The effectiveness of adalimumab biosimilars and originator for the treatment of Psoriasis: A target trial emulation study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR)

Monday, August 26, 2024

5:25 PM - 5:30 PM CEST

Location: Room III

Presenting Author(s)

Duc Binh Phan, MSc

PhD Student
Dermatology Centre, Northern Care Alliance NHS Foundation Trust, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom., United Kingdom

Slides Handouts

Co-Author(s)

AB

Anthony Bewley

Barts Health NHS Trust and Queen Mary University of London Medical School, London, United Kingdom., United Kingdom
PL

Philip Laws

Department of Dermatology, University of Leeds, Leeds, United Kingdom., United Kingdom
TM

Teena Mackenzie

Royal Berkshire NHS Foundation Trust, Reading, United Kingdom., United Kingdom
CS

Catherine Smith

St Johns Institute of Dermatology, Guys & St Thomas NHS Foundation Trust, Kings College London, London, United Kingdom., United Kingdom
CG

Christopher Griffiths

Dermatology Centre, Northern Care Alliance NHS Foundation Trust, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, Manchester, Department of Dermatology, King’s College Hospital, King’s College London, London, United Kingdom., United Kingdom
ML

Mark Lunt

Versus Arthritis Epidemiology Unit, The University of Manchester, Manchester, United Kingdom
Manchester, United Kingdom
RW

Richard B Warren

Dermatology Centre, Northern Care Alliance NHS Foundation Trust, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom., United Kingdom
ZY

Zenas Zee Ngai Yiu

Dermatology Centre, Northern Care Alliance NHS Foundation Trust, National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom., United Kingdom

Background: Adalimumab is an effective but previously expensive biologic for psoriasis. The introduction of biosimilars after the patent of the originator adalimumab – Humira® expired has reduced the treatment cost. However, the uncertainties about the real-world effectiveness of adalimumab biosimilars potentially limit their widespread adoption.

Objectives: This cohort study aims to compare the effectiveness of adalimumab biosimilars Amgevita® and Imraldi® with Humira® using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).

Methods: We emulated 2 target pragmatic randomised clinical trials (RCT): The 1st RCT compared the effectiveness of initiating Amgevita® and Imraldi® with initiating Humira® for the treatment of psoriasis among adalimumab naïve patients; The 2nd RCT compared the effectiveness of switching from Humira® to either Amgevita® or Imraldi® and continuing Humira® among patients who were using Humira® consistently for more than 2 years. The study outcomes were absolute Psoriasis Area and Severity Index (PASI) of ≤2 and of ≤4 at 12 months after the index date. We used inverse propensity score weighting of receiving either biosimilar or Humira® to account for potential confounding. We conducted per-protocol analysis and used multiple imputations (MI) to account for missing PASI at 12 months and inverse probability of censoring weighting (IPCW) to account for censorship. We censored follow-up when participants in Humira® cohorts switched to biosimilars or when patients in biosimilar cohorts shifted to another adalimumab biosimilar. We fitted logistic regression models to compare the outcomes and adjust for baseline demographics, comorbidities, concomitant conventional systemic treatments, and PASI at cohort entry.

Results: The new user analysis included 5205 patients initiating Humira®, 382 initiating Amgevita®, and 334 initiating Imraldi®. The switcher analysis included 3522 Humira® comparators, 847 Amgevita® switchers, and 581 Imraldi® switchers. No significant differences were found between Humira® new users and either Amgevita® or Imraldi® new users in the probability of achieving PASI≤2 (odds ratio [OR] [95% confidence interval [CI]]: 0.98 [0.78 – 1.25] and 0.83 [0.64 – 1.07], respectively) and PASI≤4 (OR: 1.07 [0.84 – 1.37] and 0.91 [0.69 – 1.20], respectively). Amgevita® switchers and Imraldi® switchers also had no differences in achieving PASI≤2 (OR: 1.19 [0.94 – 1.51] and 0.92 [0.72 – 1.18], respectively) and PASI≤4 (1.32 [0.96 – 1.84] and 1.00 [0.70 – 1.41], respectively) compared to those who continued Humira®.

Conclusions: Our study showed that Amgevita® and Imraldi® were as effective as Humira® for new users and switchers