EULAR 2014: Non-Tumor Necrosis Factor Biologics Update

Treatment was withdrawn after 12 months, and most patients discontinued because of an increase in disease activity. But those in the abatacept-plus-methotrexate groups were more than twice as likely as the methotrexate-alone group to have DAS28 scores of less than 2.6 at both months 12 and 18, researchers found.

A review of MRI scans found bigger improvements in synovitis, osteitis and erosion scores in the abatacept-plus-methotrexate group than methotrexate alone, said Charles Peterfy, MD, PhD, an imaging specialist with Florida-based Spire Sciences.

“AVERT is the first study to show sustained remission following the withdrawal of all RA therapy,” Dr. Emery said. “And it’s clear that those patients with a shorter duration and lower baseline disease activity and longer DAS remission—which is essentially a very early patient—were the ones more likely to sustain drug-free remission.”

Safety & Efficacy of Itolizumab

Researchers from India presented phase 2 data on the safety and efficacy of itolizumab, a first-in-class anti-CD6 antibody.

Seventy patients with active RA and inadequate response to methotrexate were randomized to receive one of three doses of itolizumab (0.2, 0.4 or 0.8 mg/kg) plus methotrexate or methotrexate alone. They were given 12 weeks of the treatment, followed by 12 weeks of methotrexate alone.

Dr. Chopra

Itolizumab patients had higher ACR20 response rates at Week 12 than those in the methotrexate group, and this difference in response was sustained at Week 24.

For every 100 infusions, there were 3.57 acute infusion reactions, with fever and cough the most common adverse events.

“These results provide strong preliminary evidence for the safety and efficacy of itolizumab in combination with methotrexate,” said Arvind Chopra, MD, of the Center for Rheumatic Diseases in Pune, India.

Infections from Rituximab

In another study, researchers examined whether taking rituximab, an anti-CD20 monoclonal antibody, increased the risk of serious infections in clinical practice.

Investigators used the British Society for Rheumatology Biologics Register, an ongoing national prospective register of RA patients started on a biologic therapy, said Lucia Silva, MD, clinical research fellow at the University of Manchester, United Kingdom.

Dr. Silva

They looked at patients who’d failed an anti-TNF and were then switched either to another anti-TNF or rituximab from 2001–2012. Patients were followed by physician visits and questionnaires.

Serious infections were those requiring intravenous antibiotics, hospitalization or both, and infections causing death.

Researchers found no difference in the risk of the infections. In the first year of follow-up after treatment was switched, 158 of 3,237 anti-TNF patients had at least one serious infection. And 47 of the 1,018 rituximab-treated patients had at least one.