Efficacy of Upadacitinib Maintained for 3 Years for Those With Psoriatic Arthritis

The efficacy of upadacitinib was maintained for 3 years in patients with psoriatic arthritis (PsA) who previously had an inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug (nbDMARD-IR), according to a study presented at the European Alliance of Associations for Rheumatology 2023 Congress.

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Additionally, after 3 years, no new safety signals were identified.

“[PsA] is ‘a disease of many parts,’ most obviously it causes arthritis and tendon problems, leading to joint pain, stiffness, and swelling, and limited range of motion, affecting many regions of the body. The severity of these symptoms can vary from mild to severe and often fluctuate, even from day to day. The other major challenge is the presence of psoriasis, a sometimes most troublesome inflammatory skin rash,” Ian McInnes, CBE, PhD, FRCP(Gla) FRCP(Edin), FRSE, FMedSci, head of the College of Medical, Veterinary, and Life Sciences at the University of Glasgow, said in an interview with Pharmacy Times. “[PsA] is associated with increased risks of cardiovascular disease, diabetes, and mental health disorders.Overall, therefore psoriatic arthritis can pose significant limitations on quality of life and if untreated carries a poor long-term prognosis.”

Upadacitinib improved symptoms of PsA with nbDMARD-IR through 104 weeks in the SELECT-PsA 1 trial (NCT03104400). Investigators of the study randomized patients to receive upadacitinib 15 mg once daily, upadacitinib 30 mg once daily, adalimumab 40 mg every other week, or a placebo. At 24 weeks, individuals on the placebo switched to 1 of the upadacitinib strengths.

After the approval of upadacitinib 15 mg, the protocol changed so that individuals on upadacitinib 30 mg switched to upadacitinib 15 mg at 104 weeks at the earliest. The efficacy was assessed through 152 weeks and safety was assessed through June 13, 2022. Out of 1704 individuals, 911 completed the 152 weeks of treatment.

“Finding the right treatment that achieves long-term disease control is essential. Longer duration of treatment usually corresponds to sustained benefits. The risks of longer-term therapeutics, however, could be that new [adverse events] emerge, or that the beneficial effects of a medicine can wane,” McInnes said in an interview with Pharmacy Times. “Ultimately, the goal is to provide patients with the best possible care, considering both symptom management and long-term disease control. It's all about tailoring the treatment approach to the individual needs and circumstances of each patient.”

Investigators said that the proportion of individuals achieving 20%/50%/70% or greater improvement in the American College of Rheumatology criteria were generally consistent with those at 104 weeks.

Upadacitinib had a greater ACR20/50/70 and minimal disease activity responses compared to adalimumab. It also had a greater mean change from baseline in Health Assessment Questionnaire-Disability Index, the patient’s assessment of pain, and Bath Ankylosing Spondylitis Disease Activity Index.

The change in baseline in modified total Sharp/van der Heijde score were similar between upadacitinib and adalimumab, which was higher than upadacitinib 15 mg.

“We offer 2 important insights from this study. The first is that the number of [individuals] with a beneficial response to upadacitinib, meaning patients who experienced improvement and reached minimal disease activity, after nearly 3 years was generally consistent to the number of patients who responded after 2 years. We also observed that the overall safety profile for upadacitinib remained unchanged and that there were no new safety signals,” McInnes said in an interview with Pharmacy Times.

The overall safety profile remained unchanged, with upadacitinib having higher rates of serious infection, herpes zoster, anemia, lymphopenia, creatine phosphokinase elevation, and non-melanoma skin cancer compared to adalimumab. Serious infection, herpes zoster, and creatine phosphokinases were dose dependent for upadacitinib, according to the investigators.

Rates of major adverse cardiovascular events, venous thromboembolism, and malignancy, excluding non-melanoma skin care, were low and similar across groups, with the most common cause of death being COVID-19.

“These insights help physicians understand how ongoing treatment with upadacitinib may help patients manage their psoriatic arthritic symptoms and achieve disease control. The more we learn from these long-term studies, the better we can tailor treatment options and improve outcomes for our patients living with [PsA],” McInnes said.

Reference

McInnes IB, Kato K, Magrey M, Merola JF, et al. Efficacy and safety of upadacitinib in patients with psoriatic arthritis: 3-year results from the phase 3 SELECT-PsA 1 study. EULAR. 2023;82(1):1137. doi:10.1136/annrheumdis-2023-eular.3116