Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial

Table 4 Patients with laboratory values meeting pre-specified protocol criteria* for safety monitoring

Criterion, % (n/N)	2 % tofacitinib BID	1 % tofacitinib BID	Vehicle BID	2 % tofacitinib QD	1 % tofacitinib QD	Vehicle QD
Any criterion	2.9 (2/70)	2.9 (2/70)	1.4 (1/69)	5.8 (4/69)	4.1 (3/73)	1.4 (1/73)
Hemoglobin^a	1.5 (1/68)	0.0 (0/70)	0.0 (0/69)	0.0 (0/67)	4.1 (3/73)	1.4 (1/72)
Neutrophil count^b	0.0 (0/68)	0.0 (0/69)	0.0 (0/69)	1.5 (1/67)	0.0 (0/73)	0.0 (0/72)
Lymphocyte count^c	0.0 (0/68)	0.0 (0/70)	0.0 (0/69)	0.0 (0/67)	0.0 (0/73)	0.0 (0/71)
Platelet count^d	0.0 (0/68)	0.0 (0/69)	0.0 (0/69)	0.0 (0/67)	0.0 (0/73)	0.0 (0/72)
Serum creatinine^e	1.4 (1/69)	0.0 (0/70)	0.0 (0/69)	1.5 (1/67)	0.0 (0/73)	0.0 (0/72)
AST/ALT^f	0.0 (0/69)	2.9 (2/70)	1.4 (1/69)	1.5 (1/67)	0.0 (0/73)	0.0 (0/72)
CPK^g	0.0 (0/69)	0.0 (0/70)	1.4 (1/69)	3.0 (2/67)	0.0 (0/73)	0.0 (0/72)

^*aAny hemoglobin value >2 g/dL (>20 g/L) below baseline; ^bAbsolute neutrophil count <1.2 × 10⁹/L (<1200/mm³); ^cAbsolute lymphocyte count <0.5 × 10⁹/L (<500 lymphocytes/mm³); ^dPlatelet count <100 × 10⁹/L (<100,000/mm³); ^eSerum creatinine increase >50 % over the average of screening and baseline values OR absolute increase in serum creatinine >0.5 mg/dL (>44.2 μmol/L) over the average of screening and baseline values; ^fAny AST and/or ALT elevation ≥3 times the ULN, regardless of the total bilirubin; ^gAny CPK >5xULN
ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, CPK creatine phosphokinase, QD once daily, ULN upper limit of normal

ISSN: 1471-5945