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Patient-reported outcomes, in addition to physician assessment, suggest apremilast improves quality of life and symptoms of psoriatic arthritis within 6 months.
Apremilast, a medication approved for treating psoriasis and psoriatic arthritis (PsA), has been shown to improve quality of life, signs, and symptoms of PsA in Belgian clinical practice, according to a study published in Springer.1
“PsA has a significant impact on the patient’s physical function, energy level, social participation, mood, and quality of life,” investigators stated. “Therefore, a key element in the management of PsA is the patient’s assessment of their disease status and the effectiveness of their treatment. In the APOLO study, patient-reported outcomes (PROs) were used to capture the patients’ global assessment, physical function and health-related quality of life, in addition to the physician’s assessments.”
APOLO (NCT03096990), a multicenter, observational, prospective study determined the effect of apremilast (30 mg twice daily) in this patient population. Eligible patients with active PsA were enrolled in Belgium between April 2017 and December 2018. The primary endpoint was the PsA Response Criteria (PsARC) after 6 months of receiving apremilast treatment. Other endpoints included PROs, measured by PsA Impact of Disease 12 (PsAID12) and a Health Assessment Questionnaire Disability Index (HAQ-DI), and disease-specific outcomes, such as Leeds Enthesitis Index (LEI) and dactylitis,. PROs of patients who received 150 days of treatment were analyzed as a part of the reference set (REF). Follow-ups were conducted at 6 months and up to 18 months.
The PsARC was determined by 68-joint count for pain/tenderness (68-TJC), 66-joint count for swelling (66-SJC), Patient Global Assessment (PtGA) of disease activity, and Physician Global Assessment (PGA) of disease activity.
PsAID12 analyzed function, fatigue, sleep, pain and discomfort, skin problems, anxiety, depression, and activity. HAQ-DI focused on health-related quality of life based on functioning and disability from the patient’s perspective.
Safety was assessed by treatment-emergent adverse events (TEAEs).
A total of 106 patients were included in the safety analysis set (SAF), of which 69 (65.1%) were placed into the REF. Approximately 20% (n = 21) of participants discontinued treatment before the 6-month mark and 46.2% discontinued the medication before 18 months. The mean age was 53 years and 77.4% had concurrent psoriasis.
Thirty of 69 (43.5%) patients in the REF and 32 (30.2%) of patients in the SAF achieved PsARC response. At month 6, 71.4% reported at least a 30% decrease in 68-TJC and an 80.0% decrease in 66-SJC. For those with 68-TJC and 66-SJC > 0 at baseline, 26.8% achieved complete joint count resolution of 68-TJC and 41.8% resolved 66-SJC.
In the REF, 37.5% achieved LEI resolution at month 6 and 71.4% of those with dactylitis achieved resolution. Results were similar in the SAF cohort.
PsAID12 scores were lower in all domains by months 3 and 6 for patients in the REF who had PsAID12 > 4 at initiation, with the mean global score decreasing to 4.4 (2.1), compared with 6.3 (1.4) at baseline.
Mean global HAQ-DI scores decreased from 1.5 to 1.0, indicating an increase in functional activity and health status. For those in the REF with an HAQ-DI assessment at baseline, only 4.5% had HAQ-DI < 0.5 at initiation, compared with 16.4% at month 6. Similar results were seen in the SAF group.
Nearly half of patients experienced at least 1 TEAE, but they were deemed non-serious, mild, or moderate in severity. The most common TEAEs were diarrhea, nausea, and headache. No new safety concerns were found, and the drug was well tolerated.
Including perspectives of both patient and physician strenghten the study. However, PROs are inherently subjective and can lead to variability. Further, as it was an observational study, missing data was an issue, and the single-arm approach was not designed for comparisons or hypothesis testing.
“Our data show that apremilast treatment had a positive impact on the patient’s physical and psychological well-being after 6 months, as assessed either by the patient or by the physician,” investigators concluded. “Improvements were observed after 3 months of treatment and maintained or improved further for up to 1 year.”
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 [published online ahead of print, 2022 Jan 3]. Adv Ther. 2022;10.1007/s12325-021-02016-x. doi:10.1007/s12325-021-02016-x