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Biologic Linked to Noninfectious Pneumonia

January 2019

Ustekinumab (Stelara) is associated with noninfectious pneumonia, according to the findings of a recent study.

In the study, the researchers searched post-marketing case reports reviewed by the FDA Adverse Event Reporting System and PubMed databases from September 25, 2009, through November 20, 2017. They identified 12 cases of new onset acute and subacute noninfectious pneumonia after the general marketing of ustekinumab (7 men and 5 women; median age 63 years). In addition, they assessed baseline and demographic information, reason for ustekinumab use, symptoms, time to onset, dose sequence, laboratory and diagnostic information, and clinical outcomes.

Of the 12 cases, 7 interstitial pneumonia (58%), 3 eosinophilic pneumonia (25%), 1 organizing pneumonia (8%), and 1 hypersensitivity pneumonitis (8%) were diagnosed.

Serious outcomes were reported with all 12 cases, including 7 hospitalizations (58%) and 1 respiratory failure that required mechanical ventilation (8%). However, no deaths were reported.

All cases were supportive of temporal association, the researchers noted. In 9 cases (75%), patients experienced pulmonary symptoms after 1 to 3 doses of ustekinumab. Seven cases (58%) of positive de-challenge were reported, including 1 case of positive re-challenge.

“The postmarketing cases suggest an association between noninfectious pneumonia and use of ustekinumab,” the researchers concluded. “These findings have led to the addition of a new warning for ustekinumab users regarding the risk of developing noninfectious pneumonia.”

Reference:

Brinker A, Cheng C, Chan V. Association of noninfectious pneumonia with ustekinumab use [published online December 12, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.4118

CAN A SIMPLIFIED EXAM CORRECTLY IDENTIFY SCABIES?

A simplified examination of the hands, feet, and legs could diagnosis approximately 90% of scabies cases, according to the findings of a recent study.

“With the recent recognition of scabies as a neglected tropical disease by the World Health Organization, there is a need for standardized approaches to disease mapping to define populations likely to benefit from intervention, and to measure the impact of interventions,” the researchers wrote. Currently, full body examinations are used to diagnose scabies, but these can be time-consuming and intrusive.

In their study, the researchers assessed the ability of a simplified clinical exam to diagnose scabies using data from 3 population-based surveys, which included 1373 individuals with scabies. Individuals in the survey were diagnosed with scabies based on whole body assessments and assessments of 9 individual body regions. The researchers calculated the sensitivity of diagnosing scabies based on the individual body regions compared with whole body exam, as well as identified regions with greater than 90% sensitivity. In addition, sensitivity was assessed based on gender, age, severity of scabies, and presence or absence of impetigo.

The hands had the highest diagnostic yield, with sensitivity of 51.2% compared with whole body examination, followed by feet (49.7%), and lower legs (48.3%). Examination of the exposed parts of arms and legs had a sensitivity of 93.2%. Additionally, the researchers found that the sensitivity of the simplified exam was greater than 90% regardless of scabies severity or the presence or absence of secondary impetigo.

“Our study adds valuable data to the development of a simplified diagnostic process for scabies that may be applied to guide decisions about future public health interventions,” the researchers concluded. “Further studies in other settings are needed to prospectively validate this simplified approach.”

Reference:

Marks M, Engelman D, Romani L, et al. Exploration of a simplified clinical examination for scabies to support public health decision-making [published online December 27, 2018]. PLoS Negl Trop Dis. doi:10.1371/journal.pntd.0006996

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