Laure Gossec, MD, PhD: The Link Between Patient-Reported Outcomes and Disease Activity

Rheumatology Network sat down with Laure Gossec, MD, PhD to discuss her upcoming ACR presentation entitled, “Association Between Clinically Meaningful Improvements in Patient-Reported Outcomes and Stringent Measures of Disease Activity in Patients With Psoriatic Arthritis Treated With Upadacitinib Versus Placebo or Adalimumab: Results From a Phase 3 Trial.” Gossec is Professor of Rheumatology at Sorbonne Université. She explains the study design and methods used, the clinical significance of the results, and why she believes patients with psoriatic arthritis who achieved clinically meaningful improvements in patient-reported outcomes involving quality of life, work productivity, and fatigue were more likely to attain disease control.

Rheumatology Network: What first sparked your interest in studying the impact of upadacitinib and adalimumab in patients with psoriatic arthritis (PsA)?

Laure Gossec, MD, PhD: Well, we all know that in psoriatic arthritis, we aim for a treatment target of remission or low disease. And we also know that this disease, psoriatic arthritis, has a huge impact on patients’ lives. So, I was really interested to cross tabulate results in terms of disease control, using stringent targets for disease remission or low disease versus patient-reported outcomes improvement.

RN: Can you tell me a bit about the study design and the methods your team used?

LG: Yes, we analyzed, as a post hoc analysis, data from the SELECT-PsA 1 study, which is a randomized controlled trial of 2 doses of upadacitinib, adalimumab, or placebo in patients with quite active psoriatic arthritis with around 10 to 11 swollen joints. And we specifically looked at week 26 in that trial, to see if they had attained status of remission or low disease and if they had improved in terms of patient-reported outcomes. We then cross tabulated these 2 types of outcomes.

RN: What are some of the patient-reported outcomes that your team focused on?

LG: We used 3 different categories of patient-reported outcomes. The first one is fatigue, where we used the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score, the second one is overall quality of life, and we used the well-known Short-Form (SF 36) score, and finally, we looked at outcomes related to work and work productivity using the Work Productivity and Activity Impairment (WPAI) score.

RN: And what were the results of this study?

LG: We analyzed 1704 patients at week 24. The first result is that it's very difficult to reach remission, with around 10 to 15% of patients reaching remission, whereas low disease activity defined by minimal disease activity (MDA) or by ACR 70, is reached in around 30 to 50% of patients. Secondly, we found that among patients who improve in their patient reported outcomes using an improvement above the minimal clinically important differences (MCID), around 30 to 50% will reach a good status defined by remission or low disease. Whereas among patients who do not reach an improvement in their patient-reported outcomes, it's only about 10 to 20% who reach a good status in terms of disease activity. We also found that the good status was more often found in patients who find a normative value in terms of patient-reported outcomes. If you reach the status of the general population, then it's around 70% of patients who are reaching good disease control in terms of inflammation. And finally, we found that it's more important to reach a good status of patient-reported outcomes for quality of life and for fatigue or for work if you want to predict good disease control in terms of minimal low disease or remission.

RN: What is the clinical significance of these results?

LG: Well, I think the clinical significance is that it confirms that stringent disease control is related in a way to good status defined by patients. And I would even say that if you want to define good treatment efficacy, you might now want to use patient-reported outcomes as one of the elements to define this good treatment efficacy.

RN: Why do you believe patients with psoriatic arthritis who reported clinically meaningful improvements in key patient-reported outcomes were more likely to achieve disease control?

LG: I think we're showing that patient-reported outcomes and inflammation control are in fact very much linked or, perhaps, overlapping. Not all patients who reach good status defined by patients will reach good status defined by composite scores, but there is indeed a strong link. The weakest link that we found was for mental quality of life. And I think that reflects that mental quality of life is in fact probably quite distinct from good control of inflammation.

RN: Does your team plan on doing any further research on this topic?

LG: Well, I'm very interested in quality of life in PsA, as many of my colleagues know. I don't think that AbbVie is pending another analysis of this data from this trial. But there's a lot of work going on regarding fatigue, quality of life, and how these interplay and interact with disease control and inflammation.

RN: Is there anything else that you would like our audience to know before we wrap up?

LG: I'd like to tell them to enjoy the ACR Congress and see you next year EULAR!