Results from a proof-of-concept study presented Monday during Plenary Session II suggest that CFZ533, a blocking, non-depleting anti-CD40 antibody, may offer a new treatment modality in clinically active primary Sjögren’s syndrome (pSS).
Benjamin Fisher, MD, Senior Lecturer in Clinical Rheumatology at the University of Birmingham, UK, said the phase IIa double-blind, placebo-controlled randomized trial found that 10 mg/kg intravenous doses of CFZ533 administered for up to 24 weeks was safe and well tolerated in pSS patients.
“Importantly, there was no major signal to suggest increased risk of infection, and there were no thromboembolic events,” he said. “We saw clear statistically significant improvement in the ESSDAI score, which exceeded the proof-of-concept criteria and also in the Physician’s Global.”
Additionally, trends in most secondary endpoints also favored treatment with CFZ533, he said, and the ESSDAI changes were sustained in the open label period. Improvement in the placebo group was also observed in the open label period when they were switched to CFZ533.
“Importantly, there were significant decreases in CXCL13 which followed the same pattern as the ESSDAI score,” he said.
A study looking at the incidence of serious infection in infants born to women with rheumatoid arthritis who were treated with a biologic medicine during pregnancy found no evidence of increased risk.
“Overall, we think these findings add to the data in the literature to address this question and are reassuring for pregnant women who require treatment with biologics in late pregnancy,” said Christina D. Chambers, PhD, MPH, Professor at the University of California, San Diego.
A researcher from New York University presented findings showing systemic lupus erythematosus patients had an overall 5-fold greater representation of a particular species in the Lachnospiracaea family in their intestinal microbiome.
Gregg Silverman, MD, Professor in the Department of Medicine at New York University, said these findings suggest a novel paradigm for the pathogenesis of lupus nephritis in which specific strains of common intestinal commensal bacteria contribute to the immune-complex mediated disease process responsible for glomerulonephritis.
“We think there is a gut microbiome product of microbe that produces an immune mimic of DNA that is really integral to lupus nephritis pathogenesis,” said Dr. Silverman. “Now we need prospective studies of inception cohorts to understand how this may play a role both in the transition between preclinical autoimmunity and overt clinical nephritis. Could this be used as a prognostic marker to identify patients that will have worse outcomes? Additionally, our findings open the door for studies of supervised modulation of the gut microbiome.”
Robert B.M. Landewé, MD, PhD, Professor of Rheumatology at the University of Amsterdam, shared results from a study looking at the effect of discontinuing adalimumab in patients with non-radiographic non-axial spondyloarthritis (nr-axSpA) in sustained remission.
Continued therapy was associated with significantly more patients maintaining remission and lower disease activity than treatment withdrawal, he said, with a relative risk of flare with treatment withdrawal of 1.77.
“Importantly, among patients who initially responded to therapy, a substantial number who flared with treatment withdrawal did not regain a state of inactive disease after retreatment with adalimumab,” said Dr. Landewé, while noting it would be important to identify predictors for the nr-axSpA population in whom it may be safely discontinued.
Chinese researchers analyzed the risk of disease progression in knee osteoarthritis due to intra-articular injection of corticosteroids (IAIC). Using data from the Osteoarthritis Initiative, their findings, presented by Jie Wei, MD, of Xiangya Hospital, Central South University, Changsha, China, were consistent with recent randomized clinical trial results that knees with IAIC experienced higher risk of knee radiographic osteoarthritis progression than those without IAIC in a real-life setting.
The final presentation provided insights from a nationwide study of end-stage renal disease (ESRD) due to granulomatosis with polyangiitis.
Zachary Wallace, MD, of Massachusetts General Hospital, said findings indicated that renal transplantation in this cohort of patients with ESRD on the transplant waitlist was associated with a significantly reduced risk of death compared to remaining on the waitlist, largely driven by a reduction in cardiovascular death. He said that the findings highlight the importance of identifying barriers to transplantation in this patient population and evaluating management strategies to reduce the risk of CVD and infection in patients on the waitlist to improve survival.