Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: a collaborative study from the ARTIS and DANBIO registers

Hellgren, Karin; Dreyer, Lene; Arkema, Elizabeth V.; Glintborg, Bente; Jacobsson, Lennart; Kristensen, Lars Erik; Feltelius, Nils; Hetland, Merete Lund; Askling, Johan

doi:10.1136/annrheumdis-2016-209270

Cited by 116 publications

(85 citation statements)

References 31 publications

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“…While findings from these studies are inconsistent, recent analyses suggest no excess NHL risk related to TNFI use. 8, 9, 14, 18, 20 In a 2011 meta-analysis of observational and prospective registry studies of patients with RA, PsA or AS, no significantly elevated risk was found (pooled risk estimate 1.11, 95% confidence interval (CI) 0.70-1.51). 20 More recently, investigators using the British Society for Rheumatology Biologics Registrar for Rheumatoid Arthritis (BSRBR-RA) concluded that their study “ruled out” the risk of lymphomas in patients with RA for up to 5 years after treatment initiation.…”

Section: Introductionmentioning

confidence: 99%

Tumor necrosis factor‐alpha inhibitors and risk of non‐Hodgkin lymphoma in a cohort of adults with rheumatologic conditions

Calip

Patel

Adimadhyam

et al. 2018

Intl Journal of Cancer

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Based on limited evidence, the U.S. Food and Drug Administration (FDA) issued a black box warning for the use of tumor necrosis factor-alpha inhibitors (TNFIs) and risk of non-Hodgkin lymphoma (NHL). Our objective was to determine the risk of NHL associated with TNFI use by duration and type of anti-TNF agent. We performed a nested case-control study within a retrospective cohort of adults with rheumatologic conditions from a U.S. commercial health insurance database between 2009 and 2015. Use of TNFIs (infliximab, adalimumab, etanercept, golimumab and certolizumab pegol) and conventional-synthetic disease-modifying antirheumatic drugs (csDMARDs) was identified, and conditional logistic regression models were used to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) for risk of NHL. From a retrospective cohort of 55,446 adult patients, 101 NHL cases and 984 controls matched on age, gender and rheumatologic indication were included. Compared to controls, NHL cases had greater TNFI use (33% vs. 20%) but were similar in csDMARD use (70% vs. 71%). TNFI ever-use was associated with nearly two-fold increased risk of NHL (OR = 1.93; 95% CI: 1.16-3.20) with suggestion of increasing risk with duration (P-trend = 0.05). TNF fusion protein (etanercept) was associated with increased NHL risk (OR = 2.73; 95% CI: 1.40-5.33), whereas risk with anti-TNF monoclonal antibodies was not statistically significant (OR = 1.77; 95% CI: 0.87-3.58). In sensitivity analyses evaluating confounding by rheumatologic disease severity, channeling bias was not likely to account for our results. Our findings support the FDA black box warning for NHL. Continued surveillance and awareness of this rare but serious adverse outcome are warranted with new TNFIs and biosimilar products forthcoming.

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Section: Introductionmentioning

confidence: 99%

Tumor necrosis factor‐alpha inhibitors and risk of non‐Hodgkin lymphoma in a cohort of adults with rheumatologic conditions

Calip

Patel

Adimadhyam

et al. 2018

Intl Journal of Cancer

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“…These results are further confirmed by real‐world data from four national biologic registries (ARTIS [Antirheumatic Therapies in Sweden], BIODASER, Corrona RA registries, DANBIO [Danish nationwide registry]), which gathered data of >4600 patients with ankylosing spondylitis treated with TNF inhibitors. All registries demonstrated no increased risk of overall malignancies among TNF inhibitors exposed patients with ankylosing spondylitis compared to both the general population and patients with ankylosing spondylitis without TNF inhibitor treatment . No increased risk was reported for specific site cancers, including lymphoma, nonmelanoma skin cancer, and melanoma .…”

Section: Malignanciesmentioning

confidence: 95%

“…All registries demonstrated no increased risk of overall malignancies among TNF inhibitors exposed patients with ankylosing spondylitis compared to both the general population and patients with ankylosing spondylitis without TNF inhibitor treatment . No increased risk was reported for specific site cancers, including lymphoma, nonmelanoma skin cancer, and melanoma . Altogether, data on malignancy risk after TNF inhibitors in patients with ankylosing spondylitis is solid enough to reassure patients with ankylosing spondylitis and their physicians considering TNF inhibitors treatment.…”

Section: Malignanciesmentioning

confidence: 96%

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The Safety Profile of Tumor Necrosis Factor Inhibitors in Ankylosing Spondylitis: Are TNF Inhibitors Safer Than We Thought?

Wroński

Fiedor

2018

The Journal of Clinical Pharma

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Tumor necrosis factor (TNF) inhibitors significantly improved the treatment options for patients with ankylosing spondylitis. Unfortunately, currently, there is no strategy for sustaining remission of the disease with TNF inhibitors; after discontinuation, a high percentage of patients experience flares in a short time. Therefore, up‐to‐date, long‐term use of TNF inhibitors in patients with ankylosing spondylitis remains necessary. For this reason, the issue of the long‐term safety of TNF inhibitors in patients with ankylosing spondylitis raises concerns. Although TNF inhibitors are well established in ankylosing spondylitis treatment, the majority of studies on TNF inhibitors’ safety have been performed in patients with rheumatoid arthritis. Until recently, there were very few studies of TNF inhibitors’ safety in ankylosing spondylitis. Meanwhile, TNF inhibitors appear to have different safety profiles in ankylosing spondylitis and rheumatoid arthritis. In this review, we describe available data on the occurrence of adverse events associated with TNF inhibitor treatment in ankylosing spondylitis, including serious adverse events, infections, serious infections, tuberculosis, opportunistic infections, hepatitis B reactivation, malignancies, laboratory test abnormalities, autoimmune diseases, paradoxical adverse events, and heart failure.

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“…International collaborations between registries, including Swedish QRs, have provided useful data (3,4). However, pooling individual-level data from registries located in different countries often raises problems of legal as well as logistic nature that may necessitate specific considerations (5,6).…”

Section: Introductionmentioning

confidence: 99%

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective

Feltelius

Gedeborg

Zethelius

2017

Upsala Journal of Medical Sciences

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AimThe aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making.MethodsA workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance.ResultsThe registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials.ConclusionsQuality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

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Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: a collaborative study from the ARTIS and DANBIO registers

Abstract: In patients with SpA, treatment with TNFi was not associated with increased risks of cancer, neither overall nor for the six most common cancer types.

Cited by 116 publications

References 31 publications

Tumor necrosis factor‐alpha inhibitors and risk of non‐Hodgkin lymphoma in a cohort of adults with rheumatologic conditions

Tumor necrosis factor‐alpha inhibitors and risk of non‐Hodgkin lymphoma in a cohort of adults with rheumatologic conditions

The Safety Profile of Tumor Necrosis Factor Inhibitors in Ankylosing Spondylitis: Are TNF Inhibitors Safer Than We Thought?

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective

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