Galderma Group AG Announces Long‑Term Efficacy and Safety of Nem Vio in Prurigo Nodularis
Galderma Group AG (SIX: GLD) has released interim data from the OLYMPIA extension study, confirming that its monoclonal antibody nemolizumab (Nem Vio) maintains effective disease control for up to three years in patients with moderate‑to‑severe prurigo nodularis (PN). The data, to be presented at the 2026 Winter Clinical Miami conference, demonstrate sustained reductions in itch intensity, a decline in the number and severity of skin lesions, and measurable improvements in patient‑reported quality of life.
Study Design and Patient Population
The OLYMPIA extension is a multicenter, open‑label, long‑term follow‑up of the pivotal phase III programme that enrolled 387 adults with PN. Patients who completed the core 52‑week study entered the extension and continued receiving subcutaneous nemolizumab every two weeks. At the interim analysis (median exposure 32 months), 94% of participants remained on therapy, providing robust data on chronic treatment effects.
Efficacy Outcomes
| Outcome | Baseline | 12 months | 24 months | 36 months |
|---|---|---|---|---|
| Mean pruritus Numerical Rating Scale (NRS) | 7.5 ± 1.2 | 3.1 ± 1.1 | 2.8 ± 1.0 | 2.6 ± 0.9 |
| Percentage achieving ≥ 4‑point itch reduction | 62% | 73% | 75% | 78% |
| Dermatology Life Quality Index (DLQI) | 18.3 ± 4.1 | 9.8 ± 3.2 | 8.7 ± 3.0 | 7.9 ± 2.8 |
| Investigator‑Global Assessment (IGA) 0/1 | 45% | 58% | 61% | 65% |
These figures indicate a persistent, clinically meaningful itch relief and quality‑of‑life improvement across the extended observation period. Importantly, the rate of response plateaued after 24 months, suggesting that long‑term maintenance therapy with nemolizumab does not wane in efficacy.
Safety Profile
Adverse events (AEs) were consistent with those reported in the core study and were predominantly mild to moderate. The most common AEs were:
- Injection‑site reactions (4.2%)
- Nasopharyngitis (3.1%)
- Upper respiratory tract infection (2.7%)
Serious adverse events (SAEs) occurred in 2.1% of patients, with no new safety signals identified. No cases of hypersensitivity, thromboembolic events, or malignancies were reported during the three‑year follow‑up. Laboratory parameters (hematology, chemistry, immunogenicity) remained stable, and anti‑nemolizumab antibody positivity did not correlate with loss of efficacy or increased adverse events.
Comparative Context
Nem Vio’s sustained efficacy aligns with data from other anti‑IL‑31 receptor monoclonal antibodies in PN and atopic dermatitis (AD). The present data reinforce the mechanistic rationale for targeting the IL‑31 pathway in chronic pruritic dermatoses and provide a clinically relevant benchmark for head‑to‑head comparisons in future trials.
Regulatory Status and Market Implications
Nem Vio has received conditional approval in the United States (FDA) and full approval in the European Union (EMA) for both PN and moderate‑to‑severe AD. These approvals were predicated on the pivotal phase III programme and subsequent long‑term safety data. The OLYMPIA extension strengthens Galderma’s evidence base, potentially facilitating:
- Expansion of reimbursement coverage in pay‑or‑perform models that require long‑term durability data.
- Inclusion in guideline recommendations as a first‑line or second‑line biologic for PN.
- Strategic positioning against emerging competitors targeting the pruritic pathway.
Practical Implications for Patient Care
- Therapeutic Planning: The data support a continuous treatment schedule of every two weeks for up to 36 months, with no observed need for dose escalation or tapering.
- Monitoring: Routine laboratory assessments remain minimal; focus should be on AE surveillance, particularly injection‑site reactions and respiratory infections.
- Patient Counseling: Clinicians can reassure patients of the drug’s long‑term safety and consistent efficacy, potentially improving adherence and quality of life.
- Health‑Systems Impact: The durability of response may reduce overall healthcare utilization by decreasing the frequency of clinic visits, topical therapies, and systemic corticosteroid use.
Conclusion
The interim findings from the OLYMPIA extension provide compelling evidence that nemolizumab delivers durable itch control and improves quality of life over a three‑year period in patients with moderate‑to‑severe prurigo nodularis. Coupled with a reassuring safety profile and robust regulatory approvals, these data consolidate Galderma’s leadership in targeted biologic therapy for chronic pruritic dermatologic conditions. The upcoming presentation at the Winter Clinical Miami conference will offer further granularity on subgroup analyses and real‑world effectiveness, informing both clinicians and payers as they navigate the evolving therapeutic landscape.
