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

Table 3.

Safety outcomes by tofacitinib formulation among patients with PsA and RA

PsA	Tofacitinib IR 14,000 PY			Tofacitinib MR 6706 PY			All tofacitinib 20,706 PY
PsA	N	%^a	RR^b	N	%^a	RR^b	N	%^a	RR^b
Case reports	2601			2425			5026
AEs	8349		59.64	7602		113.36	15,951		77.04
SAEs	1136	13.61	8.11	912	12.00	13.60	2048	12.84	9.89
AESIs^c
Serious infections	239	2.86	1.71	200	2.63	2.98	439	2.75	2.12
HZ (serious and nonserious)	49	0.59	0.35	35	0.46	0.52	84	0.53	0.41
Cardiovascular events^d	44	0.53	0.31	25	0.33	0.37	69	0.43	0.33
Malignancies (excluding NMSC)	30	0.36	0.21	27	0.36	0.40	57	0.36	0.28
NMSC	4	0.05	0.03	7	0.09	0.10	11	0.07	0.05
VTE^e	27	0.32	0.19	12	0.16	0.18	39	0.24	0.19
Fatal cases	22	0.85^f	0.16	19	0.78^f	0.28	41	0.82^f	0.20

RA	Tofacitinib IR 312,632 PY			Tofacitinib MR 126,738 PY			All tofacitinib 439,370 PY
RA	N	%^a	RR^b	N	%^a	RR^b	N	%^a	RR^b
Case reports	39,744			24,148			63,892
AEs	137,476		43.97	82,153		64.82	219,629		49.99
SAEs	24,966	18.16	7.99	11,978	14.58	9.45	36,944	16.82	8.41
AESIs^c
Serious infections	4944	3.60	1.58	2467	3.00	1.95	7411	3.37	1.69
HZ (serious and nonserious)	1194	0.87	0.38	529	0.64	0.42	1723	0.78	0.39
Cardiovascular events^d	773	0.56	0.25	413	0.50	0.33	1186	0.54	0.27
Malignancies (excluding NMSC)	941	0.68	0.30	429	0.52	0.34	1370	0.62	0.31
NMSC	193	0.14	0.06	109	0.13	0.09	302	0.14	0.07
VTE^e	318	0.23	0.10	150	0.18	0.12	468	0.21	0.11
Fatal cases	839	2.11^f	0.27	279	1.16^f	0.22	1118	1.75^f	0.25

All cases reported at least one AE. Some cases reported > 1 AE; therefore, the number of AEs exceeds the number of cases

AE adverse event, AESI adverse event of special interest, HZ herpes zoster, IR immediate release, MedDRA Medical Dictionary for Regulatory Activities, MR modified release, 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