Crohn’s Disease in 2025: First Oral JAK Inhibitor, Subcutaneous Biologics, and What They Mean for Patients

Crohn’s Disease in 2025: First Oral JAK Inhibitor, Subcutaneous Biologics, and What They Mean for Patients

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For many years, treatment of moderate-to-severe Crohn’s disease depended heavily on intravenous or subcutaneous biologics (like anti-TNF agents), immunomodulators, and steroids for flares.
Related condition guide: Crohn’s Disease

In 2023 to 2025, the therapeutic landscape expanded significantly:

  • Upadacitinib (Rinvoq®) became the first oral JAK inhibitor approved for moderate-to-severe Crohn’s disease, offering a pill option for patients who meet criteria.
  • Subcutaneous Entyvio® (vedolizumab) was approved for maintenance therapy, allowing at-home administration via a prefilled pen after IV induction.
  • In October 2025, the FDA updated the label for upadacitinib in IBD, allowing its use earlier in treatment for certain patients who are not suitable for TNF blockers but have already tried at least one systemic therapy.

These advances give patients and clinicians more choices, and also more complexity.
Support resources: Help Hub

Upadacitinib: The First Oral Pill for Moderate-to-Severe Crohn’s Disease

Upadacitinib is a JAK1-selective inhibitor originally approved for rheumatoid arthritis and other immune-mediated inflammatory diseases (IMIDs). In 2023, it was approved as the first oral agent for moderate-to-severe Crohn’s disease in adults who had an inadequate response or intolerance to conventional therapies or biologics.

Shared background on the JAK inhibitor class: Rheumatoid Arthritis

Key points:

  • taken orally (induction and maintenance dosing differ)
  • has shown higher rates of clinical remission and endoscopic response versus placebo in trials
  • carries class safety warnings familiar from RA, including infections, malignancy, and thrombosis, prompting careful patient selection and monitoring

The October 2025 label update allows:

  • use in adults with moderately to severely active Crohn’s who have had at least one systemic therapy
  • when TNF blockers are considered clinically inadvisable by the prescriber

Subcutaneous Entyvio: Moving Biologic Maintenance to the Home

Entyvio (vedolizumab) is a gut-selective integrin blocker that has been a backbone of IBD therapy given via IV infusions.

In 2024, the FDA approved subcutaneous Entyvio for maintenance therapy after IV induction in Crohn’s disease, allowing patients to self-administer at home via the Entyvio Pen.

Benefits:

  • reduced travel and infusion time
  • more flexibility
  • potential for improved adherence

Considerations:

  • ongoing need for cold-chain storage and injection training
  • continued monitoring for infections and rare adverse events

Practical caregiver and patient support tools: Help Hub

How These Therapies Fit Into a Crohn’s Treatment Journey

Modern Crohn’s management often follows a sequence:

  • Induction of remission with biologics or advanced therapies (anti-TNF, anti-integrin, anti-IL-23, or JAK inhibitors).
  • Maintenance with the same or related agents, now sometimes via subcutaneous at-home options (e.g., Entyvio, certain IL-23 inhibitors).
  • Escalation or switching based on response, side effects, and patient preference.

Therapy choice depends on:

  • disease severity and location
  • prior treatment history
  • comorbidities (e.g., RA, psoriasis)
  • risk factors, including infections, malignancy, and cardiovascular risk

JAK inhibitors like upadacitinib and biologics like vedolizumab each have distinct risk and benefit profiles that require shared decision-making.

For additional disease education and treatment context: Crohn’s Disease

Safety Considerations: JAK Inhibitors and Biologics

As with RA:

  • JAK inhibitors carry warnings about serious infections, malignancy, thrombosis, and cardiovascular events in certain populations.

Biologics like Entyvio have their own infection risks, though Entyvio’s gut-selective mechanism may offer a more favorable systemic safety profile compared to some systemic immunosuppressants.

Clinicians must:

  • evaluate each patient’s risk factors
  • monitor labs and infection markers
  • adjust or switch therapy when safety signals arise

JAK class context: Rheumatoid Arthritis

Where Personalized Medication Support Can Help in Crohn’s Disease

Even advanced therapies don’t replace the need for supportive medications such as:

  • proton pump inhibitors
  • antidiarrheals
  • nutritional supplements
  • pain management strategies

Crohn’s patients often:

  • have GI sensitivities
  • struggle with oral formulations during flares
  • have difficulty with certain excipients

Compounding may support:

  • creating tolerable formulations of adjunct medications (e.g., liquid forms, excipient reduction)
  • enabling small dose adjustments for co-medications to reduce GI burden
  • providing formulations tailored to feeding tube use when needed

These adjustments must always be made in coordination with the gastroenterology team to avoid interactions or unintended immunosuppressive overlap.

Patient planning and support: Help Hub

Questions to Ask Your GI Physician

  • “Where do upadacitinib, Entyvio, or other advanced therapies fit in my overall treatment plan?”
  • “What monitoring (labs, imaging) will I need on these medications?”
  • “If my disease is stable, can we simplify my other medications?”
  • “Are there ways to adjust formulations to help my GI symptoms or swallowing?”

Final Thoughts: More Tools, More Need for Coordination

Crohn’s disease treatment in 2025 offers more options than ever:

  • oral JAK inhibitors like upadacitinib
  • at-home subcutaneous maintenance biologics
  • new IL-23 and other targeted agents

Each advance brings both opportunity and complexity. Patients need:

  • clear explanations of risks and benefits
  • ongoing monitoring
  • medication regimens they can realistically live with

AllMedRx supports this by:

  • working with clinicians to personalize supporting medications
  • helping reduce GI and pill-burden barriers where appropriate
  • committing to clear communication and safety-first compounding practice

For clinicians managing complex Crohn’s regimens who need support with personalized adjunct medications, contact:
intake@allmedrx.org