At the annual meeting, a group of researchers led by Iain B. McInnes, MBChB, MRCP, PhD, of the University of Glasgow in the United Kingdom, presented long-term data from a phase III study evaluating the safety and efficacy of secukinumab (SEC) for active psoriatic arthritis (PsA). The study concluded that SEC led to sustained improvement in the signs and symptoms of PsA over four years, and patients tolerated the treatment well. In addition, the treatment’s effectiveness was sustained or further improved after dose escalation.
The FUTURE 2 study has been examining SEC, a fully human monoclonal IgG1 antibody that selectively neutralizes interleukin-17A. The study randomized 397 patients with active PsA to receive either SEC (300 mg, 150 mg, or 75 mg) or placebo every week, then every four weeks starting at week eight.
Starting at week 128, patients with active signs of disease received dose escalation (from 150 mg to 300 mg, or from 75 mg to 150 mg or 300 mg), which continued thereafter. At week 208, researchers performed assessments, including the American College of Rheumatology 20/50/70 Criteria, the Psoriasis Area and Severity Index 75/90, the Health Assessment Questionnaire Disability Index, and the 36-Item Short Form Health Survey Physical Component Summary; they also assessed whether resolution of dactylitis and enthesitis occurred.
Overall, 69 of 100 (69%) patients originally randomized to receive SEC 300 mg, 70 of 100 patients (70%) originally randomized to receive SEC 150 mg, and 62 of 99 patients (63%) originally randomized to receive SEC 75 mg completed 208 weeks of treatment. Subsequently, 46 of 100 patients (46%) in the 150 mg group were escalated to 300 mg, and 56 of 99 patients (57%) in the 75 mg group were escalated to 150 or 300 mg.
Researchers found that clinical responses were sustained through week 208 with 300 mg, and responses were sustained or further improved following dose escalation. Safety, type, incidence, and severity of adverse events (AEs) were consistent with previous reports from the FUTURE 2 study. Three patients experienced treatment-emergent anti-drug antibodies, but there was no neutralizing antibody or loss of efficacy. Only one death was reported in four years in a patient in the 150 mg, which was due to sepsis.
The researchers concluded that SEC 300 mg or 150 mg provided efficacy over four years against the signs and symptoms of PsA and that dose escalation sustained or improved the effects. The researchers also reported that the treatment was well tolerated, with no new or unexpected AEs.