Simponi Aria Leads to Sustained Improvements in Quality of Life for Adults with Active AS, Phase 3 Trial Shows

Treatment with Simponi Aria (golimumab) led to clinically meaningful improvements in health-related quality of life in adults with ankylosing spondylitis after four months — benefits that were maintained over one year, a Phase 3 trial shows.

The findings were presented in a poster, titled “Effects of Intravenous Golimumab, an Anti-TNFα Monoclonal Antibody, on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 1-Year Results of a Phase III Trial,” at the recent 2019 American College of Rheumatology/Association for Rheumatology Professionals Annual Meeting, in Atlanta.

Simponi, developed by Janssen, is an antibody that blocks TNF-alpha, a molecule involved in immune and inflammatory responses, and produced in excess in patients with ankylosing spondylitis (AS). By blocking TNF-alpha, Simponi is intended to reduce inflammation, damage, and pain in the patients’ joints.

Simponi Aria is a more recent formulation of Simponi that requires fewer doses per year. It is given intravenously (directly into the bloodstream), while Simponi is delivered via under-the-skin injections.

GO-ALIVE (NCT02186873) was a Phase 3, multicenter, double-blind trial, sponsored by Janssen, that investigated the efficacy of intravenous infusions of Simponi Aria in adults with active AS and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).

The study enrolled 208 participants who were randomly assigned to receive either Simponi Aria at a dose of 2 mg/kg at the study’s start, week 4, and every eight weeks thereafter, or a placebo at baseline and week 4 followed by Simponi Aria from week 16.

Patients on stable doses of medications such as methotrexate, hydroxychloroquine, NSAIDs, and/or low dose oral corticosteroids were allowed to continue on these treatments.

Earlier results showed that the study met its primary goal as, compared to placebo, Simponi Aria led to a greater percentage of patients with an improvement of at least 20% in their symptoms until week 16 (four months), according to the Assessment of SpondyloArthritis International Society 20 scale (ASAS 20).

Additional goals included assessing the proportion of participants with improvements of at least 40% or 50%, as well as changes in patients’ health-related quality of life (HRQoL), using the 36-Item Short Form Health Survey (SF-36), the Ankylosing Spondylitis Quality of Life questionnaire (ASQoL), the Medical Outcomes Study’s Sleep Scale, and the EuroQoL visual analog scale (EQ-5D VAS).

During the meeting, investigators presented HRQoL data, assessed at weeks 16, 28, and 52 (one year).

Results showed that, compared to placebo, Simponi Aria led to significant improvements in HRQoL as early as week 16. These benefits were maintained after one year of treatment and were found across all HQRoL measures. Patients who switched from placebo to Simponi Aria at week 16 showed similar improvements from week 28. At week 52, participants who switched from placebo showed a similar degree of improvement as those who received Simponi Aria from the beginning of the study.

Another poster, titled “Effects of Intravenous Golimumab on Patient-Reported Outcomes in Active Ankylosing Spondylitis: 28-Week Results of the Phase 3 Trial,” showed the effects of treatment on patient-reported outcomes of physical functioning, mental health, health state, and HRQoL.

These results revealed that patients experienced greater improvements in physical and mental health subscales of SF-36 with Simponi Aria than with a placebo. The benefits were seen at week 8 (two months) and were maintained up to week 16.

At both timepoints, the percentage of participants achieving clinically meaningful improvements was superior in the treatment group compared with the placebo group — 58.1% vs. 27.2% at week 8, and 67.6% vs. 35.9% at week 16 in the physical components; and 48.6% vs. 34.0% at week 8, and 54.3% vs. 29.1% at week 16 in the mental components.

Higher mean improvements in EQ-5D VAS and ASQoL scores were also seen among those treated with Simponi Aria than among participants on placebo.

In addition, at week 28, those who had switched from placebo to Simponi Aria achieved similar improvements in all measures of HRQoL as those assigned to the treatment from the beginning.

Altogether, these findings indicate that Simponi Aria leads to sustained improvements in HRQoL in adults with active AS.

“Adult [patients] with active AS treated with [Simponi Aria] showed marked improvements in physical functioning, mental health functioning, health state, and HRQoL,” the scientists wrote.