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Neutropenia With TNF-α Inhibitors

Neutropenia in Patients Treated With TNF-α Inhibitors: Frequency and Clinical Implications From a Retrospective Cohort

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07237906
Enrollment
122
Registered
2025-11-20
Start date
2023-09-01
Completion date
2025-09-01
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia, TNF-alpha Inhibitors

Keywords

Adverse drug event, Arthritis, Neutropenia, Tumor necrosis factor-alpha inhibitors

Brief summary

Tumor necrosis factor-alpha (TNF-α) inhibitors, including infliximab, etanercept, adalimumab, certolizumab, and golimumab, have become cornerstone therapies in the management of rheumatologic disorders. Although their efficacy and tolerability are well established, accumulating evidence indicates that these agents may also induce hematologic adverse events. The most frequently documented hematologic complication of TNF-α inhibitor therapy is neutropenia. Previous studies have reported neutropenia in approximately 10-19% of patients receiving TNF-α inhibitors. Neutropenia is defined as a decrease in circulating neutrophils to an absolute neutrophil count (ANC) below 1500 cells/μL. Clinically, neutropenia is stratified according to the ANC as mild (1000-1500/μL), moderate (500-1000/μL), or severe (\<500/μL). While mild neutropenia is frequently asymptomatic, severe neutropenia is associated with a substantially elevated risk of serious and potentially life-threatening infections . The pathophysiological mechanisms underlying drug-induced neutropenia remain incompletely understood; however, proposed explanations include immune-mediated peripheral destruction of granulocytes, bone marrow suppression or impaired maturation of granulocyte precursors. Autoimmune pathways may also contribute, as evidenced by recurrence of neutropenia following drug rechallenge. Neutropenia associated with TNF-α inhibitor therapy is typically mild; however, its development warrants careful clinical attention. Certain clinical risk factors have been identified. Identified risk factors include a previous history of neutropenia, prior neutropenia under disease-modifying antirheumatic drugs (DMARDs) therapy, and lower baseline neutrophil counts, each of which may predispose patients to subsequent neutropenia. Notably, most cases emerge within the first three months after treatment initiation. Although discontinuation is rarely required and serious infections are uncommon, the possibility of hematologic complications underscores the importance of close monitoring and routine hematologic assessments throughout therapy. Despite the growing recognition of TNF-α inhibitor-induced neutropenia, current data regarding its rate, clinical course, and impact on treatment outcomes remain limited, particularly in real-world patient populations. The present study aimed to determine the frequency of neutropenia in this population and to evaluate its clinical characteristics and impact on treatment outcomes.

Interventions

None listed

Sponsors

Burak Ugur Cetin
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Initiation of TNF-alpha inhibitor therapy at least once in our clinic between September 2023 and January 2025 * Age 18 years or older * At least one complete blood count performed during the follow-up period * Availability of complete clinical and laboratory data in the hospital's electronic medical records or patient files

Exclusion criteria

* History of other hematologic disorders that may contribute to the development of neutropenia (e.g., aplastic anemia, leukemia, myelodysplastic syndrome) * Concurrent treatment with cytotoxic chemotherapy or immunosuppressive agents (e.g., azathioprine, cyclophosphamide) * Insufficient follow-up duration or incomplete laboratory data that precluded adequate evaluation

Design outcomes

Primary

MeasureTime frameDescription
Incidence of neutropeniaFrom initiation of TNF-α inhibitor therapy to 12 months of treatmentIncidence of neutropenia in patients receiving TNF-α inhibitors

Secondary

MeasureTime frameDescription
Severity of neutropeniaFrom initiation of TNF-α inhibitor therapy to 12 months of treatmentClinically, neutropenia is stratified according to the ANC as mild (1000-1500/μL), moderate (500-1000/μL), or severe (\<500/μL).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026