More than 95% of patients with axial SpA recapture LDA with ixekizumab after withdrawal
Click Here to Manage Email Alerts
As many as 96% of patients with axial spondyloarthritis who withdrew from ixekizumab after a favorable response were able to recapture low disease activity, while 71% retained inactive disease, after resuming the drug, according to data.
“This study is mainly on whether a good response on ixekizumab can be restored, after a patient has stopped taking the drug, or, thought that they stopped taking the drug, which points to some nocebo effect,” Robert B. M. Landewé, MD, PhD, of the department of clinical immunology and rheumatology at the Amsterdam Rheumatology and Immunology Center, in the Netherlands, told Healio. “Almost all patients recaptured their good response on ixekizumab.”
To study the recapture response of ixekizumab (Taltz, Eli Lilly & Co.) in patients with axial SpA who experienced a disease flare following the cessation of therapy, Landewé and colleagues continued the COAST-Y study. According to the researchers, COAST-Y is a long-term extension study with an open-label lead-in period followed by a double-blind, placebo-controlled, randomized withdrawal-retreatment phase.
In the 24-week lead-in period, patients received ixekizumab 80 mg every 2 or 4 weeks. Those who received placebo through the end of the previous study were assigned to receive ixekizumab every 4 weeks during the lead-in period. Patients who achieved remission during this lead-in period then entered the randomized withdrawal-retreatment period, in which they were randomly assigned to receive ixekizumab every 2 or 4 weeks, or placebo. Patients who experienced flare were switched to open-label ixekizumab every 2 or 4 weeks at their next visit.
The researchers analyzed recapture rates at week 104. The authors defined recapture as achieving either Ankylosing Spondylitis Disease Activity Score (ASDAS), LDA or ASDAS inactive disease (ID) after retreatment with ixekizumab during the randomized withdrawal-retreatment period.
In all, 155 patients entered the randomization period, with 53 receiving placebo, 48 receiving ixekizumab every 4 weeks, and 54 receiving ixekizumab every 2 weeks. Of those, 138 patients completed the study through week 104. Out of the 53 patients receiving placebo, 28 demonstrated a flare sometime between weeks 24 and 104. Out of those, four patients achieved remission before therapy and 23 recaptured ASDAS, while 19 met ASDAS ID following retreatment.
According to the researchers, who published their findings in the Annals of the Rheumatic Diseases, 96% of patients who withdrew to placebo achieved LDA following retreatment, and 71% recaptured inactive disease activity.
“The main takeaway in my opinion is that if a patient has been brought into sustained remission with ixekizumab and they want to stop because it is going very well, or there is some medical reason to do so, the physician can easily agree with that, since if the patient flares the likelihood that the old favorable situation is restored is sky high,” Landewé said.
“The study also teaches us that part of the ‘good response’ of patients with axial SpA is perception,” he added. “Some patients who perhaps thought that they were assigned to placebo and reported flare, but in reality had continued ixekizumab, also did better after ‘reinstalling’ open-label ixekizumab, without realizing that they had never been off-drug — a specific kind of nocebo-effect.”
Collapse
Read more about
Click Here to Manage Email Alerts