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

Table 4.

Baseline and percentage change from baseline in fasting lipid values at month 3 and month 6, by treatment group and baseline MetS status; pooled data from OPAL Broaden and OPAL Beyond

	Tofacitinib 5 mg BID ^a				Tofacitinib 10 mg BID ^a				Placebo ^a , ^b
	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)
	N1	Mean (SD) Median [IQR]	N1	Mean (SD) Median [IQR]	N1	Mean (SD) Median [IQR]	N1	Mean (SD) Median [IQR]	N1	Mean (SD) Median [IQR]	N1	Mean (SD) Median [IQR]
LDL‐cholesterol
Baseline (mg/dL)	90	120.3 (35.0) 115.8 [94.2‐142.9]	132	114.3 (30.1) 113.7 [93.8‐134.5]	90	124.4 (37.6) 120.1 [100.0‐152.0]	119	116.5 (36.7) 110.0 [90.0‐133.2]	87	120.8 (36.4) 117.0 [95.0‐146.7]	135	110.5 (30.8) 110.0 [87‐127.8]
% change from baseline to month 3	83	10.6 (23.0) 10.7 [−5.3 to 20.8]	125	8.2 (18.4) 6.8 [−2.2 to 19.6]	87	11.9 (25.8) 6.1 [−2.0 to 21.2]	114	16.0 (25.9) 11.5 [−1.4 to 30.6]	79	4.5 (17.7) 0.9 [−6.9 to 14.3]	126	4.2 (20.0) 1.7 [−8.3 to 11.5]
% change from baseline to month 6	86	10.0 (24.2) 10.3 [−4.3 to 22.6]	124	9.6 (19.1) 4.6 [−2.9 to 20.7]	79	12.8 (22.6) 11.8 [−4.0 to 29.5]	117	15.4 (24.5) 11.7 [0.3 to 31.3]	NA	NA	NA	NA
HDL‐cholesterol
Baseline (mg/dL)	92	48.7 (15.3) 44.4 [38.5‐56.9]	132	61.0 (16.7) 58.2 [28.6‐70.3]	93	48.7 (15.7) 45.6 [38.6‐56.4]	119	62.8 (21.1) 57.5 [47.1‐72.2]	88	47.9 (13.3) 46.2 [39.6‐55.0]	136	61.0 (18.0) 58.3 [48.8‐70.7]
% change from baseline to month 3	89	11.1 (19.7) 10.2 [−2.2 to 19.5]	125	8.6 (20.6) 5.3 [−3.6 to 17.5]	90	16.4 (18.9) 14.6 [5.8 to 25.4]	116	12.6 (18.8) 11.6 [0.4 to 24.2]	84	0.4 (15.2) 0.7 [−9.3 to 8.4]	127	−1.3 (16.5) −1.6 [−8.6 to 9.4]
% change from baseline to month 6	93	10.0 (23.3) 9.8 [−2.9 to 16.5]	124	8.2 (19.2) 7.5 [−4.1 to 18.0]	83	16.3 (20.0) 14.1 [3.3 to 27.7]	117	12.3 (20.8) 11.1 [−1.8 to 23.3]	NA	NA	NA	NA
Total cholesterol
Baseline (mg/dL)	92	206.5 (44.2) 206.8 [175.6‐234.8]	132	197.3 (35.4) 197.8 [171.1‐220.1]	94	209.8 (45.6) 207.0 [178.4‐239.8]	120	199.0 (46.0) 192.3 [163.3‐227.8]	88	203.4 (43.8) 200.2 [177.0‐235.8]	136	193.2 (38.8) 193.2 [164.5‐214.7]
% change from baseline to month 3	90	9.6 (14.6) 8.7 [1.4‐15.6]	125	7.4 (13.9) 7.1 [−0.7 to 14.0]	91	10.2 (18.8) 11.0 [2.2‐18.9]	117	13.9 (18.3) 11.5 [2.3‐22.6]	84	2.5 (13.0) 0.8 [−4.9 to 7.1]	127	1.7 (13.8) 1.1 [−7.0 to 8.2]
% change from baseline to month 6	93	8.4 (16.2) 7.3 [−1.2 to 17.6]	124	7.7 (12.8) 6.7 [−2.5 to 16.0]	84	14.3 (17.3) 12.9 [2.1‐24.8]	117	14.2 (17.4) 12.1 [2.7‐23.9]	NA	NA	NA	NA
Triglycerides
Baseline (mg/dL)	92	193.4 (107.8) 179.1 [127.9‐222.1]	132	110.0 (42.9) 100.9 [83.2‐131.5]	93	202.7 (216.0) 162.0 [121.3‐210.6]	119	97.3 (37.7) 95.6 [67.0‐119.5]	88	177.7 (78.8) 169.0 [125.2‐216.8]	136	107.7 (55.6) 93.8 [73.9‐117.3]
% change from baseline to month 3	90	9.2 (44.8) −1.0 [−21.1 to 27.6]	125	9.4 (36.5) 4.5 [−15.0 to 27.7]	90	7.6 (43.1) 3.8 [−20.2 to 25.6]	116	24.1 (63.0) 8.6 [−11.1 to 49.0]	84	7.4 (48.6) −4.0 [−21.4 to 22.6]	127	11.4 (43.6) 1.4 [−15.7 to 38.0]
% change from baseline to month 6	93	6.1 (38.4) 2.1 [−19.0 to 28.1]	124	6.6 (34.9) 1.7 [−18.6 to 26.1]	83	14.9 (48.7) 8.3 [−19.8 to 34.9]	117	25.3 (59.4) 17.9 [−17.2 to 46.4]	NA	NA	NA	NA

Abbreviations: BID, twice daily; csDMARD, conventional synthetic disease‐modifying antirheumatic drug; HDL, high‐density lipoprotein; IQR, interquartile range; LDL, low‐density lipoprotein; MetS, metabolic syndrome; N, number of patients treated without regard to baseline abnormality; N1, number of patients analyzed; NA, not assessed; SD, standard deviation.

^{^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.