In the Journals

Certolizumab pegol superior to placebo in non-radiographic axial SpA

Atul Deodhar, MD,

The addition of certolizumab pegol to background medication for nonradiographic axial spondyloarthritis is superior to adding placebo, according to study results in Arthritis & Rheumatology.

“It has been suggested that axial spondyloarthritis without definite structural damage seen on X-ray — nonradiographic axial SpA — could be a self-limiting disease, with the potential for spontaneous remission,” Atul Deodhar, MD, of the Oregon Health & Science University, told Healio Rheumatology. “This, in part, has resulted in a lack of access to efficacious biologic anti-TNF agents for many patients with non-radiographic axial SpA in several countries including the United States.”

To determine the effects of certolizumab pegol (Cimzia, UCB) in patients with nonradiographic axial SpA with signs of inflammation, Deodhar and colleagues conducted the CaxSpAnd study, a 3-year, ongoing, phase 3 trial of adult patients recruited from 80 sites in Australia, Europe, North America and Taiwan. The parallel-group, double-blind study included a total of 317 patients with adult-onset axial SpA, with at least 12 months of symptom duration, as well as active disease at baseline and screening despite background treatment with nonbiologic medications, including at least two NSAIDs.

 
The addition of certolizumab pegol to background medication for nonradiographic axial AS is superior to adding placebo, according to study results.
Source: Adobe

Among the participants, 159 were randomly selected to receive certolizumab pegol plus nonbiologic background medication, with the remaining 158 receiving placebo plus nonbiologic background medication. Those in the treatment group received 400 mg of certolizumab pegol at weeks 0, 2 and 4, and then 200 mg every 2 weeks. Patients were allowed to switch to openlabel certolizumab pegol, or another biologic, or make changes to their background medication, at any point. However, changes prior to week 12 were discouraged.

The primary endpoint was the proportion of patients demonstrating major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 52.

According to the researchers, major improvement in ASDAS — defined as a decrease of at least two points from baseline or lowest possible score — was achieved in 47.2% of patients in the treatment group at week 52 patients, compared with 7% in the placebo group (P < .0001). In addition, 60.8% of patients in the placebo group switched to open-label treatment prior to week 52, compared to 12.6% of those in the treatment group.

“This is the first 52-week placebo-controlled study to demonstrate the efficacy of anti-TNF therapy in these patients, and to investigate the natural history of non-radiographic axial SpA in patients receiving standard nonbiologic therapy alone,” Deodhar said. “The study findings suggest that treatment with certolizumab pegol in patients with active nonradiographic axial SpA results in improvements of signs and symptoms of the disease.”

He added, “The high rate of treatment switching in placebo vs. certolizumab pegol groups in this study highlights the severity of active nonradiographic axial SpA, as well as the limitations of current nonbiologic conventional treatments for providing adequate disease control in these patients.” – by Jason Laday

Disclosure: Deodhar reports grant support and/or consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. Please see the study for all other relevant financial disclosures.

Atul Deodhar, MD,

The addition of certolizumab pegol to background medication for nonradiographic axial spondyloarthritis is superior to adding placebo, according to study results in Arthritis & Rheumatology.

“It has been suggested that axial spondyloarthritis without definite structural damage seen on X-ray — nonradiographic axial SpA — could be a self-limiting disease, with the potential for spontaneous remission,” Atul Deodhar, MD, of the Oregon Health & Science University, told Healio Rheumatology. “This, in part, has resulted in a lack of access to efficacious biologic anti-TNF agents for many patients with non-radiographic axial SpA in several countries including the United States.”

To determine the effects of certolizumab pegol (Cimzia, UCB) in patients with nonradiographic axial SpA with signs of inflammation, Deodhar and colleagues conducted the CaxSpAnd study, a 3-year, ongoing, phase 3 trial of adult patients recruited from 80 sites in Australia, Europe, North America and Taiwan. The parallel-group, double-blind study included a total of 317 patients with adult-onset axial SpA, with at least 12 months of symptom duration, as well as active disease at baseline and screening despite background treatment with nonbiologic medications, including at least two NSAIDs.

 
The addition of certolizumab pegol to background medication for nonradiographic axial AS is superior to adding placebo, according to study results.
Source: Adobe

Among the participants, 159 were randomly selected to receive certolizumab pegol plus nonbiologic background medication, with the remaining 158 receiving placebo plus nonbiologic background medication. Those in the treatment group received 400 mg of certolizumab pegol at weeks 0, 2 and 4, and then 200 mg every 2 weeks. Patients were allowed to switch to openlabel certolizumab pegol, or another biologic, or make changes to their background medication, at any point. However, changes prior to week 12 were discouraged.

The primary endpoint was the proportion of patients demonstrating major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 52.

According to the researchers, major improvement in ASDAS — defined as a decrease of at least two points from baseline or lowest possible score — was achieved in 47.2% of patients in the treatment group at week 52 patients, compared with 7% in the placebo group (P < .0001). In addition, 60.8% of patients in the placebo group switched to open-label treatment prior to week 52, compared to 12.6% of those in the treatment group.

“This is the first 52-week placebo-controlled study to demonstrate the efficacy of anti-TNF therapy in these patients, and to investigate the natural history of non-radiographic axial SpA in patients receiving standard nonbiologic therapy alone,” Deodhar said. “The study findings suggest that treatment with certolizumab pegol in patients with active nonradiographic axial SpA results in improvements of signs and symptoms of the disease.”

He added, “The high rate of treatment switching in placebo vs. certolizumab pegol groups in this study highlights the severity of active nonradiographic axial SpA, as well as the limitations of current nonbiologic conventional treatments for providing adequate disease control in these patients.” – by Jason Laday

Disclosure: Deodhar reports grant support and/or consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. Please see the study for all other relevant financial disclosures.