. 2020 Sep 10;2(10):543–554. doi: 10.1002/acr2.11166

Table 3.

AEs of potential interest in the context of MetS up to months 3 and 6, by treatment group and baseline MetS status; pooled data from OPAL Broaden and OPAL Beyond

	Up to Month 3						Up to Month 6
	Tofacitinib 5 mg BID ^a (N = 238)		Tofacitinib 10 mg BID ^a (N = 236)		Placebo ^a , ^b (N = 236)		Tofacitinib 5 mg BID ^a (N = 238)		Tofacitinib 10 mg BID ^a (N = 236)
n (%)	With baseline MetS (N = 99)	Without baseline MetS (N = 139)	With baseline MetS (N = 101)	Without baseline MetS (N = 135)	With baseline MetS (N = 94)	Without baseline MetS (N = 142)	With baseline MetS (N = 99)	Without baseline MetS (N = 139)	With baseline MetS (N = 101)	Without baseline MetS (N = 135)
Blood glucose increase	0	1 (0.7)	0	0	0	0	0	1 (0.7)	0	0
Diabetes	0	1 (0.7)	0	0	0	0	0	1 (0.7)	0	0
Hyperglycemia	1 (1.0)	0	1 (1.0)	0	0	0	1 (1.0)	0	1 (1.0)	0
Hypertension	2 (2.0)	2 (1.4)	4 (4.0)	1 (0.7)	1 (1.1)	2 (1.4)	5 (5.1)	4 (2.9)	4 (4.0)	3 (2.2)
Hepatic steatosis	0	0	1 (1.0)	0	0	0	1 (1.0)	0	1 (1.0)	1 (0.7)
ATE	1 (1.0)	0	0	0	0	0	1 (1.0)	0	0	0
MI	0	0	0	0	0	0	1 (1.0) ^c	0	0	0

Abbreviations: AE, adverse event; ATE, arterial thromboembolism; BID, twice daily; csDMARD, conventional synthetic disease‐modifying antirheumatic drug; MACE, major adverse cardiovascular event; MetS, metabolic syndrome; MI, myocardial infarction; N, number of patients evaluable for AEs; n, number of patients with AEs.

^{^a}

All patients received a stable dose of one background csDMARD.

^{^b}

Patients in the placebo group were advanced to tofacitinib 5 or 10 mg BID after 3 months of placebo treatment.

^{^c}

Adjudicated as a MACE.