A novel predictive method for risk stratification in acne patients receiving isotretinoin: an analysis of laboratory abnormalities and changes in inflammatory parameters

Figures & data

Table 1. Percentage of patients on isotretinoin with labs checked by month.

	Baseline	Month 1	Month 2	Month 6
Hemoglobin, n (%)	776 (87.00%)	86 (9.64)	63 (7.06)	49 (5.49)
Triglycerides, n (%)	832 (93.27)	742 (83.18)	669 (75)	394 (44.17)
Total Cholesterol, n (%)	830 (93.05)	740 (82.96)	668 (74.89)	395 (44.28)
LDL, n (%)	700 (78.48)	65 (7.29)	43 (4.82)	17 (1.91)
HDL, n (%)	696 (78.03)	61 (6.84)	42 (4.71)	17 (1.91)
AST, n (%)	853 (95.63)	748 (83.86)	674 (75.56)	401 (44.96)
ALT, n (%)	850 (95.29)	747 (83.74)	674 (75.56)	401 (44.96)
WBC, n (%)	804 (90.13)	90 (10.09)	63 (7.06)	50 (5.61)
Platelets, n (%)	796 (89.24)	89 (9.98)	63 (7.06)	49 (5.49)

Table 2. Number of patients with a lab abnormality by month of therapy.

	Baseline	Month 1	P-value	Month 2	P-value	Month 6	p Value
Hemoglobin, mg/dL	14.05 ± 1.47	14.08 ± 1.48	< 0.001	13.8 ± 1.37	< 0.001	14.01 ± 1.29	0.448
Normal, n (%)	694 (89.43)	79 (91.86)		56 (88.89)		45 (91.84)
Anemia, n (%)	73 (9.41)	6 (6.98)		6 (9.52)		4 (8.16)
Polycythemia, n (%)	9 (1.16)	1 (1.16)		1 (1.59)		0 (0.00)
Triglycerides, mg/dL	81.64 ± 39.3	98.19 ± 45.18	< 0.001	105.08 ± 49.16	< 0.001	118.62 ± 76.3	0.003
Normal	784 (94.23)	648 (87.33)		562 (84.01)		313 (79.44)
Grade 1 (150–300), n (%)	46 (5.53)	92 (12.40)		104 (15.55)		78 (19.80)
Grade 2 (300–500), n (%)	2 (0.24)	2 (0.27)		3 (0.45)		2 (0.51)
Grade 3 (500–1000), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
Grade 4 (1000), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		1 (0.25)
Total Cholesterol, mg/dL	162.23 ± 31.74	176.62 ± 32.98	< 0.001	179.24 ± 33.43	0.002	184.86 ± 35.45	< 0.001
Normal	739 (89.04)	573 (77.43)		501 (75.00)		264 (66.84)
Grade 1 (ULN-300), n (%)	91 (10.96)	167 (22.57)		165 (24.70)		131 (33.16)
Grade 2 (300–400), n (%)	0 (0.00)	0 (0.00)		2 (0.30)		0 (0.00)
Grade 3 (400–500), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
Grade 4 (>500), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
LDL^a, mg/dL	100.2 ± 36.9	115.72 ± 28.71	< 0.001	118.63 ± 31.69	< 0.001	113.88 ± 27.18	0.57
Optimal (less than 100), n (%)	386 (55.14)	23 (27.91)		12 (27.91)		5 (29.41)
Near Optima (100-129), n (%)	216 (30.86)	15 (34.88)		15 (34.88)		9 (52.94)
Borderline high (130-159), n (%)	79 (11.29)	11 (25.58)		11 (25.58)		2 (11.76)
High (160-189), n (%)	13 (1.86)	5 (11.63)		5 (11.63)		1 (5.88)
Very high (>190), n (%)	6 (0.86)	0 (0.00)		0 (0.00)		0 (0.00)
HDL^a, mg/dL	55.00 ± 12.93	55.17 ± 17.03	< 0.001	54.79 ± 10.28	< 0.001	51.05 ± 11.81	0.123
Low (< 40), n (%)	47 (6.75)	7 (11.48)		2 (4.76)		4 (23.53)
Borderline (40-60), n (%)	439 (63.07)	37 (60.66)		29 (69.05)		8 (47.06)
High (> = 60), n (%)	210 (30.17)	17 (27.87)		11 (26.19)		5 (29.41)
AST^a, IU/L	17.16 ± 9.98	19.43 ± 8.21	1.000	20.29 ± 9.93	1.000	19.87 ± 6.19	1.000
Normal	841 (98.59)	736 (98.40)		655 (97.18)		391 (97.51)
Grade 1 (ULN-3x ULN), n (%)	9 (1.06)	11 (1.47)		16 (2.37)		10 (2.49)
Grade 2 (3x ULN-5x ULN), n (%)	3 (0.35)	1 (0.13)		3 (0.45)		0 (0.00)
Grade 3 (5x ULN-20x ULN), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
Grade 4 (>20x ULN), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
ALT^a, IU/L	14.38 ± 7.72	16.00 ± 9.53	1.000	16.35 ± 13.18	1.000	17.08 ± 13.83	1.000
Normal	842 (99.06)	733 (98.13)		659 (97.77)		389 (97.01)
Grade 1 (ULN-3x ULN), n (%)	8 (0.94)	14 (1.87)		14 (2.08)		11 (2.74)
Grade 2 (3x ULN-5x ULN), n (%)	0 (0.00)	0 (0.00)		1 (0.15)		1 (0.25)
Grade 3 (5x ULN-20x ULN), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
Grade 4 (>20x ULN), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
WBC^a, ×10^3/mL	7.24 ± 1.97	6.86 ± 2.42	< 0.001	7.49 ± 2.79	< 0.001	7.01 ± 1.84	1.000
Normal	751 (93.41)	75 (83.33)		54 (85.71)		46 (92.00)
Grade 1 (3-LLN), n (%)	50 (6.22)	15 (16.67)		7 (11.11)		4 (8.00)
Grade 2 (2–3), n (%)	2 (0.25)	0 (0.00)		2 (3.17)		0 (0.00)
Grade 3 (1–2), n (%)	1 (0.12)	0 (0.00)		0 (0)		0 (0.00)
Grade 4 (<1), n (%)	0 (0.00)	0 (0.00)		0 (0)		0 (0.00)
Platelets, ×10^3/mL	275.62 ± 66.91	274.7 ± 70.66	1.000	285.19 ± 98.91	1.000	302.29 ± 88.38	1.000
Normal	788 (98.99)	88 (98.88)		62 (98.41)		46 (92.00)
Grade 1 (75-LLN), n (%)	8 (1.01)	1 (1.12)		1 (1.59)		2 (1.4)
Grade 2 (50–75), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
Grade 3 (25–50), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)
Grade 4 (<25), n (%)	0 (0.00)	0 (0.00)		0 (0.00)		0 (0.00)

^aALT: alanine aminotransferase; AST: aspartate aminotransferase; HDL: High-density lipoprotein; LDL: Low-density lipoprotein; WBC: white blood cell; ULN: upper limit of normal; LLN: lower limit of normal.

Figure 1. Association between baseline cholesterol and Subsequent Changes in cholesterol Categories.

Figure 2. ROC analysis of baseline cholesterol for sensitivity in Screening normal vs. Abnormal follow-up cholesterol levels. AUC: Area under the curve.

Figure 3. Association between baseline triglycerides levels and Subsequent Changes in triglycerides Categories.

Figure 4. ROC analysis of baseline triglycerides for sensitivity in Screening normal vs. Abnormal follow-up triglycerides levels.

Figure 5. Changes in immune cell ratios across timepoints during isotretinoin treatment.