IMPROVE PATIENTS’ POSSIBILITY OF ENDOSCOPIC REMISSION

SKYRIZI SECONDARY ENDPOINT OF ENDOSCOPIC REMISSION RATES AT WEEK 12 AND 521,3

Endoscopic remission rates for SKYRIZI (risankizumab) in clinical studies. ADVANCE double-blind RCT at week 12 shows a 24% remission rate with SKYRIZI 600 mg IV versus 9% with placebo (p<0.001). FORTIFY double-blind RCT at week 52 indicates a 41% remission with SKYRIZI 360 mg SC and a 33% remission with SKYRIZI 180 mg SC compared to 13% on Continuous Placebo, all vs 13% on placebo (induction responders). Open-label extension (OLE) at week 152 shows a 64% remission with SKYRIZI 180/360 mg SC (pooled).

DATA LIMITATIONS: Endoscopic remission at Week 52 was not statistically significant under the pre‑specified multiple testing procedure.

Results at 52 weeks are among 382 patients who achieved clinical response after 12 weeks of treatment with SKYRIZI in induction trials.

aContinuous placebo data not intended for direct comparison.

*OLE Limitations: In an OLE, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

AO Disclosure: In an as observed (AO) analysis, missing visit data was excluded from calculations for that visit, which may increase the percent of responders. All observed data was used regardless of premature discontinuation of study drug, or initiation of concomitant medication. The same patient may not have a response at each timepoint.