Immunotherapeutic Vaccine Studied
Another provocative line of research was presented at the plenary session by Frédéric Houssiau, MD, PhD, head of the Rheumatology Department at Catholic University of Louvain, Brussels.2 Interferon alpha kinoid is an investigational heterocomplex of inactivated recombinant human interferon that can act as an immunotherapeutic vaccine—stimulating the body itself to produce antibodies.
In a 36-week, phase 2b randomized controlled trial in 185 patients with moderate to severe lupus disease activity, interferon alpha kinoid indeed neutralized interferon and was well tolerated, with fewer adverse effects than treatment alternatives, Dr. Houssiau reported. But the biologic and clinical primary endpoints were negative in this first clinical trial. Modified British Isles Lupus Assessment Group-Based Composite Lupus Assessment scores did not differ significantly between interferon alpha kinoid and placebo groups at Week 36. However, its significant steroid-sparing effects merit further evaluation in a phase 3 trial, he said.
Treatment Trials
Another plenary presenter, Maria E. Silk, PharmD, clinical research advisor with Eli Lilly & Co., reviewed research on baricitinib, a widely approved rheumatoid arthritis treatment that selectively inhibits Janus kinase, for patients with lupus. In a test of baricitinib in 2 and 4 mg daily doses, the latter was associated with significant clinical improvements vs. placebo.3
Tacrolimus and other, newer calcineurin inhibitors (CNIs), including voclosporin, have potential as treatment strategies for lupus nephritis (LN), which affects about half of adults with lupus. C.C. Mok, MD, chief of rheumatology in the Department of Medicine at Tuen Mun Hospital, Hong Kong, reviewed data on tacrolimus as an alternative to, and in combination with, conventional treatments mycophenolate mofetil, cyclophosphamide and glucocorticoids.4 The advantages of tacrolimus therapy include greater safety in pregnancy, with no effect on fertility, although it can provoke higher infection rates, chronic CNI nephropathy and long-term cardiovascular risks.
Y.K. Onno Teng, MD, PhD, a nephrologist at Leiden University Medical Center, The Netherlands, outlined recent therapies that target B cells, including treatment with rituximab followed by belimumab, in response to aberrant B cell repopulation in refractory lupus patients.5 These studies include the Lupus Nephritis Assessment with Rituximab (LUNAR) study, the Beat Lupus trial and BLISS-BELIEVE.6-8
Finally, the multi-center, multi-national Efficacy and Safety of Belimumab in Black Race Patients with Systemic Lupus Erythematosus (EMBRACE) study examined lupus in 448 patients self-identifying as black, who experience increased lupus prevalence, morbidity and mortality compared with other racial groups. Historically, black patients have been under-represented in large clinical trials of lupus.
The EMBRACE study, presented at the Congress by Jim Oates, MD, professor and director of the Division of Rheumatology and Immunology at Medical University of South Carolina, Charleston, did not meet its primary endpoints, although numerical trends were observed in favor of belimumab.9 These included a lower risk of experiencing severe flares and greater prednisone drug reductions.
