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Over a 3-year period, patients treated with upadacitinib reported greater disease improvements and a greater mean change from baseline when compared with those receiving adalimumab.
In an interview with HCPLive Rheumatology,Iain McInnes, CBE, PhD, vice president, head, University of Glasgow, College of Medical, Veterinary, and Life Sciences, discussed the results of the phase 3 SELECT-PsA 1 study, presented at the European Congress of Rheumatology (EULAR) 2023.1 The study aimed to evaluate the efficacy and safety of upadacitinib in patients with psoriatic arthritis (PsA). Patients were randomized to receive either 2 doses of upadacitinib (15 mg or 30 mg), adalimumab (40 mg), or placebo.
Over a 3-year period, patients treated with upadacitinib reported greater ≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/50/70), minimal disease activity (MDA), and a greater mean change from baseline when compared with those receiving adalimumab. Further, the overall safety profile remained unchanged and major adverse events rates were low and comparable across cohorts.
What inspired your team to evaluate the long-term safety and efficacy in patients with psoriatic arthritis receiving upadacitinib?
Psoriatic arthritis is a chronic disease for which therapies may be required over a prolonged period of time. Symptoms may include joint pain, swelling, stiffness and limited range of motion and, in many patients, coincident skin rash and nail disease. Living with PsA can present challenges that significantly impact a patient’s quality of life. With chronic inflammatory diseases like psoriatic arthritis, finding a treatment that works for each individual—and most importantly, finding a treatment that works for over time—is crucial. Treatment adherence is usually associated with sustained benefits. Long-term efficacy and safety studies like SELECT-PsA 1 provide valuable insights into how a treatment is addressing symptoms of psoriatic arthritis and how that treatment is performing over time, including the ability of patients to maintain disease control. They can further help healthcare providers and patients in making more informed treatment decisions.
Did the results of the study surprise you?
With long-term studies like SELECT-PsA 1, we hope for consistent results that have no surprises as it means patients are continuing to respond to the treatment over time in a manner similar to previous data from shorter studies. The 3-year analysis found that patients who took upadacitinib continued to experience symptom control without any new safety issues arising. These insights reinforce the benefit of upadacitinib to help patients with psoriatic arthritis achieve and maintain disease control.
Were there any strengths or limitations of note?
There are always strengths and weaknesses of clinical trials and this study is no exception. A major strength of SELECT-PsA 1 is its considerable size and the quality of processes applied in the conduct of the study – it was carried out across broad geographical areas with rigorous methodology and trial procedures which give us a high level of confidence in the data, now gathered over 3 years. Potential limitations include the loss of patients over time during follow up. One should also always be cautious in generalizing data gathered in a clinical trial as patients entered into a trial represent only one part of the broad general patient population in clinical practice. In due course therefore we will also require real world evidence to learn more about the benefits and potential safety of upadacitinib in people with psoriatic arthritis.
In your opinion, what is the clinical significance of these results?
In the 3-year analysis of the SELECT-PsA 1 study, we looked at the efficacy and safety profile of upadacitinib in PsA patients who had an inadequate response or couldn’t tolerate one or more non-biologic disease modifying antirheumatic drugs (DMARDs) – a common treatment for PsA. The results showed that the number of patients who benefited from treatment with upadacitinib, meaning these patients achieved minimal disease activity, at 3 years was consistent with the 2-year analysis. We also saw a consistent and unchanged safety profile with no new safety signals. These long-term results are important insights around how patients with psoriatic arthritis are responding to upadacitinib over time – in a disease where long-term, effective treatment is crucial.
What are the next steps for your team?
Psoriatic arthritis is a chronic disease, meaning a patient’s journey never stops – and neither do we. We will continue conducting research and gathering insights to better understand the patient experience and the long-term efficacy and safety of treatments, including upadacitinib, for people living with psoriatic arthritis. This type of research is key in helping patients and their doctors create an effective health care plan to live a life unhindered by their disease.
Is there anything else you’d like our audience to know?
Our goal is always to help improve our patients’ quality of life. Insights around the proven benefits and safety of treatments over time can give healthcare providers more information to make informed decisions with their patients, especially in chronic diseases like psoriatic arthritis, where there is multi-dimensional impact beyond just the physical symptoms and where the goal is to help patients achieve and maintain disease control.