APPENDIX 6SUMMARY OF THE IM-UNITI EXTENSION STUDY

Publication Details

Objective

To summarize the efficacy and safety results of the long-term extension study following UNITI-1, UNITI-2, and IM-UNITI. The following is based on unpublished data.68

Findings

Study Design

Results

Table 38 details the patient disposition.

Table 38. Patient Disposition in the Long-Term Extension Study.

Table 38

Patient Disposition in the Long-Term Extension Study.

Clinical Remission

Table 39

Table 39. Clinical Outcomes for the Long-Term Extension Study.

Table 39

Clinical Outcomes for the Long-Term Extension Study.

Steroid-Free Clinical Remission

Table 39

Disease–Related Surgery Through Week 92

Limitations

Summary