Biosimilar equivalence questioned for pemphigus treatment
Dermatologists in NSW have questioned whether rituximab biosimilars can be assumed to be equivalent for pemphigus vulgaris after five patients of their patients developed adverse infusion reactions when Riximyo was substituted for the originator Mabthera. Dr Genevieve Ho and colleagues at St George Hospital, Sydney, said the switches were made by the hospital without the knowledge of the treating clinicians. The adverse reactions occurred despite all patients receiving hydrocortisone and antihistamine pretreatment: three patients developed cutaneous infusion reactions, one developed throat tightening and pruritus, and the other had syncope. Writing in Clinical and Experimental Dermatology they said there had been few previous infusion reactions since rituximab came into use at the hospital for pemphigus in 2008. Hospital policy has now been changed to ensure that patients with pemphigus only receive Mabthera, they wrote.
Guselkumab approved for PsA
The TGA has approved guselkumab (Tremfya) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. The monoclonal antibody is already approved for the treatment of patients with moderate to severe plaque psoriasis.
Neoadjuvant immunotherapy success in melanoma
Pathological response is associated with recurrence-free survival (RFS) and overall survival (OS) with neoadjuvant therapy in melanoma and should be a new benchmark for development and approval in melanoma, according to Australian researchers. In a study that pooled data from six trials involving 192 patients treated with anti-PD-1-based immunotherapy (mostly ipilimumab and nivolumab) or BRAF/MEK targeted therapy, a pathological complete response (pCR) occurred in 47% with targeted therapy and 33% with immunotherapy. The pCR correlated with improved RFS (pCR 2-year 89% versus no pCR 50%, P < 0.001) and OS (pCR 2-year OS 95% versus no pCR 83%, P = 0.027). According to researchers form the Melanoma Institute Australia, very few relapses were seen (2-year RFS 96%) in patients with pCR, near pCR or partial pathological response with immunotherapy, whereas, even with pCR from targeted therapy, the 2-year RFS was 79%, and OS was 91%. The findings are published in Nature Medicine.