Anemia in Systemic Lupus Erythematosus Specially Refractory Type

June 5, 2024 updated by: Shymaa Saber, Assiut University

What is Behind Anemia in Systemic Lupus Erythematosus With Special Reference to Referactory Anemia

Systemic lupus erythroematosis (SLE) is a systemic autoimmune disease with multisystemic involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Several immunopathogenic pathways play a role in the development of SLE. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risks in patients[1].

Haematological abnormalities are common in systemic lupus erythroematosis. Anemia is found in about 50% of patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Causes of anemia in SLE:

Anemia due to chronic disease is the most frequent in patients with SLE, representing approximately one-third of the cases [2].

Iron deficiency anemia is also a common cause, usually caused by blood loss (menorrhagia or gastrointestinal bleeding) [3].

Autoimmune hemolytic anemia (AIHA) a classification criteria for SLE [4]. The mechanism is thought to be caused by the destruction of red blood cells through warm or cold antibodies [5]. Patients with AIHA may present with symptoms of anemia or hemolysis or symptoms of an underlying disorder. Severe hemolysis may lead to hepatosplenomegaly, hemoglobinuria, and signs of heart failure [6]. Maanaging patients with AIHA may be challenging because specific therapy should be individualized in accordance with the disease manifestations and its severity [7].

Hemopoietic failure is the suspected to be the result of an immunologically damaged bone marrow (BM) .

Overall, hypocellularity, morphological dysplasia, increased fibrosis, and BM necrosis were common findings in patients with SLE with hemocytopenias, suggesting a primary BM involvement in pathogenesis of the disease, probably mediated by auto-antibodies, immune complexes, and immunopotent T cells [8, 9].

Solid proof of the participation of humoral immune mechanisms in hemopoietic dysfunction was obtained from patients with SLE with aplastic anemia, a BM failure syndrome of a definite immune pathogenesis [10-12].

In these cases, complement dependent or independent autoantibodies were found to suppress erythroid and granulocytic colony formation of BM progenitor cells [10-12].

Targeted by autoantibodies, the progenitor BM cells lead to various syndromes of hemopoietic failure, such as aplastic anaemia, hypoplasia of myeloid line, amegakaryocytic thrombocytopenia, and the extremely rare pure red cell aplasia (PRCA) [13-19].

The presence of the inhibitory autoantibody is typically related to SLE activity and can be suppressed by successful treatment-that is, by immunosuppression. However, PRCA can occur in the absence of disease activity or even precede the appearance of SLE [15].

In our study we will search for the most common causes of anemia in SLE in our environment ,focusing on the most common causes of refractory anemia in SLE.

Study Type

Observational

Enrollment (Estimated)

67

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient diagnosed as systemic lupus erythematosus with anemia aged more than 18 year old

Description

Inclusion Criteria:

  • -Adult patients (≥18 years) satisfying 2019 EULAR/ACR classification for systemic lupus erythroematosis[24].
  • Patients satisfying WHO criteria definition of anemia.

Exclusion Criteria:

  • Mixed connective tissue disorders.
  • Pregnancy .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anemia and Systemic lupus erythematosus
Systemic lupus patients with anemia and searching for causes of anemia and what is the most common and what are the causes of refractory anemia and relation of bone marrow affection
Combination product: Laboratory investigtions
To study causes of anemia in SLE in our environment and causes of refractory type and its relation to bone marrow affection and different drugs used in SLE
Other Names:
  • Bone marrow study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Causes of anemia
Time Frame: One week
Assess causes of anemia in SLE and which of them is most common in our locality
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 9, 2024

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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