Chia-Yu Huang, from Taichung Tzu Chi Hospital in Taiwan, and colleagues conducted a propensity score-matched cohort study involving 23,226 patients with newly diagnosed RA between January 1, 1997, and December 31, 2010. The acupuncture cohort included patients who were administered acupuncture therapy from the initial date of RA diagnosis to December 31, 2010; the no-acupuncture cohort included patients who did not receive acupuncture during the same time interval.

The researchers found that the cumulative incidence of ischemic stroke was lower in the acupuncture cohort. At the end of the study, 341 and 605 patients in the acupuncture and no-acupuncture groups, respectively, experienced ischemic stroke (5.95 and 12.4 per 1,000 person-years, respectively; adjusted subhazard ratio, 0.57). The reduction in incidence of ischemic stroke was independent of sex, age, types of drugs used, and comorbidities.

“Our study demonstrates that the ischemic stroke risk could be reduced by acupuncture treatment in patients with RA in Taiwan,” the authors write. “The possible mechanism may involve reducing proinflammatory cytokines through acupuncture therapy, thereby attenuating cardiovascular disease, including ischemic stroke.”

Abstract/Full Text

Adalimumab-adbm injection, a biosimilar to Humira^® (adalimumab), has been made available by Boehringer Ingelheim.

Adalimumab-adbm injection is an interchangeable biosimilar and can be substituted for the reference product without requiring a prescription change. The substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs. According to the Company, Adalimumab-adbm injection has been priced at an 81% discount to Humira.  

Adalimumab-adbm injection is indicated for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis, moderate to severe hidradenitis suppurativa, and noninfectious intermediate, posterior, and panuveitis.

The product is also approved to treat moderately to severely active Crohn disease in children 6 years of age and older, as well as moderately to severely active polyarticular juvenile idiopathic arthritis in children 2 years of age and older.

Adalimumab-adbm injection is a citrate-free formulation and is supplied as 40mg/0.8mL, 20mg/0.4mL and 10mg/0.2mL prefilled syringes and as a 40mg/0.8mL prefilled autoinjector.

In July 2023, Boehringer Ingelheim launched a branded version of adalimumab-adbm called Cyltezo^®. This product will remain available at a 5% discount to Humira.

“Biosimilars are intended to contribute to the economic sustainability of health care systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.

Amjevita (adalimumab-atto), a citrate-free biosimilar to Humira^® (adalimumab), is now available in the US.

Amjevita, a tumor necrosis factor (TNF) blocker, is indicated for:

• Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.
• Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
• Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA; may be used alone or with non-biologic DMARDs.
• Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
• Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.
• Ulcerative colitis (UC): moderately to severely active UC in adult patients.
• Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

The Food and Drug Administration (FDA) approved Amjevita in September 2016 based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents. Amjevita is not interchangeable with Humira. 

Amjevita is supplied in a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and in 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes. 

References

1. Amjevita (adalimumab-atto), first biosimilar to Humira^®, now available in the United States. News release. Amgen. Accessed January 31, 2023. https://www.prnewswire.com/news-releases/amjevita-adalimumab-atto-first-biosimilar-to-humira-now-available-in-the-united-states-301734177.html.
2. Amjevita. Package insert. Amgen; 2022. Accessed January 31, 2022. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Amjevita/amjevita_pi_hcp_english.pdf.

Antirheumatic Indications: NSAIDs

Arnicare Arthritis Cream is now available over-the-counter (OTC) for the temporary relief of minor joint pain, muscle pain, and stiffness due to arthritis for individuals aged 12 years and older.

The cream is part of Boiron’s Arnicare product line, which also includes oral pellets and tablets, as well as arthritis tablets. Arnicare Arthritis Cream contains Arnica montana and Harpagophytum (devil’s claw). These homeopathic agents are expected to improve muscle pain and stiffness. The fragrance-free formulation does not contain ingredients that may irritate the skin such as camphor and menthol.

Arnicare Arthritis Cream is supplied in a 2.5oz tube and retails for $17.99.

“We are excited to bring Arnicare Arthritis Cream to the market as an affordable and alternative pain relief option for the millions of Americans living with arthritis,” said Ron Gentry, vice president of Marketing, Boiron USA. “Harpagophytum has demonstrated its versatility and utility in the joint supplement space, and our homeopathic medicine now brings this ingredient to the OTC world.”

A recent review of articles published about devil’s claw found the medicinal plant to have both anti-inflammatory and analgesic properties, though the study’s authors note that additional clinical trials in humans would help close the gap on research regarding its efficacy and safety.

Products labeled as homeopathic medicines have not been evaluated by the Food and Drug Administration for safety and effectiveness.

Arthritis Treatments: NSAIDS

Cyltezo^® (adalimumab-adbm), an interchangeable biosimilar to Humira^® (adalimumab), will soon be available in a new autoinjector device, in addition to the prefilled syringe.

Cyltezo is a tumor necrosis factor (TNF) blocker approved for the following indications:

• Rheumatoid arthritis: To reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in adult patients with moderately to severely active rheumatoid arthritis; can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
• Juvenile idiopathic arthritis: To reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; can be used alone or in combination with methotrexate.
• Psoriatic arthritis: To reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in adult patients with active psoriatic arthritis; can be used alone or in combination with non-biologic DMARDs.
• Ankylosing spondylitis: To reduce signs and symptoms in adult patients with active ankylosing spondylitis.
• Crohn disease: Treatment of moderately to severely active Crohn disease in adults and pediatric patients 6 years of age and older.
• Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adult patients.
• Plaque psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate; should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
• Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurativa in adult patients.

The prefilled Cyltezo Pen 40mg/0.8mL will be available in 2-, 4- and 6-pack options on July 1, 2023. According to Boehringer Ingelheim, the pen was designed with patient-centered features to simplify the administration process.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.

Among Black patients with refractory hip or knee OA, lower rates of JRS have been reported among multiple studies. To explore the reasons for these lower rates, researchers in the United States conducted a systematic review to examine how differences in patient and cultural characteristics, outcomes after JRS, and structural barriers may affect patients’ decision making and JRS utilization rates.

The study population included Black patients with hip and/or knee OA and White patients with hip and/or knee OA as a comparator group. The primary outcome was differences in decision making regarding JRS. The review was conducted according to Preferred Reporting Items of Systematic reviews and Meta-Analyses guidelines.

A total of 96 studies were included in the analysis. Of these, 17 covered patient characteristics, 17 explored cultural characteristics, 55 reviewed joint replacement outcomes, and 35 analyzed structural barriers.

Black patients reported higher levels of pain catastrophizing and disability and lower levels of physical function compared with White patients. Additionally, Black patients had longer lengths of stay and reported more visits to the emergency department following both total knee arthroplasty (TKA) and total hip arthroplasty, compared with White patients.

Compared with White patients, Black patients received fewer outpatient surgeries, had a higher rate of discharge to postacute care facilities, and were at greater risk of requiring revision surgery after TKA.

According to certain analyses, the effect of race was mediated by socioeconomic status and comorbidities.

The study authors concluded, “While some of this difference can be explained by lower preference for JRS vs. other arthritis treatments among Black patients, there are significant structural, financial, provider, and patient factors that contribute to this difference. Some of these factors could be targeted for intervention to improve access to JRS for Black patients.”