Using Rituximab to treat pulmonary arterial hypertension in lupus patients

Efficacy and Mechanism of Anti-CD20 Antibodies in Systemic Lupus Erythematosus Associated Pulmonary Arterial Hypertension Based on Multi Omics Studies

This study is testing if Rituximab can help improve the condition of lupus patients who have pulmonary arterial hypertension while they are on standard treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (Academic / other)
• Drugs / interventions: tocilizumab, infliximab, Rituximab, prednisone
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05828147 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of Rituximab on disease progression in patients with systemic lupus erythematosus-associated pulmonary arterial hypertension (SLE-PAH) who are receiving standard medical therapy. It is a prospective, single-arm, single-center study that will assess clinical responses and safety measures over time. Participants will receive two intravenous infusions of Rituximab, and the study will also investigate biomarkers related to treatment efficacy and autoantibody responses. The trial aims to provide insights into the safety and effectiveness of Rituximab in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of SLE-PAH and specific pulmonary pressure measurements.

Not a fit: Patients currently receiving immunocompromising biologic agents or those with other severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease management and outcomes for patients with SLE-PAH.

How similar studies have performed: While the use of Rituximab in other autoimmune conditions has shown promise, this specific application in SLE-PAH is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 1. Subject has provided written informed consent.
* 2. Subject must be between the ages of 18 and 65, inclusive at the time of recruitment
* 3. Clinical diagnosis of systemic lupus erythematosus. Diagnosis of SLE-PAH within the past 5 years, with a mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg, PAWP ≤15mmHg, mean PVR of \> 3 Wood units at entry.
* 4. WHO Functional Class II, III, or IV.
* 5. Subjects must have been treated with background medical therapy for PAH (prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators) for a minimum of 8 weeks and have been on stable dose(s) of those medical therapy(ies) for at least 4 weeks prior to randomization with no expectation of change for 24 weeks after randomization.

Exclusion Criteria:

* 1. Treatment with immunocompromising biologic agents (including, but not limited to TNF inhibitors, anakinra, abatacept, and tocilizumab) within 4 weeks prior to treatment initiation or treatment with infliximab within 8 weeks prior to treatment initiation.
* 2. SLE combined with important organ damage endangers life:

  1. Neuropsychiatric lupus with high risk such as status epilepticus;
  2. Refractory thrombocytopenic purpura has a clear bleeding tendency;
  3. Pulmonary alveolar hemorrhage leads to respiratory failure;
* 3. Uncontrolled infection;
* 4. Severe organ dysfunction:

  1. Patients with moderate or severe liver function impairment (Child-Pugh grade B and C);
  2. Patients with left ventricular dysfunction (left ventricular ejection fraction\<45%);
* 5. Other diseases are limited to completing a 6-minute walking test: angina pectoris, vascular, musculoskeletal lesions, etc
* 6. Abnormal laboratory test: platelet\<100 × 109/L, or hemoglobin\<9 g/dL, or white blood cell count\<3 × 109/L, or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal value, or total bilirubin and blood lipids greater than 2 times the upper limit of normal value
* 7. Persistent hypotension, i.e. systolic blood pressure (SBP)\<90 mmHg
* 8. PAH caused by any reason other than SLE: other rheumatic diseases (such as SSc, rheumatoid arthritis, dermatomyositis, etc.); Portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and poisons;
* 9. Chronic hypoxic disease related pulmonary hypertension: moderate or severe obstructive pulmonary disease: FEV1\<55%; Moderate or severe restrictive pulmonary disease: TLC\<60%;
* 10. Chronic thromboembolic pulmonary hypertension: Pulmonary ventilation/perfusion imaging indicates moderate to high suspicion of pulmonary thromboembolism;
* 11. Existing infections or uncontrollable infections that require antibiotic or antiviral treatment;
* 12. Women who are breastfeeding or pregnant or who plan to become pregnant during the study;
* 13. History of malignant tumors in the past 5 years
* 14. Mental, addictive, or other illnesses that restrict patients from providing informed consent or complying with research requirements;
* 15. Any condition or treatment that the investigator believes puts the subject at an unacceptable risk as a test participant.

Where this trial is running

Beijing, Beijing

• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Mengtao Li, Prof — Peking Union Medical College Hospital
• Study coordinator: Mengtao Li, Prof

Conditions Systemic Lupus Erythematosus; Pulmonary Arterial Hypertension; anti-CD20 antibodies; multi-omics