Practical insights into the VALUE study for chronic inflammatory skin diseases

At the recent World Conference on Psoriasis and Psoriatic Arthritis (IFPA) in Stockholm, Sweden, AbbVie presented new data from a 148-week interim analysis of the ongoing VALUE study.¹

This prospective, multi-country, post-marketing observational study evaluated the real-world efficacy of risankizumab in the treatment of moderate to severe psoriasis. Results showed that risankizumab demonstrated significantly better durable clinical responses, including the proportions of patients achieving PASI 90 and PASI 100, compared with a cohort of patients treated with other biologics.

The interim analysis of over 2600 patients showed that patients treated with risankizumab achieved complete or near-complete skin healing and maintained their effects significantly more often than patients in the other biologics cohort. Specifically, 67.2% of patients treated with risankizumab achieved PASI 90 compared to 45.3% in the other biologics cohort, and 55.2% achieved PASI 100 compared to 34.6%.

In addition, patients treated with risankizumab switched treatment significantly less frequently and reported higher scores on the Treatment Satisfaction Questionnaire for Medication (TSQM), indicating an overall better patient experience.

In a recent question-and-answer session Dermatology Times spoke with one of the researchers involved in the VALUE study, Diamant Thaçi, MD, PhD, to further explore these findings and their implications for clinical practice. Thaçi is a university professor at the University of Lübeck in Germany and has a particular interest in chronic inflammatory skin diseases.

questions and answers

Q: Can you give a brief overview of the VALUE study, its main objectives and results?

A: We have done a lot of randomized controlled clinical trials in the past where we included different types of patients: patients who are eligible to participate in the clinical trials, patients who don’t have this or that, and then there is a direct comparison with adalimumab, TNF or IL-23. It is always good when the data comes from the real world as well. The real world is very important because it not only reflects what is eligible for clinical trials, but also brings what is important in daily practice because we are more interested in knowing: does the data we see in a clinical trial reflect what we see in daily practice or not?

Finally, you also want to compare with the general population treated with biologics in a similar setting. When you’re making decisions: should I choose risankizumab, for example? And how does that compare to my decision, to other biologics? That’s interesting too. There’s no bias. It’s a 2:1 randomization, so twice for one patient with risankizumab versus the others. But it’s still a huge number of patients. However high the number of patients is, it’s even better because then we have more power. What we presented was 3 years of data on continuous treatment and comparing risankizumab and other biologics. There were about 2000 patients with risankizumab and almost 900 patients with other biologics.

Q: What were the main challenges in conducting this field study and how were they overcome?

A: Every country has a specific level, and in the clinical trials you can include patients who are biologically naive, patients who have not received any systemic treatment. You don’t worry about the cost. That’s so nice. But in real life there are so many aspects that are important. What’s important is: what was the previous treatment? Are they eligible? Are they insured? Or what about insurance? What is the likelihood of their disease improving? And usually there are also treatment-refractory cases, cases that are usually very biased when you put them in a clinical trial because they don’t want a placebo control. You want to have something that is as prescribed, as labeled. I think that’s the beauty of these types of trials, that you also prescribe according to the local label, so according to what you will do in daily practice, and that’s important because it reflects daily practice.

Q: How has risankizumab compared to other biologics in terms of long-term clinical responses and durability of treatment?

A: In terms of durability of treatment, IL-23 inhibitors are expected to have excellent durability and risankizumab in particular has excellent durability. But I think it is also very important that we look for endpoints such as improvement in PASI90 and PASI100. As expected, the durability of risankizumab in daily practice was even better or, I would say, as good as what we observed in the clinical trials. What we also expected was that a patient or another biologic slowly loses its effect over time, which is also what we saw in clinical trials but also in the registries. What I personally love about this type of clinical trial is that everything is controlled. It is still a real trial, but it is well controlled. You control the patient. You follow the patient. We capture everything: adverse events, improvement in quality of life, etc., but it was interesting to see that the delta was higher than expected.

Q: What do the DLQI and TSQM scores provide regarding patient experience and satisfaction with risankizumab treatment?

A: What I personally like first of all is the absolute PASI. Because we don’t have to wait, screen and observe for hours, days or weeks. Usually the patient moves from one treatment to the next very quickly and there is no time for washout. In a very short time the patient’s condition deteriorated, he reached a very high PASI and then a PASI90. I personally love the absolute PASI improvement and that was also presented at the IFPA and that is very important for my daily practice.

The second issue is that over time I also see an improvement in the quality of life of patients. I think all biologics are very effective in improving the signs and symptoms of psoriasis and then we see the delta that occurs at week 16, which is also no surprise but interesting: as long as you treat the patient, you see that even with the small changes they are not happier. This is reflected in the DLQI. It’s like a relapse of that, your patient has almost the same absolute PASI, so no changes in the skin, but they are not more comfortable and over time, when they are no longer responding, the DLQI also goes up, which shows the correlation between what they feel, what they see, the benefit of the treatment and the impact of their disease on their quality of life, not only in terms of improvement but also on the other side when the disease comes back.

Q: While the study is ongoing, what are the next steps for the VALUE study and what additional data would you like to access?

A: We look at a lot of data. For example, we look at: what about the patient? Is the patient-reported outcome, work, productivity improving? How is that changing or not? We also look at the safety profile of different compounds, and I think safety is important for our patients as well. It is extremely important to see, for example, if you prescribed risankizumab versus the other biologics, is the safety profile similar to what we expected? Are we seeing any new signals that might emerge in clinical trials like this one, or are we seeing confirmation of the safety profile that was well established in the clinical trials? Why is this important? In daily practice, we see that this is very important because our patients also have a lot of comorbidities, and this is important to study exactly this subset of patients.

Q: What impact might these preliminary findings have on clinical practice and the treatment of moderate to severe psoriasis?

A: Risankizumab is now established as a valid treatment option. This is nothing new and we see more and more patients taking risankizumab and the VALUE study highlights the value of risankizumab treatment in everyday life compared to other treatment options. It’s not about making a direct comparison but comparing in general the treatment options that we have and showing everyone how we should do it in the future. We should probably not save the best for last but save the first as the best because it really doesn’t matter if you save something for later because that’s important. Once you have the treatment option you don’t really need to switch from one or two other treatment options because the probability of switching is very low if the patient is treated with risankizumab, for example. For me it’s also interesting to see work productivity as mentioned. How is that reflected in the DLQI? But it was another facet of the different questionnaires that we used in this clinical trial. These data were mainly generated by practitioners and are of even greater value to me because they also show clinical relevance in daily practice and not just statistically significant improvements.

Q: Is there anything else you would like to share with dermatologists?

A: In my personal opinion, it is very important that we aim higher: we aim for a very significant improvement in the skin. We have found that our patients really appreciate the profound improvement in the skin. In my personal opinion, this is data that is more aimed at practitioners. It is more aimed at the people who treat on a daily basis and it can be a tool to help them make easier decisions about which biological agents they should use in their daily practice and which of these could be a treatment of choice compared to the general or the other biological agents.

reference

1. Thaçi D, Ohtsuki M, Maul JT, et al. Real-world efficacy of risankizumab in the multi-country post-marketing VALUE study: 148-week interim analysis. Presented at: World Psoriasis & Psoriatic Arthritis Conference; 27-29 June 2024; Stockholm, Sweden.