Q&A: Real-World Insights on the VALUE Study for Chronic Inflammatory Skin Diseases

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

This multi-country, prospective post-marketing observational study evaluated the performance of risankizumab in real-world practice for the treatment of moderate-to-severe psoriasis. The results highlighted risankizumab’s significantly higher durable clinical responses, including the proportions of patients achieving PASI 90 and PASI 100, compared to a cohort of patients treated with other biologics.

The interim analysis, involving over 2600 patients, revealed that those receiving risankizumab achieved complete or near-complete skin clearance and maintained their response at significantly higher rates than those in the other biologics cohort. Specifically, 67.2% of patients treated with risankizumab reached PASI 90 compared to 45.3% in the other biologics cohort, and 55.2% achieved PASI 100 compared to 34.6%.

Furthermore, patients treated with risankizumab changed treatments significantly less often and reported higher Treatment Satisfaction Questionnaire for Medication (TSQM) scores, indicating a superior overall patient experience.

In a recent Q&A, Dermatology Times spoke with one of the researchers involved in the VALUE study, Diamant Thaçi, MD, PhD, to delve deeper into these findings and their implications for clinical practice. Thaçi is a university professor at University of Lübeck in Germany and has a special interest in chronic inflammatory skin diseases.

Q&A

Q: Can you provide a brief overview of the VALUE study, its primary objectives, and findings?

A: We have had a lot of clinical trials in the past, randomized controlled, where we include different sorts of patients: patients who are eligible to participate in the clinical trials, not having this one, not having that one, and then you have a head-to-head comparator to adalimumab, TNF, or IL-23. It's always good to have the data also coming from the real world. The real world is very important because it's mirroring not what is eligible for clinical trials only, but it's also bringing what matters in a daily practice, because we have more interest to know: Are the data that we're seeing in a clinical trial mirroring that which we see in daily practice or not?

Finally, you would like also to compare with the general population, which is treated with biological in a similar setting. Once you are making decisions: Should I select, let's say, risankizumab? And how is this doing compared to my decision, to other biologics? This is also interesting. It's not been biased. It's 2:1 randomization, twice for a patient on risankizumab compared to the others. But it's still a huge number of the patients. As high as the number of patients are, it's even better, because then we have more power. What we have presented, it was 3 years of data on continuous treatment and comparing risankizumab and other biologics. There were about almost 2000 patients on risankizumab and almost 900 patient on other biologics.

Q: What were the key challenges faced during the execution of this real-world study, and how were they addressed?

A: Every country has a special level, and in the clinical trial, you can include patients who are biologic naive, patients who have not received any systemic treatment. You don't worry about the cost. It's so nice. But in the real life, there are so many aspects that matter. It matters: What is the previous treatment? Are they eligible? Are they covered? Or what about insurance? What about the probability to get them to get improvement, and usually, you also get treatment refractory cases, cases that usually will be very biased, to put them in a clinical trial, because they don't want the placebo control. They would like to have something which is as prescribed, as labeled. I think this is the beauty of these kinds of trials, that you prescribe also according to the local label, so according to that which you will do in daily practice, which matters, mirroring the daily practice.

Q: How did risankizumab perform in comparison to other biologics in terms of long-term clinical responses and treatment durability?

A: Regarding the treatment durability, it is expected that IL-23 inhibitors have excellent durability, and especially risankizumab, has an excellent durability. But I think what is also very important is that we are looking for endpoints like PASI90 and PASI100 improvement. As expected, you know that durability with risankizumab in the daily practice was even better, or as good, I will say, as that which we have observed in the clinical trials. What we also expected was that a patient or other biologic, within time, they slowly lose the response, which is also mirroring that which we have seen in clinical trials, but also in the registries. What I personally love about this kind of clinical trial is everything is controlled. It is still a real life trial, but it is well-controlled. You are controlling the patient. You are tracking the patient. We are capturing everything: adverse events, improvement of the quality of life, etc., but it was interesting to see that the delta was more than I expected.

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

A: What I personally love, first, is the the absolute PASI. Because we are not waiting and screening and watching for hours or for days or weeks. Usually, the patient has switched very fast from 1 treatment to another treatment, and there is no time for washout. In no time did the patient exacerbate; they get in a very high PASI, and then you have a PASI90. I personally love, and this is also presented at the IFPA, the absolute PASI improvement, which is very important for my daily practice.

The second issue is that what I see with the time that patients also show it with the improvement of the quality of life. I think all the biologics are very effective in improving signs and symptoms of psoriasis, and then we see in the delta, which comes at week 16, also no surprise, but that which is interesting: As long as you treat the patient, then you see that the patient are not any more happy, even with the small changes. This is mirrored with the DLQI. It is like a rebound of that, your patient having almost the same absolute PASI, so no changes in the skin, but they do not feel more comfortable, and with the time that they lose response, the DLQI is also increasing, showing the correlation between that which they feel, what they see, the benefit of the treatment, and how the quality of life is impacted by their disease, not only in improving, but also at the other side, where that disease is coming back.

Q: With the study ongoing, what are the next steps for the VALUE trial, and what additional data are you looking forward to collecting?

A: We are looking a lot of the data. We are looking, for example, at: What about the patient? Improvement on the patient reported outcome, work, productivity. How is this changing or not? We are looking also at the safety profile of different compounds, and I think safety also matters for our patient. It's extremely important to see if you prescribed, for example, risankizumab compared to the other biologics. Is the safety profile similar than that which we were expecting? Do we see any new signals that might happen in the clinical trials like this, or do we see any confirmation of safety profile which was well-established in the clinical trials? Why is this important? In daily practice, we see this is very important, because our patients also have a lot of comorbidities, and this matters to investigate exactly in this subgroup of patient.

Q: How might these interim findings influence clinical practice and the management of moderate-to-severe psoriasis?

A: Risankizumab is established now as a valid treatment option. This is not new news, and that we see that more and more patients on risankizumab has risen, and the VALUE study is adding the value of risankizumab treatment in a daily practice compared to other treatment options. It means not comparing head-to-head one, but comparing, in general, the treatment options that we are having, showing for all of how we should do it in the future, probably not saving the best as the last, probably doing the first as the best, because it doesn't matter, really, if you are saving something for later on, because this matters. Once you get the treatment option, you do not really have a need to switch from 1 or 2 other treatment options, because there was a very low switch probability if the patient is under treatment with risankizumab, for example. For me, it is also interesting to see, as I mentioned, the work productivity. How is this mirrored with the DLQI? But it was a different facet of the different questionnaires that we have used in this clinical trial. This data were generated by mainly practitioners, and for me, they are of even higher value, because they are showing also the clinical relevance in daily practice, and not only statistically significant improvement.

Q: Is there anything else that you would like to share with dermatology clinicians?

A: In my personal opinion, it is very important that we are aiming for higher: We are aiming for very high improvement of the skin. What we have seen is that our our patients are really appreciating the deep improvement of the skin. In my personal opinion, these are data which are more addressed to practitioners. They are more addressed to the people who are treating daily, and it can be a tool which will help them in making easier decisions as to which biology should they use in a daily practice, and which of them, compared to the general or the other biologics, might be a treatment of choice.

Reference

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