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. 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.