Guselkumab launched for the treatment of plaque psoriasis
A new biological therapy has been launched in the UK for the management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Guselkumab (Tremfya) is a fully human monoclonal antibody that selectively blocks interleukin (IL)-23, a cytokine that is thought to play a key role in inflammatory responses in psoriasis.
Marketing approval for guselkumab was based on clinical trials including the phase 3 VOYAGE 1 and VOYAGE 2 trials, which showed significantly greater PASI 90 (90% reduction in Psoriasis Area and Severity Index score) responses after 16 weeks treatment with guselkumab compared with the TNF inhibitor adalimumab (70–73% with guselkumab vs 47–50% with adalimumab) in patients with moderate to severe psoriasis; responses were maintained up to 48 weeks in VOYAGE 1.
In clinical trials, the most common adverse event was upper respiratory tract infection; other common side-effects include gastroenteritis, herpes simplex and tinea infections, headache, diarrhea, urticarial and arthralgia.
Guselkumab is administered by subcutaneous injection and the recommended dosage is 100mg at weeks 0 and 4, followed by a maintenance dose every eight weeks. Discontinuation of treatment should be considered in patients who have shown no response after 16 weeks of treatment.
NICE is already appraising guselkumab for moderate to severe psoriasis, with publication expected in June 2018.