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Can IL-23 Drugs for Crohn's Start at Home?
Some Crohn's drugs already start with injections or a pill, but most IL-23 drugs still begin with clinic or hospital infusions. AbbVie wants to change that for Skyrizi, after its AFFIRM trial showed that starting with injections works.
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If a Crohn’s patient starts Skyrizi today, the first three doses go into a vein, one infusion of at least an hour at weeks 0, 4 and 8, in a clinic or hospital.
Some Crohn’s treatments already start at home. The IL-23 drugs, which the American Gastroenterological Association (AGA) guideline lists among the higher-efficacy options for patients starting their first advanced therapy (AGA 2025), mostly do not. AbbVie has asked regulators to let Skyrizi patients start with injections as an alternative to the infusions. The trial behind that request, AFFIRM, also reports how the drug did in patients who had or had not already failed another advanced therapy.
The short answer
In this brief, “IL-23 drugs” means Tremfya, Skyrizi and Omvoh. Each blocks only interleukin-23, one of the signals that drives inflammation in Crohn’s, by grabbing a part of it called p19. Stelara blocks IL-23 as well, along with a second signal, IL-12, and it also starts with an infusion.
One of the three can already start at home. Since Tremfya (guselkumab, J&J) was approved for Crohn’s on 20 March 2025, patients have been able to choose between IV infusions and injections under the skin (FDA letter, label at approval). The EU approved it on 2 May 2025 (EMA). AbbVie hopes Skyrizi (risankizumab) will follow, and it filed for an injectable start with the FDA in April and with the EMA in August (FDA filing, EMA filing). In April it said it expected FDA approval “later this year”. Omvoh (mirikizumab, Lilly) still starts with three infusions of at least 90 minutes each, and we found no adult trial of an injectable start on ClinicalTrials.gov.
How every Crohn’s drug starts today
The table lists every advanced Crohn’s drug and how it starts, taken from each drug’s current US label. By “advanced therapy” we mean a biologic or a JAK inhibitor. Conventional therapy means drugs such as steroids and immunomodulators.
Adult dosing from current US prescribing information (DailyMed, linked per drug). “At home” means injections or a pill. Humira’s and Tremfya’s labels call for the first injection to be supervised (see below). Biosimilar counts are FDA biosimilar licenses for the molecule. “Only after” shows where the label limits use to patients who have tried another treatment first.
| Drug | Starts | First doses | Then | Only after |
|---|---|---|---|---|
| Humira anti-TNF · + 10 biosimilars | At home | Injections: 160 mg on day 1, 80 mg on day 15 | 40 mg injection every 2 weeks | – |
| Cimzia anti-TNF | At home | Injections: 400 mg at weeks 0, 2 and 4 | 400 mg injection every 4 weeks | conventional therapy |
| Rinvoq JAK inhibitor (pill) | At home | Pill: 45 mg once a day for 12 weeks | 15 mg (or 30 mg) pill once a day | a TNF blocker (or another approved systemic therapy if TNF blockers are inadvisable) |
| Tremfya IL-23 | Either | IV 200 mg, or injections 400 mg, at weeks 0, 4 and 8 | Injection: 100 mg every 8 weeks or 200 mg every 4 weeks | – |
| Skyrizi IL-23 · injectable start filed | Infusion | IV 600 mg at weeks 0, 4 and 8 | Injection (on-body injector or prefilled syringes): 180 or 360 mg every 8 weeks | – |
| Omvoh IL-23 | Infusion | IV 900 mg at weeks 0, 4 and 8 | Injections: 300 mg every 4 weeks | – |
| Stelara IL-12/23 · + 8 biosimilars | Infusion | One IV infusion, dose by body weight | 90 mg injection every 8 weeks | – |
| Entyvio α4β7 integrin | Infusion | IV 300 mg at weeks 0 and 2 (and week 6 if staying on IV) | IV every 8 weeks, or 108 mg injection every 2 weeks after two IV doses | – |
| Tysabri α4 integrin · + 1 biosimilar · restricted program | Infusion | IV 300 mg every 4 weeks | Same, IV every 4 weeks | conventional therapy and a TNF blocker |
| Remicade (infliximab) anti-TNF · + 4 biosimilars (1 discontinued) | Infusion | IV 5 mg/kg at weeks 0, 2 and 6 | IV every 8 weeks, or Zymfentra 120 mg injection every 2 weeks from week 10 | conventional therapy (except fistulizing disease) |
A patient can already start an advanced therapy at home with Humira, one of its biosimilars, or Cimzia. Rinvoq is a pill, but its label reserves it for patients whose disease did not respond to a TNF blocker or who could not tolerate one. If TNF blockers are not advisable, patients must first have tried another approved systemic therapy. Of the biologics that do not target TNF, Tremfya is the only one a patient can start without an infusion today.
For the injected drugs, starting at home usually means one training visit first. Humira’s label says the first injection is to be performed “under the supervision of a qualified health care professional” (label). Tremfya’s gives the reason, which is “proper training in subcutaneous injection technique, including injection of the full dose” (label). If the FDA approves an injectable start for Skyrizi, a patient could swap three infusions of an hour or more for one training visit and injections at home. How that works in practice will depend on the dose and schedule the FDA approves.
What AFFIRM showed
AbbVie’s AFFIRM trial enrolled 289 adults with moderately to severely active Crohn’s disease. Two out of three were randomly assigned risankizumab injections and the rest got placebo (AbbVie topline, 2 Mar 2026; NCT06063967). Every patient had already been let down by earlier treatment. Their disease had not responded well enough or had stopped responding, or they could not tolerate the drugs, whether conventional or advanced. Patients who had already taken an IL-23 (p19) drug were left out. Two-thirds had failed at least one advanced therapy, and on average they had lived with Crohn’s for more than seven years (AbbVie, 13 Oct 2026). AbbVie has not said what dose it injected or how many injections each visit involved.
Every dose, drug or placebo, was an injection under the skin. In Period A, patients, investigators and outcome assessors were blinded. AbbVie has not disclosed the induction doses, which the trial registry lists only as Dose A to C. It says Period C uses the approved maintenance treatment. Sources: NCT06063967, AbbVie topline.
289 adults with moderately to severely active Crohn’s disease
Weeks 0–12 · Period A
Randomized 2 : 1
Week 12: co-primary endpoints
clinical remission and endoscopic response
Weeks 12–24 · Period B
Next step depends on the week-12 response
Week 24 results
reported among week-12 responders only
From week 24 · Period C
Open-label extension, up to 52 weeks
The trial met both of its main goals at week 12. On risankizumab, 55% of patients reached clinical remission, meaning their symptom score (CDAI) fell below 150, compared with 29.6% on placebo. Endoscopic response, where an inflammation score read through the scope falls by more than half, reached 44% against 14.3%. Serious side effects in the first 12 weeks affected 0.5% of patients on the drug and 3.1% on placebo (AbbVie topline). On the stricter measure of endoscopic remission, where the bowel lining looks close to healed, the rates were 27.7% and 10.2%. AbbVie saw no new safety concerns through week 24 (AbbVie, 13 Oct 2026).
AbbVie also split both main results by prior treatment (AbbVie topline). Of the 289 patients, 189 had already failed at least one advanced therapy, and half of those had failed two or more. AbbVie names ustekinumab and JAK inhibitors among the drugs they had failed, while the other 100 had not failed one. Among the 100, 73.1% of those given risankizumab reached clinical remission against 27.3% on placebo, and 61.2% reached endoscopic response against 15.2%. Among the 189, the figures were 45.2% against 30.8% and 34.7% against 13.8%. These two groups were not randomized against each other, and with fewer patients in each, the numbers are less certain.
Because AFFIRM compared the injections with placebo, it shows that an injectable start works. It does not show whether it works as well as the infusion. No trial has compared the two routes, and lining up numbers from different trials is unreliable, since the trials differ in their patients, placebo rates and definitions.
What it means for patients
If the FDA approves AbbVie’s filing, two of the three IL-23 drugs will let patients start either way. AbbVie’s FDA filing release says patients “would have a choice to receive their SKYRIZI induction via SC injection or through IV infusion” (FDA filing). Some of them will choose the infusion. In a survey of 1,077 people with IBD, 51% preferred an IV drug every eight weeks over an injection every two weeks (Dig Dis 2023). The route people already knew was the best predictor of what they chose. Those schedules differ from the IL-23 ones, but the survey shows that patients do not all want the same thing.
What to watch
- The FDA decision on injectable Skyrizi, including the dose and the number of injections.
- CHARGE, a J&J trial of Tremfya started with injections against Skyrizi started with infusions (NCT07499232). It is the first head-to-head trial of two IL-23 (p19) drugs in Crohn’s. Patients and doctors know which drug is given, about 530 patients are planned, and the main results are expected around 2028. Since its Skyrizi patients start with infusions, it will not tell us how injected Skyrizi compares.
- An IL-23 pill for Crohn’s. J&J’s icotrokinra, a once-daily pill that blocks the IL-23 receptor, was approved in 2026 as Icotyde for plaque psoriasis (label). It is now in a Phase 2/3 Crohn’s trial with about 1,092 patients planned, recruiting since October 2025 (NCT07196722). If it is approved for Crohn’s, IL-23 treatment could start with a pill.
- Whether Lilly follows for Omvoh. If Skyrizi’s injectable start is approved, Omvoh will be the only one of the three that still has to start with an infusion.
Sources & methods
- Dosing, restrictions and supervision of the first injection are from each drug’s current US prescribing information on DailyMed, read on 15 October 2026. Biosimilar counts are the FDA biosimilar licenses for each molecule in the FDA Purple Book.
- AFFIRM results are from AbbVie’s releases of 2 March 2026 and 13 October 2026 (ACG 2026 presentation by Long et al.) and the trial registry. AbbVie has not disclosed the injected dose, and its week-24 results come only from patients who responded by week 12 (topline release), so this brief uses week-12 figures.
- “No adult trial of an injectable Omvoh start” reflects a ClinicalTrials.gov search on 15 October 2026. We could not find a statement from Lilly either way.
AFFIRM and AbbVie
US prescribing information and approvals
- Skyrizi
- Tremfya
- Tremfya FDA approval letter for Crohn's disease (20 March 2025)
- Tremfya label at Crohn's approval (March 2025)
- Tremfya EMA procedural steps (Crohn's disease, decision 2 May 2025)
- Omvoh
- Humira
- Cimzia
- Remicade (infliximab)
- Zymfentra (infliximab-dyyb, subcutaneous)
- Entyvio
- Stelara
- Rinvoq
- Tysabri (natalizumab)
- Icotyde (icotrokinra)
- FDA Purple Book (biosimilars)
Trials and literature
Research and labeling current through 15 October 2026. Spot an error? Reach out at hello@theraradar.com.
Frequently asked
Starting Crohn’s treatment at home, IL-23 drugs and the AFFIRM trial
- Can IL-23 drugs for Crohn's disease start at home?
- Tremfya (guselkumab) already can, because its label lets patients start with either IV infusions or 400 mg injections under the skin at weeks 0, 4 and 8. Skyrizi (risankizumab) still starts with three 600 mg IV infusions, and AbbVie has filed with the FDA and EMA for an injectable start. Omvoh (mirikizumab) starts with three 900 mg infusions of at least 90 minutes.
- Which Crohn's drugs already start without an infusion?
- Humira and its biosimilars start with injections under the skin, 160 mg on day 1 and then 80 mg on day 15. Cimzia starts with 400 mg injections at weeks 0, 2 and 4, and Rinvoq with a 45 mg pill once a day. Rinvoq is for patients who have had an inadequate response or intolerance to a TNF blocker, or who have tried another approved systemic therapy when TNF blockers are not advisable. Infliximab, Entyvio, Stelara, natalizumab (Tysabri), Skyrizi and Omvoh all start with IV infusions.
- Does the first injection have to be given in a clinic?
- For Humira and Tremfya, the labels call for the first injection to be supervised so the patient learns to inject correctly. Humira's says it is to be performed under the supervision of a qualified health care professional. Tremfya's gives the reason as proper training in subcutaneous injection technique, including injection of the full dose. After that first visit, patients inject at home.
- What did AbbVie's AFFIRM trial show?
- AFFIRM randomized 289 adults with moderately to severely active Crohn's disease 2:1 to injected risankizumab or placebo, and 65% had already failed an advanced therapy. At week 12, 55% reached clinical remission against 29.6% on placebo, and 44% reached endoscopic response against 14.3%. AbbVie has not said what dose it injected.
- Do injections work as well as the IV infusion for starting Skyrizi?
- Nobody knows yet, because no trial has compared the injections with the infusion. AFFIRM compared the injections with placebo, so it shows an injectable start works. Numbers from different trials cannot be lined up reliably.
- Is there an IL-23 pill for Crohn's disease?
- Not for Crohn's disease yet, though J&J's icotrokinra, a once-daily pill that blocks the IL-23 receptor, was approved in 2026 as Icotyde for plaque psoriasis and is now in a Phase 2/3 Crohn's trial (ICONIC-CD, NCT07196722), which began recruiting in October 2025 with about 1,092 patients planned.
Related briefs
- Can an IBD Biologic Last Six Months? The other way companies are making IBD treatment easier to live with: fewer doses.
- IBD and Precision Medicine: Not Yet. Why IBD trials still enroll everyone instead of picking the patients most likely to respond.
- When an IBD Trial Is Terminated, the Drug Usually Didn’t Fail. How to read a stopped IBD trial.
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