10.6084/m9.figshare.7961642.v1
Jürgen Wollenhaupt
Jürgen
Wollenhaupt
Eun-Bong Lee
Eun-Bong
Lee
Jeffrey Curtis
Jeffrey
Curtis
Joel Silverfield
Joel
Silverfield
Ketti Terry
Ketti
Terry
Koshika Soma
Koshika
Soma
Chris Mojcik
Chris
Mojcik
Ryan DeMasi
Ryan
DeMasi
Sander Strengholt
Sander
Strengholt
Kenneth Kwok
Kenneth
Kwok
Irina Lazariciu
Irina
Lazariciu
Lisy Wang
Lisy
Wang
Stanley Cohen
Stanley
Cohen
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
Springer Nature
2019
Rheumatoid arthritis
Tofacitinib
Long-term extension
2019-04-05 05:00:00
Journal contribution
https://springernature.figshare.com/articles/journal_contribution/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/7961642
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.