Results from the CHOICE study suggest that both a 150 mg and 300 mg dose of secukinumab improved symptoms of psoriatic arthritis (PsA) in biologic-naïve patients, with higher response rates for the 300 mg dose.
A randomized study found that secukinumab (Cosentyx) 300 mg resulted in rapid and significant improvements in symptoms of psoriatic arthritis (PsA) in biologic-naive patients, compared with placebo.
The CHOICE study, which was published in The Journal of Rheumatology, also found improvements in patients who received secukinumab 150 mg, but the response was generally higher for the 300 mg dose.
The randomized, double-blind, controlled trial included a total of 258 patients with PsA who had not previously used biologics. Patient age ranged between 19 and 82 years, and the mean time since PsA diagnosis ranged between 3 and 3.9 years. The mean body mass index at baseline was greater than 30 kg/m2, indicating the sample population was generally obese. Additionally, at baseline, 73.3% of patients had enthesitis and 48.1% had dactylitis.
In a 2:2:1 ratio, 103 patients received secukinumab 300 mg, 103 received secukinumab 150 mg, and 52 received placebo. All groups received their treatment every 4 weeks for 16 weeks in treatment period 1.
At week 16, patients who were receiving secukinumab 300 mg continued receiving the same dose during treatment period 2 up to week 52, and patients receiving placebo began receiving secukinumab 300 mg every 4 weeks up to week 52.
Patients in the secukinumab 150 mg group who reached less than 20% improvement in tender and swollen joint counts at weeks 16, 28, or 40 compared with baseline were considered nonresponders and received the 300 mg dose every 4 weeks. Meanwhile, patients who did respond by achieving at least 20% improvement continued with the 150 mg dosage every 4 weeks.
The authors noted that, if the dose was stable, patients were allowed to receive concomitant treatment with nonsteroidal anti-inflammatory drugs or corticosteroids up to week 16, or with methotrexate up to week 52. About a third of patients were receiving methotrexate at baseline.
Proportionally, more patients in the 300 mg group completed treatment up to week 52 (80.6%), compared with the 150 mg group (74.8%) or originally placebo group (76.9%).
According to the authors, the main reasons for discontinuation in treatment period 1 were withdrawal of informed consent and loss to follow-up, while the main reasons for discontinuation in treatment period 2 were withdrawal of informed consent and experience of adverse events (AEs).
At week 16, higher proportion of patients who received secukinumab 300 mg (51.5%) achieved a 20% improvement in American College of Rheumatology score (ACR20), compared with patients who received placebo (23.1%), which the authors deemed statistically significant (OR, 3.51; 95% CI, 1.65-7.45; P =.0011).
While patients who received secukinumab 150 mg (36.9%) also achieved a higher ACR20 response rate compared with the placebo group, OR was not considered statistically significant (OR, 1.92; 95% CI, 0.89-4.15; P = .0961).
Both secukinumab 300 mg (28.2%) and 150 mg (24.3%) also led to higher ACR50 response rates at week 16 compared with placebo (5.8%), both with significant ORs. They also both led to higher ACR70 response rates compared with placebo, but only the 300 mg dose resulted in a significant OR.
Regarding Psoriasis Area and Severity Index (PASI) scores, patients receiving either dose of secukinumab also had substantial improvements in psoriasis and achieved higher PASI75, PASI90, and PASI100 response rates compared with patients receiving placebo, with significant ORs.
In terms of safety, the authors noted that the most common AEs among patients in either secukinumab group were upper respiratory tract infection and. At week 52, serious AEs were reported in 9.6% of patients receiving secukinumab 300 mg and in 7.8% of patients receiving secukinumab 150 mg. However, AEs were generally mild or moderate and were not found to be related to secukinumab dosage.
According to the authors, these findings were consistent with those of prior research and suggest the 300 mg dosage of secukinumab is safe and efficacious as afirst-line biologic treatment for patients with PsA.
“Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” they wrote.
Nguyen T, Churchill M, Levin R, et al. Secukinumab in US biologic-naive patients with psoriatic arthritis: results from the randomized, placebo-controlled CHOICE study. J Rheumatol. Published online April 15, 2022. doi:10.3899/jrheum.210912