MADRID—Recent research analyzing the experience of psoriatic arthritis (PsA) patients in Spain using secukinumab was presented during the 2019 European Congress of Rheumatology (EULAR), June 12–15. This investigation was a multi-center, observational, longitudinal, retrospective study conducted in four Madrid-area tertiary hospitals.1 Patients were included if they had PsA and received at least one dose of secukinumab.
For the study, patient medical records were reviewed to collect demographic and clinical data, features of PsA, including extra-articular involvement and radiological damage. Records also provided information on prior therapies, disease assessment and response data at Month 6 of secukinumab treatment. The Month 6 response data included joint counts, C-reactive protein CRP measures, DAPsA (disease activity in psoriatic arthritis), treatment discontinuation reason(s) and adverse events.
The Patients
A total of 177 patients, most of whom were female (n=115; 65%), were included in the study. The mean patient age was 53 years old, with an average disease duration of nine years. Most of the patients (n=169; 95%) had peripheral disease, with 34% having joint erosions and 47% (n=84) having axial disease, with 68 of those individuals having radiologic damage. Also, 148 patients (84%) had psoriasis, 61 patients (34%) had dactylitis and 111 patients (63%) had enthesitis. The average body mass index was 28.4, with 37% (n=52) of patients being obese.
Patient co-morbidities included hypertension, diabetes mellitus, dyslipidemia, hepatitis B infection, hepatitis C infection and malignancy. Additionally, 55 patients (31%) were active smokers.
Previous treatment use included conventional disease-modifying antirheumatic drugs (DMARDs) (90%), mostly methotrexate (77%) and biologic DMARDs (67%). Of the patients who had previously used biologic DMARDs, 32% had used one biologic DMARD, 25% had used two biologic DMARDs, 20% had used three biologic DMARDs and 21% had used four or more biologic DMARDs. Sixty-nine percent of patients received 150 mg of secukinumab, and 31% received 300 mg of secukinumab.
At baseline the average tender joint count was seven, the swollen joint count was four, CRP was 7 mg/L and DAPsA was 26.
The Results
By Month 6 of secukinumab therapy, the average tender joint count decreased to five, swollen joint count had decreased to two, the CRP level had decreased to 5 mg/L and the DAPsA had decreased to 17.
For the 80 patients with DAPsA data available, 47% (n=38) had DAPsA scores of 14 or less, indicating low disease activity. Nine patients had DAPsA scores of four or less, indicating remission. In biologic DMARD-naive patients, DAPsA was variable, being around 27 at baseline and decreasing to 16 at Month 6. For biologic DMARD-experienced patients, DAPsA varied at Month 6 between 24 and 17. For patients with exposure to three or more biologic DMARDs, the DAPsA at Month 6 varied from 18 to 10.
The average drug survival time was 20 months, with 79 patients (45%) discontinuing therapy due to primary ineffectiveness (n=40), secondary ineffectiveness (n=26), adverse events (n=9) and additional reasons (n=3). The reported adverse events were no different from those reported in previous secukinumab clinical trials.
For the study, the researchers pooled retrospective data of patients who had tried other treatments but still had active disease. About 90% of patients had been treated with a DMARD and 67% of the patients had been treated with biologic agents before using secukinumab.
In this real-world setting, secukinumab-treated patients responded positively, with 47% of patients obtaining remission or low disease activity. In approval clinical trials, patients rarely vary by many parameters. This study showed that despite this patient population’s high percentage (47%) of axial involvement, previous biologic DMARD treatment (77%) and multiple co-morbidities, secukinumab therapy response was still high. Additionally, patients’ adverse event profiles were similar to those previously reported in clinical trials.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
Reference
- Lopez MM, Valero M, Emperiale V, et al. Real-world experience of secukinumab for psoriatic arthritis. Ann Rheum Dis. 2019 Jun;78 (suppl 2):A915.