Maarten Cozijnsen

130 Table 3. Continued Type Year Authors Patients N Treatment Duration Post-hoc analysis of 6 ADA RCTs* 2014 Osterman et al (47) Adult CD 1594 [1] ADA+IM; [2] ADA 4-204 wks Observational 2014 Lichtenstein et al (TREAT) (48) Adult CD 6273 [1] IFX+IM [2] IFX [3] IM Case-control study 2011 Herrinton et al (49) Adult CD&UC 16023 [1] Anti-TNF+TP [2] Anti-TNF [3] TP Case-control study 2013 Deepak et al Adult CD&UC 45 [1] IFX+TP; [2] IFX [3] TP [4] Control drugs N=number; RCT=randomized clinical trial; CD=Crohn’s disease; UC=ulcerative colitis; ADA=adalimumab; IM=immunomodulator (AZA or 6-mercaptopurine or MTX); IFX=infliximab; AZA=azathioprine; PCB=placebo; MTX=methotrexate; TP=thiopurines (AZA/6MP); wks=weeks; AE=adverse event; SAE=serious adverse event; PY=patient-years; SIRR=standardized incidence risk ratio, i.e. risk as compared to a control population; OR=odds ratio. * Treatment of the two groups of the sub analysis, not of the randomization arms. ** When the P-value is followed by the “≈” symbol, no P-value is provided in the original article; we calculated an estimated P-value using Fisher Exact Test. *** No overall percentage of AEs in each group is given, only a list of the most common AEs in both groups and their between group difference