Two Phase 3 trials have shown that epratuzumab did not meet its primary endpoints for treating SLE. Meanwhile, a Phase 3 study has shown adalimumab is effective for treating enthesitis-related arthritis in juveniles…
Biosimilar Drugs for RA Studied in Multiple Trials
Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…
Similar RA Outcomes with Abatacept & Tocilizumab
NEW YORK (Reuters Health)—Clinical outcomes of rheumatoid arthritis (RA) are similar with abatacept and tocilizumab treatment, but the factors that predict efficacy differ for the two agents. “The recommendations for RA treatment from the U.S. and EU describe the use of abatacept and tocilizumab as first-line biologics along with anti-TNF (anti-tumor necrosis factor) inhibitors,” Dr….
Brentuximab Vedotin Enters Phase 2 Trials & More
Phase 2 clinical trials have begun to assess the safety of brentuximab vedotin for the treatment of SLE. Also, the FDA is reviewing an application for a once-daily tofacitinib citrate tablet to treat RA…
Adalimumab Remains Safe, Effective for Psoriasis
NEW YORK (Reuters Health)—In adults with chronic plaque psoriasis, adalimumab (Humira, AbbVie) was generally well tolerated and effective during five years of therapy, according to a new analysis. The interim analysis is from ESPRIT, a 10-year multinational post-marketing registry. “Clinical trials are not the real world,” in part because patients with comorbidities are screened out…
Evidence Lacking for Tests for Psoriasis Patients Using Biologic Agents
NEW YORK (Reuters Health)—Various organizations recommend dozens of screening and monitoring tests for patients with psoriasis or psoriatic arthritis who are using systemic biologic agents, despite sparse evidence to support any of them. “At a population level, these medications have proven to be very safe and the evidence does not support such extensive and frequent…
Most Rheumatologists Want FDA to Better Regulate Biosimilars
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…
Certolizumab Pegol Effective for Treating Rheumatoid Arthritis
NEW YORK (Reuters Health)—Certolizumab pegol, a humanized anti-TNF antibody fragment conjugated to polyethylene glycol, is effective for treating early rheumatoid arthritis (RA) with poor prognostic factors, according to results from the C-OPERA study. Certolizumab is approved in the U.S. and other countries for treating inflammatory diseases, including RA, but its effectiveness in methotrexate-naïve early RA…
Tofacitinib Not Tied to More Malignancies in RA Patients
NEW YORK (Reuters Health)—The oral Janus kinase inhibitor tofacitinib (Xeljanz, Pfizer) does not increase the risk of malignancies, according to pooled data from more than 5000 rheumatoid arthritis (RA) patients. In an April 22 online paper in Annals of the Rheumatic Diseases, Dr. Lisy Wang of Pfizer, Groton, Connecticut, and colleagues noted that in RA…
Teriparatide to Denosumab Switch Helpful in Osteoporosis
NEW YORK (Reuters Health)—In postmenopausal osteoporotic women, changing from teriparatide to denosumab benefits bone mineral density (BMD) but switching from denosumab to teriparatide may result in bone loss, according to new research. In a July 3 online paper in The Lancet, Dr. Benjamin Z. Leder, of Massachusetts General Hospital, Boston, and colleagues noted that many…
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