Subcutaneous infliximab listed on PBS

A subcutaneous biosimilar formulation of infliximab, Remsima SC, is listed on the PBS from 1 July.

In contrast to current infliximab products that require IV infusion, Remsima SC allows subcutaneous self administration with a pre-filled pen and syringe device.

The newly listed product is indicated for the treatment of moderate to severe ulcerative colitis (UC) and severe refractory Crohn’s disease (CD), as well as severe active
rheumatoid arthritis (RA).

The listing was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2020, based on the equi-effective dose of infliximab SC 120 mg every 2 weeks and infliximab IV 5 mg/kg every 8 weeks in UC and CD.

However the PBAC did not consider extrapolation of clinical evidence to complex refractory fistulising Crohn’s disease (RFCD) was adequate to support
PBS listings for Remsima SC.

Filgotinib induction and maintenance therapy for ulcerative colitis

Patients with moderately to severely active ulcerative colitis  were able to achieve clinical remission of the condition with use of the JAK inhibitor Filgotinib at 200 mg, a double-blind, randomised phase 2b/3 trial shows.

The therapy was well tolerated among the 659 patients enrolled in induction study A and the 689 patients enrolled in induction study B all of who were randomised to receive filgotinib 100 mg, filgotinib 200 mg or placebo once daily for 11 weeks.

According to investigators from the international trial, which was carried out in over 40 countries, serious adverse events occurred in 28 (5·0%) of 562 patients given filgotinib 100 mg, 22 (4·3%) of 507 patients given filgotinib 200 mg, and 13 (4·7%) of 279 patients given placebo in the induction studies.

Patients who had either clinical remission or a Mayo Clinic Score response at week 10 in either induction study entered the maintenance study.

Researchers say at week 58, 37·2% of patients given filgotinib 200 mg had clinical remission versus 11·2% in the respective placebo group (difference 26·0%, 95% CI 16·0–35·9; p<0·0001).

While clinical remission wasn’t significantly different between filgotinib 100 mg and placebo at week 10, that difference did reach significance by week 58 (23·8% vs 13·5%, 10·4%; 0·0–20·7, p=0·0420).

Serious adverse events were reported in eight (4·5%) of 179 patients given filgotinib 100 mg, seven (7·7%) of 91 patients in the respective placebo group, nine (4·5%) of 202 patients in the filgotinib 200 mg group, and none in the placebo groups.

Read more.

DAA usage broadens for HCV

Direct acting antiviral (DAA) uptake for treatment of chronic HCV has broadened towards younger patients, regional and poorer areas since the drugs were listed on the PBS in 2016, a study has shown.

In the initial months of PBS availability, patients prescribed DAAs were more likely to be aged 50 years or over, have liver cirrhosis, have an aminotransferase-to-platelet ratio index score greater than one and live in urban areas.

The study based on included MedicineInsight data from 2,251 patients, concluded this trend “may reflect a ‘warehouse’ effect”, of a backlog of patients who were already diagnosed with chronic hepatitis C accessing treatment in the initial months of PBS listing.

Subsequently, DAA prescription rates in under 50’s rose from 32% in 2016 to 51% in 2018, despite Australia’s overall DAA prescription rates declining. Likewise, regional/remote patient prescriptions increased from 36% to 47% and those in socioeconomically disadvantaged areas grew from 35% to 44%.

“While uptake of DAA medicines in some population subgroups appears to have improved, continuous efforts to improve uptake across the Australian population are essential,” concluded the authors of the study in JGH Open.