Apremilast for Psoriatic Arthritis Significantly Improves Pain

Vinod Chandran, MBBS, MD, DM, PhD, FRCPC

Credit: University of Toronto

A new study demonstrated the clinical effectiveness of apremilast in patients with active psoriatic arthritis (PsA), as well as patient satisfaction with the treatment.¹

“In this real-world analysis, patients with PsA who continued apremilast treatment in Canada achieved improvements in clinical and PRO parameters after 4 months, and the majority reported being satisfied with their achieved disease state,” wrote investigators, led by Vinod Chandran, MBBS, MD, DM, PhD, FRCPC, from the Schroeder Arthritis Institute, Krembil Research Institute at Toronto Western Hospital.

Phase 3 studies demonstrated the effectiveness of apremilast for PsA, using the Clinical Disease Activity Index, particularly for patients with moderate disease activity.² There even is evidence for the real-world effectiveness of apremilast for patients with PsA and psoriasis.

Although real-world data exists on the effectiveness of apremilast for PSA treatment, no prospective real-world studies with apremilast for PsA treatment existed in the Canadian population.

Thus, APPRAISE, a prospective, multicenter, observational study, sought to assess the 12-month effectiveness, tolerability, and patient satisfaction with apremilast treatment for PsA patients in Canada.¹ The study included 102 patients aged ≥ 18 years who were prescribed apremilast between July 2018 – March 2020 in Ontario, Quebec, British Columbia, Saskatchewan, and Nova Scotia, and were followed for 12 months with suggested visits every 4 months. Patients were prescribed apremilast before the study and were excluded if they started apremilast treatment > 30 days before the baseline visit.

Most patients were White (96.1%) and women (56.9%). The mean age of the sample was 51.8 years, and the mean duration of PsA was 5.5 years. The most common types of PsA were oligoarticular arthritis (41.4%) and polyarticular arthritis (34.3%).

Many patients had comorbidities, with 74.5% of participants having ≥ 1 comorbidity and 45.1% having ≥ 2 comorbidities. Half of the patients had cardiometabolic disease and a quarter had either anxiety or depression.

The team assessed for the primary outcome of either achievement of remission or low disease activity. Using the Clinical Disease Activity Index for PSA, disease activity scores were high disease (≥ 27), moderate disease activity (> 13 to ≤ 27), low disease activity (> 4 to ≤ 13), and achievement of remission (≤ 4).

Patient satisfaction and patient-reported outcomes were assessed through the Health Assessment Questionnaire-Disability Index and the 36-item Short Form physical and mental component scores.

Most patients (75.5%) had moderate or high disease activity, and 24.5% had either achievement of remission or low disease activity at baseline. At months 4, 8, and 12, the achievement of remission or low disease activity was 63.7%, 67.2%, and 53.8%, respectively.

Although more than half of patients saw improvements with apremilast, 44.1% discontinued the study by 12 months. For those who stayed, the team observed significant improvements in swollen and tender joint counts, pain visual analog scale, psoriasis body surface area, and complete dactylitis resolution.

Additionally, they noted enthesitis reduction; for 60% of patients with this condition, their enthesitis was resolved. Furthermore, patients with dactylitis reported a 100% recovery.

The number of patients meeting a Patient-Acceptable Symptom State increased significantly from baseline to months 4, 8, and 12 (P < .001). Overall, apremilast was well-tolerated, with the most frequent adverse events leading to discontinuation being diarrhea (8.8%), nausea (3.9%), and migraine (3.9%). More than 80% of patients experienced treatment-emergent adverse events, but most were mild to moderate in severity.

Investigators highlighted many limitations, such as a lack of racial diversity, COVID-19 preventing in-person assessment visits, the lack of data on concurrent treatment, reasons for starting apremilast, not addressing fatigue, and not evaluating fibromyalgia and chronic pain syndrome which could have influenced pain scores. Other factors that could have influenced the results were the aggregate analyses and people leaving the study.

Additionally, since apremilast was prescribed by doctors outside of the study, there was no threshold of disease activity. Therefore, some patients had low disease activity at the start of the study, preventing investigators from seeing an improvement with the treatment.

“Apremilast demonstrated effectiveness over 12 months in patients with PsA in Canadian clinical practices, with an efficacy and safety profile consistent with previously reported clinical data,” investigators concluded.

^References

1. ^{Chandran V, Bessette L, Thorne C, et al. Use of Apremilast to Achieve Psoriatic Arthritis Treatment Goals and Satisfaction at 1 Year in the Canadian Real-World APPRAISE Study. Rheumatol Ther. 2024;11(2):443-455. doi:10.1007/s40744-024-00641-w}
2. ^{de Vlam K, Toukap AN, Kaiser MJ, et al. Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study. Adv Ther. 2022;39(2):1055-1067. doi:10.1007/s12325-021-02016-x}