Year’s Use of Cimzia Can Lead to Sustained Remission, Phase 3b Trial Shows
Nearly one year of treatment with Cimzia (certolizumab pegol) led to sustained disease remission and a better quality of life in adults with early axial spondyloarthritis (axSpA), according to data from a Phase 3b clinical trial.
Notably, people with either axSpA subtype (radiographic and non-radiographic) showed comparable responses, supporting Cimzia as a suitable treatment option for all axSpA patients, and axSpA as a single disease.
The study, “Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE,” was published in the journal Rheumatology and Therapy.
axSpA is a type of arthritis that mainly affects the joints of the spine, causing chronic back pain. The disease is called ankylosing spondylitis (AS) if joint damage is visible on X-rays, and non-radiographic axSpA (nr-axSpA) when no such changes can be seen with this approach.
“Despite this difference, the burden of disease for patients in terms of clinical presentation, quality of life, and extra-musculoskeletal manifestations is comparable between r-axSpA [AS] and nr-axSpA,” the researchers wrote.
Cimzia, developed by Belgium-based UCB, is a biologic disease-modifying therapy approved for both AS and nr-axSpA. It works by blocking the activity of tumor necrosis factor alpha, a key mediator of inflammation in axSpA and other disorders.
While clinical remission is now the major goal of axSpA therapies, few studies have evaluated the maintenance of remission following dose reduction or withdrawal, and none has assessed maintenance in both the AS and nr-axSpA subpopulations.
A two-part, international Phase 3b clinical trial, called C-OPTIMISE (NCT02505542), evaluated the use of Cimzia for the induction and maintenance of remission in 736 adults with early axSpA (symptoms for less than five years). In total, 407 of those enrolled had AS, and 329 had nr-axSpA.
In the study’s first part (induction period), patients were treated with Cimzia for 48 weeks — nearly one year — to promote sustained disease remission. Participants achieving remission were eligible to move to the maintenance period, during which the effects of Cimzia dose continuation, a dose reduction, or treatment withdrawal on disease flares were evaluated.
An international team that included researchers from UCB reported data from C-OPTIMISE’s induction period, during which patients received a loading dose of 400 mg of Cimzia at study start and at weeks 2 and 4, followed by 200 mg of Cimzia every two weeks up to week 48.
This part’s main goal was to assess the proportion of patients achieving sustained clinical remission, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 1.3 at weeks 32 or 36, and week 48. Enrolled patients at the study’s start had ASDAS scores of 2.1 or greater.
Secondary goals included assessing patients’ disease activity, physical function, mobility, and quality of life, using several validated measures.
Patients with either disease subtype had generally comparable characteristics, except for the proportion of men and mean symptom duration, which were both higher among the AS group. A total of 89.2% of people with AS and 90% with nr-axSpA completed the trial’s induction period.
After nearly one year of Cimzia treatment, more than 40% of trial participants achieved sustained remission, regardless of AS (42.8%) or nr-axSpA (45.3%) disease type, results showed.
The proportion of patients achieving and then maintaining disease remission gradually increased up to week 48. Almost a quarter (23.5%) were in a state of sustained remission for nearly a year (since week 4), and approximately half (52%) for six months — since week 24.
Treatment with Cimzia also led to substantial reductions in axSpA symptoms and inflammation in the sacroiliac joints and spine (assessed by MRI), as well as improvements in physical function and quality of life. These responses were also comparable across the AS and nr-axSpA groups.
These findings highlighted the “benefits of early treatment in patients with axSpA,” the scientists wrote.
Cimzia’s safety profile was comparable to that reported in prior trials, with no new safety concerns identified. Adverse events occurred in 67.9% of participants, 6% of which were serious. Similar frequencies were found for both disease subtypes.
Overall, having similar proportions of patients with AS and nr-axSpA achieving remission and clinical improvements with Cimzia treatment “further supports the concept of axSpA as a single disease, encompassing both r- and nr-axSpA,” the team wrote.
Results from the maintenance period of C-OPTIMISE, reported in a separate study, showed that patients with sustained remission at 48 weeks could safely reduce, but not discontinue, their Cimzia maintenance dose without disease relapse.