Table C-10KQ 3a: TPMT status to guide therapy, clinical outcomes – characteristics and results of included study

StudyStudy Design

Study Region

Study Setting
Inclusion and exclusion criteriaThiopurine treatment in group that was genotyped apriori (intervention group)

N=167
Thiopurine treatment in group that was not genotyped apriori (control group)

N=166
Intervention group descriptionControl group descriptionResults (n/N)
Newman, 201045RCT

Europe

Outpatient specialty clinics at 19 study centers
Inclusion: Adults with chronic inflammatory diseases, mostly IBD, eligible for azathioprine therapy

Exclusion: Nursing and pregnant women and those likely to experience adverse events were excluded
AZA

Mean (SD) starting dose was 0.92 (0.61) in non-carriers and 0.67 (0.35) in heterozygous carriers. There were no homozygous carriers in this group
AZA

Mean (SD) starting dose 0.88 (0.54) in those later found out to be non-carriers and 0.94 (0.68) in heterozygous carriers. There was one homozygous carrier in this group
Therapy was advised to be guided by genotyping results, however, all treatment decisions were at the discretion of treating physiciansPatient management was at the discretion of the treating physicianOver a 4 month duration, there were no significant differences in the outcomes of mortality (1/167 vs.3/166); SAE (4/167 vs. 8/166); and WDAE (0/167 vs. 0/166). Odds ratios of 0.33 (0.03, 3.18), 0.48 (0.14, 1.64) and non-estimibale, respectively

From: Appendix C, Evidence Tables

Cover of Assessment of Thiopurine Methyltransferase Activity in Patients Prescribed Azathioprine or Other Thiopurine-Based Drugs
Assessment of Thiopurine Methyltransferase Activity in Patients Prescribed Azathioprine or Other Thiopurine-Based Drugs.
Evidence Reports/Technology Assessments, No. 196.
Booth RA, Ansari MT, Tricco AC, et al.

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