Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2021 Jul 15;204(2):123-125.
doi: 10.1164/rccm.202103-0612ED.

A Phase-2 NIH-sponsored Randomized Clinical Trial of Rituximab in Scleroderma-associated Pulmonary Arterial Hypertension Did Not Reach Significance for Its Endpoints: End of Story? Not So Fast!

Affiliations
Editorial

A Phase-2 NIH-sponsored Randomized Clinical Trial of Rituximab in Scleroderma-associated Pulmonary Arterial Hypertension Did Not Reach Significance for Its Endpoints: End of Story? Not So Fast!

Yongneng Zhang et al. Am J Respir Crit Care Med. .
No abstract available

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
(A) Data sent to us by the authors show that patients with the proposed biomarker (low levels of RF, IL2, and IL17) have a remarkable improvement in both the 6MWD and PVR at 24 weeks in response to rituximab, whereas patients with the biomarker on placebo had a significant worsening in both the 6MWD and PVR. (B) A hypothetical schematic on how some patients with SSC-PAH can have an increased proportion of activated autoimmune B-cell lineages because of genetic mutations in BMP signaling (or perhaps other pathways) and how these lineages can be depleted by rituximab. 6MWD = 6-minute-walk distance; BMP = bone morphogenetic protein; PVR = pulmonary vascular resistance; RF = rheumatoid factor; SSC-PAH = scleroderma-associated pulmonary arterial hypertension.

Comment on

References

    1. Zamanian RT, Badesch D, Chung L, Domsic RT, Medsger T, Pinckney A, et al. NIH ASC01 Study Group Safety and efficacy of B-cell depletion with rituximab for the treatment of systemic sclerosis–associated pulmonary arterial hypertension: a multicenter, double-blind, randomized, placebo-controlled trial Am J Respir Crit Care Med 2021204209–221 - PMC - PubMed
    1. Bodenheimer T. Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med . 2000;342:1539–1544. - PubMed
    1. Coyle SL. Ethics and Human Rights Committee, American College of Physicians–American Society of Internal Medicine. Physician-industry relations: part 1. Individual physicians. Ann Intern Med . 2002;136:396–402. - PubMed
    1. Grady C. Payment of clinical research subjects. J Clin Invest . 2005;115:1681–1687. - PMC - PubMed
    1. Chopra SS. MSJAMA: industry funding of clinical trials: benefit or bias? JAMA . 2003;290:113–114. - PubMed

MeSH terms