The Effects of Arthritis Medication on Cancer Patients with Inflammatory Arthritis
Scientific study title:
Early Adalimumab Induction for Treatment of Steroid-Dependent Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial
Study Start Date:
July 2023
Study End Date:
June 2025
Why do this research?
Immune checkpoint inhibitors (ICI) are new cancer treatments that activate the immune system in order to fight cancer. They have revolutionized cancer outcomes, but their use is limited by the development of new autoimmune reactions, one of them being inflammatory arthritis (ICI-IA) which can be severe and significantly impact the quality of life. The optimal treatment of these autoimmune reactions is unknown.
Short-term use of TNF alpha inhibitors has been to stop bowel inflammation, allowing patients to resume their cancer therapy, without interfering with their cancer outcomes.
This study aims to answer two fundamental questions:
1. Are TNF inhibitors a good option to induce remission for cancer patients who developed inflammatory arthritis as a side effect of their cancer treatment?
2. Can Adalimumab be used to reduce the requirement of steroids and turn off chronic inflammation without negatively impacting cancer therapy?
The results of this study will hopefully give us some insight into optimal early treatment of patients with ICI-induced arthritis and help us to design larger studies in the future. As immune checkpoint inhibitors are used in more cancer types, it is important to understand how to manage and prevent toxicities, particularly those that significantly impact quality of life, without negatively impacting cancer treatment outcomes.
What will be done?
In this study, investigators will conduct a clinical trial comparing short-term use of a TNF alpha inhibitor (Adalimumab) to usual care to see if this is effective in “turning off” the arthritis, preventing long-term joint inflammation, and allowing ongoing cancer treatment.
Patients who develop inflammatory arthritis after receiving an immune checkpoint inhibitor for their cancer will be included. Those who are unable to taper off prednisone will be randomized to receive usual care or a 3 month trial of adalimumab (12 doses). All patients will be followed for at least 24 weeks. Researchers want to know if early use of short-term adalimumab “turns off” the arthritis, leads to less total use of prednisone and reduced persistence of arthritis without impacting how the cancer responds to its treatment.
Who is involved?
This study will be conducted at multiple sites across Canada. Patients who are seen in rheumatology clinics with specialized interest in cancer therapy toxicity (CanRIO clinics) in Vancouver, Edmonton, London and Montreal will be invited to participate.
Principal Investigator:
Shahin Jamal, MD, FRCPC, MSc, Clinician Investigator, Arthritis Research Canada; Rheumatologist, Department of Medicine, Division of Rheumatology at Vancouver Coastal Health; Clinical Associate Professor at the University of British Columbia
Tom Appleton, MD, PhD, Assistant Professor, Schulich School of Medicine & Dentistry, Western University
Co-Investigators:
Carrie Ye, MD, FRCPC, Assistant Professor, Faculty of Medicine & Dentistry, University of Alberta
Janet Pope, MD, MPH, Professor of Medicine, Epidemiology & Biostatistics, Bone and Joint Institute, Western University
Marie Hudson, MD, MPH, FRCPC, Research Scientist, Arthritis Research Canada; Clinician-scientist, Jewish General Hospital and Lady Davis Institute; Associate Professor, Department of Medicine, McGill University
How are Equity, Diversity and Inclusion addressed or taken into consideration?
Patients will be included if they are seen in one of the participating sites and meet the inclusion criteria for the study. Patients of all genders, ethnicities, and socioeconomic backgrounds can participate as long as they meet study inclusion criteria.
Funding Agency
Canadian Initiative for Outcomes in Rheumatology cAre (CIORA)
How can people get involved?
Appropriate patients will be invited to participate at their respective sites. This is a pilot study and will include 30 patients in total.
