The FDA has three phases of drug development. The first phase generally looks at whether a drug is safe or not. The second phase looks at safety and if the drug is effective. The last phase looks at how effective the drug is. The two major phase three trials done were the ADVANCE and MOTIVATE studies. Between the two studies over 1400 patients were looked at. The type of patients in the study were patients that were not in great shape with their Crohn's. For example one measure they look at in these studies is the Crohn's Daily Activity Index (CDAI). This is one metric for how well a Crohn's patient is doing not only with their GI issues but also their well-being. For example my score is under 100. The scores can range from 0-600. Patients in the studies for Skyrizi had a CDAI between 220-450. So for example these patients would have had more than 4 soft bowel movements per day. In the ADVANCE study the researchers looked at those who actually failed a previous biologic before taking Skyrizi. This is important since many people with Crohn's will start on one biologic and then have to continually try new biologics until they find that works.
In results from the ADVANCE trial show that 45% of patients taking the 600 mg treatment were in remission (compared to just 24.6% in the placebo group) after 4 months. What is interesting though is that in the MOTIVATE trial (were patients had not failed a biologic the remission rate was lower at only 42%).
This result is quite remarkable is quite comparable to other biologics out on the market. According to inflammatory bowel expert from Dr. David Rubin at The University of Chicago patients that start the drug "feel better within a few weeks" as the "drug works fast".
What is interesting though is that for Crohn's 600 mg is required (and has to be given through an IV infusion for the first dose followed by 360 mg every 2 months afterwards. It is interesting to note that Skyrizki was also approved for psoriasis back in 2019. Usually drugs that are approved for psoriasis have some chance of getting approved for Crohn's given that both diseases are autoimmune diseases.
Skyrizi falls under a class of drug of IL-23 inhibitors. The inhibitor is just trying to tamp down the immune from overreacting. Currently there are three IL-23 inhibitors currently that have potential for Crohn's. The first being Skyrizi (which was just approved). Another IL-23 inhibitor is Tremfya which had good results in Phase 2 trials. The last IL-23 inhibitor is mirikizumab (which is made by Eli Lilly-as far I can see I don't see a street name for the drug yet). However mirikizumab has shown good results recently and almost half of patients in a clinical trial were in remission for ulcerative colitis (after taking the drug for one year). One recent paper suggests that IL-23 inhibitors may be superior to anti-TNF treatments like
Personally I am pretty amazed at how many drugs have come on to the market for Crohn's since I was originally diagnosed back in 2011. Although having Crohn's can be awful and not fun it really is a golden time in terms of drug development. If you think about a drug potentially putting 40%-50% of patients into remission ends up being many hundreds of thousands of people feeling better. Also patients in remission allows gastroenterologist more time to work with other patients.
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