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Study: PROs show improvement with Cimzia in patients with AS, axial SpA
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Patient-reported outcomes from patients with ankylosing spondylitis and nonradiographic axial spondyloarthritis (n = 147) showed improvements as quickly as day 2 in a trial with Cimzia, according to a recently published report.
Patients with ankylosing spondylitis (AS, n= 178) and nonradiographic axial spondyloarthritis (nr-ax-SpA, n = 147) were randomized 1:1:1 to 400-mg (certolizumab pegol, UCB Pharma) at week 0, 2 and 4 as a loading dose, followed by 200-mg Cimzia every 2 weeks, 400mg certolizumab pegol every 4 weeks or placebo. Patients kept a daily pain diary with a numeric rating scale for back pain and other quality-of-life measures. At week 14 and 16, nonresponders in the placebo group were randomized to treatment.
Of 325 total patients, 298 remained enrolled through week 24. The mean improvement by reduction of pain and fatigue scores by day 2 represented more than half the response seen at day 28.
Minimum clinically important differences (MCIDs) were defined as a 1 or greater change from baseline in total back pain, a decrease of 6 points or greater on the Medical Outcomes Study Sleep Scale, a decrease of 2 points or more in the Ankylosing Spondylitis Quality of Life (ASQOL) assessment and a 2.5 or greater increase in the Medical Outcome Study Short Form-36 (SF-36). MCIDs were achieved by patients who received either dosing schedule of certolizumab pegol for total back pain and sleep scores at week 24 compared to placebo, with 80.2% in the 200-mg every 2 weeks regimen, 77.6% in the 400-mg every 4 weeks regimen and 35.8% in patients who received placebo for total back pain. Sleep scores met MCIDs by 57.7% of patients who received the 200-mg schedule, 61.7% of patients who received the 400-mg regimen and by 22.4% of patients who received placebo.
The ASQOL improved by the MCIDs or greater in 69.4% of patients on the 200-mg regimen, 69.2% of patients who received the 400-mg regimen and in 28.3% of patients who received placebo. All domains of the SF-36 improved at weeks 4, 8 and 24, with the physical component score improved to a MCID in 76.6% of patients who received the 200-mg regimen, 70.1% of patients who received the 400-mg schedule27.4% of patients who received placebo 53.2% of patients in the 200-mg schedule group, 60.7% of patients who received 400-mg dosing and 23.6% of patients who received placebo in the mental component score. – by Shirley Pulawski
Disclosure: Sieper reports the receipt of consulting fees from AbbVie, Abbott, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma. Please see the full study for a list of all other authors’ relevant financial disclosures.
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