Neutropenia With TNF-α Inhibitors

NCT07237906 | Completed

• 1 other identifier: IstanbulUC-BCetin-02
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenia; TNF-alpha Inhibitors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of neutropenia

  Incidence of neutropenia in patients receiving TNF-α inhibitors

  From initiation of TNF-α inhibitor therapy to 12 months of treatment

Secondary Outcomes (1)

• Severity of neutropenia

  From initiation of TNF-α inhibitor therapy to 12 months of treatment

Study Arms (1)

Patient Group

Patients receiving TNF-α inhibitor therapy for inflammatory arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory arthritis who were treated with TNF-α inhibitor therapy at the Physical Medicine and Rehabilitation Department of Istanbul University-Cerrahpasa, a tertiary care center in Istanbul, Turkey, between September 2023 and January 2025.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burak Ugur Cetin: lead

Study Sites (1)

Istanbul University - Cerrahpasa (IUC)

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neutropenia; Drug-Related Side Effects and Adverse Reactions; Arthritis

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Chemically-Induced Disorders; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)