Skip to main content
Journal cover image

Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial.

Publication ,  Journal Article
St Clair, EW; Baer, AN; Wei, C; Noaiseh, G; Parke, A; Coca, A; Utset, TO; Genovese, MC; Wallace, DJ; McNamara, J; Boyle, K; Keyes-Elstein, L ...
Published in: Arthritis Rheumatol
September 2018

OBJECTIVE: To evaluate the clinical efficacy and safety of baminercept, a lymphotoxin β receptor IgG fusion protein (LTβR-Ig), for the treatment of primary Sjögren's syndrome (SS), and to explore the possible mechanisms of action of this treatment. METHODS: In this multicenter trial, 52 patients with primary SS were randomized in a 2:1 ratio to receive subcutaneous injections of 100 mg of baminercept every week for 24 weeks or matching placebo. The primary end point was the change between screening and week 24 in the stimulated whole salivary flow (SWSF) rate. Secondary end points included the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), as well as measurements of select chemokines and cytokines and enumeration of peripheral blood B and T cell subsets. RESULTS: The change from baseline to week 24 in the SWSF rate was not significantly different between the baminercept and placebo treatment groups (baseline-adjusted mean change -0.01 versus 0.07 ml/minute; P = 0.332). The change in the ESSDAI during treatment was also not significantly different between the treatment groups (baseline-adjusted mean change -1.23 versus -0.15; P = 0.104). Although the incidence of adverse events was similar between the treatment groups, baminercept therapy was associated with a higher incidence of liver toxicity, including 2 serious adverse events. Baminercept also produced a significant decrease in plasma levels of CXCL13 and significant changes in the number of circulating B and T cells, consistent with its known inhibitory effects on LTβR signaling. CONCLUSION: In this trial, treatment with baminercept failed to significantly improve glandular and extraglandular disease in patients with primary SS, despite evidence from mechanistic studies showing that it blocks LTβR signaling.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Arthritis Rheumatol

DOI

EISSN

2326-5205

Publication Date

September 2018

Volume

70

Issue

9

Start / End Page

1470 / 1480

Location

United States

Related Subject Headings

  • Treatment Outcome
  • T-Lymphocytes
  • Sjogren's Syndrome
  • Recombinant Fusion Proteins
  • Middle Aged
  • Male
  • Lymphotoxin beta Receptor
  • Humans
  • Female
  • Double-Blind Method
 

Citation

APA
Chicago
ICMJE
MLA
NLM
St Clair, E. W., Baer, A. N., Wei, C., Noaiseh, G., Parke, A., Coca, A., … Autoimmunity Centers of Excellence, . (2018). Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol, 70(9), 1470–1480. https://doi.org/10.1002/art.40513
St Clair, E William, Alan N. Baer, Chungwen Wei, Ghaith Noaiseh, Anne Parke, Andreea Coca, Tammy O. Utset, et al. “Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial.Arthritis Rheumatol 70, no. 9 (September 2018): 1470–80. https://doi.org/10.1002/art.40513.
St Clair, E. William, et al. “Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial.Arthritis Rheumatol, vol. 70, no. 9, Sept. 2018, pp. 1470–80. Pubmed, doi:10.1002/art.40513.
St Clair EW, Baer AN, Wei C, Noaiseh G, Parke A, Coca A, Utset TO, Genovese MC, Wallace DJ, McNamara J, Boyle K, Keyes-Elstein L, Browning JL, Franchimont N, Smith K, Guthridge JM, Sanz I, James JA, Autoimmunity Centers of Excellence. Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2018 Sep;70(9):1470–1480.
Journal cover image

Published In

Arthritis Rheumatol

DOI

EISSN

2326-5205

Publication Date

September 2018

Volume

70

Issue

9

Start / End Page

1470 / 1480

Location

United States

Related Subject Headings

  • Treatment Outcome
  • T-Lymphocytes
  • Sjogren's Syndrome
  • Recombinant Fusion Proteins
  • Middle Aged
  • Male
  • Lymphotoxin beta Receptor
  • Humans
  • Female
  • Double-Blind Method