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A recent study in the British Journal of Dermatology showed the monoclonal antibody namilumab, an inhibitor of granulocyte-macrophage colony-stimulating factor (GM-CSF), to be ineffective in the treatment of moderate to severe plaque psoriasis.
The study evaluated the efficacy and safety of namilumab in participants with plaque psoriasis (moderate to severe). This randomized, multi-center, double-blind, parallel-group, phase 2 study had 5 treatment conditions: placebo (n=24), namilumab 20 mg (n=24), namilumab 50 mg (n=24), namilumab 80 mg (n=25), and namilumab 150 mg (n=25). The monoclonal antibody was administered subcutaneously. The mean age of the study population was 40.6 and 31% were women and 69% were men with psoriasis. The study endpoint was the proportion of participants who achieved ≥75% reduction in [Psoriasis Area Severity Index (PASI)] score from baseline to week 12 (ie PASI75).
The researchers showed there was no statistically significant difference between treatment groups and their effect on PASI75. No significance was noted in the affected body surface area, Nail Psoriasis Severity Index, quality of life, or participant assessments at week 12. There were some adverse effects and injection site reactions noted. Treatment-emergent adverse events were observed in 41% of patients, however, more participants in the placebo arm noted adverse effects (62.5%).
The authors noted the limited dose range and study population as limitations in this study.
These findings suggest namilumab to be ineffective the treatment of moderate to severe plaque psoriasis.
Disclosures: This study was supported by Takeda Development Centre Europe Ltd. Please refer to original reference for a full list of authors’ disclosures.
Reference
Papp KA, Gooderham M, Jenkins R, et al; on behalf of NEPTUNE investigators. GM-CSF as a therapeutic target in psoriasis: randomised, controlled investigation using namilumab – a specific, human anti-GM-CSF monoclonal antibody [published online September 12, 2018]. Br J Dermatol. doi: 10.1111/bjd.17195
