Adverse Drug Events in Inﬂiximab-treated Patients Compared With the General and Psoriasis Populations
December 2008 | Volume 7 | Issue 12 | Original Article | 1137 | Copyright © December 2008
Alan Menter MD, Kristian Reich MD, Alice B. Gottlieb MD PhD, Mohan Bala PhD, Shu Li MS, Ming-Chun Hsu PhD, Cynthia Guzzo MD, Joris Diels MSc, Joel M. Gelfand MD MSCE
Methods: Integrated data (n=1373 patients) were compared with external databases.
Results: The analyses reported here are based on 1106 patient years and 116 patient years of follow-up in the inﬂiximab group and the placebo group, respectively. The standardized mortality ratio in inﬂiximab-treated patients (0.17 [95% conﬁdence interval [CI]: 0.00-0.92], 1 patient died) was lower than that of the general PsO population. No death occurred in the placebo group. Comparing with the psoriasis population, the standardized incidence ratios (SIRs) for hospitalization were 1.16 (95%CI: 0.92-1.43) in inﬂiximab-treated patients and 1.07 (95%CI: 0.46-2.11) in placebo-treated patients. For serious infection, the SIRs were 1.28 (95%CI: 0.78-1.97) in inﬂiximab-treated patients and 1.47 (95% CI: 0.18-5.32) in placebo patients. The incidence of tuberculosis (TB) among inﬂiximab-treated patients was 0.18 per 100 pa- tient-years (95% CI: 0.02-0.65). No TB occurred in the placebo group. Standardized incidence ratio for malignancy (excluding nonmelanoma skin cancers) was 0.39 (95% CI: 0.05-1.42; 2 malignancies) in inﬂiximab-treated patients. No malignancy occurred in the placebo group.
Limitations: Exclusion criteria in clinical studies may bias selection of subjects who are healthier than the general population. Additionally, the limited number of patients followed over a maximum of 1 year can limit the ability to detect infrequent events or those events that require prolonged follow-up to detect. Nonmelanoma skin cancers were excluded from the analysis. Finally, populations and adverse event deﬁnitions may have differed in external databases and studies.
Conclusion: Based on the data from external databases, mortality, hospitalization, and serious infection rates in inﬂiximab-treated patients were generally comparable to or less than that of the PsO population. Internal malignancy rates were similar to that expected in the general US population. However, the limitations of these data must be considered when compared with the totality of the safety proﬁle of inﬂix- imab generated across all indications.