NMSC)	32	0.31	0.24	19	0.54	0.26	38	0.33	0.27	17	0.45	0.27
NMSC	6	0.06	0.04	5	0.14	0.07	10	0.09	0.07	1	0.03	0.02
VTE^e	21	0.21	0.16	11	0.31	0.15	22	0.19	0.15	16	0.42	0.25
Fatal cases	10	0.30^f	0.07	26	2.69^f	0.36	24	0.69^f	0.17	14	1.05^f	0.22

RA	Age < 65 years 247,644 PY			Age ≥ 65 years 191,726 PY			Female sex 336,013 PY			Male sex 103,357 PY
RA	N	%^a	RR^b	N	%^a	RR^b	N	%^a	RR^b	N	%^a	RR^b
Case reports	42,923			22,076			49,300			10,757
AEs	142,559		57.57	80,419		41.94	176,244		52.45	33,014		31.94
SAEs	20,472	14.36	8.27	17,104	21.27	8.92	29,088	16.50	8.66	6292	19.06	6.09
AESIs^c
Serious infections	4326	3.03	1.75	3238	4.03	1.69	5904	3.35	1.76	1253	3.80	1.21
HZ (serious and nonserious)	1013	0.71	0.41	769	0.96	0.40	1389	0.79	0.41	229	0.69	0.22
Cardiovascular events^d	519	0.36	0.21	655	0.81	0.34	831	0.47	0.25	303	0.92	0.29
Malignancies (excluding NMSC)	615	0.43	0.25	791	0.98	0.41	979	0.56	0.29	331	1.00	0.32
NMSC	117	0.08	0.05	181	0.23	0.09	211	0.12	0.06	78	0.24	0.08
VTE^e	222	0.16	0.09	222	0.28	0.12	332	0.19	0.10	117	0.35	0.11
Fatal cases	312	0.73^f	0.13	825	3.74^f	0.43	744	1.51^f	0.22	332	3.09^f	0.32

AE adverse event, AESI adverse event of special interest, HZ herpes zoster, MedDRA Medical Dictionary for Regulatory Activities, NMSC nonmelanoma skin cancer, PsA psoriatic arthritis, PT Preferred Term, PY patient-years, RA rheumatoid arthritis, RR reporting rate, SAE serious adverse event, VTE venous thromboembolism

^aPercentages are based on total AEs by formulation except where otherwise indicated

^bEvents/100 PY (exposure estimated from IQVIA’s Multinational Integrated Data Analysis System and Prescriber Insights databases)

^cSearch criteria for AESI categories are described in the Supplementary Methods

^dIncludes the following Standardised MedDRA Queries: central nervous system vascular disorders, myocardial infarction and associated terms, ischemic heart disease and associated terms; and the following PTs: cardiac death, cardiac failure congestive, sudden cardiac death, and pulmonary embolism

^ePulmonary embolism events are captured in the cardiovascular events and VTE categories

^fPercentages based on total case reports by formulation