News & Trends

01/02/2019

FDA Approves New Biosimilar

The FDA recently approved adalimumab-adaz (Hyrimoz), a biosimilar of adalimumab (Humira), for the treatment of patients with psoriatic arthritis and plaque psoriasis. Adalimumab-adaz is also indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. 

Approval was based on analytical, preclinical, and clinical data that demonstrated adalimumab-adaz matched the reference biologic in safety, efficacy, and quality. The pharmacokinetics, immunogenicity, and safety of adalimumab-adaz was confirmed in a randomized, double-blind, 3-arm biosimilarity study. In addition, a confirmatory efficacy and safety biosimilarity study showed therapeutic equivalence among patients with moderate to severe chronic plaque psoriasis.

melanoma

Melanoma Death Rate Among Men Increasing

More men are dying from melanoma compared with women, according to a recent study. Findings from the study, which highlighted trends in global melanoma deaths, were presented at the 2018 National Cancer Research Institute Cancer Conference in Glasgow, United Kingdom. 

In the study, the researchers used the World Health Organization’s mortality database to identify deaths from melanoma. A total of 33 countries with reliable data were included in the final analysis, and age-standardized death rates were calculated.

The 3-year average age-standardized death rates for 2013 through 2015 were highest in Australia (5.72 per 100,000 in men and 2.53 per 100,000 in women) and Slovenia (3.86 per 100,000 in men and 2.58 per 100,000 in women), but lowest in Japan (0.24 per 100,000 in men and 0.18 per 100,000 in women).

Overall, the melanoma mortality rate was greater among men compared with women. All countries showed increased melanoma mortality rates among men, aside from the Czech Republic, which showed a single decreasing trend in mortality. Conversely, the majority of countries showed decreases or stabilizing trends in melanoma mortality among women. The greatest decreases were observed in Israel (−23.4%) and the Czech Republic (−15.5%).

“There is a persisting global sex disparity in melanoma mortality over the past 30 years. In some regions, this is due either to greater increases in mortality rates in males compared to females, or to decreasing or stabilizing mortality trends in females not paralleled in males,” the researchers concluded. “Future work will explore potential explanatory factors for the observed trends and sex disparity in melanoma mortality.” 

Reference

Yang D, Salciccioli J, Marshall D, Shalhoub J. Trends in mortality from malignant melanoma: an observational study of the World Health Organization mortality database from 1985 to 2015. Presented at: 2018 National Cancer Research Institute Cancer Conference; November 4-6, 2018; Glasgow, United Kingdow.

Antibiotic Resistance High Among HS Patients

A recent study found high levels of antibiotic resistance among bacterial growths collected from patients with hidradenitis suppurativa (HS). This included resistance to rifampicin, clindamycin, and tetracyclines, which are cited as an empiric choice in HS therapeutic guidelines, the researchers said.

In the study, the researchers collected purulent material from 137 skin lesions of patients with HS, including samples from the axillae, groin, and perianal areas. They assessed bacterial floral and antibiotic sensitivity using microbiological cultures for aerobic and anaerobic bacteria. The primary outcome included the prevalence of antibiotic resistant bacterial growths.

Overall, 114 samples tested positive for bacteria and a total of 163 single bacterial growths were observed. Of these growths, 55% were gram-positive, 44% were gram-negative, and 18.5% were anaerobic. 

The most frequent bacterial families the researchers observed included Enterobacteriaceae (30.7%), staphylococcus (25.2%), and streptococcus (14.1%), and the most frequent genus were Proteus spp (13.5%) and Escherichia coli (9.8%).

In addition, the prevalence of antibiotic resistance observed was clindamycin 65.7%, rifampicin 69.3%, penicillin 70.0%, ciprofloxacin 74%, tetracycline 84.7% and erythromycin 89.0%. One limitation of the study, the researchers noted, was the short cultural period that could have impaired the isolation of anaerobic bacteria.

“A targeted and specific antibiotic therapy, driven by microbiological evaluations with prolonged culture periods, seems more appropriate than empiric, generic, non-specific, therapeutic approaches,” the researchers concluded. “Current knowledge regarding HS bacterial antibiotic resistance should be considered in the update of current therapeutic guidelines for HS.” 

Reference

Bettoli V, Manfredini M, Massoli L, et al. Rates of antibiotic resistance/sensitivity in bacterial cultures of hidradenitis suppurativa patients [published online November 5, 2018]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.15332