Maarten Cozijnsen

105 Chapter 5 Adalimumab therapy in children with infliximab-refractory CD No differences in remission or failure rates were found between patients who did and did not receive induction treatment (remission: 26/39 (67%) vs 8/14 (57%), P=0.54; failure: 12/39 (31%) vs 6/14 (43%), P=0.31; HR 0.5, CI 0.16-1.57), nor between patients who did and did not receive concomitant immunomodulators at baseline (remission: 22/32 (69%) vs 12/21 (57%), P=0.28; failure: 9/32 (28%) vs 9/21 (43%), P=0.21; HR 0.7, CI 0.28-1.95). Adverse events In 21 patients (40%), a total 37 adverse events were recorded, being related to adalimumab by the treating physician, of which 14 (38%) where infections (Table 3). Only one serious adverse event occurred, a sepsis and meningitis secondary to a sinusitis (1 SAE per 66 patient years(PY), 1.5 SAE/100PY). In three patients adalimumab therapy was stopped due to adverse effects, in one patient because of fatigue, hair loss, and pain and redness at the injection site, in the second because of discomfort after injections and recurring upper respiratory tract infections, and vasculitis associated skin manifestation in the third.                                      Figure 4. Comparing the risk of adalimumab failure between those with vs. without prior ATI formation ATI=antibodies to infliximab. Kaplan-Meier analysis displaying adalimumab failure over time in relation to prior ATI status. After 12 and 24 months, 14% and 22% of the patients with prior ATI formation failed adalimumab versus 40% and 55% of the patients without ATI formation at the time of infliximab failure (HR 0.37, CI 0.11-1.23).