Ilumya / Ilumetri 5 Year Sustained Efficacy and Safety Results

[Fred]

Sun Pharma have published 5 year results for Ilumya / Ilumetri (tildrakizumab)

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Sun Pharma today  announced  that  one  of  its  wholly  owned subsidiaries presented positive, five-year Phase 3 data for ILUMYA® (tildrakizumab-asmn) from the combined  reSURFACE  1  and  reSURFACE  2  extension  studies.  Patients  with  moderate-to-severe plaque  psoriasis  who  continued  to  receive  ILUMYA  through  five  years  of  continuous  treatment maintained consistent and extensive skin clearance with no new safety issues reported. These data were presented for the first time at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.“These results are important as we now have five-year  data  reinforcing  our  understanding  that ILUMYA may provide patients with sustained skin clearance and a well understood safety profile that was comparable to placebo,”said Richard Langley,M.D.,FRCPC, professor of medicine and director of research, Department of Medicine, Dalhousie University. “ILUMYA is a valued option for patients in  the  treatment  of  moderate-to-severe  plaque  psoriasis,  and  these  findings  are  reassuring  for physicians and their patients living with this chronic disease.”In an analysis of the pooled reSURFACE 1 and reSURFACE 2 extension studies, patients received ILUMYA100mg or 200mg through five years of continuous treatment. ILUMYA 100mg is approved in  the  U.S.,  Japan  and  Australia,  and  200  mg  is  additionally  approved  under  the  brand  name ILUMETRI™ in Europe.

In patients who were treated with ILUMYA 100mg, clear or almost clear skin (PASI 90) was achieved by 65.9% of patients and 32.8% of patients achieved completely clear skin (PASI  100)  at  Week  244.  The  standard  goal of  treatment,  a  PASI  75  response,  was  achieved  by 88.7%  of  patients  at  Week  244.1 The  long-term  analyses  also  showed  absolute  PASI  <1/<3/<5 scores  at  Week  28  (50.8%,  85.1%  and  96.4%,  respectively)  were  sustained  through  Week  244 (47.7%,  78.8%  and  88.7%,  respectively). Absolute  PASI  scores  can  provide  an  indication  of  the extent of residual disease after treatment. Achievement of an absolute PASI score of <3 has been proposed as comparable to a PASI 90 response, which is equivalent to clear or almost clear skin.

ILUMYA  100  mg  was  well-tolerated  during  the  Phase  3  trials.  The  three  adverse  reactions  that occurred more frequently than placebo and ≥1% in clinical trials were upper respiratory infections (14% vs. 12%), injection site reactions (3% vs. 2%) and diarrhea (2% vs. 1%). Furthermore, the analysis  demonstrated  similar  exposure-adjusted  incidence  rates  of  malignancies  throughout  five years  of  study.  A  majority  of  malignancies  were  singular  events  with  similar  incidence  rates  as seen in the general US population.

“These impressive results show that ILUMYA keeps working year-on-year, maintaining a high level of  skin  clearance  and  a  durable  safety  profile  regardless  of  baseline  level  of  skin  disease,  age  or background illnesses,” said Abhay Gandhi, CEO, Sun Pharma, North America. “Patients living with moderate-to-severe plaque psoriasis need therapies they can use over long periods of time without loss of efficacy, and weare pleased these data show that ILUMYA is a sustainable choice for patients over the long term.”

Source: sunpharma.com

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[jiml]

It's great to see results of a bio giving efficacy over such a long period

[KatT]

Hope they do tests for PSA and also that it get approved in Canada   I find we don't have that many options for PSA