The IBD treatment landscape is continuously evolving with emergence of new therapeutic classes (e.g. JAKs, S1P) and growing biosimilar market (US in particular). The increasing number of treatment options highlights the need for product differentiation, including within the first, second and third+ advanced therapy lines market, with data needed on real-world effectiveness (within the context of sequencing) and safety. Treatment guidelines are being continuously updated and it is likely that we will see a greater emphasis on treat-to-target in the coming years.

Despite the increase in treatment options, significant unmet need remains amongst a significant group of patients (incl. paediatric). Indeed, many patients still do not achieve remission with current standard of care or continue to experience high disease activity and key symptoms despite being classified as in remission, often leaving the patient undertreated. Understanding the clinical burden and patient reported outcomes of those groups is critical, alongside factors impacting health equity and accessibility.

In addition, there are indications within the gastroenterology space where advanced therapies are not available yet (celiac disease, food allergy) and therefore there is limited understanding of patient populations and their unmet needs.

Adelphi Real World’s unique offering, the Disease Specific Programmes™️, is designed to provide real-world insights from patients and physicians on those questions and evidence to support existing and development of new therapies, incl. biosimilars, new classes and novel treatment approaches.

Dermatology incorporates many long-term conditions associated with significant burden of disease which can have devastating effects on the quality of life (QoL) of not only the patient but also their family. A number of advanced therapeutic options are available for the treatment of the more established indications such as Psoriasis and more recently Atopic Dermatitis leading to an increasingly competitive landscape with many novel therapeutic options including JAK inhibitors and biologics in AD and the first-in-class oral TYK2-inhibitor for Psoriasis. The majority of these new treatments are only indicated for moderate to severe disease with treatment options for milder patients reliant on topicals, phototherapy and conventional systemics.

However, treatment options for rarer skin conditions such as Hidradenitis Suppurativa, blistering diseases (BP, PV, PF), Prurigo Nodularis, Generalised Pustular Psoriasis and Palmoplantar pustulosis are limited with significant unmet need among these patient populations. For many of these diseases, there are few formalised diagnostic criteria based on medical history and clinical presentation, frequently resulting in a significant delay to a formal diagnosis in turn leading to poor outcomes. An example of this can be seen in our HS patients, where ¾ were already moderate or severe at the time of diagnosis.

In addition, conditions historically considered to be cosmetic, such as alopecia and vitiligo, are increasingly recognised as having significant impact on patients’ mental health and wellbeing. DSP data has highlighted potential inequities in delay to diagnosis and adequate treatment for many of these conditions in relation to sex and ethnicity. There is also growing evidence that existing disease activity measures lack the sensitivity to accurately measure disease impact across skin tones. The role of real world evidence is crucial here to better understand the impact of such health inequalities.

Adelphi Real World’s Disease Specific Programmes™️ cover both established (e.g. PsO, AD) and rare derm indications (e.g. HS, GPP) and are designed to provide real-world insights from patients, physicians and caregivers regarding existing and pipeline treatments and highlight the ongoing need for improved diagnostic pathways and more efficacious treatments.

Research in rheumatology-focussed diseases ranges from well-researched areas with multiple treatment options, to disease areas with very limited research and no treatment options.

In established areas such as rheumatoid arthritis and psoriatic arthritis, an ever-increasing number of available advanced therapies places greater emphasis on product differentiation. This is further compounded by the recent Article 20 ruling and the growing availability of biosimilar options. However, a growing treatment armamentarium doesn’t necessarily translate into a lack of unmet need, with many patients unable to achieve clinical remission or being considered ‘super-refractory’ – experiencing a high symptom burden, significantly impacting their quality of life, despite receiving multiple lines of therapy with different modes of action.

Counter to this, patients with diseases including Lupus, Sjogren’s or Systemic Sclerosis for example, currently have a notable lack of treatment options available to them. Data is needed to understand where the focus of new treatments should be and possible segmentation of patients to differentiate between the vastly heterogeneous patient presentation in these diseases. Identification of patients whose disease may progress to more sinister manifestations may become important, for example lung involvement in patients with SSc or blindness in patients with Giant Cell Arteritis.

Adelphi Real World’s Disease Specific Programmes™️ can address questions across this spectrum, providing real-world insights and evidence from patients and physicians to assess unmet need, understand patient populations and quantify disease burden, all in the context of the current treatment landscape in a given disease area. The Disease Specific Programmes™️ also place emphasis on patient centricity and understanding physician/patient disconnect which is extremely valuable when assessing areas like the impact of treat-to-target.