TOCILIZUMAB

First drug approval for giant cell arteritis

After expedited development and review, tocilizumab (Actemra) has been FDA-approved to treat adults with giant cell arteritis (GCA), a type of vasculitis affecting cranial branches of the external and internal carotid artery, particularly the temporal and ophthalmic arteries. High doses of corticosteroids such as prednisone tapered over time is the standard treatment.

Administered subcutaneously to treat GCA, tocilizumab is an interleukin-6 (IL-6) receptor antagonist. In a double-blind, placebo-controlled study, more patients taking subcutaneous tocilizumab plus a standardized prednisone regimen achieved sustained remissions compared with those taking placebo with the prednisone regimen. Patients in the first group also received lower cumulative doses of prednisone.

Tocilizumab was previously approved to treat certain patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. It carries a boxed warning about the risk of serious infections during treatment.

For more about GCA, see "On Alert for Giant Cell Arteritis" in the June issue of Nursing2017.

Sources: Food & Drug Administration. FDA approves first drug to specifically treat giant cell arteritis. News release. May 22, 2017. Actemra (tocilizumab). Prescribing information.

HAIR-RAISING EXPERIENCES

Women may pay more for minoxidil than men

Approved to treat androgenetic alopecia, minoxidil is a topical drug marketed and sold over the counter to both men and women. The drug is available in several forms: a 5% solution for men, a 2% solution for women (both applied twice daily), and a 5% foam to be used twice a day for men and once a day for women. To investigate possible gender-based price differences, researchers collected 41 minoxidil products from six of the largest chain pharmacies in four states. For each product they collected data on retailer, brand, vehicle, price (excluding sales price), percentage of minoxidil, volume, application directions, gender specification, and inactive ingredients.

Comparing cost, they found that the price per 30 mL of 2% "regular strength" solution for women cost about the same as 30 mL of 5% "extra strength" solution marketed for men (on average, $7.61 for women versus $7.63 for men). For 5% foam products with identical matched ingredients, they found a 40% mean increase in cost of the product sold to women compared with the product sold to men ($11.27 versus $8.05).

Differences in inactive ingredients may explain why the 2% solution for women costs the same as the more potent 5% solution for men. But the ingredients in the foam products are identical, the researchers say.

Currently the foam product is available only under the brand name Rogaine. A spokesperson for the manufacturer notes that foam products for men and women are identically priced on the company website but that individual retailers set their own prices.

Sources: Wehner MR, Nead KT, Lipoff JB. Association between gender and drug cost for over-the-counter minoxidil. JAMA Dermatol. [e-pub June 7, 2017.] Seaman AM. Women may pay more than men for hair loss treatment. Reuters Health. June 9, 2017.

ANTICOAGULANTS

Inconsistent dosing patterns scrutinized

In a study, researchers investigated dosing patterns for non-vitamin K antagonist oral anticoagulants (NOACs) prescribed to prevent thromboembolism in patients with atrial fibrillation (AF), and analyzed the association of dosing patterns with ischemic stroke, systemic embolism, and major bleeding. Involving 14,865 patients with AF treated with apixaban, dabigatran, or rivaroxaban between October 1, 2010, and September 30, 2015, the study examined "use of a standard dose in patients with a renal indication for dose reduction (potential overdosing) and use of a reduced dose when the renal indication is not present (potential underdosing)." Findings included the following:

* Among 1,473 patients with a renal indication for dose reduction, 43.0% were potentially overdosed, which was associated with a higher risk of major bleeding but no statistically significant difference in stroke.

* Among 13,392 patients with no renal indication for dose reduction, 13.3% were potentially underdosed, which was associated with a higher risk of stroke but no statistically significant difference in major bleeding in apixaban-treated patients. No statistically significant relationships were found in patients without a renal indication for dose reduction who were treated with dabigatran or rivaroxaban.

The researchers say that in clinical practice, prescribing patterns for NOACs are often inconsistent with the drugs' labeling. They concluded, "These prescribing patterns may be associated with worse safety with no benefit in effectiveness in patients with severe kidney disease and worse effectiveness with no benefit in safety in apixaban-treated patients with normal or mildly impaired renal function."

Source: Yao X, Shah ND, Sangaralingham LR, Gersh BJ, Noseworthy PA. Non-vitamin K antagonist oral anticoagulant dosing in patients with atrial fibrillation and renal dysfunction. J Am Coll Cardiol. 2017;69(23):2779-2790.

HIV THERAPY

Patients sticking with the regimen 50% longer

When treated with ongoing antiretroviral therapy (ART), HIV infection is a manageable chronic disease-if patients persist with ART as prescribed. However, for various reasons, many patients discontinue ART after a short period. A large national study of Medicaid patients in treatment for HIV infection reveals an encouraging trend: The median duration of persistence with HIV ART increased by more than 50% from 2001 to 2010.

The study looked at data on 43,598 patients in 14 states over a decade. In 2001-2003, about half of patients stopped ART within 24 months after starting it. By 2004-2006, the duration of persistence rose to 35.4 months. For those starting ART in 2007-2010, more than half of patients were still on therapy when the study ended.

For patients with HIV, adhering to the treatment regimen is especially important, notes study coauthor Ira B. Wilson. Besides preserving the patient's health, treatment adherence reduces the risk that HIV will be transmitted to others or develop resistance to available drugs.

"This represents a lot of people who are not dying and not infecting others," Dr. Wilson comments. "These differences represent tremendous, very real benefit."

Sources: Youn B, Shireman TI, Le Y, et al. Ten-year trends in anti-retroviral therapy persistence among U.S. Medicaid beneficiaries, 2001-2010. AIDS. [e-pub May 16, 2017.] HIV patients sticking with therapy longer, Medicaid data show. Brown University. News release. May 26, 2017.