For patients with active psoriatic arthritis (PsA), treatment with secukinumab at subcutaneous (SC) doses of 300 and 150 mg confers rapid and clinically significant improvement in signs, symptoms, physical function, and quality of life with no unexpected safety findings.

Iain B. McInnes, MD, University of Glasgow, United Kingdom, reported on the results of the Efficacy at 24 Weeks With Long-Term Safety, Tolerability, and Efficacy Up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis [FUTURE 2; NCT01752634].

FUTURE 2 is a multicenter, randomized, placebo-controlled phase 3 study in which patients with PsA were randomized to 1 of 3 loading doses of secukinumab SC at 75 mg (n = 99), 150 mg (n = 100), or 300 mg (n = 100) every week for the first 4 weeks of treatment followed by the same monthly SC maintenance dose or placebo (n = 98).

Along with active PsA (defined as ≥ 3/78 tender joints and ≥ 3/76 swollen joints), patients in the study had a diagnosis of or documented history of active plaque psoriasis, nail changes consistent with psoriasis, and had not responded adequately to prior treatments with nonsteroidal anti-inflammatory drugs, methotrexate (MTX), and/or anti-tumor necrosis factor (TNF) therapy.

The primary end point of the study was the proportion of responders with American College of Rheumatology 20% improvement response criteria (ACR20) at week 24.

Secondary end points included 75% and 90% improvement in Psoriasis Area and Severity Index score (PASI 75 and PASI 90), change from baseline in 28-joint Disease Activity Score using C-reactive protein, physical function assessed by Medical Outcome Short Form (36), Health Survey physical component summary scores, and by the Health Assessment Questionnaire Disability Index, ACR50 response, proportion of patients with dactylitis and enthesitis, and overall safety and tolerability.

The study found that significantly more patients treated with secukinumab at 150 and 300 mg achieved ACR20 at 24 weeks compared with placebo (51.0% and 54.0%, respectively, vs 15.3%; P < .0001) as well as those treated with secukinumab 75 mg (29.3% vs 15.3% for placebo; P < .05).

Regarding secondary measures, Prof McInnes noted the improvements seen with the 2 higher doses of secukinumab (150 and 300 mg) compared with the lower dose of 75 mg and placebo. Significantly more patients treated with secukinumab 150 and 300 mg achieved ACR50 (P = .01, both) and ACR70 responses (P = .05, both).

Patients receiving the 2 higher doses of secukinumab also had the most improvement in other secondary outcomes, including quality of life, physical function, resolution of dactylitis and enthesitis, and PASI 75 and PASI 90 responses.

In a separate subset analysis that compared anti-TNF-naïve patients to anti-TNF responders, the study found that the clinical benefits of secukinumab, particularly at 150 and 300 mg, were observed regardless of exposure to anti-TNF therapy. Similarly, the clinical benefits of secukinumab at the 2 higher doses in particular were seen in patients concurrently receiving MTX therapy.

In terms of safety, Prof McInnes emphasized there has not been sufficient time and the numbers are too small to determine any differences between the groups. Candida infections and neutropenia are 2 adverse events of interest that are being monitored.

The FUTURE 2 study showed that SC secukinumab provided important clinical improvements in patients with active PsA.