Mole near nose

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Mole near nose

The differential diagnosis for this lesion included a benign intradermal nevus and a basal cell carcinoma. So the FP recommended a shave biopsy to be sure that it was not cancer. (See the Watch & Learn video on “Shave biopsy.”)

After obtaining patient consent, he injected the 1% lidocaine with epinephrine and waited 5 minutes for the epinephrine to begin to work. He performed the shave with a Dermablade, and used a cotton-tipped applicator to apply aluminum chloride to the site. He used a twisting motion and pressure to achieve hemostasis. He dressed the lesion with petrolatum and some gauze.

Dermatopathology showed that this mole was a benign intradermal nevus. The FP reassured the patient and recommended that she be careful to avoid sun exposure.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

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Mole near nose

The differential diagnosis for this lesion included a benign intradermal nevus and a basal cell carcinoma. So the FP recommended a shave biopsy to be sure that it was not cancer. (See the Watch & Learn video on “Shave biopsy.”)

After obtaining patient consent, he injected the 1% lidocaine with epinephrine and waited 5 minutes for the epinephrine to begin to work. He performed the shave with a Dermablade, and used a cotton-tipped applicator to apply aluminum chloride to the site. He used a twisting motion and pressure to achieve hemostasis. He dressed the lesion with petrolatum and some gauze.

Dermatopathology showed that this mole was a benign intradermal nevus. The FP reassured the patient and recommended that she be careful to avoid sun exposure.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Mole near nose

The differential diagnosis for this lesion included a benign intradermal nevus and a basal cell carcinoma. So the FP recommended a shave biopsy to be sure that it was not cancer. (See the Watch & Learn video on “Shave biopsy.”)

After obtaining patient consent, he injected the 1% lidocaine with epinephrine and waited 5 minutes for the epinephrine to begin to work. He performed the shave with a Dermablade, and used a cotton-tipped applicator to apply aluminum chloride to the site. He used a twisting motion and pressure to achieve hemostasis. He dressed the lesion with petrolatum and some gauze.

Dermatopathology showed that this mole was a benign intradermal nevus. The FP reassured the patient and recommended that she be careful to avoid sun exposure.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

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Novel topical JAK inhibitor shows promise for atopic dermatitis

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– A cream formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and 2, outperformed triamcinolone cream 0.1% and vehicle control in a large, phase 2, dose-ranging, randomized trial in patients with atopic dermatitis (AD), Brian S. Kim, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

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Dr. Brian S. Kim

This novel topical JAK inhibitor not only modulates inflammatory cytokines involved in the pathogenesis of AD, including interleukin-4, -5, -13, and -31, but Dr. Kim and his coinvestigators also demonstrated that ruxolitinib has antipruritic effects achieved by acting directly on sensory nerve fibers.

“Ultimately, these findings show that ruxolitinib cream may represent a novel and effective treatment for patients with atopic dermatitis going forward,” said Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch at Washington University, St. Louis.

The trial included 307 adults, mean age 35 years, with a median 21-year disease history and a mean of 7.3 flares within the past 12 months. Dr. Kim characterized the study population as having AD of “high-moderate” severity, with a mean involved body surface area of 9.7%, half of patients having a baseline Eczema Area and Severity Index (EASI) score greater than 7, and having a mean itch numeric rating scale of 7. Two-thirds of patients had an Investigator’s Global Assessment (IGA) score of 3 and the rest had scores of 2.



Patients were randomized to one of six study arms entailing 8 weeks of double-blind therapy: ruxolitinib cream 1.5% once daily, 1.5% twice daily; 0.5% once daily; 0.15% once daily; twice-daily vehicle; or triamcinolone cream 0.1% twice a day for 4 weeks followed by 4 weeks of vehicle.

All the ruxolitinib regimens provided dose- and time-dependent efficacy, compared with vehicle. The best results were seen with ruxolitinib 1.5% twice daily, which outperformed triamcinolone cream.

The primary study endpoint was change in EASI score from baseline to week 4, but the week 2 and week 8 data were also informative. Key secondary endpoints included the proportion of subjects achieving an EASI-75 response and/or an IGA response, which required improvement to an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

As for itch, ruxolitinib cream provided rapid and sustained improvement, said Dr. Kim. Indeed, within the first 2 days of the study, the ruxolitinib 1.5% twice-daily group had a mean 1.8-point reduction on the numeric rating scale, compared with a 0.2-point drop with vehicle and a 1-point drop with triamcinolone cream twice a day. By week 4, the twice-daily ruxolitinib 1.5% group had about a 4-point drop from baseline, the once-daily ruxolitinib 1.5% group had a 3.5-point drop, and the triamcinolone-treated patients had a 2.5-point drop.

Topical ruxolitinib was not associated with any significant safety or tolerability issues, and there were no clinically significant application site reactions, according to the dermatologist.

Session cochair Konstantine Buxtorf Friedli, MD, a Swiss dermatologist, commented that she could easily imagine this topical JAK inhibitor also being useful in other diseases with itch.

Dr. Kim reported serving as a consultant to and recipient of research funding from Incyte, which sponsored the study.

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– A cream formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and 2, outperformed triamcinolone cream 0.1% and vehicle control in a large, phase 2, dose-ranging, randomized trial in patients with atopic dermatitis (AD), Brian S. Kim, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News
Dr. Brian S. Kim

This novel topical JAK inhibitor not only modulates inflammatory cytokines involved in the pathogenesis of AD, including interleukin-4, -5, -13, and -31, but Dr. Kim and his coinvestigators also demonstrated that ruxolitinib has antipruritic effects achieved by acting directly on sensory nerve fibers.

“Ultimately, these findings show that ruxolitinib cream may represent a novel and effective treatment for patients with atopic dermatitis going forward,” said Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch at Washington University, St. Louis.

The trial included 307 adults, mean age 35 years, with a median 21-year disease history and a mean of 7.3 flares within the past 12 months. Dr. Kim characterized the study population as having AD of “high-moderate” severity, with a mean involved body surface area of 9.7%, half of patients having a baseline Eczema Area and Severity Index (EASI) score greater than 7, and having a mean itch numeric rating scale of 7. Two-thirds of patients had an Investigator’s Global Assessment (IGA) score of 3 and the rest had scores of 2.



Patients were randomized to one of six study arms entailing 8 weeks of double-blind therapy: ruxolitinib cream 1.5% once daily, 1.5% twice daily; 0.5% once daily; 0.15% once daily; twice-daily vehicle; or triamcinolone cream 0.1% twice a day for 4 weeks followed by 4 weeks of vehicle.

All the ruxolitinib regimens provided dose- and time-dependent efficacy, compared with vehicle. The best results were seen with ruxolitinib 1.5% twice daily, which outperformed triamcinolone cream.

The primary study endpoint was change in EASI score from baseline to week 4, but the week 2 and week 8 data were also informative. Key secondary endpoints included the proportion of subjects achieving an EASI-75 response and/or an IGA response, which required improvement to an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

As for itch, ruxolitinib cream provided rapid and sustained improvement, said Dr. Kim. Indeed, within the first 2 days of the study, the ruxolitinib 1.5% twice-daily group had a mean 1.8-point reduction on the numeric rating scale, compared with a 0.2-point drop with vehicle and a 1-point drop with triamcinolone cream twice a day. By week 4, the twice-daily ruxolitinib 1.5% group had about a 4-point drop from baseline, the once-daily ruxolitinib 1.5% group had a 3.5-point drop, and the triamcinolone-treated patients had a 2.5-point drop.

Topical ruxolitinib was not associated with any significant safety or tolerability issues, and there were no clinically significant application site reactions, according to the dermatologist.

Session cochair Konstantine Buxtorf Friedli, MD, a Swiss dermatologist, commented that she could easily imagine this topical JAK inhibitor also being useful in other diseases with itch.

Dr. Kim reported serving as a consultant to and recipient of research funding from Incyte, which sponsored the study.

 

– A cream formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and 2, outperformed triamcinolone cream 0.1% and vehicle control in a large, phase 2, dose-ranging, randomized trial in patients with atopic dermatitis (AD), Brian S. Kim, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News
Dr. Brian S. Kim

This novel topical JAK inhibitor not only modulates inflammatory cytokines involved in the pathogenesis of AD, including interleukin-4, -5, -13, and -31, but Dr. Kim and his coinvestigators also demonstrated that ruxolitinib has antipruritic effects achieved by acting directly on sensory nerve fibers.

“Ultimately, these findings show that ruxolitinib cream may represent a novel and effective treatment for patients with atopic dermatitis going forward,” said Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch at Washington University, St. Louis.

The trial included 307 adults, mean age 35 years, with a median 21-year disease history and a mean of 7.3 flares within the past 12 months. Dr. Kim characterized the study population as having AD of “high-moderate” severity, with a mean involved body surface area of 9.7%, half of patients having a baseline Eczema Area and Severity Index (EASI) score greater than 7, and having a mean itch numeric rating scale of 7. Two-thirds of patients had an Investigator’s Global Assessment (IGA) score of 3 and the rest had scores of 2.



Patients were randomized to one of six study arms entailing 8 weeks of double-blind therapy: ruxolitinib cream 1.5% once daily, 1.5% twice daily; 0.5% once daily; 0.15% once daily; twice-daily vehicle; or triamcinolone cream 0.1% twice a day for 4 weeks followed by 4 weeks of vehicle.

All the ruxolitinib regimens provided dose- and time-dependent efficacy, compared with vehicle. The best results were seen with ruxolitinib 1.5% twice daily, which outperformed triamcinolone cream.

The primary study endpoint was change in EASI score from baseline to week 4, but the week 2 and week 8 data were also informative. Key secondary endpoints included the proportion of subjects achieving an EASI-75 response and/or an IGA response, which required improvement to an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

As for itch, ruxolitinib cream provided rapid and sustained improvement, said Dr. Kim. Indeed, within the first 2 days of the study, the ruxolitinib 1.5% twice-daily group had a mean 1.8-point reduction on the numeric rating scale, compared with a 0.2-point drop with vehicle and a 1-point drop with triamcinolone cream twice a day. By week 4, the twice-daily ruxolitinib 1.5% group had about a 4-point drop from baseline, the once-daily ruxolitinib 1.5% group had a 3.5-point drop, and the triamcinolone-treated patients had a 2.5-point drop.

Topical ruxolitinib was not associated with any significant safety or tolerability issues, and there were no clinically significant application site reactions, according to the dermatologist.

Session cochair Konstantine Buxtorf Friedli, MD, a Swiss dermatologist, commented that she could easily imagine this topical JAK inhibitor also being useful in other diseases with itch.

Dr. Kim reported serving as a consultant to and recipient of research funding from Incyte, which sponsored the study.

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Key clinical point: A novel topical Janus kinase inhibitor may provide a valuable alternative to potent topical steroids in atopic dermatitis.

Major finding: At week 4, the mean improvement in Eczema Area and Severity Index score was 72% with ruxolitinib cream 1.5% twice a day, compared with 60% with triamcinolone cream 0.1% twice a day.

Study details: This 8-week, phase 2 clinical trial included 307 adult atopic dermatitis patients randomized to ruxolitinib cream, triamcinolone cream, or vehicle.

Disclosures: The study was sponsored by Incyte. The presenter reported serving as a consultant to and recipient of research funding from the company.

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Second-melanoma risk higher with indoor tanning

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Patients who use indoor tanning beds are more likely to develop a second primary melanoma, and do it more quickly, than those who avoid indoor tanning, according to a retrospective study involving 434 melanoma patients.

Over the course of the study, 88 patients developed multiple primary melanomas. In the year after the original diagnosis, 56% of the patients exposed to artificial UV radiation (UVR) were diagnosed with a second primary melanoma versus 18% of the nonexposed subjects, Yang Li of Washington University, St. Louis, and her associates said in the Journal of the American Academy of Dermatology.

The incidence of second melanomas over the entire 16-year course of the study was 25.2% among the tanning-bed users and 18.6% for nonusers. Among these study subjects – 27 with tanning-bed exposure and 61 without – median time to the second tumor was 225 days (0.62 years) for exposed patients and 1,280 days (3.50 years) for those with no exposure, the investigators reported.

This study, they wrote, is the first to show that “patients who had second primary melanoma diagnoses were more likely to have had” exposure to artificial UVR. The increased radiation intensity of tanning beds, “as opposed to UVR from ambient sunlight, in a physiologically vulnerable patient population [fair-skinned persons] at an early age contributes to our findings of decreased tumor lag time.”

SOURCE: Li Y et al. J Am Acad Dermatol. 2018;79(6):1101-8.

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Patients who use indoor tanning beds are more likely to develop a second primary melanoma, and do it more quickly, than those who avoid indoor tanning, according to a retrospective study involving 434 melanoma patients.

Over the course of the study, 88 patients developed multiple primary melanomas. In the year after the original diagnosis, 56% of the patients exposed to artificial UV radiation (UVR) were diagnosed with a second primary melanoma versus 18% of the nonexposed subjects, Yang Li of Washington University, St. Louis, and her associates said in the Journal of the American Academy of Dermatology.

The incidence of second melanomas over the entire 16-year course of the study was 25.2% among the tanning-bed users and 18.6% for nonusers. Among these study subjects – 27 with tanning-bed exposure and 61 without – median time to the second tumor was 225 days (0.62 years) for exposed patients and 1,280 days (3.50 years) for those with no exposure, the investigators reported.

This study, they wrote, is the first to show that “patients who had second primary melanoma diagnoses were more likely to have had” exposure to artificial UVR. The increased radiation intensity of tanning beds, “as opposed to UVR from ambient sunlight, in a physiologically vulnerable patient population [fair-skinned persons] at an early age contributes to our findings of decreased tumor lag time.”

SOURCE: Li Y et al. J Am Acad Dermatol. 2018;79(6):1101-8.

 

Patients who use indoor tanning beds are more likely to develop a second primary melanoma, and do it more quickly, than those who avoid indoor tanning, according to a retrospective study involving 434 melanoma patients.

Over the course of the study, 88 patients developed multiple primary melanomas. In the year after the original diagnosis, 56% of the patients exposed to artificial UV radiation (UVR) were diagnosed with a second primary melanoma versus 18% of the nonexposed subjects, Yang Li of Washington University, St. Louis, and her associates said in the Journal of the American Academy of Dermatology.

The incidence of second melanomas over the entire 16-year course of the study was 25.2% among the tanning-bed users and 18.6% for nonusers. Among these study subjects – 27 with tanning-bed exposure and 61 without – median time to the second tumor was 225 days (0.62 years) for exposed patients and 1,280 days (3.50 years) for those with no exposure, the investigators reported.

This study, they wrote, is the first to show that “patients who had second primary melanoma diagnoses were more likely to have had” exposure to artificial UVR. The increased radiation intensity of tanning beds, “as opposed to UVR from ambient sunlight, in a physiologically vulnerable patient population [fair-skinned persons] at an early age contributes to our findings of decreased tumor lag time.”

SOURCE: Li Y et al. J Am Acad Dermatol. 2018;79(6):1101-8.

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AEDs strongly linked to rare serious skin reactions

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Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.

Researchers at the University of Rhode Island College of Pharmacy in Kingston, who performed the retrospective study, also found that six drugs within the antiepileptic drug (AED) class had a reporting odds ratio estimate of more than 20, compared with other non-AEDs.

“Although several antiepileptic drugs have been associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the class effect and impact of other AEDs are not well described,” Eric P. Borrelli, PharmD, and his colleagues reported in Epilepsia.

The investigators examined rates of SJS and TEN for several AEDs using adverse event data from the Food and Drug Administration Adverse Event Reporting System between July 2014 and December 2017. The study investigators examined 198 adverse reaction reports related to AEDs, which was greater than any other drug class.

Overall, AEDs as a group had a reporting odds ratio risk estimate of 8.7 (95% confidence interval, 7.5-10.2), compared with non-AEDs. Similarly, the proportional reporting ratio was found to be 8.7 (95% CI, 7.5-10.2) in the AED group.

Within the class, the medications with the highest risk were zonisamide, rufinamide, and clorazepate, which had about 70-, 60-, and 56-fold higher odds for SJS and TEN, compared with all other medications. Other high-risk AEDs in the group included lamotrigine (reporting odds ratio, 53.0), carbamazepine (reporting OR, 24.5), and phenytoin (reporting OR, 26.3).

“Greater than 90% of SJS [and] TEN reactions associated with AEDs occur within the first 2 months of treatment initiation, although some AEDs have been associated with such reactions during long‐term use,” the researchers wrote.

The authors acknowledged that measures of prevalence and incidence could not be determined from these data since the number of patients taking AEDs is unknown.

“Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS [and] TEN signs [and] symptoms, may help mitigate the number and severity of these adverse events,” the researchers concluded.

The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.

SOURCE: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.

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Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.

Researchers at the University of Rhode Island College of Pharmacy in Kingston, who performed the retrospective study, also found that six drugs within the antiepileptic drug (AED) class had a reporting odds ratio estimate of more than 20, compared with other non-AEDs.

“Although several antiepileptic drugs have been associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the class effect and impact of other AEDs are not well described,” Eric P. Borrelli, PharmD, and his colleagues reported in Epilepsia.

The investigators examined rates of SJS and TEN for several AEDs using adverse event data from the Food and Drug Administration Adverse Event Reporting System between July 2014 and December 2017. The study investigators examined 198 adverse reaction reports related to AEDs, which was greater than any other drug class.

Overall, AEDs as a group had a reporting odds ratio risk estimate of 8.7 (95% confidence interval, 7.5-10.2), compared with non-AEDs. Similarly, the proportional reporting ratio was found to be 8.7 (95% CI, 7.5-10.2) in the AED group.

Within the class, the medications with the highest risk were zonisamide, rufinamide, and clorazepate, which had about 70-, 60-, and 56-fold higher odds for SJS and TEN, compared with all other medications. Other high-risk AEDs in the group included lamotrigine (reporting odds ratio, 53.0), carbamazepine (reporting OR, 24.5), and phenytoin (reporting OR, 26.3).

“Greater than 90% of SJS [and] TEN reactions associated with AEDs occur within the first 2 months of treatment initiation, although some AEDs have been associated with such reactions during long‐term use,” the researchers wrote.

The authors acknowledged that measures of prevalence and incidence could not be determined from these data since the number of patients taking AEDs is unknown.

“Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS [and] TEN signs [and] symptoms, may help mitigate the number and severity of these adverse events,” the researchers concluded.

The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.

SOURCE: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.

Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.

Researchers at the University of Rhode Island College of Pharmacy in Kingston, who performed the retrospective study, also found that six drugs within the antiepileptic drug (AED) class had a reporting odds ratio estimate of more than 20, compared with other non-AEDs.

“Although several antiepileptic drugs have been associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the class effect and impact of other AEDs are not well described,” Eric P. Borrelli, PharmD, and his colleagues reported in Epilepsia.

The investigators examined rates of SJS and TEN for several AEDs using adverse event data from the Food and Drug Administration Adverse Event Reporting System between July 2014 and December 2017. The study investigators examined 198 adverse reaction reports related to AEDs, which was greater than any other drug class.

Overall, AEDs as a group had a reporting odds ratio risk estimate of 8.7 (95% confidence interval, 7.5-10.2), compared with non-AEDs. Similarly, the proportional reporting ratio was found to be 8.7 (95% CI, 7.5-10.2) in the AED group.

Within the class, the medications with the highest risk were zonisamide, rufinamide, and clorazepate, which had about 70-, 60-, and 56-fold higher odds for SJS and TEN, compared with all other medications. Other high-risk AEDs in the group included lamotrigine (reporting odds ratio, 53.0), carbamazepine (reporting OR, 24.5), and phenytoin (reporting OR, 26.3).

“Greater than 90% of SJS [and] TEN reactions associated with AEDs occur within the first 2 months of treatment initiation, although some AEDs have been associated with such reactions during long‐term use,” the researchers wrote.

The authors acknowledged that measures of prevalence and incidence could not be determined from these data since the number of patients taking AEDs is unknown.

“Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS [and] TEN signs [and] symptoms, may help mitigate the number and severity of these adverse events,” the researchers concluded.

The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.

SOURCE: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.

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Key clinical point: Collectively, AEDs were associated with an almost ninefold greater risk of Stevens‐Johnson syndrome and toxic epidermal necrolysis versus non-AEDs.

Major finding: The reporting odds ratio risk estimate for SJS and TEN in the AED group was 8.7 (95% CI, 7.5-10.2), compared with non-AEDs.

Study details: A retrospective analysis of 198 adverse reaction reports from the Food and Drug Administration Adverse Event Reporting System.

Disclosures: The study was partially funded by the Department of Veterans Affairs. One coauthor reported receiving research funding from Pfizer, Merck (Cubist), and The Medicines Company.

Source: Borrelli EP et al. Epilepsia. 2018 Nov 5. doi: 10.1111/epi.14591.

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Multiple growths on face

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Multiple growths on face

While the differential diagnosis for these lesions (FIGURE 1A) included basal cell carcinoma, the FP had reason to suspect that these papules were actually sebaceous hyperplasia.

The FP saw a pattern of crown-like vessels and popcorn-like structures (FIGURE 1B) when he examined the patient with his dermatoscope. None of the vessels crossed the midline, and the popcorn-like structures were hyperplastic sebaceous glands. The FP photographed the largest lesion with a dermatoscope attached to his smart phone and showed the reassuring pattern to the anxious patient. He explained to her why this was not skin cancer and how hyperplasia of sebaceous glands is often normal for aging facial skin. He also offered her treatment if she thought that the lesions were cosmetically unappealing.

The patient said that she would be grateful to have the largest lesion treated because it did bother her when she looked in the mirror. The FP treated this lesion using electrosurgery with a blunt tipped electrode, on a setting of 2.1, without anesthesia. He warned the patient before he applied the activated electrode to the skin, and the patient tolerated the procedure well. The sebaceous glands melted easily with the current. The result appeared gray and was expected to heal with minimal to no scarring. At a future visit, the patient said that she was happy with the result and asked if additional lesions could be treated with the same electrosurgical approach.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

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Figure 1

Multiple growths on face

While the differential diagnosis for these lesions (FIGURE 1A) included basal cell carcinoma, the FP had reason to suspect that these papules were actually sebaceous hyperplasia.

The FP saw a pattern of crown-like vessels and popcorn-like structures (FIGURE 1B) when he examined the patient with his dermatoscope. None of the vessels crossed the midline, and the popcorn-like structures were hyperplastic sebaceous glands. The FP photographed the largest lesion with a dermatoscope attached to his smart phone and showed the reassuring pattern to the anxious patient. He explained to her why this was not skin cancer and how hyperplasia of sebaceous glands is often normal for aging facial skin. He also offered her treatment if she thought that the lesions were cosmetically unappealing.

The patient said that she would be grateful to have the largest lesion treated because it did bother her when she looked in the mirror. The FP treated this lesion using electrosurgery with a blunt tipped electrode, on a setting of 2.1, without anesthesia. He warned the patient before he applied the activated electrode to the skin, and the patient tolerated the procedure well. The sebaceous glands melted easily with the current. The result appeared gray and was expected to heal with minimal to no scarring. At a future visit, the patient said that she was happy with the result and asked if additional lesions could be treated with the same electrosurgical approach.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Figure 1

Multiple growths on face

While the differential diagnosis for these lesions (FIGURE 1A) included basal cell carcinoma, the FP had reason to suspect that these papules were actually sebaceous hyperplasia.

The FP saw a pattern of crown-like vessels and popcorn-like structures (FIGURE 1B) when he examined the patient with his dermatoscope. None of the vessels crossed the midline, and the popcorn-like structures were hyperplastic sebaceous glands. The FP photographed the largest lesion with a dermatoscope attached to his smart phone and showed the reassuring pattern to the anxious patient. He explained to her why this was not skin cancer and how hyperplasia of sebaceous glands is often normal for aging facial skin. He also offered her treatment if she thought that the lesions were cosmetically unappealing.

The patient said that she would be grateful to have the largest lesion treated because it did bother her when she looked in the mirror. The FP treated this lesion using electrosurgery with a blunt tipped electrode, on a setting of 2.1, without anesthesia. He warned the patient before he applied the activated electrode to the skin, and the patient tolerated the procedure well. The sebaceous glands melted easily with the current. The result appeared gray and was expected to heal with minimal to no scarring. At a future visit, the patient said that she was happy with the result and asked if additional lesions could be treated with the same electrosurgical approach.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

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Tofacitinib impresses in first trial for dermatomyositis

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– Oral tofacitinib demonstrated strong clinical efficacy and good safety in the first-ever formal study of a Janus kinase inhibitor in patients with active, treatment-resistant dermatomyositis, Julie J. Paik, MD, reported at the annual meeting of the American College of Rheumatology.

Dr. Julie J. Paik

Based upon the encouraging results of this small, open-label, proof-of-concept study, a larger randomized controlled trial is being planned, according to Dr. Paik, a rheumatologist at Johns Hopkins University in Baltimore.

The study included 10 dermatomyositis patients enrolled at the Johns Hopkins Myositis Clinic. All had previously failed at least two steroid-sparing drugs and/or high-dose steroids. After first going off all steroid-sparing agents and being limited to a maximum of 20 mg/day of prednisone, the participants were placed on 11 mg of open-label, extended-release tofacitinib (Xeljanz XR) once daily. Dr. Paik only reported results in 9 patients because the 10th hadn’t yet reached the 12-week mark.

The primary outcome was the rate of achievement of significant improvement at week 12 as defined using the validated International Myositis Assessment and Clinical Studies (IMACS) criteria, which require at least a 20% improvement in three of six core set measures coupled with no more than two measures worsening by 25% or more. By this standard, all nine patients met the primary endpoint. Five were rated as showing moderate improvement, and the other four demonstrated minimal improvement, based on the Total Improvement Score of the Myositis Response criteria. The median Total Improvement Score was 40, indicative of at least moderate improvement.

The mean CDASI (Cutaneous Dermatomyositis Disease Area and Severity Index) activity score – a key secondary endpoint – improved from 28 at baseline to 9.5 at week 12, which translates to a shift from moderate or severe disease to mild disease.

Levels of the alpha-chemokines CXCL9 and CXCL10, which are expressed in muscle affected by idiopathic inflammatory myopathies such as dermatomyositis, declined strongly over the course of 12 weeks of treatment to an extent that was just shy of statistical significance.



Myositis antibody titers didn’t change in response to tofacitinib therapy. Of note, six patients were positive for antitranscriptional intermediary factor 1-gamma, and five of the six were moderate responders to JAK inhibitor therapy.

Four patients were on 20 mg/day of prednisone at baseline; three of the four were able to go off steroids altogether over the course of 12 weeks.

The treatment was well tolerated, with no serious adverse events.

Asked if she thought 11 mg/day of tofacitinib was the right dose for this population of refractory dermatomyositis patients, Dr. Paik replied, “We’re not sure we have the right dose. We had one patient who didn’t have as robust a response, and I really wonder, if we gave her a higher dose, it would have made a difference.”

Extended-release tofacitinib at 11 mg/day is the approved dose for rheumatoid arthritis and psoriatic arthritis. However, 20 mg/day is approved for patients with ulcerative colitis, and Dr. Paik is lobbying for inclusion of a higher-dose arm in the randomized, controlled trial.

Prior to this formal proof-of-concept study, which was funded by Pfizer, the experience with tofacitinib in refractory dermatomyositis was limited to anecdotal case reports.

Dr. Paik reported having no financial conflicts.

SOURCE: Paik JJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L02.

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– Oral tofacitinib demonstrated strong clinical efficacy and good safety in the first-ever formal study of a Janus kinase inhibitor in patients with active, treatment-resistant dermatomyositis, Julie J. Paik, MD, reported at the annual meeting of the American College of Rheumatology.

Dr. Julie J. Paik

Based upon the encouraging results of this small, open-label, proof-of-concept study, a larger randomized controlled trial is being planned, according to Dr. Paik, a rheumatologist at Johns Hopkins University in Baltimore.

The study included 10 dermatomyositis patients enrolled at the Johns Hopkins Myositis Clinic. All had previously failed at least two steroid-sparing drugs and/or high-dose steroids. After first going off all steroid-sparing agents and being limited to a maximum of 20 mg/day of prednisone, the participants were placed on 11 mg of open-label, extended-release tofacitinib (Xeljanz XR) once daily. Dr. Paik only reported results in 9 patients because the 10th hadn’t yet reached the 12-week mark.

The primary outcome was the rate of achievement of significant improvement at week 12 as defined using the validated International Myositis Assessment and Clinical Studies (IMACS) criteria, which require at least a 20% improvement in three of six core set measures coupled with no more than two measures worsening by 25% or more. By this standard, all nine patients met the primary endpoint. Five were rated as showing moderate improvement, and the other four demonstrated minimal improvement, based on the Total Improvement Score of the Myositis Response criteria. The median Total Improvement Score was 40, indicative of at least moderate improvement.

The mean CDASI (Cutaneous Dermatomyositis Disease Area and Severity Index) activity score – a key secondary endpoint – improved from 28 at baseline to 9.5 at week 12, which translates to a shift from moderate or severe disease to mild disease.

Levels of the alpha-chemokines CXCL9 and CXCL10, which are expressed in muscle affected by idiopathic inflammatory myopathies such as dermatomyositis, declined strongly over the course of 12 weeks of treatment to an extent that was just shy of statistical significance.



Myositis antibody titers didn’t change in response to tofacitinib therapy. Of note, six patients were positive for antitranscriptional intermediary factor 1-gamma, and five of the six were moderate responders to JAK inhibitor therapy.

Four patients were on 20 mg/day of prednisone at baseline; three of the four were able to go off steroids altogether over the course of 12 weeks.

The treatment was well tolerated, with no serious adverse events.

Asked if she thought 11 mg/day of tofacitinib was the right dose for this population of refractory dermatomyositis patients, Dr. Paik replied, “We’re not sure we have the right dose. We had one patient who didn’t have as robust a response, and I really wonder, if we gave her a higher dose, it would have made a difference.”

Extended-release tofacitinib at 11 mg/day is the approved dose for rheumatoid arthritis and psoriatic arthritis. However, 20 mg/day is approved for patients with ulcerative colitis, and Dr. Paik is lobbying for inclusion of a higher-dose arm in the randomized, controlled trial.

Prior to this formal proof-of-concept study, which was funded by Pfizer, the experience with tofacitinib in refractory dermatomyositis was limited to anecdotal case reports.

Dr. Paik reported having no financial conflicts.

SOURCE: Paik JJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L02.

 

– Oral tofacitinib demonstrated strong clinical efficacy and good safety in the first-ever formal study of a Janus kinase inhibitor in patients with active, treatment-resistant dermatomyositis, Julie J. Paik, MD, reported at the annual meeting of the American College of Rheumatology.

Dr. Julie J. Paik

Based upon the encouraging results of this small, open-label, proof-of-concept study, a larger randomized controlled trial is being planned, according to Dr. Paik, a rheumatologist at Johns Hopkins University in Baltimore.

The study included 10 dermatomyositis patients enrolled at the Johns Hopkins Myositis Clinic. All had previously failed at least two steroid-sparing drugs and/or high-dose steroids. After first going off all steroid-sparing agents and being limited to a maximum of 20 mg/day of prednisone, the participants were placed on 11 mg of open-label, extended-release tofacitinib (Xeljanz XR) once daily. Dr. Paik only reported results in 9 patients because the 10th hadn’t yet reached the 12-week mark.

The primary outcome was the rate of achievement of significant improvement at week 12 as defined using the validated International Myositis Assessment and Clinical Studies (IMACS) criteria, which require at least a 20% improvement in three of six core set measures coupled with no more than two measures worsening by 25% or more. By this standard, all nine patients met the primary endpoint. Five were rated as showing moderate improvement, and the other four demonstrated minimal improvement, based on the Total Improvement Score of the Myositis Response criteria. The median Total Improvement Score was 40, indicative of at least moderate improvement.

The mean CDASI (Cutaneous Dermatomyositis Disease Area and Severity Index) activity score – a key secondary endpoint – improved from 28 at baseline to 9.5 at week 12, which translates to a shift from moderate or severe disease to mild disease.

Levels of the alpha-chemokines CXCL9 and CXCL10, which are expressed in muscle affected by idiopathic inflammatory myopathies such as dermatomyositis, declined strongly over the course of 12 weeks of treatment to an extent that was just shy of statistical significance.



Myositis antibody titers didn’t change in response to tofacitinib therapy. Of note, six patients were positive for antitranscriptional intermediary factor 1-gamma, and five of the six were moderate responders to JAK inhibitor therapy.

Four patients were on 20 mg/day of prednisone at baseline; three of the four were able to go off steroids altogether over the course of 12 weeks.

The treatment was well tolerated, with no serious adverse events.

Asked if she thought 11 mg/day of tofacitinib was the right dose for this population of refractory dermatomyositis patients, Dr. Paik replied, “We’re not sure we have the right dose. We had one patient who didn’t have as robust a response, and I really wonder, if we gave her a higher dose, it would have made a difference.”

Extended-release tofacitinib at 11 mg/day is the approved dose for rheumatoid arthritis and psoriatic arthritis. However, 20 mg/day is approved for patients with ulcerative colitis, and Dr. Paik is lobbying for inclusion of a higher-dose arm in the randomized, controlled trial.

Prior to this formal proof-of-concept study, which was funded by Pfizer, the experience with tofacitinib in refractory dermatomyositis was limited to anecdotal case reports.

Dr. Paik reported having no financial conflicts.

SOURCE: Paik JJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L02.

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Key clinical point: The future looks promising for tofacitinib as a treatment for refractory dermatomyositis.

Major finding: Among patients with refractory dermatomyositis, the mean Cutaneous Dermatomyositis Disease Area and Severity Index activity score improved from 28 at baseline to 9.5 after 12 weeks on oral tofacitinib.

Study details: This first-in-class, open-label, 12-week study included 10 patients with refractory dermatomyositis placed on extended-release tofacitinib at 11 mg once daily.

Disclosures: The presenter reported having no financial conflicts regarding the study, sponsored by Pfizer.

Source: Paik JJ et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract L02

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New pediatric therapies show promise for influenza, multidrug-resistant pathogens

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More therapies are becoming available for children for the treatment of influenza and multidrug-resistant infections such as Enterobacteriaceae and Acinetobacter, John S. Bradley, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. John S. Bradley

Dr. Bradley, director of the division of infectious diseases at Rady Children’s Hospital–San Diego, discussed a therapy for influenza, baloxavir, which was recently approved as a fast-acting single-dose medication and currently is under study in children. Also, a recent double-blind, phase 3 trial in the New England Journal of Medicine recruited patients as young as 12 years old. In the study, patients in the intervention group resolved their fever in median 25 hours, compared with 42 hours in the placebo group. Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups. There was a greater incidence of nausea and vomiting among the oseltamivir group, while the baloxavir group had a higher rate of diarrhea (N Engl J Med 2018;379:913-23).

However, Dr. Bradley noted baloxavir is much more expensive than oseltamivir, which may not justify the better tolerance of the drug for influenza treatment.

You don’t get better with it faster, so I’m not going to be recommending you all run to baloxavir this flu season for kids 12 years of age and older,” Dr. Bradley said. “I think oseltamivir is still fine, unless we end up with oseltamivir resistance.”

Solithromycin, an intravenous and oral fluoroketolide, has shown promising results against gram-positive and gram-negative pathogens for community-acquired pneumonia and other infections. During the drug’s study period, Cempra sold solithromycin to Melinta. However, one trial showed elevated liver functions in a higher number of patients than expected, and the Food and Drug Administration asked Melinta to conduct additional studies. Investigations on solithromycin have currently stopped until Melinta secures funding. “Until they get better resources, this particular drug is on hold, but you’ll see it again, I’m sure,” said Dr. Bradley, who also is professor and chief of the division of infectious diseases at the University of California, San Diego.

Dr. Bradley also discussed the efficacy of tedizolid, a protein synthesis inhibitor similar to linezolid approved in adults for the treatment of skin infections. He noted tedizolid is more active than linezolid, but the treatment course is a shorter dose for a shorter amount of time. Compared with linezolid, which can cause thrombocytopenia or neutropenia if taken for more than 10 days to 14 days, there also are fewer side effects.

“The tedizolid is much, much safer,” Dr. Bradley said, who added that trials for efficacy of tedizolid are currently underway in pediatric patients. “We’re hoping that will end up being the pediatric oxazolidinone.”

Other investigative therapies approved for adults and under study for use in children include ceftazidime/avibactam for treatment of urinary tract and complicated intra-abdominal infections, which is effective against meropenem-resistant Enterobacteriaceae and resistant Escherichia coli with extended-spectrum beta-lactamases (ESBL); ceftolozane/tazobactam has also been approved for adults, is pending approval in pediatric patients, and is active against ESBLs such as Pseudomonas; and meropenem/vaborbactam, which is active against Klebsiella pneumoniae carbapenemase (KPC)–producing isolates. Plazomicin, an aminoglycoside similar to gentamicin used to treat KPC-producing isolates, is stable against enzymes that degrade gentamicin and tobramycin.

CDC/ Matthew J. Arduino

Therapies currently under study for adults and being considered for children include imipenem/relebactam for treatment against E. coli, Enterobacter species, and KPC-producing isolates, and cefiderocol, a siderophore cephalosporin antibiotic – commonly described as a “Trojan horse” antibiotic because it binds to iron and is actively transported into the organism – is effective against Pseudomonas and has finished phase 2 trials in adults, with researchers looking to do single-dose trials in children, Dr. Bradley noted.

More experimentally, phage therapy for multidrug-resistant Acinetobacter baumannii proved effective in a 68-year-old patient with necrotizing pancreatitis who continued to deteriorate over a 4-month period despite multiple courses of antibiotics and attempted drainage of a pancreatic pseudocyst. Researchers selected a phage-specific bacterium with specificity for A. baumannii and cured him. “This is like science fiction,” Dr. Bradley said.

Dr. Bradley reported no relevant conflicts of interest.

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More therapies are becoming available for children for the treatment of influenza and multidrug-resistant infections such as Enterobacteriaceae and Acinetobacter, John S. Bradley, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. John S. Bradley

Dr. Bradley, director of the division of infectious diseases at Rady Children’s Hospital–San Diego, discussed a therapy for influenza, baloxavir, which was recently approved as a fast-acting single-dose medication and currently is under study in children. Also, a recent double-blind, phase 3 trial in the New England Journal of Medicine recruited patients as young as 12 years old. In the study, patients in the intervention group resolved their fever in median 25 hours, compared with 42 hours in the placebo group. Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups. There was a greater incidence of nausea and vomiting among the oseltamivir group, while the baloxavir group had a higher rate of diarrhea (N Engl J Med 2018;379:913-23).

However, Dr. Bradley noted baloxavir is much more expensive than oseltamivir, which may not justify the better tolerance of the drug for influenza treatment.

You don’t get better with it faster, so I’m not going to be recommending you all run to baloxavir this flu season for kids 12 years of age and older,” Dr. Bradley said. “I think oseltamivir is still fine, unless we end up with oseltamivir resistance.”

Solithromycin, an intravenous and oral fluoroketolide, has shown promising results against gram-positive and gram-negative pathogens for community-acquired pneumonia and other infections. During the drug’s study period, Cempra sold solithromycin to Melinta. However, one trial showed elevated liver functions in a higher number of patients than expected, and the Food and Drug Administration asked Melinta to conduct additional studies. Investigations on solithromycin have currently stopped until Melinta secures funding. “Until they get better resources, this particular drug is on hold, but you’ll see it again, I’m sure,” said Dr. Bradley, who also is professor and chief of the division of infectious diseases at the University of California, San Diego.

Dr. Bradley also discussed the efficacy of tedizolid, a protein synthesis inhibitor similar to linezolid approved in adults for the treatment of skin infections. He noted tedizolid is more active than linezolid, but the treatment course is a shorter dose for a shorter amount of time. Compared with linezolid, which can cause thrombocytopenia or neutropenia if taken for more than 10 days to 14 days, there also are fewer side effects.

“The tedizolid is much, much safer,” Dr. Bradley said, who added that trials for efficacy of tedizolid are currently underway in pediatric patients. “We’re hoping that will end up being the pediatric oxazolidinone.”

Other investigative therapies approved for adults and under study for use in children include ceftazidime/avibactam for treatment of urinary tract and complicated intra-abdominal infections, which is effective against meropenem-resistant Enterobacteriaceae and resistant Escherichia coli with extended-spectrum beta-lactamases (ESBL); ceftolozane/tazobactam has also been approved for adults, is pending approval in pediatric patients, and is active against ESBLs such as Pseudomonas; and meropenem/vaborbactam, which is active against Klebsiella pneumoniae carbapenemase (KPC)–producing isolates. Plazomicin, an aminoglycoside similar to gentamicin used to treat KPC-producing isolates, is stable against enzymes that degrade gentamicin and tobramycin.

CDC/ Matthew J. Arduino

Therapies currently under study for adults and being considered for children include imipenem/relebactam for treatment against E. coli, Enterobacter species, and KPC-producing isolates, and cefiderocol, a siderophore cephalosporin antibiotic – commonly described as a “Trojan horse” antibiotic because it binds to iron and is actively transported into the organism – is effective against Pseudomonas and has finished phase 2 trials in adults, with researchers looking to do single-dose trials in children, Dr. Bradley noted.

More experimentally, phage therapy for multidrug-resistant Acinetobacter baumannii proved effective in a 68-year-old patient with necrotizing pancreatitis who continued to deteriorate over a 4-month period despite multiple courses of antibiotics and attempted drainage of a pancreatic pseudocyst. Researchers selected a phage-specific bacterium with specificity for A. baumannii and cured him. “This is like science fiction,” Dr. Bradley said.

Dr. Bradley reported no relevant conflicts of interest.

 

More therapies are becoming available for children for the treatment of influenza and multidrug-resistant infections such as Enterobacteriaceae and Acinetobacter, John S. Bradley, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. John S. Bradley

Dr. Bradley, director of the division of infectious diseases at Rady Children’s Hospital–San Diego, discussed a therapy for influenza, baloxavir, which was recently approved as a fast-acting single-dose medication and currently is under study in children. Also, a recent double-blind, phase 3 trial in the New England Journal of Medicine recruited patients as young as 12 years old. In the study, patients in the intervention group resolved their fever in median 25 hours, compared with 42 hours in the placebo group. Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups. There was a greater incidence of nausea and vomiting among the oseltamivir group, while the baloxavir group had a higher rate of diarrhea (N Engl J Med 2018;379:913-23).

However, Dr. Bradley noted baloxavir is much more expensive than oseltamivir, which may not justify the better tolerance of the drug for influenza treatment.

You don’t get better with it faster, so I’m not going to be recommending you all run to baloxavir this flu season for kids 12 years of age and older,” Dr. Bradley said. “I think oseltamivir is still fine, unless we end up with oseltamivir resistance.”

Solithromycin, an intravenous and oral fluoroketolide, has shown promising results against gram-positive and gram-negative pathogens for community-acquired pneumonia and other infections. During the drug’s study period, Cempra sold solithromycin to Melinta. However, one trial showed elevated liver functions in a higher number of patients than expected, and the Food and Drug Administration asked Melinta to conduct additional studies. Investigations on solithromycin have currently stopped until Melinta secures funding. “Until they get better resources, this particular drug is on hold, but you’ll see it again, I’m sure,” said Dr. Bradley, who also is professor and chief of the division of infectious diseases at the University of California, San Diego.

Dr. Bradley also discussed the efficacy of tedizolid, a protein synthesis inhibitor similar to linezolid approved in adults for the treatment of skin infections. He noted tedizolid is more active than linezolid, but the treatment course is a shorter dose for a shorter amount of time. Compared with linezolid, which can cause thrombocytopenia or neutropenia if taken for more than 10 days to 14 days, there also are fewer side effects.

“The tedizolid is much, much safer,” Dr. Bradley said, who added that trials for efficacy of tedizolid are currently underway in pediatric patients. “We’re hoping that will end up being the pediatric oxazolidinone.”

Other investigative therapies approved for adults and under study for use in children include ceftazidime/avibactam for treatment of urinary tract and complicated intra-abdominal infections, which is effective against meropenem-resistant Enterobacteriaceae and resistant Escherichia coli with extended-spectrum beta-lactamases (ESBL); ceftolozane/tazobactam has also been approved for adults, is pending approval in pediatric patients, and is active against ESBLs such as Pseudomonas; and meropenem/vaborbactam, which is active against Klebsiella pneumoniae carbapenemase (KPC)–producing isolates. Plazomicin, an aminoglycoside similar to gentamicin used to treat KPC-producing isolates, is stable against enzymes that degrade gentamicin and tobramycin.

CDC/ Matthew J. Arduino

Therapies currently under study for adults and being considered for children include imipenem/relebactam for treatment against E. coli, Enterobacter species, and KPC-producing isolates, and cefiderocol, a siderophore cephalosporin antibiotic – commonly described as a “Trojan horse” antibiotic because it binds to iron and is actively transported into the organism – is effective against Pseudomonas and has finished phase 2 trials in adults, with researchers looking to do single-dose trials in children, Dr. Bradley noted.

More experimentally, phage therapy for multidrug-resistant Acinetobacter baumannii proved effective in a 68-year-old patient with necrotizing pancreatitis who continued to deteriorate over a 4-month period despite multiple courses of antibiotics and attempted drainage of a pancreatic pseudocyst. Researchers selected a phage-specific bacterium with specificity for A. baumannii and cured him. “This is like science fiction,” Dr. Bradley said.

Dr. Bradley reported no relevant conflicts of interest.

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A 77-year-old white male with a history of multiple nonmelanoma skin cancers as well as melanoma presented with an asymptomatic pink plaque on the vertex of the scalp.

 

Atypical fibroxanthoma (AFX) is a low grade, indolent sarcoma that tends to occur on sun-exposed areas, such as the head and neck. White individuals over aged 50 years are more frequently affected. Both genders are equally affected, and 25% of cases occur on the covered areas (trunk or extremities) of younger patients. Clinically, lesions present as pink to red plaques or nodules that exhibit rapid growth. Ulceration or crusting may be present. Causes of AFX include ultraviolet radiation and ionizing radiation. AFX is considered a superficial variant of malignant fibrous histiocytoma (MFH), the most common soft tissue sarcoma of adults. Clinically, MFH involves deeper tissues than does AFX, often on the thighs or buttocks. MFH is a more aggressive malignancy that regularly metastasizes.

Dr. Donna Bilu Martin
Another AFX case, in a 94-year-old white female, who presented with a 1-month history of an asymptomatic, pink nodule on her left eyebrow. She has a history of non-melanoma skin cancers on the face.

Histologically, the tumor occurs as a dermal proliferation of “bizarre” spindle cells, epithelioid cells, and atypical histiocytes. Vesicular changes may be present in the nucleus or cytoplasm of the spindle cells. Mitotic figures are present. Multinucleated giant cells may be present. Solar elastosis is often seen, as well. Vimentin and histiocyte stains are positive. Unlike melanoma, S-100 staining is minimal. Unlike squamous cell carcinoma, prekeratin staining is negative. CD34 is negative. AFX resembles MFH histologically.

Surgical excision by the Mohs procedure is preferred over wide excision as there is a risk of recurrence. AFX rarely metastasizes. This is more likely if inadequately excised or the patient is immunosuppressed. Sun protective practices, such as applying and reapplying sunscreen regularly, wearing sun protective clothing, and avoiding excessive UV exposure during peak hours is recommended.

Dr. Donna Bilu Martin


This case and photo were submitted by Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

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Atypical fibroxanthoma (AFX) is a low grade, indolent sarcoma that tends to occur on sun-exposed areas, such as the head and neck. White individuals over aged 50 years are more frequently affected. Both genders are equally affected, and 25% of cases occur on the covered areas (trunk or extremities) of younger patients. Clinically, lesions present as pink to red plaques or nodules that exhibit rapid growth. Ulceration or crusting may be present. Causes of AFX include ultraviolet radiation and ionizing radiation. AFX is considered a superficial variant of malignant fibrous histiocytoma (MFH), the most common soft tissue sarcoma of adults. Clinically, MFH involves deeper tissues than does AFX, often on the thighs or buttocks. MFH is a more aggressive malignancy that regularly metastasizes.

Dr. Donna Bilu Martin
Another AFX case, in a 94-year-old white female, who presented with a 1-month history of an asymptomatic, pink nodule on her left eyebrow. She has a history of non-melanoma skin cancers on the face.

Histologically, the tumor occurs as a dermal proliferation of “bizarre” spindle cells, epithelioid cells, and atypical histiocytes. Vesicular changes may be present in the nucleus or cytoplasm of the spindle cells. Mitotic figures are present. Multinucleated giant cells may be present. Solar elastosis is often seen, as well. Vimentin and histiocyte stains are positive. Unlike melanoma, S-100 staining is minimal. Unlike squamous cell carcinoma, prekeratin staining is negative. CD34 is negative. AFX resembles MFH histologically.

Surgical excision by the Mohs procedure is preferred over wide excision as there is a risk of recurrence. AFX rarely metastasizes. This is more likely if inadequately excised or the patient is immunosuppressed. Sun protective practices, such as applying and reapplying sunscreen regularly, wearing sun protective clothing, and avoiding excessive UV exposure during peak hours is recommended.

Dr. Donna Bilu Martin


This case and photo were submitted by Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

 

Atypical fibroxanthoma (AFX) is a low grade, indolent sarcoma that tends to occur on sun-exposed areas, such as the head and neck. White individuals over aged 50 years are more frequently affected. Both genders are equally affected, and 25% of cases occur on the covered areas (trunk or extremities) of younger patients. Clinically, lesions present as pink to red plaques or nodules that exhibit rapid growth. Ulceration or crusting may be present. Causes of AFX include ultraviolet radiation and ionizing radiation. AFX is considered a superficial variant of malignant fibrous histiocytoma (MFH), the most common soft tissue sarcoma of adults. Clinically, MFH involves deeper tissues than does AFX, often on the thighs or buttocks. MFH is a more aggressive malignancy that regularly metastasizes.

Dr. Donna Bilu Martin
Another AFX case, in a 94-year-old white female, who presented with a 1-month history of an asymptomatic, pink nodule on her left eyebrow. She has a history of non-melanoma skin cancers on the face.

Histologically, the tumor occurs as a dermal proliferation of “bizarre” spindle cells, epithelioid cells, and atypical histiocytes. Vesicular changes may be present in the nucleus or cytoplasm of the spindle cells. Mitotic figures are present. Multinucleated giant cells may be present. Solar elastosis is often seen, as well. Vimentin and histiocyte stains are positive. Unlike melanoma, S-100 staining is minimal. Unlike squamous cell carcinoma, prekeratin staining is negative. CD34 is negative. AFX resembles MFH histologically.

Surgical excision by the Mohs procedure is preferred over wide excision as there is a risk of recurrence. AFX rarely metastasizes. This is more likely if inadequately excised or the patient is immunosuppressed. Sun protective practices, such as applying and reapplying sunscreen regularly, wearing sun protective clothing, and avoiding excessive UV exposure during peak hours is recommended.

Dr. Donna Bilu Martin


This case and photo were submitted by Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

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A 77-year-old white male with a history of multiple nonmelanoma skin cancers as well as melanoma presented with an asymptomatic pink plaque on the vertex of the scalp.
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A 77-year-old white male with a history of multiple nonmelanoma skin cancers as well as melanoma presented with an asymptomatic pink plaque on the vertex of the scalp. The lesion appeared rather quickly, over the span of a few weeks.

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Atopic dermatitis hits mental health, quality of life

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Atopic dermatitis (AD) places a considerable burden on mental health and quality of life for patients with disease of even moderate severity, according to a cross-sectional study of data from the Atopic Dermatitis in America survey.

Among adults with severe AD, the mean score on the Dermatology Life Quality Index was 11.4, with a score of 6-30 representing a moderate to large effect on quality of life. The mean for those with moderate disease, 5.9, was just below that range, but 37% of that group did have scores between 6 and 30, Zelma C. Chiesa Fuxench, MD, of the University of Pennsylvania, Philadelphia, and her associates said in the Journal of Investigative Dermatology.

The mean on the Dermatology Life Quality Index for all AD patients was 4.1, with 24% falling into the moderate to large effect range, compared with 1% and 5% for controls. Results were similar on the mental health measure used, the Hospital Anxiety and Depression Scale (HADS). Mean HADS-anxiety scores were 7.0 for all AD patients and 4.7 for controls, and HADS-depression means were 5.8 for AD patients and 3.6 for controls, the investigators reported.

Analysis by disease severity found that 32% of those with moderate AD and almost 56% with severe AD had clinical anxiety (HADS-A score of 11-21), while somewhat lower prevalences were seen for clinical depression (HADS-D score of 11-21): 19.5% for those with moderate AD and 19.7% for patients with severe AD, Dr. Chiesa Fuxench and her associates said.

“An increasing number of studies provide evidence that AD is associated with marked [quality of life] impairment and increased health care costs with higher burden and costs in those with more severe disease. Additional studies should center on exploring those factors associated with AD, and AD disease severity, which lead to increased disease burden in this population,” they wrote.

Respondents to the Atopic Dermatitis in America survey were part of the GfK Knowledge Panel. The study involved a two-stage sampling process: one group of 1,278 adults determined prevalence ,and an oversample of 602 AD patients assessed severity differences.

Dr. Chiesa Fuxench has received research grants from Regeneron, Sanofi, Tioga, and Vanda for work related to atopic dermatitis and has received honoraria for CME work in atopic dermatitis sponsored by educational grants from Regeneron and Sanofi.

SOURCE: J Invest Dermatol. 2018. doi: 10.1016/j.jid.2018.08.028.

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Atopic dermatitis (AD) places a considerable burden on mental health and quality of life for patients with disease of even moderate severity, according to a cross-sectional study of data from the Atopic Dermatitis in America survey.

Among adults with severe AD, the mean score on the Dermatology Life Quality Index was 11.4, with a score of 6-30 representing a moderate to large effect on quality of life. The mean for those with moderate disease, 5.9, was just below that range, but 37% of that group did have scores between 6 and 30, Zelma C. Chiesa Fuxench, MD, of the University of Pennsylvania, Philadelphia, and her associates said in the Journal of Investigative Dermatology.

The mean on the Dermatology Life Quality Index for all AD patients was 4.1, with 24% falling into the moderate to large effect range, compared with 1% and 5% for controls. Results were similar on the mental health measure used, the Hospital Anxiety and Depression Scale (HADS). Mean HADS-anxiety scores were 7.0 for all AD patients and 4.7 for controls, and HADS-depression means were 5.8 for AD patients and 3.6 for controls, the investigators reported.

Analysis by disease severity found that 32% of those with moderate AD and almost 56% with severe AD had clinical anxiety (HADS-A score of 11-21), while somewhat lower prevalences were seen for clinical depression (HADS-D score of 11-21): 19.5% for those with moderate AD and 19.7% for patients with severe AD, Dr. Chiesa Fuxench and her associates said.

“An increasing number of studies provide evidence that AD is associated with marked [quality of life] impairment and increased health care costs with higher burden and costs in those with more severe disease. Additional studies should center on exploring those factors associated with AD, and AD disease severity, which lead to increased disease burden in this population,” they wrote.

Respondents to the Atopic Dermatitis in America survey were part of the GfK Knowledge Panel. The study involved a two-stage sampling process: one group of 1,278 adults determined prevalence ,and an oversample of 602 AD patients assessed severity differences.

Dr. Chiesa Fuxench has received research grants from Regeneron, Sanofi, Tioga, and Vanda for work related to atopic dermatitis and has received honoraria for CME work in atopic dermatitis sponsored by educational grants from Regeneron and Sanofi.

SOURCE: J Invest Dermatol. 2018. doi: 10.1016/j.jid.2018.08.028.

Atopic dermatitis (AD) places a considerable burden on mental health and quality of life for patients with disease of even moderate severity, according to a cross-sectional study of data from the Atopic Dermatitis in America survey.

Among adults with severe AD, the mean score on the Dermatology Life Quality Index was 11.4, with a score of 6-30 representing a moderate to large effect on quality of life. The mean for those with moderate disease, 5.9, was just below that range, but 37% of that group did have scores between 6 and 30, Zelma C. Chiesa Fuxench, MD, of the University of Pennsylvania, Philadelphia, and her associates said in the Journal of Investigative Dermatology.

The mean on the Dermatology Life Quality Index for all AD patients was 4.1, with 24% falling into the moderate to large effect range, compared with 1% and 5% for controls. Results were similar on the mental health measure used, the Hospital Anxiety and Depression Scale (HADS). Mean HADS-anxiety scores were 7.0 for all AD patients and 4.7 for controls, and HADS-depression means were 5.8 for AD patients and 3.6 for controls, the investigators reported.

Analysis by disease severity found that 32% of those with moderate AD and almost 56% with severe AD had clinical anxiety (HADS-A score of 11-21), while somewhat lower prevalences were seen for clinical depression (HADS-D score of 11-21): 19.5% for those with moderate AD and 19.7% for patients with severe AD, Dr. Chiesa Fuxench and her associates said.

“An increasing number of studies provide evidence that AD is associated with marked [quality of life] impairment and increased health care costs with higher burden and costs in those with more severe disease. Additional studies should center on exploring those factors associated with AD, and AD disease severity, which lead to increased disease burden in this population,” they wrote.

Respondents to the Atopic Dermatitis in America survey were part of the GfK Knowledge Panel. The study involved a two-stage sampling process: one group of 1,278 adults determined prevalence ,and an oversample of 602 AD patients assessed severity differences.

Dr. Chiesa Fuxench has received research grants from Regeneron, Sanofi, Tioga, and Vanda for work related to atopic dermatitis and has received honoraria for CME work in atopic dermatitis sponsored by educational grants from Regeneron and Sanofi.

SOURCE: J Invest Dermatol. 2018. doi: 10.1016/j.jid.2018.08.028.

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FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY

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Growing lesion on cheek

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Growing lesion on cheek

The FP suspected that this was a basal cell carcinoma (BCC) or squamous cell carcinoma. He leaned toward a BCC because of the pearly border on the edge, but knew that a biopsy diagnosis was needed before planning definitive treatment.

The FP recommended performing a shave biopsy that day. (See the Watch & Learn video on “Shave biopsy.”) After obtaining patient consent, he injected 1% lidocaine with epinephrine and waited for the epinephrine to work. He performed the shave biopsy with a Dermablade, and used a cotton-tipped applicator to vigorously apply aluminum chloride to the site. He used a twisting motion and pressure to achieve hemostasis. The bleeding stopped, and the FP dressed the lesion with petrolatum and some gauze. Dermatopathology revealed a sclerosing BCC.

The FP realized this was an aggressive tumor and referred the patient for Mohs surgery. The surgery required 4 excisions to get clean margins (FIGURE 1B). The usual 4- to 5-mm margins with an elliptical excision would not have removed the full tumor.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

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Figure 1

Growing lesion on cheek

The FP suspected that this was a basal cell carcinoma (BCC) or squamous cell carcinoma. He leaned toward a BCC because of the pearly border on the edge, but knew that a biopsy diagnosis was needed before planning definitive treatment.

The FP recommended performing a shave biopsy that day. (See the Watch & Learn video on “Shave biopsy.”) After obtaining patient consent, he injected 1% lidocaine with epinephrine and waited for the epinephrine to work. He performed the shave biopsy with a Dermablade, and used a cotton-tipped applicator to vigorously apply aluminum chloride to the site. He used a twisting motion and pressure to achieve hemostasis. The bleeding stopped, and the FP dressed the lesion with petrolatum and some gauze. Dermatopathology revealed a sclerosing BCC.

The FP realized this was an aggressive tumor and referred the patient for Mohs surgery. The surgery required 4 excisions to get clean margins (FIGURE 1B). The usual 4- to 5-mm margins with an elliptical excision would not have removed the full tumor.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Figure 1

Growing lesion on cheek

The FP suspected that this was a basal cell carcinoma (BCC) or squamous cell carcinoma. He leaned toward a BCC because of the pearly border on the edge, but knew that a biopsy diagnosis was needed before planning definitive treatment.

The FP recommended performing a shave biopsy that day. (See the Watch & Learn video on “Shave biopsy.”) After obtaining patient consent, he injected 1% lidocaine with epinephrine and waited for the epinephrine to work. He performed the shave biopsy with a Dermablade, and used a cotton-tipped applicator to vigorously apply aluminum chloride to the site. He used a twisting motion and pressure to achieve hemostasis. The bleeding stopped, and the FP dressed the lesion with petrolatum and some gauze. Dermatopathology revealed a sclerosing BCC.

The FP realized this was an aggressive tumor and referred the patient for Mohs surgery. The surgery required 4 excisions to get clean margins (FIGURE 1B). The usual 4- to 5-mm margins with an elliptical excision would not have removed the full tumor.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Basal cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:989-998.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

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