Reassurance on multiple IFX switching
Multiple switches from originator infliximab to its biosimilars does not appear to impact efficacy, immunogenicity or safety of anti-TNF therapy in patients with IBD.
A French study of 158 patients compared outcomes after a single switch to a biosimilar with outcomes after a double switch to a second biosimilar. It found steroid-free clinical remission was mostly maintained in both groups (91.5% v 92.0%) and all other measures were stable and comparable between groups.
There were slightly higher rates of infectious adverse events in the double-switch group while rates of overall and serious adverse events were similar in both groups.
An Australian editorial said the study supports the safety and effectiveness of multiple switches between biosimilar infliximab formulations in clinically stable IBD patients.
It noted however that patients express concerns that decisions to use biosimilar medications may be driven by cost advantages rather than efficacy and/or safety.
“Most patients did, however, report that they would accept a recommendation to commence biosimilar medicines if adequately explained by their physician.”
AMR study rules clindamycin out for C. diff
Clindamycin resistance is common in C. difficile infections in Australia.
According to the national C. difficile Antimicrobial Resistance Surveillance (CDARS) study, 1091 strains of C. difficile were isolated in the county between 2015 and 2018.
All strains were susceptible to metronidazole, fidaxomicin, rifaximin and amoxicillin/clavulanate and low numbers of resistant strains were observed for meropenem (0.1%), moxifloxacin (3.5%;) and vancomycin (5.7%).
However 85.2% of strains were resistant to clindamycin and 18.8% resistant to ceftriaxone.
The prevalence of multidrug resistant C. difficile ( ≥3 antimicrobial classes) was a low 1.7%.
Journal of Antimicrobial Chemotherapy
Stronger mesalazine dose on PBS
Federal Health Minister Greg Hunt has announced an expanded PBS listing of mesalazine (Asacol) with a new strength tablet for ulcerative colitis .
At its November 2020 meeting, the PBAC recommended the 1600 mg enteric coated tablet for listing under the same circumstances as Asacol 800.
The PBAC noted Asacol 1600 would reduce pill burden and the frequency of multi-day dosing, which in turn would lower the risk of non-adherence in patients.
The PBAC advised that the maximum number of repeats should be four, to provide six months’ supply at the maximum recommended dose. As a flow-on change of listing the new 1600mg strength, the maximum quantity of 800 mg will be reduced to 90.
The Minister said over 650 patients with ulcerative colitis will benefit from PBS listing of the new treatment option.
“Without PBS subsidy, patients might pay more than $1,400 per course of treatment with this medicine.”