- The P-lll IM-UNITI LTE study involves assessing of Stelara (SC, 90mg, q8w/q12w) vs PBO as maintenance therapy in 1,281 patients with moderate to severe CD. All patients completing 44wks. were eligible to enter the LTE program, continuing their current regimen ~252wks.
- 50%+ patients were randomized to q8w dosing and continued to receive this dosage in the LTE study, maintained CR (57%) and remission (55 %) through 5 yrs. of treatment while (93%) were steroid-free. Among patients who had prior exposure to & failed to TNF-α biologics, clinical remission (59% & 44%) respectively
- Stelara is a fully human mAb & is the first and only biologic treatment to selectively inhibit the (IL)-12 and IL-23 pathways and is approved in the US for multiple diseases
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