Nemolizumab effectively reduced pruritus and helped clear skin lesions in patients with prurigo nodularis when compared with placebo, despite being associated with adverse events, according to study research published in New England Journal of Medicine.
The investigators of this multicenter, randomized, double-blind phase 2 study sought to assess the efficacy and safety of nemolizumab vs placebo for treating patients with prurigo nodularis.
The study included a total of 70 adults with moderate to severe prurigo nodularis and severe pruritus who were randomly assigned to receive nemolizumab (N=34) or placebo (N=36). All participants were administered subcutaneous injections at baseline, week 4, and week 8; week 12 was specified as the end of the intervention period with follow-up visits conducted at week 16 and week 18. Moderate to severe prurigo nodularis was defined as ≥20 nodules; severe pruritis was defined by a mean score of ≥7 on the numerical rating scale for worst daily intensity of pruritis (0=no itch, 10=worst itch imaginable). The primary study outcome was the percent change in peak pruritus score from baseline to week 4, in which a change of 4 points indicated clinical significance. Secondary outcomes included additional pruritus and disease severity measures, and the effect of nemolizumab on prurigo skin lesions and quality of life. Safety outcomes were assessed through 18 weeks.
Baseline peak pruritus score for both the nemolizumab and placebo group was 8.4 points. At week 4, the peak pruritus score for the intervention group was reduced by 4.5 points (-53.0% change) compared with the control group whose score was reduced by 1.7 points (-20.2% change) for a difference of -32.8% (95% CI, -46.8 to -18.8; P <.001). Secondary outcomes supported a similar trend in which between-group differences favored nemolizumab. The proportion of participants who experienced adverse events was similar in both groups (68% of the nemolizumab group and 67% of the placebo group). Four patients receiving nemolizumab and 3 patients receiving placebo reported serious adverse events, including psoriasiform rash, atopic dermatitis, clavicular fracture, spinal fracture, musculoskeletal pain, and bladder lithiasis. The most common adverse events associated with nemolizumab were abdominal pain and diarrhea (21%); musculoskeletal symptoms (18%); injury, poisoning, or procedural complications (12%); and bronchitis (6%).
Limitations to the study included the small sample population and analyses were not adjusted for multiplicity, meaning that clinical inferences could not be drawn from this data.
In patients with prurigo nodularis, nemolizumab was associated with a greater reduction in pruritus and severity of skin lesions compared with placebo. However, nemolizumab exposure was also associated with adverse abdominal and nonspecific musculoskeletal symptoms. The researchers suggest that larger studies with longer treatment durations are needed to understand the long-term efficacy and safety profile of nemolizumab for managing prurigo nodularis.
Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Stander S, Yosipovitch G, Legat FJ, et al. Trial of nemolizumab in moderate-to-severe prurigo nodularis. N Engl J Med. 2020; 382:706-716.