Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis

Launched by TOM APPLETON · Sep 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of adalimumab, a medication commonly used to treat various types of inflammatory arthritis, for patients who have recently developed inflammatory arthritis after receiving immune checkpoint inhibitor therapy. The goal is to see if starting adalimumab early can help reduce arthritis symptoms and decrease the reliance on steroids, which are often used to manage such conditions. Participants in the trial will be randomly assigned to either receive adalimumab or continue with standard steroid treatment over a 12-week period.

Eligible participants are adults aged 18 and older who have developed inflammatory arthritis within the last six months after starting or stopping immune checkpoint inhibitor therapy. They should have symptoms that don’t fully improve with low doses of steroids. It's important for potential participants to understand that they will need to give their consent to join the study and will be monitored throughout the process. If you or someone you know is experiencing these symptoms and meets the criteria, this study may offer a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * • Patients are deemed eligible for study participation if they meet all the following:
• • Adult patients (age 18 or older)
• * New (within the last 6 months prior to enrollment) inflammatory arthritis defined by any of the following at the time of screening (either on physical exam or by ultrasound) by a certified rheumatologist:
• • 1 or more swollen joints OR
• • 1 or more tenosynovitis OR
• • 1 or more enthesitis
• • Arthritis onset with taking ICI therapy OR within 4 weeks of stopping ICI therapy including CTLA-4, PD-1, and PDL-1 inhibitors
• • Initiation of ICI therapy must predate the onset of inflammatory arthritis
• • Arthritis either does not respond completely to prednisone doses of 10mg (equivalent) OR recurs with prednisone taper below 10mg daily.
• • Negative tuberculosis (TB) status within the past 12 months (TB skin test or quantiferon) for the patients in the adalimumab group. If not available, the status should be confirmed within 6 months of enrollment in the study (adalimumab group only)
• • Written informed consent provided by patient or power of attorney
• Exclusion Criteria:
• * Patients are excluded if they meet any of the following:
• • Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)
• • Including but not limited to: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic vasculitis, undifferentiated inflammatory arthritis, undifferentiated connective tissue disease
• • Tenosynovitis, synovitis or enthesitis attributed to another cause, fracture or acute gout/CPPD flare.
• • Presence of a contraindication to adalimumab therapy
• • Any of the following in the 7 days prior to initiation of adalimumab: positive tuberculin skin test (\>5mm induration within 48 to 72 hours) or positive quantiferon, evidence of untreated active infection including fungal infection, opportunistic infection, hepatitis B/C, or HIV
• • Personal history of congestive heart failure
• • Personal or family history of demyelinating neurologic disease
• • History of previous TNF inhibitor use
• • Current use of other disease modifying agents including: Chloroquine, Sulfasalazine, Azathioprine, 6-MP, and Leflunomide
• • Presence of a concomitant non-rheumatic irAE which required systemic immunosuppression within the past 3 months e.g. pneumonitis, hepatitis, colitis, scleritis, nephritis
• • Require chronic steroid treatment for adrenal insufficiency or another medical reason other than ir-IA
• • Pregnancy, breastfeeding or childbearing potential without practicing highly effective contraception.
• • Inability to participate in follow-up visits