Study: No significant difference in cancer risk among rheumatology patients with a history of malignancy taking DMARDs

Study: No significant difference in cancer risk among rheumatology patients with a history of malignancy taking DMARDs

New research presented this week at ACR Convergence 2022, the annual meeting of the American College of Rheumatology, found no significant difference in cancer risk in patients with a history of rheumatic diseases and malignancies who took biologic or targeted synthetic DMARDs compared to patients treated with TNF inhibitors (Abstract #0267).

Patients with a history of cancer are routinely excluded from randomized controlled trials, so data on cancer risk are limited. This is particularly problematic in older adults with rheumatic diseases, who are increasingly treated with biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) despite a higher prevalence of comorbidities, including cancer. Researchers conducted this prospective observational study to examine the incidence and relative risk of cancer in patients with a history of malignancy treated with these drugs.

The 352 patients in the study were from BIOBADASER 3.0, a multicenter prospective registry of patients in Spain treated with biologic and targeted synthetic DMARDs. The new version of BIOBADASER was introduced specifically to address the increasing use of these medications and changes in adverse event reporting.

The cohort consisted primarily of women with rheumatoid arthritis (RA) and was enrolled in the registry through 2021. The majority of patients used TNF inhibitors and interleukin (IL)-17 inhibitors were used the least. Other medications included Janus kinase (JAK) inhibitors, IL-6 inhibitors, anti-CD20 antibodies, and anti-CTLA-4 antibodies.

The researchers defined incident cancer as any cancer, including new primary cancers, local recurrences or metastases, that led to discontinuation of drug therapy. Among 352 patients, there were 32 incident cancers with an overall rate of 27.1 events per 1,000 person-years (PY), ranging from no event per 1,000 PY in the group taking IL-17 inhibitors to 51.7 events per 1,000 PY in the anti-CTLA-4 group. The overall incidence was not significantly different compared to TNF inhibitors, regardless of whether patients were treated with JAK inhibitors, anti-CD20 antibodies, IL-6 or IL-17 inhibitors, or anti-CTLA-4 antibodies. The rates of various types of cancer (one melanoma, 14 non-melanoma skin cancers and 17 solid tumors) also did not differ between the different treatment groups compared to TNF inhibitor therapy.

However, the study's statistically insignificant results and high confidence intervals are not necessarily definitive, says Juan Molina-Collada, MD, a rheumatologist at Hospital General Universitario Gregorio Marañón in Madrid and lead author of the study.

We should say that we have not found an increased risk of cancer in this population, although our data cannot exclude a potential risk.”

Dr. Juan Molina-Collada, MD, rheumatologist, Hospital General Universitario Gregorio Marañón, Madrid

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Dr. Molina-Collada also cites several limitations of the study, including selection bias, survival bias and more stringent cancer screening in patients on immunosuppressive therapies.

He also notes that long periods of observation are needed to assess the risk of diseases such as cancer. In the study cohort, the median follow-up period ranged from 11.5 to 23 months. Dr. Molina-Collada adds: “National medical registries such as BIOBADSER have intrinsic limitations in terms of the quality of data collected, although external audits of participating centers are routinely carried out.”

However, he points out that because this large study did not find an increase in the overall incidence of cancer in patients with rheumatic diseases and previous cancer, the "results are reassuring regarding the pattern of use of these therapies." He notes that "to our knowledge, this is the first study to provide safety data on the use of targeted synthetic DMARDs or anti-IL-17 inhibitors in patients with a history of cancer."

Source:

American College of Rheumatology

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