Crohn’s disease management has entered a new era, one defined by early, targeted interventions and broader access to advanced therapies. In the UAE, these global shifts are being rapidly adopted and adapted through a unique blend of clinical innovation and forward-thinking healthcare policy. In this expert insight, Dr. Mohammed Nabil Quraishi, Consultant Gastroenterologist and Director of the IBD Service at Sheikh Shakhbout Medical City (SSMC), discusses how the evolving treatment landscape, national strategies, and cutting-edge research are collectively transforming outcomes for patients across the region.
The management of Crohn’s disease has been revolutionized over the past two decades, and the Middle East, particularly the UAE, is at the forefront of adopting these transformative therapeutic strategies. For patients across the region, this new era offers unprecedented hope for achieving lasting remission and an improved quality of life.
An evolving treatment paradigm
Historically, we managed Crohn’s with a “step-up” approach, starting with conventional drugs and escalating therapy only when the disease worsened. However, our understanding has shifted significantly following recent seminal clinical trials such as the PROFILE study. We now recognize the disabling long-term consequences of uncontrolled inflammation, including bowel damage and the need for surgery. This has led to a paradigm shift towards an accelerated or “top-down” strategy for many patients. By introducing highly effective biologic therapies earlier in the disease course for individuals with moderate-to-severe illness, we can alter the natural history of the disease, prevent complications, and help patients achieve better long-term outcomes.
The UAE’s proactive approach to IBD therapies
The UAE has distinguished itself as a global leader in ensuring patients have rapid access to the most advanced therapies. A key part of the national strategy involves a forward-thinking approach to both innovation and sustainability. The financial considerations of advanced biologic therapies are significant, and to ensure broad and equitable access for the UAE’s diverse population, the promotion of biosimilars is a cornerstone of the healthcare policy. Biosimilars are highly similar versions of original biologics that offer the same therapeutic benefits at a significantly lower cost. For instance, the introduction of infliximab biosimilars has reduced treatment costs by approximately 30-35%, while adalimumab biosimilars have lowered costs by as much as 50%. This strategy enhances the sustainability of the healthcare system and, most importantly, expands patient access to these life-changing treatments.
Beyond ensuring affordability, the UAE is committed to being at the forefront of innovation. Through the Emirates Drug Establishment’s (EDE) proactive policies and “Fast Track” mechanism, novel medicines are often approved and launched in the UAE almost immediately after global authorizations. A recent example is Guselkumab (Tremfya), which was approved for Crohn’s disease in the UAE soon after its authorization in the United States, making the UAE the second country in the world to authorize it for this indication. This commitment ensures that patients in the UAE do not face delays in accessing the very latest breakthroughs in IBD care.
The science and policy of biosimilars
To fully appreciate their role, it is important to understand what biosimilars are and what they are not. Unlike generic drugs, which are exact chemical copies of small-molecule medicines, biosimilars are not identical to their originator biologic. Biologics are large, complex molecules produced in living cells. This intricate manufacturing process can lead to minor, clinically insignificant variations in the final molecule, known as post-translational modifications. Therefore, a biosimilar is defined as being “highly similar” to its reference product, but not an exact copy.
The path to approving a biosimilar is far more rigorous than for a generic drug. Regulatory bodies like the FDA and EMA require a comprehensive demonstration of similarity, which includes showing that the biosimilar has an equivalent pharmacokinetic (PK) and pharmacodynamic (PD) profile to the originator. Crucially, approval also requires dedicated clinical trials to prove that there are no clinically meaningful differences in efficacy, safety, and immunogenicity (the potential to cause an immune response) compared to the original biologic. The PLANETRA study, for example, was a robust clinical trial that demonstrated the infliximab biosimilar CT-P13 was equivalent in efficacy and comparable in safety and immunogenicity to its originator, Remicade, in patients with Rheumatoid Arthritis.
The use of these rigorously tested medicines in Abu Dhabi is guided by the Department of Health’s (DoH) comprehensive “Guide to Biosimilars for Healthcare Professionals“. This framework empowers physicians by stating that the decision to interchange or switch a therapy rests solely with the prescribing doctor, and must be made in consultation with the patient. Crucially, the guide specifies that biological medicines are excluded from automatic substitution at the pharmacy level, a critical distinction from the practice with generic small-molecule drugs. The guide also outlines the principle of extrapolation, a scientifically rigorous process where a biosimilar can be approved for an indication (like Crohn’s disease) based on its successful trials in another sensitive indication (like Rheumatoid Arthritis), provided the mechanism of action is the same.
From a practical standpoint, the DoH framework emphasizes the importance of pharmacovigilance. To ensure robust safety monitoring, it mandates that all biological medicines be prescribed by their brand name, with the batch number also recorded whenever possible. This allows any adverse drug reactions to be accurately tracked. This aligns with important clinical nuances, such as the fact that if a patient has lost response to an originator biologic due to the formation of anti-drug antibodies, they cannot be switched to the biosimilar, as the antibodies will recognize and neutralize both molecules. Furthermore, clinicians and patients must be mindful of the “nocebo effect,” where a patient’s negative expectation about a new therapy can lead to them perceiving negative outcomes. This is particularly relevant when switching to certain adalimumab biosimilars, which can have minor differences in formulation (e.g., presence of citrate), concentration, or injection device, sometimes leading to patient-reported issues like injection site pain.
Looking ahead, the future of IBD management is being reshaped by an even deeper understanding of the disease’s complex pathways.
Emerging molecular therapies and targets
The research pipeline is moving beyond established mechanisms to target new molecules involved in the inflammatory cascade. A key emerging target is the tumor necrosis factor-like cytokine 1A (TL1A), another member of the TNF family that regulates mucosal immunity and is found in elevated levels in patients with IBD. Several anti-TL1A agents are now in late-phase development and show great promise. Our IBD center at SSMC, along with few others in the UAE, will soon be opening clinical trials to explore the efficacy of this exciting novel therapy in the coming months. Another area of significant innovation is drug delivery. Given that studies confirm patients prefer oral treatments over infusions or injections, major efforts are underway to develop effective oral therapies. This includes not only new small molecules but also futuristic concepts like a “robotic pill” designed to deliver a drug payload, such as a biologic, directly to the inflamed tissue in the intestine.
Other pioneering approaches are also under investigation. These include therapies targeting fibrosis, a major complication that leads to bowel narrowing, with oral drugs designed to inhibit key fibrotic regulators specifically within the gut. Furthermore, microRNA-based therapies are being developed; these work by upregulating the body’s own anti-inflammatory pathways to help restore balance in the gut.
Precision medicine and artificial intelligence
Perhaps the most significant paradigm shift is the move towards precision medicine—tailoring treatment based on an individual’s genetic profile, disease characteristics, and even their gut microbiome. Making sense of this vast amount of data is a monumental task where Artificial Intelligence is becoming an indispensable tool. AI-driven models are being developed in major academic institutes to analyse a patient’s unique biological data to predict their response to different therapies, helping us select the right drug for the right patient from the very beginning. Of course as it stands brining this to the bedside maybe a long way away. In clinical practice, AI is already enhancing endoscopy, with systems that help clinicians more accurately detect subtle signs of disease activity, reducing variability between assessments and leading to more objective and reproducible monitoring.
Barriers to Innovation and Future Directions
While the UAE has made immense strides, several challenges must be addressed to optimize IBD care across the region. A critical barrier is that patients in the Middle East have historically been underrepresented in the pivotal clinical trials that lead to drug approvals. As a result, clinical decisions often rely on data from Western cohorts, which may not be fully applicable due to potential differences in genetic, environmental, and healthcare system factors. This highlights an urgent need for dedicated academic research within the region to truly understand the disease’s impact on our population.
To address this, we must focus on generating high-quality real-world evidence (RWE) on the use of advanced therapies in our local patient cohorts. Our own analysis of the available medical literature reveals a significant gap in robust RWE from the Middle East, with most existing data originating from only a few countries and often from retrospective, single-centre studies. Generating prospective local data is essential for health authorities to make informed reimbursement decisions, ensuring resources are allocated effectively. This is where biosimilars play a crucial role, providing a highly effective, cost-efficient option that improves both patient access to therapies and the long-term sustainability of the healthcare system.
Looking forward, a multi-faceted approach is needed. We must strive to increase the inclusion of UAE-based cohorts in global clinical trials to ensure new therapies are validated in our population. Furthermore, a collaborative, pan-regional vision is required to establish large patient registries, similar to successful international models. These registries would harmonize data collection and create a powerful resource for research. By building this local evidence base, we can develop region-specific treatment guidelines and pave the way for a future of truly personalized and accessible IBD care.
