Musculoskeletal/Rheumatology

This is the eighth biosimilar to reference the blockbuster rheumatoid arthritis drug Humira that will launch in 2023.

The acceptance of Biogen’s application follows regulator’s acceptance of an application by Fresenius Kabi for another Actemra biosimilar.

OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first PBM to make public its plans for the seven Humira biosimilars that could be introduced in 2023.

Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.

Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.

The FDA approved a supplemental BLA for use of Krystexxa with methotrexate for the treatment of uncontrolled gout.

Riabni is now approved to treat all available Rituxan indications.

The FDA needs more time to assess information submitted by the company.

The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.

Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.

For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.

Patients with inflammatory rheumatic disease may need 2 doses of adjuvanted split influenza A vaccine to elicit the same antibody response as healthy individuals, reported a recent Swiss study published in Arthritis & Rheumatism.

An analysis of data from more than 90,000 Medicare managed care enrollees who received care for rheumatoid arthritis found that more than one-third did not receive the recommended treatment with a disease-modifying antirheumatic drug, and that receipt varied by demographic factors, socioeconomic status, geographic location, and health plan, according to a study in JAMA.

Patients with rheumatoid arthritis who are seen by a rheumatologist within 12 weeks of symptom onset were likely to experience less joint destruction and have a higher chance of achieving disease modifying anti-rheumatic drug-free remission, according to a new study published December 2010 in Arthritis & Rheumatism.

Researchers from the Cincinnati Children's Hospital Medical Center have demonstrated that the tumor necrosis factor-alpha inhibitor etanercept is associated with significant increases in height, weight, and body mass index in children with juvenile idiopathic arthritis, according to a study recently published in Arthritis & Rheumatism.

A newly approved drug, denosumab (Xgeva, Amgen), delays skeletal-related side effects for 5 months longer compared to zoledronic acid (Zometa and Reclast, Novartis) in patients with breast cancer and bone metastases, according to phase 3 trial results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

New indication: Zoledronic acid (Reclast), a bisphosphonate, was approved on May 29, 2009, for the prevention of osteoporosis in postmenopausal women

Centocor Ortho Biotech has issued a Dear Healthcare Professionals letter to remind healthcare providers that golimumab (Simponi), a tumor necrosis factor (TNF)-alpha blocker, is associated with a risk of serious fungal infections.

Osteoarthritis (OA) is the most common form of arthritis and the leading cause of disability in the United States, especially among older adults. This article reviews nonpharmacologic and pharmacologic approaches to management of OA of the knee and hip.

In a study published in the Journal of the American Medical Association, investigators demonstrated an association between treatment with the anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies (mAbs) adalimumab and infliximab and risk of herpes zoster events in patients with rheumatoid arthritis (RA).

In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.

The Long-Term Intervention on Fractures with Tibolone (LIFT) study demonstrated a reduced risk of vertebral fracture, breast cancer, and possibly colon cancer but a significantly increased risk of stroke in older postmenopausal women treated with tibolone versus those treated with placebo.

The first phase of a double-blind, randomized, parallel-group, multicenter, outpatient study demonstrated that treatment with the combination of etanercept and methotrexate was more effective in inducing both clinical remission and radiographic nonprogression than methotrexate alone in patients with early moderate-to-severe rheumatoid arthritis (RA).

Tocilizumab, an investigational agent for the treatment of moderate-to-severe rheumatoid arthritis, is a humanized anti-IL-6 receptor monoclonal antibody. Because tocilizumab contains a mouse monoclonal antibody grafted onto human immunoglobulin, the grafted antibody is less antigenic and has a longer half-life than the mouse antibody. When administered, tocilizumab inhibits IL-6 activity by competing for both the membrane-bound and soluble types of IL-6 receptors, thus eliminating IL-6 transduction into the cell.

Drugs in development for the treatment of adult and juvenile rheumatoid arthritis

Treatment options for osteoporosis include calcium, vitamin D, estrogen plus progesterone, calcitonin, and bisphosphonates.

The use of biologic treatment for rheumatoid arthritis (RA) is associated with an increased risk of nonmelanotic skin cancer and melanoma, according to a large observational study published that included 13,001 patients.

A summary of agents in late-stage development for the prevention and/or treatment of osteoporosis.

In 2 prospective cohort studies published in the Archives of Internal Medicine, researchers demonstrated that selective serotonin-reuptake inhibitor (SSRI) use, but not the use of other common antidepressants, was associated with a significant decrease in total hip and lumbar spine bone mineral density (BMD) among older patients compared with nonuse of antidepressants.

In a large cohort study, it was demonstrated that the use of intravenous (IV) bisphosphonates was associated with an increased risk of inflammatory conditions or osteomyelitis of the jaw and the need for jaw or facial bone surgery.