Patients with rheumatoid arthritis (RA) are at an increased risk of malignancies compared with the general population [2]. Abatacept is a biologic immune modulator for RA, selectively blocking the specific interaction of CD80/CD86 receptors to CD28 and, therefore, inhibiting T cell proliferation and B cell immunological response. Abatacept has demonstrated efficacy and safety in the treatment of RA. “We have observed that, in clinical trial data, malignancy rates are similar for abatacept compared with placebo-treated patients and that post-marketing observational studies are valuable to assess the long-term risk associated with the medication,” said Dr Teresa Simon (Bristol-Myers Squibb, USA). The prospective cohort study aimed to assess the risk of solid tumour malignancies in RA patients treated with abatacept versus conventional synthetic disease-modifying drugs (csDMARDs) and other biologics or targeted synthetic DMARDs.
Four cohorts of data were analysed: the Swedish Anti-Rheumatic Therapy Registry (ARTIS), the German Registry for Rheumatoid Arthritis Observation of Biological Therapy (RABBIT), a disease registry (FORWARD; The National Databank for Rheumatic Diseases in the USA) and a healthcare claims database (the population-based British Columbia Canadian RA Cohort). “This analysis represents the largest safety study of abatacept treatment to date,” said Dr Simon. A total of 2,653 patients treated with abatacept and 1,485 given placebo were included. Seven trials used intravenous abatacept and two used the subcutaneous form. The outcomes were prespecified and agreed upon by the health authorities and they included overall malignancy, breast cancer, lung cancer, and lymphoma. The baseline data, rates, and summarised statistics were provided by the individual registries and databases. Complex multivariate analysis was performed by the individual registries and estimated adjusted rate ratios were provided.
The majority of patients were female (71% to 86%), with an approximate age of 55-63 years old. A history of malignancy was found in 4-34% of the patients. A greater number of abatacept-treated patients had been treated with ≥2 prior biologics (abatacept, 44 to 85%; csDMARDs, 11% [FORWARD] and other biological/targeted syntetic DMARDs, 0 to 19%). The incidence rate of overall malignancy in abatacept-treated patients was low (see Table). For all drugs, adjusted rate ratios showed no increased risk in overall malignancy. Individual registries showed a small increase in the breast (Canada), lung (Germany), and lymphoma (Sweden) cancers in abatacept-treated patients, but numbers were too low to assess relative risk. Given that blockade of the CTLA-4 pathway with resultant immune stimulation is an integral component of cancer immune checkpoint inhibition strategies in oncology, it is reassuring that suppression of this pathway is not linked to emergent cancer.
Table: Incidence rates for malignancies per 1,000 patient-years
- Simon T, et al. Abstract OP0226. EULAR 2019
- Simon TA, et al. Arthritis Res Ther. 2015 Aug 15;17:212
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Table of Contents: EULAR 2019
Featured articles
Efficacy and safety of ixekizumab versus adalimumab in patients with PsA
Rheumatoid Arthritis
Cohort study shows improvement during 25 years of RA treatment
Filgotinib in RA patients with inadequate response or naïve to methotrexate
Clinical effectiveness of fenebrutinib in RA patients with methotrexate or TNFi failure
Short methotrexate stop is safe in patients with RA
Tofacitinib is safe according to real-world data analysis
Tapering of prednisone in RA patients who achieved low disease activity or remission with tocilizumab
Efficacy and safety of E6011 in RA patients with inadequate response to methotrexate
Preliminary efficacy and safety data of RG6125 in RA patients with an inadequate response to TNF inhibitors
Integrated 10-year analysis confirms safety profile abatacept
Switching among multiple infliximab biosimilars does not cause immunogenicity
Switch to sarilumab from adalimumab is efficacious and safe
Axial Spondyloarthritis
Treat-to-target approach emerging in axial spondyloarthritis
NSAIDs consumption is linked to patient-assessed disease activity and decreases with use of TNF inhibitors
Psoriatic Arthritis
Efficacy and safety of ixekizumab versus adalimumab in patients with PsA
Efficacy and safety of bimekizumab in patients with active PsA
Filgotinib is efficacious and safe in PsA
Ixekizumab improves signs and symptoms in TNFi-naïve PsA patients
Etanercept and methotrexate as first-line treatment in PsA
Unacceptable pain is common in patients with psoriatic arthritis
Osteoarthritis and Osteoporosis
Miscellaneous
Interstitial lung disease in rheumatic diseases and systemic sclerosis
Emapalumab in patients with macrophage activation syndrome
Support for tocilizumab use in giant cell arteritis
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