Biologic therapy utilization trends in inflammatory bowel disease: A narrative review from Saudi Arabia

Abstract

With a rising prevalence of inflammatory bowel disease (IBD) in Saudi Arabia, understanding national trends in biologic utilization is essential for optimizing clinical care and healthcare resource allocation. However, available data from the region remain very limited, and no prior comprehensive synthesis has been conducted to evaluate utilization patterns, outcomes, or cost implications. A comprehensive literature search was performed across PubMed, Cochrane Library, Google Scholar, and local Saudi medical journals up to April 2025. Studies reporting on biologic utilization, cost, effectiveness, or outcomes in Saudi IBD populations were included. Data were synthesized narratively due to heterogeneity in study designs. Seven studies encompassing nearly 1000 patients were analysed. Infliximab and adalimumab were the most prescribed biologics, with higher use in Crohn’s disease (CD) than ulcerative colitis (UC). UC patients and those receiving adalimumab had higher odds of treatment failure. Ustekinumab and vedolizumab demonstrated efficacy in anti-tumor necrosis factor (anti-TNF)-refractory cases, including paediatric cohorts. Health-related quality of life (HRQoL) improved in 99% of patients on biologics. Annual treatment costs ranged from $5,572 (Ustekinumab) to $18,424 (vedolizumab). Biosimilars were reported as effective and potentially cost-saving, although detailed outcome data remain limited. The use of biologic therapy in Saudi Arabia is increasing, with emerging trends favouring personalized treatment approaches and the adoption of newer agents. Wider adoption of biosimilars and dose optimization strategies may offer cost-saving opportunities while maintaining therapeutic efficacy. There is a pressing need for high-quality, longitudinal data supported by a national IBD registry to guide clinical decision-making, monitor outcomes, and inform future healthcare policy.

INTRODUCTION

Crohn’s Disease (CD) and Ulcerative Colitis (UC) are the two primary forms of Inflammatory Bowel Disease (IBD), characterized by chronic inflammation of the digestive tract.[1] Historically considered uncommon in regions like Saudi Arabia, recent data indicates a rising incidence of IBD, suggesting a shift in disease patterns. A systematic review reported a pooled incidence rate of 2.33 per 100,000 persons per year for UC and 1.46 per 100,000 persons per year for CD in the Arab world.[2] Another study in Riyadh observed that the incidence of CD increased from 0.32 per 100,000 persons per year during 1983–1993 to 1.66 per 100,000 persons per year during 1994–2004.[3] These findings underscore the increasing burden of IBD in Saudi Arabia and highlight the need for comprehensive epidemiological data to inform healthcare strategies.[4] This trend underscores the necessity for a comprehensive understanding of IBD’s clinical presentation and management within the Saudi healthcare context. To our knowledge, this is the first systematic review to consolidate and analyse available data on the trends, utilization patterns, clinical outcomes, and economic implications of biologic therapy in the management of IBD in Saudi Arabia.

In light of the increasing prevalence of IBD, the Saudi healthcare system has proactively enhanced its diagnostic and therapeutic strategies. Collaborative efforts have led to the development of consensus guidelines for diagnosing and managing IBD in adults, aiming to standardize care and ensure that patients receive evidence-based interventions tailored to individual disease profiles.[5]

Despite ongoing efforts, significant data gaps persist regarding the management of IBD, particularly concerning the disease patterns, application of modern therapeutic strategies, patient demographics, and the various factors influencing treatment choices. Addressing these gaps is crucial for enhancing patient care and optimizing treatment outcomes. This review aims to evaluate the clinical effectiveness and economic impact of biologic therapies in the management of IBD within the Saudi healthcare context. By synthesizing current evidence, the review seeks to inform treatment strategies and guide future research directions.

A cornerstone of modern IBD management is the use of biologic therapies, particularly anti-tumor necrosis factor (TNF) agents such as infliximab and adalimumab.[6] In Saudi Arabia, the utilization of these biologics has risen markedly, reflecting a growing recognition of their efficacy in managing moderate to severe IBD cases.[7]

However, the increased adoption of biologics has significant economic implications. Studies have highlighted the substantial costs associated with these therapies, with annual expenses ranging from $5,572 for ustekinumab to $18,424 for vedolizumab. These figures underscore the need for cost-effective treatment strategies within the Saudi healthcare system.[7] The introduction of biosimilars offers a potential solution; recent studies have demonstrated that biosimilars are well-tolerated and effective in achieving disease control, clinical response, and remission in patients with CD and UC.[8]

Despite the benefits of biologic therapies, treatment failure remains a concern. Research indicates that UC patients had higher odds of treatment failure compared to those with CD. These findings highlight the importance of personalized treatment approaches and vigilant monitoring to optimize patient outcomes.

In summary, the rising incidence of IBD in Saudi Arabia necessitates a nuanced understanding of disease management, particularly concerning the utilization of biologic therapies. While these treatments have transformed IBD care, offering improved clinical outcomes, they also present economic challenges and potential risks of treatment failure. Ongoing research and the development of tailored guidelines are essential to address these complexities, ensuring that patients receive effective and sustainable care.

METHODS

A comprehensive literature search was conducted to investigate the prevalence, patterns, and outcomes of biologic therapy utilization among patients with IBD in Saudi Arabia. The search encompassed databases such as PubMed and EMBASE, as well as regional medical journals, covering publications up to March 2025. Keywords utilized in the search strategy included “Inflammatory Bowel Disease,” “biologic therapy,” “Crohn’s Disease,” “Ulcerative Colitis,” and “Saudi Arabia.”

Studies were selected based on specific inclusion criteria:

• Reports focusing on the prevalence and patterns of biologic therapy utilization among Saudi IBD patients.

• Studies evaluating clinical outcomes associated with biologic therapy in this population.

• Case reports, reviews and systematic reviews were omitted.

Data extraction from the eligible studies concentrated on several key aspects:

• Study design and sample size: Information regarding the methodological framework and the number of participants involved in each study.

• Patient demographics: Details such as age, gender, and disease subtype (CD or UC) of the study participants.

• Types of biologics used: Identification of specific biologic agents administered, including infliximab, adalimumab, vedolizumab, and others.

• Temporal trends in utilization: Analysis of changes in the prescription patterns of biologic therapies over time within the Saudi healthcare context.

This structured methodology facilitated a rigorous evaluation of the extant literature, yielding critical insights into the utilization and clinical impact of biologic therapies in the management of IBD within the Saudi context. The selection process is delineated in the PRISMA flow diagram [Figure 1]. Of the 122 records initially identified, 100 were eligible for screening following the removal of duplicates. Subsequent title, abstract, and full-text assessments resulted in the inclusion of seven studies in the final narrative synthesis.

Figure 1.

PRISMA flow diagram illustrating the study selection process

RESULTS

From the limited but growing body of literature (n = 7 studies), several key insights emerge regarding patterns of biologic utilization, associated costs, and clinical outcomes in IBD management across various Saudi populations and care settings [Table 1].

Table 1.

Studies highlighting utilization rates, cost Implications, and clinical outcomes associated with biologic therapy in IBD patients within Saudi Arabia

Study	Design	Sample Size	Biologics Utilized	Utilization Rates	Cost Implications	Clinical Outcomes
Alruthia et al. (2019)[7]	Retrospective chart review	507 patients (258 CD, 249 UC)	Infliximab, Adalimumab Ustekinumab Vedolizumab	CD: Infliximab 36.82%, Adalimumab 20.54%<br>UC: Infliximab 11.24%, Adalimumab 9.64%	Annual cost: Biologics range from $5,572 (Ustekinumab) to $18,424 (Vedolizumab); Non-biologics range from $16 (Prednisone) to $527 (Methotrexate)	Not specified
Alruthia et al. (2020)[9]	Retrospective cohort study	156 patients (87 CD, 69 UC)	Infliximab, Adalimumab	37.82% treated with biologics (specific rates for CD and UC not specified)	Biologic treatment costs higher by SAR 25,690.46 ($ 6,850.79) over six months	Biologics improved health-related quality of life (HRQoL) 99.45% of the time
Alharbi et al. (2022)[10]	Prospective cohort study	146 patients (109 CD, 37 UC)	Infliximab, Adalimumab	CD: Infliximab 83.5%, Adalimumab 16.5%<br>UC: Infliximab 73%, Adalimumab 27%	Not specified	UC patients had higher odds of treatment failure compared to CD patients; Adalimumab users had higher odds of treatment failure compared to Infliximab users
Al Jedai et al. (2019)[11]	Retrospective study	Not specified	Biologics (unspecified)	Not specified	Not specified	Provided real-world evidence on biosimilar therapy effectiveness
Alamer et al. (2024)[12]	Observational comparative study with Bayesian analysis	Not specified	Ustekinumab, Vedolizumab	Not specified	Not specified	Assessed short-term effectiveness of ustekinumab versus vedolizumab in Crohn’s disease patients after failure of anti-TNF agents
Alhadab et al. (2025)[13]	Retrospective cohort study	13 paediatric patients (8 CD, 5 UC)	Ustekinumab	Not specified	Not specified	Ustekinumab was effective as a secondary biologic therapy for induction and maintenance of remission in paediatric patients with anti-TNFα refractory IBD; 76.9% achieved clinical remission; 84% remained on Ustekinumab at one year with no severe adverse reactions reported
Azzam et al. (2025)[14]	Retrospective cohort study	153 UC patients	Vedolizumab	Clinical remission rates: 61.9% (every 8 weeks dosing), 89.3% (every 4 weeks dosing)	Not specified	Vedolizumab effectively achieved clinical response and remission in advanced therapy-experienced UC patients treated for up to 12 months; female gender, fewer prior biologics, extensive disease, and increased dosing frequency were associated with higher remission rates.

Note: CD=Crohn’s Disease; UC=Ulcerative Colitis; TNF=Tumour Necrosis Factor; SAR=Saudi Riyal

Utilization trends and economic burden

A retrospective analysis of 507 IBD patients (258 with CD and 249 with UC) evaluated patterns of biologic use and associated treatment costs, specifically focusing on infliximab and adalimumab.[7] Biologic use was substantially higher among CD patients, with 36.82% receiving infliximab and 20.54% adalimumab, compared to 11.24% and 9.64%, respectively, in UC patients. While clinical efficacy was not reported, the study highlighted the financial contrast between biologic and non-biologic therapies. Annual treatment costs for biologic agents, based on 2019 pricing, ranged from $ 5,572 for ustekinumab to $ 18,424 for vedolizumab, whereas non-biologic therapies such as methotrexate and prednisone cost approximately $ 527 and $ 16 respectively, on an annual basis. Although infliximab and adalimumab were the most used biologics in the cohort, their individual cost data were not specified within this range. Reported figures were based on institutional estimates and were not adjusted for inflation.

Another retrospective cohort study of 156 IBD patients (87 CD, 69 UC) further emphasized this cost differential.[9] In this cohort, 37.82% of patients were treated with biologic agents, primarily infliximab and adalimumab. The mean treatment cost over a six-month period was SAR 25,690.46 (approximately $ 6,850.79, based on 2020 exchange rates) substantially exceeding the cost of non-biologic management. The study did not apply inflation adjustments, and costs were reported in local currency. However, the clinical return on investment was notable: 99.45% of patients reported significant improvements in health-related quality of life (HRQoL), reinforcing the value of biologics despite their high cost.

Comparative efficacy and predictors of failure

A prospective cohort study involving 146 patients (109 with CD and 37 with UC) was conducted to evaluate real-world outcomes of anti-TNF therapy. Infliximab was the predominant agent used in both conditions (CD: 83.5%, UC: 73%), while adalimumab was less commonly prescribed (CD: 16.5%, UC: 27%).[10] The study reported two critical findings:

• UC patients had significantly higher odds of treatment failure than CD patients (OR: 2.585; 95% CI: 1.066–6.266; P = 0.0355).

• Patients on adalimumab had significantly higher odds of failure compared to those on infliximab (OR: 26.91; 95% CI: 7.75–93.39; P = 0.0001).

These observations suggest that infliximab may offer superior durability and effectiveness, particularly in CD, and support the need for careful patient selection and monitoring.

Biosimilars and economic feasibility

A cost-focused abstract presented at ISPOR Europe in 2019 provided real-world insights into the use of biosimilars in Saudi Arabia.[11] Although patient-level data and specific biologic agents were not detailed, the study indicated that biosimilars were associated with favourable clinical outcomes and may offer a cost-effective alternative to originator biologics. However, the lack of standardized outcome measures and comparative data limits the strength of this conclusion. The authors emphasized their potential to reduce national healthcare spending without compromising quality of care, particularly in the context of rising IBD prevalence and biologic demand.

Second-line biologics and refractory IBD

A Bayesian comparative model was used in 2024 to evaluate the short-term effectiveness of Ustekinumab versus vedolizumab in CD patients with prior anti-TNF failure.[12] Although specific sample size and cost metrics were not provided, the study concluded that both agents demonstrated acceptable efficacy and safety profiles in this difficult-to-treat population. These findings align with international literature supporting the role of these agents as second-line or salvage therapies.

Outcomes from a paediatric cohort (n = 13; 8 with CD, 5 with UC) treated with Ustekinumab following failure of anti-TNF therapy were reported in 2025.[13] At 12-month follow-up, 76.9% achieved clinical remission, and 84% remained on therapy. Notably, no serious adverse events were observed. Although limited by small sample size, this study highlights the potential of Ustekinumab in paediatric IBD, where treatment options are particularly constrained.

Optimizing dosing strategies

An analysis conducted in 2025 examined 153 UC patients receiving vedolizumab across two maintenance dosing regimens: every 8 weeks versus every 4 weeks.[14] Clinical remission was achieved in 61.9% of patients on the standard 8-week interval, compared to 89.3% among those receiving intensified 4-week dosing. Additionally, better outcomes were associated with female gender, fewer prior biologic failures, extensive colitis, and more frequent dosing. These findings underscore the importance of individualized treatment strategies based on patient profile and disease behaviour.

Across these studies, several common themes emerge. There is a clear trend toward increased utilization of biologic therapies, particularly in CD, with infliximab being the most frequently used agent. The emergence of newer agents such as vedolizumab and Ustekinumab reflects growing clinical experience and a need for alternatives in refractory cases. Cost remains a significant factor, with biologic therapies being substantially more expensive than traditional treatments, although their use is consistently associated with improved patient-reported outcomes and remission rates. Additionally, patient- and disease-specific factors appear to influence response to therapy, underscoring the importance of personalized treatment approaches. Collectively, these findings provide valuable real-world evidence to inform clinical decision-making, policy development, and future research in IBD management in the region. The included studies varied in design and reporting quality, with most being retrospective and lacking standardized outcome measures. Due to this heterogeneity, formal quality grading was not feasible; however, common limitations included small sample sizes, single-centre settings, and limited follow-up duration.

DISCUSSION

The management of IBD in Saudi Arabia has evolved significantly, particularly with the increased adoption of biologic therapies such as anti-tumour necrosis factor (anti-TNF) agents like infliximab and adalimumab. While these treatments have proven effective in managing moderate to severe cases of CD and UC, their high costs have imposed substantial financial burdens on the healthcare system. This economic challenge has prompted the exploration of cost-effective alternatives, notably biosimilars.

Biosimilars are biologic medical products highly similar to already approved reference products, offering comparable therapeutic benefits and safety profiles at reduced costs. In Saudi Arabia, real-world evidence supports the effectiveness and safety of biosimilars in treating IBD. Studies suggest that biosimilars demonstrate clinical outcomes comparable to those of originator biologics; however, these observations are derived from limited real-world data and lack standardized outcome reporting. Importantly, no direct comparative trials have been conducted to evaluate the efficacy and safety of biosimilars, specifically within Saudi Arabia. The adoption of biosimilars presents a viable strategy to alleviate the financial burden on the healthcare system while maintaining high standards of patient care.[15]

Despite the economic advantages, the cost-effectiveness of biologic therapies remains a topic of discussion. Research indicates that while biologic-based treatments are more expensive, they significantly improve health-related quality of life (HRQoL).[9] However, the high costs associated with biologics necessitate careful consideration in treatment planning, emphasizing the need for strategies that balance clinical benefits with economic sustainability.

Innovative approaches, such as combination biologic therapy, are emerging to enhance treatment efficacy, particularly in refractory IBD cases.[16] Combining biologic agents with different mechanisms of action show promise in managing patients who have not responded adequately to conventional therapies. For instance, studies have reported that combination therapy is an effective therapeutic strategy with an acceptable safety profile in refractory IBD patients. Additionally, research indicates that combination therapy can lead to clinical improvements in disease activity and associated immune-mediated inflammatory disorders.[17] These findings suggest that combination biologic therapy may offer a valuable treatment option for patients with medically refractory IBD.

Furthermore, the development and approval of new biologic agents continue to expand the therapeutic landscape for IBD. For example, the Saudi Food and Drug Administration (SFDA) has approved the use of drugs like Guselkumab and Risankizumab for the treatment of adults with UC and CD, providing additional options for patients who may not have responded to existing therapies. The introduction of small molecules into the field expands the therapeutic armamentarium and has the potential to lower the cost of advanced therapies.[18] The oral route of administration had a higher rating by patients, in terms of convenience, compared to the intravenous and subcutaneous routes.[19] From a cost-saving perspective, generic formulations for some of these oral agents were introduced in several low-income countries for around 1% of what the originator product is sold for.[20] Such advancements underscore the dynamic nature of IBD treatment and the ongoing efforts to improve patient outcomes through innovative therapeutic strategies.

This review has several limitations. The scarcity of studies focusing on the Saudi Arabian population with IBD restricts the generalizability of the findings. Moreover, the available studies often lack detailed information on patient demographics, disease severity, and factors influencing therapy choices, such as patient and physician preferences. Data on adverse events and complications associated with biologic therapies are also limited. Additionally, there is insufficient reporting on the utilization and outcomes of newer biologic agents within this population. Addressing these gaps requires more comprehensive and region-specific research to inform effective management strategies for IBD patients in Saudi Arabia. Therefore, there is a pressing need for more studies and the establishment of a national IBD patient registry to evaluate the cost and efficacy of different therapeutic interventions, the choice of a specific biologic therapy based on factors such as patient preferences (e.g. route of administration), physician considerations (e.g. safety profiles and clinical experience), disease characteristics (e.g. severity and location), and comorbidities in the management of IBD in Saudi population [Figure 2].[21] Such initiatives would provide valuable insights into treatment outcomes, facilitate the development of tailored guidelines, and inform policy decisions to optimize patient care.[7]

Figure 2.

Summary of the biologic utilization for IBD in Saudi Arabia

CONCLUSION

In conclusion, while biologic therapies have revolutionized IBD management in Saudi Arabia, their economic implications necessitate the consideration of cost-effective alternatives like biosimilars. The introduction of newer biologics and combination therapies offers additional avenues for improving patient outcomes. However, the limited availability of local data underscores the need for ongoing research and the dissemination of clinical experiences. Developing tailored guidelines and conducting comprehensive studies are essential to optimize treatment strategies, ensuring both clinical efficacy and economic sustainability within the Saudi healthcare context.

Conflicts of interest

Dr. T Alameel has received speaker fees and consultation fees from Abbvie, Takeda, Janssen, Hikma, Ferring, Amgen, Sandoz, Lilly, Pfizer, BMS, Tabuk, and NewBridge. The other authors have nothing to disclose.

Funding Statement

Nil.