Out from Medpage Today, good information for those considering Anti-TNF drugs to help with AS symptoms.
WASHINGTON — Treatment with the tumor necrosis factor (TNF) inhibitor certolizumab pegol (Cimzia) led to significant improvements in the symptoms and signs of axial spondyloarthritis, whether or not there were accompanying radiographic changes in the spine, a researcher reported here.
Among patients meeting all the diagnostic requirements for ankylosing spondylitis, including sacroiliitis visible on imaging, a 20% improvement was seen in 63.6% of patients receiving 400 mg of certolizumab pegol once monthly (P<0.001 versus placebo), according to Robert B. Landewé, MD, of the University of Amsterdam, and colleagues.
And among those who had nonradiographic axial spondyloarthritis, 62.7% on that dosage had a 20% response, he reported at the annual meeting of the American College of Rheumatology.
Certolizumab pegol is approved for use in rheumatoid arthritis and Crohn’s disease in the U.S., but this agent has not previously been evaluated for efficacy in the group of patients who fall into the broad category of axial spondyloarthritis, and particularly for those who don’t have definitive radiographic sacroiliitis.
To investigate a possible role for this agent, which is a pegylated Fab’ fragment of a humanized anti-TNF monoclonal antibody, Landewé and colleagues enrolled 325 patients who had not responded to at least one nonsteroidal anti-inflammatory drug.
All had disease onset after age 40 and met the criteria established by the Assessments in Ankylosing Spondylitis (ASAS) group for axial spondyloarthritis.
They also had scores of 4 or higher on the Bath Ankylosing Disease Activity Index (BASDAI), which represents high disease activity, spinal pain of 4 or higher on a 10-point scale, and elevated C-reactive protein or spinal changes on MRI.
Patients were randomized to placebo or one of two active treatment arms: 400 mg every 4 weeks or 200 mg every 2 weeks for 3 months.
Outcomes were evaluated on the ASAS 20% improvement criteria (ASAS20), as well as on the ASAS40 and other measures of response.
The results with the 200-mg dose were similar to those seen with the 400-mg dose, with ASAS20 responses seen in 57.7% of the radiographic group and 58.7% of the nonradiographic group, compared with only 38% of the placebo group (P=0.004), the investigators reported.
A greater 40% clinical response was seen in 48.6% and 43.2% of the 400-mg and 200-mg treatment groups, respectively, but ASAS40 responses were seen in only 17.8% of the placebo group (P<0.001).
In the radiographic group, an even higher level of response, ASAS partial remission, was seen in 24.3%, 23.4%, and 1.8% of the 400-mg, 200-mg, and placebo groups, respectively, while among the nonradiographic group that response was reported by 29.4%, 28.3%, and 6%.
And on another measure of clinical efficacy that also reflects spinal inflammation, the ASDAS, responses were seen in 50.5% and 43.9% of the active treatment groups versus 3.7% of the placebo group (P<0.001).
This level of response represented a major improvement, according to the investigator.
When he performed a subgroup analysis looking at possible differences in response between the radiographic and nonradiographic groups, he found “no meaningful difference.”
This was important, he said, because the disease burden was similar in terms of the BASDAI and ASDAS at baseline, meaning that the treatment was clinically relevant for both radiographic and nonradiographic patients.
The results validated the scientific credibility of the hypothesis that patients with nonradiographic disease should be included — along with those meeting all criteria for ankylosing spondylitis — in the broader category of axial spondyloarthritis, he stated.
There were no new safety signals in the study.
Overall adverse events occurred in 70.4% and 62.6% of patients in the active treatment and placebo groups, while serious adverse events were seen in 4.7% of both groups. Serious infections were reported in 1.1% of the certolizumab-treated patients and in none of the placebo patients, and there were no deaths or malignancies in either group.