Additional file 2: of Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study
2019-04-05T05:00:00Z (GMT) by
Figure S1. Patient disposition (a) and discontinuation over time (b). aFour patients in the tofacitinib 10 mg BID arm had a missing end-of-study page. bEvaluable for AEs (evaluable for laboratory data: tofacitinib 5 mg BID n = 1118, tofacitinib 10 mg BID n = 3346, and all tofacitinib n = 4464). cTwo patients in the tofacitinib 10 mg BID arm did not have recorded AEs. Safety analysis set: all patients who received at least one dose of study medication; efficacy analysis set: all patients who received at least one dose of study medication and had at least one post-baseline efficacy measurement available. Time to discontinuation: difference between the end-of-study date and first tofacitinib dose date plus 1 day; completers are censored at the end-of-study date. Study discontinuation occurred with the following scenarios: serious infections requiring antimicrobial therapy or hospitalization; opportunistic infections judged to be significant by the investigator; two sequential lymphocyte or neutrophil counts < 500 mm3 (neutrophil counts < 1000 mm3 for patients from Croatia, Czech Republic, Denmark, Germany, Ireland, Korea, Spain, Sweden, and the UK); two sequential platelet counts < 75,000 mm3; two sequential AST or ALT elevations > 3 times the ULN with ≥ 1 total bilirubin value > 2 times the ULN, abnormal International Normalized Ratio liver function test, or symptoms consistent with hepatic injury (or elevations > 5 times the ULN regardless); single positive HBcAb and a negative HBsAb; two sequential hemoglobins < 8.0 g/dL or a decrease > 30% from baseline; two sequential increases in serum creatinine > 100% of the average baseline/screening values (> 50% for Korea); other serious or severe AEs. Database lock: March 2, 2017. AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, HBcAb hepatitis B core antibody, HBsAb hepatitis B surface antibody, ULN upper limit of normal.