MidwireMost patients with axSpA who discontinue ixekizumab respond to treatment when re-introduced after an outbreak, according to an analysis of COAST-Y data.
“Expected or otherwise, patients sometimes pause or discontinue biologic medications, and clinicians and patients may have concerns about regaining efficacy when the medications are restarted,” explains Robert Landiwe, MD, of the Amsterdam Center for Rheumatology in the Netherlands, and the co-researchers.
They highlight the following: “The current findings may be relevant to patients who may need temporary withdrawal from treatment due to pregnancy, related comorbidities, or surgery, for example.”
For the previously reported Phase 3 COAST-Y trial, 741 patients with axSpA were treated with ixekizumab 80 mg every 2 or 4 weeks for 24 weeks, after which 155 patients achieved remission (sixes <1.3 indicates inactive disease at least once in 16 or 20 weeks and <2.1 indicates low disease activity [LDA] at both visits) and were randomly assigned to continue treatment with an interleukin-17a inhibitor or switch to placebo for a further 40 weeks.
During this time, significantly more patients who continued treatment remained outbreak-free, defined as an ASDAS of at least 2.1 at two consecutive visits or less than 2.1 at both visits, compared to those who discontinued, at 83.3% vs. 54.7%.
The current analysis examined data from 138 of these patients over an additional 40 weeks (80 weeks of treatment withdrawal) and found that of the 53 who discontinued ixekizumab treatment, 53% experienced an outbreak. However, most (96%) ASDAS LDA was recovered by restarting open ixekizumab in the original dosing regimen. This occurred in 14% of patients before restarting ixekizumab and in 82% within 16 weeks of starting treatment.
Inactive ASDAS was achieved by 71% of patients: before retreatment in 4%, during 16 weeks of treatment in 50%, and after 16 weeks in 18%.
“This data may provide further support for patients who require an interruption in active therapy,” the researchers wrote. Annals of rheumatic diseases.
Of the 102 patients who continued treatment with ixekizumab, 13 had a seizure. Of these, 92% regained LDA – 54% before retreatment, 15% within 16 weeks of retreatment, and 23% after 16 weeks. Dormant disease was observed in 38%, occurring mostly within 16 weeks of retreatment.
The researchers looked at potential indicators of flare-ups and found that “patients with higher disease activity over time were more likely to have seizures than those with consistently lower disease activity,” such as those who stopped taking the treatment.
They also note that longer duration of symptoms – at least 5 years – was associated with disease exacerbation in patients who discontinued ixekizumab, “while this association was not observed in patients who continued [ixekizumab] treatment or treatment.
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