Nemolizumab withdraw leads to prurigo nodularis relapse
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Key takeaways:
- Clinical relapse occurred in 75% of patients who withdrew from nemolizumab treatment, compared with 16.7% of those who continued.
- Mean time to relapse was 112.5 days in the withdraw group.
For patients using nemolizumab to treat prurigo nodularis, withdrawing medication led to a greater risk for relapse, according to a study presented at the European Academy of Dermatology and Venereology meeting.
“Prurigo nodularis is a chronic neuroimmune skin disease characterized by debilitating itch and multiple pruriginous lesions. It is one of the itchiest of all,” Franz J. Legat, MD, of the department of dermatology and venereology at Medical University of Graz, said in the presentation. “In this study, we wanted to know what happened to patients with prurigo nodularis who responded to nemolizumab treatment with a significant reduction in itch and skin lesions when we take away or withdraw nemolizumab treatment.”
The randomized, double-blind, placebo-controlled, parallel-group phase 3b OLYMPIA DURABILITY study included 34 patients who successfully completed 52 weeks of nemolizumab treatment during the OLYMPIA LTE study and showed a clinical response.
Clinical response was defined as an IGA score or 0 or 1 (clear or almost clear) and a four-point or greater improvement in average Peak Pruritus Numerical Rating Scale (PP-NRS).
Patients were randomly assigned to continue nemolizumab treatment (n=18) or switch to placebo (n=16) for 24 weeks.
Clinical relapse, defined as a four-point or greater increase in PP-NRS score and/or a two-point or greater increase in IGA score, occurred in three (16.7%) patients in the treatment arm, compared with 12 (75%) of those in the placebo arm (HR = .125; 95% CI, 0.034-0.462).
Patients in the withdraw arm also had a median time to relapse of 112.5 days (95% CI, 84-161). The researchers were unable to determine the median time to relapse in the nemolizumab group due to low relapse rates.
Treatment-emergent adverse events were similar in both arms, with most being mild to moderate, according to Legat. Two serious adverse events were reported in the treatment arm and no serious events were reported in the placebo arm.
“These findings support the continued use of nemolizumab beyond 52 weeks of treatment among patients who are clinical responders,” Legat said.