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Exploring the Newest Crohn's Disease Medications (2024)

Discover the latest advancements in Crohn's disease treatment with an in-depth look at the five newest FDA-approved medications, transforming patient care and management.

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Crohn's disease, a chronic inflammatory bowel disease, presents significant treatment challenges. The introduction of new medications offers renewed hope for patients seeking relief from its debilitating symptoms

Latest Crohn's Disease Medications

  1. Mesenchymal stem cell therapy: A unique new approach to reducing inflammation and modulation the immune system.
  2. Risankizumab-rzaa (Skyrizi): A cutting-edge IL-23 inhibitor offering a new approach for those with moderate to severe disease.
  3. Ustekinumab-auub (Wezlana): A biosimilar to Ustekinumab, providing a more accessible option without compromising efficacy.
  4. Etrasimod (Velsipity): Currently under study, this S1P receptor modulator could soon join the list of Crohn's disease treatments.
  5. Adalimumab-afzb (Amjevita): This biosimilar to Adalimumab offers a blend of efficacy and cost-effectiveness.
  6. Infliximab-axxq (Avsola): Another biosimilar, extending the range of biologic treatments available to patients.

Historical Treatments for Crohn's Disease

Traditionally, Crohn's disease management has relied on a combination of anti-inflammatory drugs, immune system suppressors, and biologic therapies targeting specific pathways in the immune response.

While effective for many, these treatments often come with significant side effects and the risk of long-term complications.

Evolution in Crohn's Disease Management

The landscape of Crohn's disease treatment is evolving, with a shift towards more targeted therapies that offer improved efficacy and reduced side effects.

This evolution is marked by the introduction of new biologics and the growing availability of biosimilars, which promise to make advanced treatments more accessible to a broader patient population. Some patients have noted improvements with a healthy probiotic supplementation regime.

MedicationTypeApproval Year
Risankizumab-rzaa (Skyrizi)Biologic2022
Ustekinumab-auub (Wezlana)Biosimilar2022
Etrasimod (Velsipity)Small molecule S1P receptor modulatorUnder Study for Crohn's
Adalimumab-afzb (Amjevita)Biosimilar2016
Infliximab-axxq (Avsola)Biosimilar2019

The introduction of Risankizumab-rzaa (Skyrizi) and Ustekinumab-auub (Wezlana) represents a significant milestone in Crohn's disease treatment, offering new mechanisms of action with the potential for improved patient outcomes. Similarly, Etrasimod (Velsipity), though still under investigation for Crohn's disease, shows promise as a novel treatment option with a unique target in the immune pathway. Biosimilars like Adalimumab-afzb (Amjevita) and Infliximab-axxq (Avsola) are making biologic treatments more accessible and affordable, presenting a viable option for many patients who previously faced barriers to these advanced therapies.

mscs for crohns

Mesenchymal Stem Cell Therapy

Mesenchymal stem cell (MSC) therapy is gaining attention as a promising approach for treating Crohn's disease, particularly for the management of complex perianal fistulas, which are often resistant to conventional treatments.

This innovative therapy utilizes the immunomodulatory and regenerative properties of MSCs to address the underlying inflammation and tissue damage in Crohn's disease.

Efficacy of MSC Therapy for Perianal Fistulas

A case series focusing on Crohn's disease patients with complex perianal fistulas treated with allogeneic cord tissue-derived mesenchymal stem cells showed promising results.

A significant number of patients achieved complete closure of their fistulas, highlighting the potential of MSC therapy as an effective treatment option for this challenging condition​​.

Perianal fistulas, notably complex in nature, have traditionally posed significant challenges in treatment, often leading to unsatisfactory outcomes with conventional anal surgery. This has adversely affected patient quality of life and incurred high healthcare costs. The advent of Mesenchymal Stem Cells (MSCs) in clinical trials, however, is shining a beacon of hope for effective management of this condition.

Key Findings from Clinical Trials

Clinical trials have illuminated the promising potential of MSC transplantation as a novel treatment for complex perianal fistulas. Remarkable efficacy has been observed across varying durations - from short-term to beyond long-term phases, showcasing MSCs' sustained healing capabilities. This marks a pivotal shift in the approach to managing perianal fistulas.

Interestingly, factors such as the type of cells used, their source, and the dosage administered have been found not to significantly alter the efficacy of MSCs in treating perianal fistulas. This versatility underscores MSCs' reliability as a therapeutic option, highlighting their broad applicability regardless of these variables.

Particularly noteworthy is the success of local MSC therapy in treating fistulas related to Crohn's Disease (CD), offering a glimmer of hope for patients grappling with this complex aspect of the disease.

MSCs: Modulation of the Immune System

MSCs have a notable ability to modulate the immune response, particularly by inhibiting T-cell alloreactivity. This property is particularly beneficial in autoimmune conditions like Crohn's disease, where an overactive immune response contributes to inflammation and tissue damage. The safety profile of MSC therapy is favorable, with no reported acute toxicity or ectopic tissue formation, making it a viable option for patients​​.

Durability of MSC Therapy Effects

A study examining the long-term effects of mesenchymal stem cells for treating fistulizing Crohn's disease found that the treatment response was durable at 12 months. This study, which included phase IB/IIA clinical trials for various fistula types associated with Crohn's disease, demonstrated significant and sustained clinical and radiographic healing in a substantial percentage of patients, underscoring the potential of MSC therapy as a safe and effective alternative treatment​​.

These findings underscore the potential of mesenchymal stem cell therapy as a novel and effective treatment modality for patients with Crohn's disease, offering hope for those with treatment-refractory conditions and complex fistulas. The durability of the treatment effect, coupled with a favorable safety profile, positions MSC therapy as a promising avenue for future research and application in the management of Crohn's disease.

Risankizumab-rzaa (Skyrizi)

Risankizumab-rzaa (Skyrizi)

Risankizumab-rzaa represents a significant advancement in Crohn's disease treatment.As an IL-23 inhibitor, it targets a specific pathway in the immune system believed to play a key role in the inflammatory process of Crohn's disease.Clinical trials have demonstrated its efficacy in achieving and maintaining remission in patients with moderate to severe forms of the disease.

Patients considering Risankizumab-rzaa should discuss potential side effects with their healthcare provider, such as increased risk of infections.

Ustekinumab-auub (Wezlana)

Ustekinumab-auub (Wezlana)

Ustekinumab-auub, a biosimilar to Ustekinumab, offers a cost-effective alternative without compromising on efficacy.It works by inhibiting the interleukin-12 and interleukin-23 pathways, which are involved in inflammatory and immune responses.For patients who have not responded well to conventional therapies, Ustekinumab-auub presents a promising option.

The safety profile is similar to the original biologic, with common side effects including respiratory infections and injection site reactions.

Etrasimod (Velsipity)

Etrasimod is a novel S1P receptor modulator currently being studied for its effectiveness in Crohn's disease.While approved for ulcerative colitis, its potential in Crohn's disease is supported by its mechanism of action, which involves modulating immune cell circulation to reduce inflammation in the gut.Ongoing clinical trials are closely watched for results that could make Etrasimod a valuable addition to Crohn's disease management.

Patients interested in Etrasimod may consider enrolling in clinical trials to gain early access.

Adalimumab-afzb (Amjevita)

Adalimumab-afzb is a biosimilar to Adalimumab, designed to lower treatment costs while providing the same efficacy in managing moderate to severe Crohn's disease.It targets TNF-alpha, a substance in the body that causes inflammation.Adalimumab-afzb has been a game-changer for many patients, making biologic therapy more accessible.

Before starting treatment, patients should be screened for infections, as the medication can lower the body's ability to fight them.

Infliximab-axxq (Avsola)

Infliximab-axxq, another biosimilar, specifically to Infliximab, offers similar benefits in reducing symptoms and inducing remission in Crohn's disease patients.Like its counterparts, it targets TNF-alpha but at a potentially more affordable price point.Its approval has expanded treatment options, especially for those with severe disease courses.

Patients should be aware of the risk of infusion reactions and the importance of regular monitoring during treatment.

Each of these medications brings new hope to Crohn's disease patients, offering more personalized and effective treatment options.The choice of medication should be a joint decision between the patient and their healthcare provider, considering the individual's disease severity, previous treatment responses, and personal preferences.As research progresses, the future for Crohn's disease treatment looks promising, with more targeted therapies on the horizon offering the potential for better disease management and improved quality of life for patients.


The application of mesenchymal stem cell (MSC) therapy in Crohn's disease, particularly for complex perianal fistulas, represents a significant advancement in the field of regenerative medicine. MSCs, with their potent immunomodulatory and regenerative capabilities, offer a novel therapeutic approach that directly targets the underlying pathology of Crohn's disease. By modulating the immune system and promoting tissue repair, MSC therapy provides a promising alternative for patients who have not responded to traditional treatments.

The evidence from clinical trials, including those assessing the efficacy and safety of allogeneic adipose-derived and bone marrow-derived MSCs, highlights the potential of this therapy to achieve sustained remission and fistula closure. The durability of the treatment effects, coupled with a favorable safety profile, underscores the therapeutic value of MSCs in managing this challenging condition.

As research continues to evolve, MSC therapy could redefine the standard of care for Crohn's disease, offering hope to patients with refractory disease and improving their quality of life. The exploration of MSC therapy in clinical settings, such as outlined by protocols on specialized websites, further emphasizes the commitment to advancing patient care through innovative treatments.

For more detailed information on specific protocols and applications of MSC therapy in Crohn's disease, visiting dedicated medical and research websites like DVC Stem could provide valuable insights.


(1) Wang, H., Jiang, H. Y., Zhang, Y. X., Jin, H. Y., Fei, B. Y., & Jiang, J. L. (2023). Mesenchymal stem cells transplantation for perianal fistulas: a systematic review and meta-analysis of clinical trials. Stem cell research & therapy, 14(1), 103.

(2) Cheng, F., Huang, Z., & Li, Z. (2019). Mesenchymal stem-cell therapy for perianal fistulas in Crohn's disease: a systematic review and meta-analysis. Techniques in coloproctology, 23(7), 613–623.

(3) Cheng, F., Huang, Z., & Li, Z. (2020). Efficacy and Safety of Mesenchymal Stem Cells in Treatment of Complex Perianal Fistulas: A Meta-Analysis. Stem cells international, 2020, 8816737.

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