Blastomycosis is a systemic fungal infection that is endemic in the South Central, Midwest, and southeastern regions of the United States, as well as in provinces of Canada bordering the Great Lakes. After inhalation of Blastomyces dermatitidis spores, which are taken up by bronchopulmonary macrophages, there is an approximate 30- to 45-day incubation period. The initial response at the infected site is suppurative, which progresses to granuloma formation. Blastomyces dermatitidis most commonly infects the lungs, followed by the skin, bones, prostate, and central nervous system (CNS). Therapy for blastomycosis is determined by the severity of the clinical presentation and consideration of the toxicities of the antifungal agent.

We present the case of a 38-year-old man with a medical history of human immunodeficiency virus (HIV) infection and AIDS who reported a 3- to 4-week history of respiratory and cutaneous symptoms. Initial clinical impression favored secondary syphilis; however, after laboratory evaluation and lack of response to treatment for syphilis, further investigation revealed a diagnosis of widespread cutaneous North American blastomycosis.

Case Report

A 38-year-old man with a medical history of HIV infection and AIDS presented to the emergency department at a medical center in Minneapolis, Minnesota, with a cough; chest discomfort; and concomitant nonpainful, mildly pruritic papules and plaques of 3 to 4 weeks’ duration that initially appeared on the face and ears and spread to the trunk, arms, palms, legs, and feet. He had a nonpainful ulcer on the glans penis. Symptoms began while he was living in Atlanta, Georgia, before relocating to Minneapolis. A chest radiograph was negative.

The initial clinical impression favored secondary syphilis. Intramuscular penicillin G benzathine (2.4 million U) weekly for 3 weeks was initiated by the primary care team based on clinical suspicion alone without laboratory evidence of a positive rapid plasma reagin or VDRL test. Because laboratory evaluation and lack of response to treatment did not support syphilis, dermatology consultation was requested.

The patient had a history of crack cocaine abuse. He reported sexual activity with a single female partner while living in a halfway house in the Minneapolis–St. Paul area. Physical examination showed an age-appropriate man in no acute distress who was alert and oriented. He had well-demarcated papules and plaques on the forehead, ears, nose, cutaneous and mucosal lips, chest, back, arms, legs, palms, and soles. Many of the facial papules were pink, nonscaly, and concentrated around the nose and mouth; some were umbilicated (Figure 1). Trunk and extensor papules and plaques were well demarcated, oval, and scaly; some had erosions centrally and were excoriated. Palmar papules were round and had peripheral brown hyperpigmentation and central scale (Figure 2). A 1-cm, shallow, nontender, oval ulceration withraised borders was located on the glans penis under the foreskin (Figure 3).

A rapid plasma reagin test was nonreactive; a fluorescent treponemal antibody absorption test was negative. Chest radiograph, magnetic resonance imaging, and electroencephalogram were normal. In addition, spinal fluid drawn from a tap was negative on India ink and Gram stain preparations and was negative for cryptococcal antigen. In addition, spinal fluid was negative for fungal and bacterial growth, as were blood cultures.

Abnormal tests included a positive enzyme-linked immunosorbent assay and Western blot test for HIV, with an absolute CD4 count of 6 cells/mL and a viral load more than 100,000 copies/mL. Urine histoplasmosis antigen was markedly elevated. A potassium hydroxide preparation was performed on the skin of the right forearm, revealing broad-based budding yeast, later confirmed on skin and sputum cultures to be B dermatitidis.

Punch biopsy from the upper back revealed a mixed acute and granulomatous infiltrate with numerous yeast forms (Figure 4A) that were highlighted by Grocott-Gomori methenamine-silver (Figure 4B) and periodic acid–Schiff (Figure 4C) stains.

Comment

Diagnosis
Our patient had an interesting and dramatic presentation of widespread cutaneous North American blastomycosis that was initially considered to be secondary syphilis because of involvement of the palms and soles and the presence of the painless penile ulcer. In addition, the initial skin biopsy finding was considered morphologically consistent with Cryptococcus neoformans based on positive Grocott-Gomori methenamine-silver and periodic acid–Schiff stains and an equivocal mucicarmine stain. However, the potassium hydroxide preparation of skin and positive urine histoplasmosis antigen strongly suggested blastomycosis, which was confirmed by culture of B dermatitidis. The urine histoplasmosis antigen can cross-react with B dermatitidis and other mycoses (eg, Paracoccidioides brasiliensis and Penicillium marneffei); however, because the treatment of either of these mycoses is similar, the value of the test remains high.¹

Skin tests and serologic markers are useful epidemiologic tools but are of inadequate sensitivity and specificity to be diagnostic for B dermatitidis. Diagnosis depends on direct examination of tissue or isolation of the fungus in culture.²

Source of Infection
The probable occult source of cutaneous infection was the lungs, given the natural history of disseminated blastomycosis; the history of cough and chest discomfort; the widespread nature of skin lesions; and the ultimate growth of rare yeast forms in sputum. Cutaneous infection generally is from disseminated disease and rarely from direct inoculation.

Unlike many other systemic dimorphic mycoses, blastomycosis usually occurs in healthy hosts and is frequently associated with point-source outbreak. Immunosuppressed patients typically develop infection following exposure to the organism, but reactivation also can occur. Blastomycosis is uncommon among HIV-infected individuals and is not recognized as an AIDS-defining illness.

In a review from Canada of 133 patients with blastomycosis, nearly half had an underlying medical condition but not one typically associated with marked immunosuppression.³ Only 2 of 133 patients had HIV infection. Overall mortality was 6.3%, and the average duration of symptoms before diagnosis was less in those who died vs those who survived the disease.³ In the setting of AIDS or other marked immunosuppression, disease usually is more severe, with multiple-system involvement, including the CNS, and can progress rapidly to death.²

Treatment
Therapy for blastomycosis is determined by the severity of the clinical presentation and consideration of the toxicities of the antifungal agent. There are no randomized, blinded trials comparing antifungal agents, and data on the treatment of blastomycosis in patients infected with HIV are limited. Amphotericin B 3 mg/kg every 24 hours is recommended in life-threatening systemic disease and CNS disease as well as in patients with immune suppression, including AIDS.⁴ In a retrospective study of 326 patients with blastomycosis, those receiving amphotericin B had a cure rate of 86.5% with a relapse rate of 3.9%; patients receiving ketoconazole had a cure rate of 81.7% with a relapse rate of 14%.⁴ Although data are limited, chronic suppressive therapy generally is recommended in patients with HIV who have been treated for blastomycosis. Fluconazole, itraconazole, and ketoconazole are all used as chronic suppressive therapy; however, given the higher relapse rate observed with ketoconazole, itraconazole is preferred. Because neither ketoconazole nor itraconazole penetrates the blood-brain barrier, these drugs are not recommended in cases of CNS involvement. Patients with CNS disease or intolerance to itraconazole should be treated with fluconazole for chronic suppression.³

Blastomycosis is a systemic fungal infection that is endemic in the South Central, Midwest, and southeastern regions of the United States, as well as in provinces of Canada bordering the Great Lakes. After inhalation of Blastomyces dermatitidis spores, which are taken up by bronchopulmonary macrophages, there is an approximate 30- to 45-day incubation period. The initial response at the infected site is suppurative, which progresses to granuloma formation. Blastomyces dermatitidis most commonly infects the lungs, followed by the skin, bones, prostate, and central nervous system (CNS). Therapy for blastomycosis is determined by the severity of the clinical presentation and consideration of the toxicities of the antifungal agent.

We present the case of a 38-year-old man with a medical history of human immunodeficiency virus (HIV) infection and AIDS who reported a 3- to 4-week history of respiratory and cutaneous symptoms. Initial clinical impression favored secondary syphilis; however, after laboratory evaluation and lack of response to treatment for syphilis, further investigation revealed a diagnosis of widespread cutaneous North American blastomycosis.

Case Report

A 38-year-old man with a medical history of HIV infection and AIDS presented to the emergency department at a medical center in Minneapolis, Minnesota, with a cough; chest discomfort; and concomitant nonpainful, mildly pruritic papules and plaques of 3 to 4 weeks’ duration that initially appeared on the face and ears and spread to the trunk, arms, palms, legs, and feet. He had a nonpainful ulcer on the glans penis. Symptoms began while he was living in Atlanta, Georgia, before relocating to Minneapolis. A chest radiograph was negative.

The initial clinical impression favored secondary syphilis. Intramuscular penicillin G benzathine (2.4 million U) weekly for 3 weeks was initiated by the primary care team based on clinical suspicion alone without laboratory evidence of a positive rapid plasma reagin or VDRL test. Because laboratory evaluation and lack of response to treatment did not support syphilis, dermatology consultation was requested.

The patient had a history of crack cocaine abuse. He reported sexual activity with a single female partner while living in a halfway house in the Minneapolis–St. Paul area. Physical examination showed an age-appropriate man in no acute distress who was alert and oriented. He had well-demarcated papules and plaques on the forehead, ears, nose, cutaneous and mucosal lips, chest, back, arms, legs, palms, and soles. Many of the facial papules were pink, nonscaly, and concentrated around the nose and mouth; some were umbilicated (Figure 1). Trunk and extensor papules and plaques were well demarcated, oval, and scaly; some had erosions centrally and were excoriated. Palmar papules were round and had peripheral brown hyperpigmentation and central scale (Figure 2). A 1-cm, shallow, nontender, oval ulceration withraised borders was located on the glans penis under the foreskin (Figure 3).

A rapid plasma reagin test was nonreactive; a fluorescent treponemal antibody absorption test was negative. Chest radiograph, magnetic resonance imaging, and electroencephalogram were normal. In addition, spinal fluid drawn from a tap was negative on India ink and Gram stain preparations and was negative for cryptococcal antigen. In addition, spinal fluid was negative for fungal and bacterial growth, as were blood cultures.

Abnormal tests included a positive enzyme-linked immunosorbent assay and Western blot test for HIV, with an absolute CD4 count of 6 cells/mL and a viral load more than 100,000 copies/mL. Urine histoplasmosis antigen was markedly elevated. A potassium hydroxide preparation was performed on the skin of the right forearm, revealing broad-based budding yeast, later confirmed on skin and sputum cultures to be B dermatitidis.

Punch biopsy from the upper back revealed a mixed acute and granulomatous infiltrate with numerous yeast forms (Figure 4A) that were highlighted by Grocott-Gomori methenamine-silver (Figure 4B) and periodic acid–Schiff (Figure 4C) stains.

Comment

Diagnosis
Our patient had an interesting and dramatic presentation of widespread cutaneous North American blastomycosis that was initially considered to be secondary syphilis because of involvement of the palms and soles and the presence of the painless penile ulcer. In addition, the initial skin biopsy finding was considered morphologically consistent with Cryptococcus neoformans based on positive Grocott-Gomori methenamine-silver and periodic acid–Schiff stains and an equivocal mucicarmine stain. However, the potassium hydroxide preparation of skin and positive urine histoplasmosis antigen strongly suggested blastomycosis, which was confirmed by culture of B dermatitidis. The urine histoplasmosis antigen can cross-react with B dermatitidis and other mycoses (eg, Paracoccidioides brasiliensis and Penicillium marneffei); however, because the treatment of either of these mycoses is similar, the value of the test remains high.¹

Skin tests and serologic markers are useful epidemiologic tools but are of inadequate sensitivity and specificity to be diagnostic for B dermatitidis. Diagnosis depends on direct examination of tissue or isolation of the fungus in culture.²

Source of Infection
The probable occult source of cutaneous infection was the lungs, given the natural history of disseminated blastomycosis; the history of cough and chest discomfort; the widespread nature of skin lesions; and the ultimate growth of rare yeast forms in sputum. Cutaneous infection generally is from disseminated disease and rarely from direct inoculation.

Unlike many other systemic dimorphic mycoses, blastomycosis usually occurs in healthy hosts and is frequently associated with point-source outbreak. Immunosuppressed patients typically develop infection following exposure to the organism, but reactivation also can occur. Blastomycosis is uncommon among HIV-infected individuals and is not recognized as an AIDS-defining illness.

In a review from Canada of 133 patients with blastomycosis, nearly half had an underlying medical condition but not one typically associated with marked immunosuppression.³ Only 2 of 133 patients had HIV infection. Overall mortality was 6.3%, and the average duration of symptoms before diagnosis was less in those who died vs those who survived the disease.³ In the setting of AIDS or other marked immunosuppression, disease usually is more severe, with multiple-system involvement, including the CNS, and can progress rapidly to death.²

Treatment
Therapy for blastomycosis is determined by the severity of the clinical presentation and consideration of the toxicities of the antifungal agent. There are no randomized, blinded trials comparing antifungal agents, and data on the treatment of blastomycosis in patients infected with HIV are limited. Amphotericin B 3 mg/kg every 24 hours is recommended in life-threatening systemic disease and CNS disease as well as in patients with immune suppression, including AIDS.⁴ In a retrospective study of 326 patients with blastomycosis, those receiving amphotericin B had a cure rate of 86.5% with a relapse rate of 3.9%; patients receiving ketoconazole had a cure rate of 81.7% with a relapse rate of 14%.⁴ Although data are limited, chronic suppressive therapy generally is recommended in patients with HIV who have been treated for blastomycosis. Fluconazole, itraconazole, and ketoconazole are all used as chronic suppressive therapy; however, given the higher relapse rate observed with ketoconazole, itraconazole is preferred. Because neither ketoconazole nor itraconazole penetrates the blood-brain barrier, these drugs are not recommended in cases of CNS involvement. Patients with CNS disease or intolerance to itraconazole should be treated with fluconazole for chronic suppression.³

Blastomycosis is a systemic fungal infection that is endemic in the South Central, Midwest, and southeastern regions of the United States, as well as in provinces of Canada bordering the Great Lakes. After inhalation of Blastomyces dermatitidis spores, which are taken up by bronchopulmonary macrophages, there is an approximate 30- to 45-day incubation period. The initial response at the infected site is suppurative, which progresses to granuloma formation. Blastomyces dermatitidis most commonly infects the lungs, followed by the skin, bones, prostate, and central nervous system (CNS). Therapy for blastomycosis is determined by the severity of the clinical presentation and consideration of the toxicities of the antifungal agent.

We present the case of a 38-year-old man with a medical history of human immunodeficiency virus (HIV) infection and AIDS who reported a 3- to 4-week history of respiratory and cutaneous symptoms. Initial clinical impression favored secondary syphilis; however, after laboratory evaluation and lack of response to treatment for syphilis, further investigation revealed a diagnosis of widespread cutaneous North American blastomycosis.

Case Report

A 38-year-old man with a medical history of HIV infection and AIDS presented to the emergency department at a medical center in Minneapolis, Minnesota, with a cough; chest discomfort; and concomitant nonpainful, mildly pruritic papules and plaques of 3 to 4 weeks’ duration that initially appeared on the face and ears and spread to the trunk, arms, palms, legs, and feet. He had a nonpainful ulcer on the glans penis. Symptoms began while he was living in Atlanta, Georgia, before relocating to Minneapolis. A chest radiograph was negative.

The initial clinical impression favored secondary syphilis. Intramuscular penicillin G benzathine (2.4 million U) weekly for 3 weeks was initiated by the primary care team based on clinical suspicion alone without laboratory evidence of a positive rapid plasma reagin or VDRL test. Because laboratory evaluation and lack of response to treatment did not support syphilis, dermatology consultation was requested.

The patient had a history of crack cocaine abuse. He reported sexual activity with a single female partner while living in a halfway house in the Minneapolis–St. Paul area. Physical examination showed an age-appropriate man in no acute distress who was alert and oriented. He had well-demarcated papules and plaques on the forehead, ears, nose, cutaneous and mucosal lips, chest, back, arms, legs, palms, and soles. Many of the facial papules were pink, nonscaly, and concentrated around the nose and mouth; some were umbilicated (Figure 1). Trunk and extensor papules and plaques were well demarcated, oval, and scaly; some had erosions centrally and were excoriated. Palmar papules were round and had peripheral brown hyperpigmentation and central scale (Figure 2). A 1-cm, shallow, nontender, oval ulceration withraised borders was located on the glans penis under the foreskin (Figure 3).

A rapid plasma reagin test was nonreactive; a fluorescent treponemal antibody absorption test was negative. Chest radiograph, magnetic resonance imaging, and electroencephalogram were normal. In addition, spinal fluid drawn from a tap was negative on India ink and Gram stain preparations and was negative for cryptococcal antigen. In addition, spinal fluid was negative for fungal and bacterial growth, as were blood cultures.

Abnormal tests included a positive enzyme-linked immunosorbent assay and Western blot test for HIV, with an absolute CD4 count of 6 cells/mL and a viral load more than 100,000 copies/mL. Urine histoplasmosis antigen was markedly elevated. A potassium hydroxide preparation was performed on the skin of the right forearm, revealing broad-based budding yeast, later confirmed on skin and sputum cultures to be B dermatitidis.

Punch biopsy from the upper back revealed a mixed acute and granulomatous infiltrate with numerous yeast forms (Figure 4A) that were highlighted by Grocott-Gomori methenamine-silver (Figure 4B) and periodic acid–Schiff (Figure 4C) stains.

Comment

Diagnosis
Our patient had an interesting and dramatic presentation of widespread cutaneous North American blastomycosis that was initially considered to be secondary syphilis because of involvement of the palms and soles and the presence of the painless penile ulcer. In addition, the initial skin biopsy finding was considered morphologically consistent with Cryptococcus neoformans based on positive Grocott-Gomori methenamine-silver and periodic acid–Schiff stains and an equivocal mucicarmine stain. However, the potassium hydroxide preparation of skin and positive urine histoplasmosis antigen strongly suggested blastomycosis, which was confirmed by culture of B dermatitidis. The urine histoplasmosis antigen can cross-react with B dermatitidis and other mycoses (eg, Paracoccidioides brasiliensis and Penicillium marneffei); however, because the treatment of either of these mycoses is similar, the value of the test remains high.¹

Skin tests and serologic markers are useful epidemiologic tools but are of inadequate sensitivity and specificity to be diagnostic for B dermatitidis. Diagnosis depends on direct examination of tissue or isolation of the fungus in culture.²

Source of Infection
The probable occult source of cutaneous infection was the lungs, given the natural history of disseminated blastomycosis; the history of cough and chest discomfort; the widespread nature of skin lesions; and the ultimate growth of rare yeast forms in sputum. Cutaneous infection generally is from disseminated disease and rarely from direct inoculation.

Unlike many other systemic dimorphic mycoses, blastomycosis usually occurs in healthy hosts and is frequently associated with point-source outbreak. Immunosuppressed patients typically develop infection following exposure to the organism, but reactivation also can occur. Blastomycosis is uncommon among HIV-infected individuals and is not recognized as an AIDS-defining illness.

In a review from Canada of 133 patients with blastomycosis, nearly half had an underlying medical condition but not one typically associated with marked immunosuppression.³ Only 2 of 133 patients had HIV infection. Overall mortality was 6.3%, and the average duration of symptoms before diagnosis was less in those who died vs those who survived the disease.³ In the setting of AIDS or other marked immunosuppression, disease usually is more severe, with multiple-system involvement, including the CNS, and can progress rapidly to death.²

Treatment
Therapy for blastomycosis is determined by the severity of the clinical presentation and consideration of the toxicities of the antifungal agent. There are no randomized, blinded trials comparing antifungal agents, and data on the treatment of blastomycosis in patients infected with HIV are limited. Amphotericin B 3 mg/kg every 24 hours is recommended in life-threatening systemic disease and CNS disease as well as in patients with immune suppression, including AIDS.⁴ In a retrospective study of 326 patients with blastomycosis, those receiving amphotericin B had a cure rate of 86.5% with a relapse rate of 3.9%; patients receiving ketoconazole had a cure rate of 81.7% with a relapse rate of 14%.⁴ Although data are limited, chronic suppressive therapy generally is recommended in patients with HIV who have been treated for blastomycosis. Fluconazole, itraconazole, and ketoconazole are all used as chronic suppressive therapy; however, given the higher relapse rate observed with ketoconazole, itraconazole is preferred. Because neither ketoconazole nor itraconazole penetrates the blood-brain barrier, these drugs are not recommended in cases of CNS involvement. Patients with CNS disease or intolerance to itraconazole should be treated with fluconazole for chronic suppression.³

More is not better when it comes to radiation therapy administered with concurrent chemotherapy for unresectable stage III non–small cell lung cancer (NSCLC), suggests a long-term update of the RTOG 0617 trial.

Initial results of the phase 3 randomized controlled trial, at a median follow-up of 1.9 years, showed that median overall survival was about 8 months longer with the 60-Gy standard dose of radiation compared with a 74-Gy high dose, each given along with paclitaxel and carboplatin (Lancet Oncol. 2015;16:187-99).

The update, now at a median follow-up of 5.1 years and reported in the Journal of Clinical Oncology, recapitulates that finding, again showing a roughly 8-month longer overall survival with the standard dose of radiation. Results continue to show no benefit of adding the anti-EGFR antibody cetuximab (Erbitux) to treatment.

“The 5-year overall survival estimate for the standard-dose radiation arm of RTOG 0617, regardless of cetuximab delivery, was 32.1%. This is among the highest overall survival results of any phase III trial for patients with stage III NSCLC,” noted the investigators, led by Jeffrey D. Bradley, MD, department of radiation oncology, Emory University, Atlanta.

“These results argue strongly that the current standard-of-care radiation dose should be 60 Gy given in 2-Gy daily fractions to a target volume directed at tumor plus margin on the basis of CT and PET/CT, excluding elective nodal irradiation.”

The RTOG 0617 trial was conducted among 496 patients with unresectable stage III NSCLC in the United States and Canada. They were randomized to receive standard-dose or high-dose radiation in addition to concurrent chemotherapy, and randomized again to receive cetuximab or not.

SOURCE: Bradley JD et al. J Clin Oncol. 2019 Dec 16. doi: 10.1200/JCO.19.01162.

More is not better when it comes to radiation therapy administered with concurrent chemotherapy for unresectable stage III non–small cell lung cancer (NSCLC), suggests a long-term update of the RTOG 0617 trial.

Initial results of the phase 3 randomized controlled trial, at a median follow-up of 1.9 years, showed that median overall survival was about 8 months longer with the 60-Gy standard dose of radiation compared with a 74-Gy high dose, each given along with paclitaxel and carboplatin (Lancet Oncol. 2015;16:187-99).

The update, now at a median follow-up of 5.1 years and reported in the Journal of Clinical Oncology, recapitulates that finding, again showing a roughly 8-month longer overall survival with the standard dose of radiation. Results continue to show no benefit of adding the anti-EGFR antibody cetuximab (Erbitux) to treatment.

“The 5-year overall survival estimate for the standard-dose radiation arm of RTOG 0617, regardless of cetuximab delivery, was 32.1%. This is among the highest overall survival results of any phase III trial for patients with stage III NSCLC,” noted the investigators, led by Jeffrey D. Bradley, MD, department of radiation oncology, Emory University, Atlanta.

“These results argue strongly that the current standard-of-care radiation dose should be 60 Gy given in 2-Gy daily fractions to a target volume directed at tumor plus margin on the basis of CT and PET/CT, excluding elective nodal irradiation.”

The RTOG 0617 trial was conducted among 496 patients with unresectable stage III NSCLC in the United States and Canada. They were randomized to receive standard-dose or high-dose radiation in addition to concurrent chemotherapy, and randomized again to receive cetuximab or not.

SOURCE: Bradley JD et al. J Clin Oncol. 2019 Dec 16. doi: 10.1200/JCO.19.01162.

More is not better when it comes to radiation therapy administered with concurrent chemotherapy for unresectable stage III non–small cell lung cancer (NSCLC), suggests a long-term update of the RTOG 0617 trial.

Initial results of the phase 3 randomized controlled trial, at a median follow-up of 1.9 years, showed that median overall survival was about 8 months longer with the 60-Gy standard dose of radiation compared with a 74-Gy high dose, each given along with paclitaxel and carboplatin (Lancet Oncol. 2015;16:187-99).

The update, now at a median follow-up of 5.1 years and reported in the Journal of Clinical Oncology, recapitulates that finding, again showing a roughly 8-month longer overall survival with the standard dose of radiation. Results continue to show no benefit of adding the anti-EGFR antibody cetuximab (Erbitux) to treatment.

“The 5-year overall survival estimate for the standard-dose radiation arm of RTOG 0617, regardless of cetuximab delivery, was 32.1%. This is among the highest overall survival results of any phase III trial for patients with stage III NSCLC,” noted the investigators, led by Jeffrey D. Bradley, MD, department of radiation oncology, Emory University, Atlanta.

“These results argue strongly that the current standard-of-care radiation dose should be 60 Gy given in 2-Gy daily fractions to a target volume directed at tumor plus margin on the basis of CT and PET/CT, excluding elective nodal irradiation.”

The RTOG 0617 trial was conducted among 496 patients with unresectable stage III NSCLC in the United States and Canada. They were randomized to receive standard-dose or high-dose radiation in addition to concurrent chemotherapy, and randomized again to receive cetuximab or not.

SOURCE: Bradley JD et al. J Clin Oncol. 2019 Dec 16. doi: 10.1200/JCO.19.01162.

ORLANDO – Lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has demonstrated manageable toxicity and promising clinical activity in the phase 1 portion of a trial enrolling heavily pretreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, according to an investigator.

Andrew D. Bowser/MDedge News

The overall response rate exceeded 80%, and most patients in response at 6 months had maintained that response at the 9-month mark, said Tanya Siddiqi, MD, of City of Hope National Medical Center, Duarte, Calif.

“Clinical responses were rapid, improved with time, and were deep and durable,” Dr. Siddiqi said at the annual meeting of the American Society of Hematology.

These findings have provided justification for conducting the phase 2 portion of the study, which is currently enrolling at the higher of two dose levels evaluated in phase 1, she added.

Dr. Siddiqi reported on a total of 23 patients enrolled in the study, known as TRANSCEND CLL 004. All patients had relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and had received at least two prior therapies, including ibrutinib, while about one-third had failed venetoclax as well.

The median patient age was 66 years, and 83% had high-risk features, according to Dr. Siddiqi, who said patients had received a median of five prior lines of therapy.

Nine patients were treated at dose level 1, or 50 x 10⁶ CAR+ T cells, while 14 were treated at dose level 2, or 100 x 10⁶ CAR+ T cells. Two patients experienced grade 3 or 4 dose-limiting toxicities at the second level, including hypertension in one patient, and encephalopathy, muscle weakness, and tumor lysis syndrome (TLS) in the other.

Cytokine release syndrome (CRS) occurred in 17 patients, though only two cases reached grade 3. Neurologic adverse events were seen in nine patients, of which five were grade 3 or 4.

SOURCE: Siddiqi T et al. ASH 2019, Abstract 503.

ORLANDO – Lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has demonstrated manageable toxicity and promising clinical activity in the phase 1 portion of a trial enrolling heavily pretreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, according to an investigator.

Andrew D. Bowser/MDedge News

The overall response rate exceeded 80%, and most patients in response at 6 months had maintained that response at the 9-month mark, said Tanya Siddiqi, MD, of City of Hope National Medical Center, Duarte, Calif.

“Clinical responses were rapid, improved with time, and were deep and durable,” Dr. Siddiqi said at the annual meeting of the American Society of Hematology.

These findings have provided justification for conducting the phase 2 portion of the study, which is currently enrolling at the higher of two dose levels evaluated in phase 1, she added.

Dr. Siddiqi reported on a total of 23 patients enrolled in the study, known as TRANSCEND CLL 004. All patients had relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and had received at least two prior therapies, including ibrutinib, while about one-third had failed venetoclax as well.

The median patient age was 66 years, and 83% had high-risk features, according to Dr. Siddiqi, who said patients had received a median of five prior lines of therapy.

Nine patients were treated at dose level 1, or 50 x 10⁶ CAR+ T cells, while 14 were treated at dose level 2, or 100 x 10⁶ CAR+ T cells. Two patients experienced grade 3 or 4 dose-limiting toxicities at the second level, including hypertension in one patient, and encephalopathy, muscle weakness, and tumor lysis syndrome (TLS) in the other.

Cytokine release syndrome (CRS) occurred in 17 patients, though only two cases reached grade 3. Neurologic adverse events were seen in nine patients, of which five were grade 3 or 4.

SOURCE: Siddiqi T et al. ASH 2019, Abstract 503.

ORLANDO – Lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has demonstrated manageable toxicity and promising clinical activity in the phase 1 portion of a trial enrolling heavily pretreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, according to an investigator.

Andrew D. Bowser/MDedge News

The overall response rate exceeded 80%, and most patients in response at 6 months had maintained that response at the 9-month mark, said Tanya Siddiqi, MD, of City of Hope National Medical Center, Duarte, Calif.

“Clinical responses were rapid, improved with time, and were deep and durable,” Dr. Siddiqi said at the annual meeting of the American Society of Hematology.

These findings have provided justification for conducting the phase 2 portion of the study, which is currently enrolling at the higher of two dose levels evaluated in phase 1, she added.

Dr. Siddiqi reported on a total of 23 patients enrolled in the study, known as TRANSCEND CLL 004. All patients had relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and had received at least two prior therapies, including ibrutinib, while about one-third had failed venetoclax as well.

The median patient age was 66 years, and 83% had high-risk features, according to Dr. Siddiqi, who said patients had received a median of five prior lines of therapy.

Nine patients were treated at dose level 1, or 50 x 10⁶ CAR+ T cells, while 14 were treated at dose level 2, or 100 x 10⁶ CAR+ T cells. Two patients experienced grade 3 or 4 dose-limiting toxicities at the second level, including hypertension in one patient, and encephalopathy, muscle weakness, and tumor lysis syndrome (TLS) in the other.

Cytokine release syndrome (CRS) occurred in 17 patients, though only two cases reached grade 3. Neurologic adverse events were seen in nine patients, of which five were grade 3 or 4.

SOURCE: Siddiqi T et al. ASH 2019, Abstract 503.

The groove in the patient’s nail, and associated splitting, was due to a digital mucous cyst seen in the photo proximal to the cuticle.

In spite of the name, these cysts do not contain mucus. Instead, they contain synovial fluid and represent an outpouching of the distal interphalangeal joint of the index finger. This same process is called a ganglion cyst when it is seen at the wrist and a Baker’s cyst when it is behind the knee. These cysts typically form from an increase in synovial fluid, often due to underlying osteoarthritis, injury, or degenerative changes of the joint capsule. If the patient is asymptomatic, no treatment is required. Half of the lesions spontaneously resolve. If the patient is symptomatic, treatment options include a steroid injection; aspirating the cyst and then using a compressive cryosurgery tip to freeze the superficial and deep aspects of the cyst to scar it down; and surgical resection of the cyst.

In this case, the patient was in pain because the abnormally shaped nail was breaking. She elected to have a steroid injection into the cyst—0.25 ml of triamcinolone 20 mg/ml. The family physician (FP) advised her that this would reduce the inflammation in the distal interphalangeal joint, hopefully reducing the size of the digital mucous cyst. The FP also indicated that she might require several injections to achieve a positive outcome and that it would take 6 months for her fingernail to return to normal.

‌

Images and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

The groove in the patient’s nail, and associated splitting, was due to a digital mucous cyst seen in the photo proximal to the cuticle.

In spite of the name, these cysts do not contain mucus. Instead, they contain synovial fluid and represent an outpouching of the distal interphalangeal joint of the index finger. This same process is called a ganglion cyst when it is seen at the wrist and a Baker’s cyst when it is behind the knee. These cysts typically form from an increase in synovial fluid, often due to underlying osteoarthritis, injury, or degenerative changes of the joint capsule. If the patient is asymptomatic, no treatment is required. Half of the lesions spontaneously resolve. If the patient is symptomatic, treatment options include a steroid injection; aspirating the cyst and then using a compressive cryosurgery tip to freeze the superficial and deep aspects of the cyst to scar it down; and surgical resection of the cyst.

In this case, the patient was in pain because the abnormally shaped nail was breaking. She elected to have a steroid injection into the cyst—0.25 ml of triamcinolone 20 mg/ml. The family physician (FP) advised her that this would reduce the inflammation in the distal interphalangeal joint, hopefully reducing the size of the digital mucous cyst. The FP also indicated that she might require several injections to achieve a positive outcome and that it would take 6 months for her fingernail to return to normal.

‌

Images and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

The groove in the patient’s nail, and associated splitting, was due to a digital mucous cyst seen in the photo proximal to the cuticle.

In spite of the name, these cysts do not contain mucus. Instead, they contain synovial fluid and represent an outpouching of the distal interphalangeal joint of the index finger. This same process is called a ganglion cyst when it is seen at the wrist and a Baker’s cyst when it is behind the knee. These cysts typically form from an increase in synovial fluid, often due to underlying osteoarthritis, injury, or degenerative changes of the joint capsule. If the patient is asymptomatic, no treatment is required. Half of the lesions spontaneously resolve. If the patient is symptomatic, treatment options include a steroid injection; aspirating the cyst and then using a compressive cryosurgery tip to freeze the superficial and deep aspects of the cyst to scar it down; and surgical resection of the cyst.

In this case, the patient was in pain because the abnormally shaped nail was breaking. She elected to have a steroid injection into the cyst—0.25 ml of triamcinolone 20 mg/ml. The family physician (FP) advised her that this would reduce the inflammation in the distal interphalangeal joint, hopefully reducing the size of the digital mucous cyst. The FP also indicated that she might require several injections to achieve a positive outcome and that it would take 6 months for her fingernail to return to normal.

‌

Images and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

MADRID – A parental history of asthma or allergic rhinitis significantly increases the risk that a child will develop atopic dermatitis, and that risk doubles if a parent has a history of atopic dermatitis rather than another atopic disease, Nina H. Ravn reported at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

She presented a comprehensive meta-analysis of 149 published studies addressing the risk of developing atopic dermatitis according to parental history of atopic disease. The studies included more than 656,000 participants. The picture that emerged from the meta-analysis was one of a stepwise increase in the risk of pediatric atopic dermatitis according to the type and number of parental atopic diseases present.

“This is something that hopefully can be useful when you talk with parents or parents-to-be with atopic diseases and they want to know how their disease might affect their child,” explained Ms. Ravn of the University of Copenhagen.

It’s also information that clinicians will find helpful in appropriately targeting primary prevention interventions if and when methods of proven efficacy become available. That’s a likely prospect, as this is now an extremely active field of research, she noted.

Bruce Jancin/MDedge News

“An interesting result that was new to me what that fathers’ and mothers’ contribution to risk is equal,” said session cochair Andreas Wollenberg, MD, professor of dermatology at Ludwig Maximilian University of Munich. “For the past 2 decades we were always taught that the mother would have a greater impact on that risk.”

“I was also surprised by our findings,” Ms. Ravn replied. “But when we pooled all the data there really was no difference, nor in any of our subanalyses.”

She reported having no financial conflicts regarding her study.

[email protected]

SOURCE: Ravn NH. THE EADV CONGRESS.

MADRID – A parental history of asthma or allergic rhinitis significantly increases the risk that a child will develop atopic dermatitis, and that risk doubles if a parent has a history of atopic dermatitis rather than another atopic disease, Nina H. Ravn reported at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

She presented a comprehensive meta-analysis of 149 published studies addressing the risk of developing atopic dermatitis according to parental history of atopic disease. The studies included more than 656,000 participants. The picture that emerged from the meta-analysis was one of a stepwise increase in the risk of pediatric atopic dermatitis according to the type and number of parental atopic diseases present.

“This is something that hopefully can be useful when you talk with parents or parents-to-be with atopic diseases and they want to know how their disease might affect their child,” explained Ms. Ravn of the University of Copenhagen.

It’s also information that clinicians will find helpful in appropriately targeting primary prevention interventions if and when methods of proven efficacy become available. That’s a likely prospect, as this is now an extremely active field of research, she noted.

Bruce Jancin/MDedge News

“An interesting result that was new to me what that fathers’ and mothers’ contribution to risk is equal,” said session cochair Andreas Wollenberg, MD, professor of dermatology at Ludwig Maximilian University of Munich. “For the past 2 decades we were always taught that the mother would have a greater impact on that risk.”

“I was also surprised by our findings,” Ms. Ravn replied. “But when we pooled all the data there really was no difference, nor in any of our subanalyses.”

She reported having no financial conflicts regarding her study.

[email protected]

SOURCE: Ravn NH. THE EADV CONGRESS.

MADRID – A parental history of asthma or allergic rhinitis significantly increases the risk that a child will develop atopic dermatitis, and that risk doubles if a parent has a history of atopic dermatitis rather than another atopic disease, Nina H. Ravn reported at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

She presented a comprehensive meta-analysis of 149 published studies addressing the risk of developing atopic dermatitis according to parental history of atopic disease. The studies included more than 656,000 participants. The picture that emerged from the meta-analysis was one of a stepwise increase in the risk of pediatric atopic dermatitis according to the type and number of parental atopic diseases present.

“This is something that hopefully can be useful when you talk with parents or parents-to-be with atopic diseases and they want to know how their disease might affect their child,” explained Ms. Ravn of the University of Copenhagen.

It’s also information that clinicians will find helpful in appropriately targeting primary prevention interventions if and when methods of proven efficacy become available. That’s a likely prospect, as this is now an extremely active field of research, she noted.

Bruce Jancin/MDedge News

“An interesting result that was new to me what that fathers’ and mothers’ contribution to risk is equal,” said session cochair Andreas Wollenberg, MD, professor of dermatology at Ludwig Maximilian University of Munich. “For the past 2 decades we were always taught that the mother would have a greater impact on that risk.”

“I was also surprised by our findings,” Ms. Ravn replied. “But when we pooled all the data there really was no difference, nor in any of our subanalyses.”

She reported having no financial conflicts regarding her study.

[email protected]

SOURCE: Ravn NH. THE EADV CONGRESS.

The Food and Drug Administration has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Olivier Le Moal/Getty Images

Ubrogepant is the first drug in the class of oral calcitonin gene–related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” Billy Dunn, MD, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

Ubrogepant represents “an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” added Dr. Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1,439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

“Both 50-mg and 100-mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours, compared with placebo,” Allergan said in a news release announcing approval.

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Olivier Le Moal/Getty Images

Ubrogepant is the first drug in the class of oral calcitonin gene–related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” Billy Dunn, MD, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

Ubrogepant represents “an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” added Dr. Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1,439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

“Both 50-mg and 100-mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours, compared with placebo,” Allergan said in a news release announcing approval.

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Olivier Le Moal/Getty Images

Ubrogepant is the first drug in the class of oral calcitonin gene–related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” Billy Dunn, MD, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

Ubrogepant represents “an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” added Dr. Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1,439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

“Both 50-mg and 100-mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours, compared with placebo,” Allergan said in a news release announcing approval.

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

A version of this story originally appeared on Medscape.com.

The 2020 open enrollment period on HealthCare.gov ended on Dec. 18 after an unplanned extension, but Centers for Medicare & Medicaid Services Administrator Seema Verma touted the system’s stability.

“We are reporting that for the third year in a row enrollment in the Federal Exchange remained stable,” she said in a statement. “For all our successes, too many Americans who do not qualify for subsidies still cannot afford premiums that remain in the stratosphere – constituting a new class of uninsured. The Affordable Care Act remains fundamentally broken and nothing less than wholesale reforms can fix it.”

The open enrollment period was scheduled to end on Dec. 15, but some individuals had problems signing up for coverage that day so the CMS extended the deadline to Dec. 18. During that last “week,” consumers selected over 4.4 million plans – 3.4 million were renewals and just under 1 million were new – bringing the cumulative total for the 2020 enrollment period to 8.3 million plans selected from Nov. 1 to Dec. 17, CMS reported.

Plans selected during the last 3 hours of open enrollment – 12:00 a.m. to 3:00 a.m. on Dec. 18 – are not included in the weekly or final counts, so it’s still possible that the 2020 enrollment could surpass last year’s total of 8.45 million plan selections. The fully updated enrollment data will be released during the second week of January, CMS said.

[email protected]

The 2020 open enrollment period on HealthCare.gov ended on Dec. 18 after an unplanned extension, but Centers for Medicare & Medicaid Services Administrator Seema Verma touted the system’s stability.

“We are reporting that for the third year in a row enrollment in the Federal Exchange remained stable,” she said in a statement. “For all our successes, too many Americans who do not qualify for subsidies still cannot afford premiums that remain in the stratosphere – constituting a new class of uninsured. The Affordable Care Act remains fundamentally broken and nothing less than wholesale reforms can fix it.”

The open enrollment period was scheduled to end on Dec. 15, but some individuals had problems signing up for coverage that day so the CMS extended the deadline to Dec. 18. During that last “week,” consumers selected over 4.4 million plans – 3.4 million were renewals and just under 1 million were new – bringing the cumulative total for the 2020 enrollment period to 8.3 million plans selected from Nov. 1 to Dec. 17, CMS reported.

Plans selected during the last 3 hours of open enrollment – 12:00 a.m. to 3:00 a.m. on Dec. 18 – are not included in the weekly or final counts, so it’s still possible that the 2020 enrollment could surpass last year’s total of 8.45 million plan selections. The fully updated enrollment data will be released during the second week of January, CMS said.

[email protected]

The 2020 open enrollment period on HealthCare.gov ended on Dec. 18 after an unplanned extension, but Centers for Medicare & Medicaid Services Administrator Seema Verma touted the system’s stability.

“We are reporting that for the third year in a row enrollment in the Federal Exchange remained stable,” she said in a statement. “For all our successes, too many Americans who do not qualify for subsidies still cannot afford premiums that remain in the stratosphere – constituting a new class of uninsured. The Affordable Care Act remains fundamentally broken and nothing less than wholesale reforms can fix it.”

The open enrollment period was scheduled to end on Dec. 15, but some individuals had problems signing up for coverage that day so the CMS extended the deadline to Dec. 18. During that last “week,” consumers selected over 4.4 million plans – 3.4 million were renewals and just under 1 million were new – bringing the cumulative total for the 2020 enrollment period to 8.3 million plans selected from Nov. 1 to Dec. 17, CMS reported.

Plans selected during the last 3 hours of open enrollment – 12:00 a.m. to 3:00 a.m. on Dec. 18 – are not included in the weekly or final counts, so it’s still possible that the 2020 enrollment could surpass last year’s total of 8.45 million plan selections. The fully updated enrollment data will be released during the second week of January, CMS said.

[email protected]

Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.

Alicia Ault/MDedge News

The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.

The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.

The appropriations bill offers no offset for the lost revenue.

The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.

Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.

H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.

The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.

There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.

One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.

Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.

“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.

However, ACP called for more action in this area.

“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”

H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.

[email protected]

Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.

Alicia Ault/MDedge News

The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.

The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.

The appropriations bill offers no offset for the lost revenue.

The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.

Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.

H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.

The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.

There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.

One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.

Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.

“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.

However, ACP called for more action in this area.

“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”

H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.

[email protected]

Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.

Alicia Ault/MDedge News

The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.

The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.

The appropriations bill offers no offset for the lost revenue.

The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.

Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.

H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.

The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.

There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.

One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.

Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.

“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.

However, ACP called for more action in this area.

“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”

H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.

[email protected]

At least a quarter of rehospitalizations for vaping-related lung injuries occurred within 2 days of initial discharge, and 13.5% of all deaths have occurred after patients left the hospital, according to the U.S. Centers for Disease Control and Prevention.

Those who required rehospitalization for e-cigarette or vaping product use–associated lung injury (EVALI) and those who died after discharge were more likely to have one or more chronic conditions than were other EVALI patients, and those “who died also were more likely to have been admitted to an intensive care unit, experienced respiratory failure necessitating intubation and mechanical ventilation, and were significantly older,” Christina A. Mikosz, MD, and associates wrote in the Morbidity and Mortality Weekly Report.

Their analysis included the 1,139 EVALI patients who were discharged on or after Oct. 31, 2019. Of that group, 31 (2.7%) patients were rehospitalized and subsequently discharged and another 7 died after the initial discharge. The median age was 54 years for those who died, 27 years for those who were rehospitalized, and 23 for those who survived without rehospitalization, said Dr. Mikosz of the CDC National Center for Injury Prevention and Control, Atlanta, and associates.

Those findings, along with the rates of one or more comorbidities – 83% for those who died, 71% for those who were rehospitalized, and 26% for those who did not die or get readmitted – prompted the CDC to update its guidance for postdischarge follow-up of EVALI patients.

That update involves six specific recommendations to determine readiness for discharge, which include “confirming no clinically significant fluctuations in vital signs for at least 24-48 hours before discharge [and] preparation for hospital discharge and postdischarge care coordination to reduce risk of rehospitalization and death,” Mary E. Evans, MD, and associates said in a separate CDC communication (MMWR. 2019 Dec. 20. 68[early release]:1-6).

As of Dec. 17, the CDC reports that 2,506 patients have been hospitalized with EVALI since March 31, 2019, and 54 deaths have been confirmed in 27 states and the District of Columbia. The outbreak appears to have peaked in September, but cases are still being reported: 13 during the week of Dec. 1-7 and one case for the week of Dec. 8-14.

[email protected]

SOURCE: Mikosz CA et al. MMWR. 2019 Dec. 20. 68[early release]:1-7.

At least a quarter of rehospitalizations for vaping-related lung injuries occurred within 2 days of initial discharge, and 13.5% of all deaths have occurred after patients left the hospital, according to the U.S. Centers for Disease Control and Prevention.

Those who required rehospitalization for e-cigarette or vaping product use–associated lung injury (EVALI) and those who died after discharge were more likely to have one or more chronic conditions than were other EVALI patients, and those “who died also were more likely to have been admitted to an intensive care unit, experienced respiratory failure necessitating intubation and mechanical ventilation, and were significantly older,” Christina A. Mikosz, MD, and associates wrote in the Morbidity and Mortality Weekly Report.

Their analysis included the 1,139 EVALI patients who were discharged on or after Oct. 31, 2019. Of that group, 31 (2.7%) patients were rehospitalized and subsequently discharged and another 7 died after the initial discharge. The median age was 54 years for those who died, 27 years for those who were rehospitalized, and 23 for those who survived without rehospitalization, said Dr. Mikosz of the CDC National Center for Injury Prevention and Control, Atlanta, and associates.

Those findings, along with the rates of one or more comorbidities – 83% for those who died, 71% for those who were rehospitalized, and 26% for those who did not die or get readmitted – prompted the CDC to update its guidance for postdischarge follow-up of EVALI patients.

That update involves six specific recommendations to determine readiness for discharge, which include “confirming no clinically significant fluctuations in vital signs for at least 24-48 hours before discharge [and] preparation for hospital discharge and postdischarge care coordination to reduce risk of rehospitalization and death,” Mary E. Evans, MD, and associates said in a separate CDC communication (MMWR. 2019 Dec. 20. 68[early release]:1-6).

As of Dec. 17, the CDC reports that 2,506 patients have been hospitalized with EVALI since March 31, 2019, and 54 deaths have been confirmed in 27 states and the District of Columbia. The outbreak appears to have peaked in September, but cases are still being reported: 13 during the week of Dec. 1-7 and one case for the week of Dec. 8-14.

[email protected]

SOURCE: Mikosz CA et al. MMWR. 2019 Dec. 20. 68[early release]:1-7.

At least a quarter of rehospitalizations for vaping-related lung injuries occurred within 2 days of initial discharge, and 13.5% of all deaths have occurred after patients left the hospital, according to the U.S. Centers for Disease Control and Prevention.

Those who required rehospitalization for e-cigarette or vaping product use–associated lung injury (EVALI) and those who died after discharge were more likely to have one or more chronic conditions than were other EVALI patients, and those “who died also were more likely to have been admitted to an intensive care unit, experienced respiratory failure necessitating intubation and mechanical ventilation, and were significantly older,” Christina A. Mikosz, MD, and associates wrote in the Morbidity and Mortality Weekly Report.

Their analysis included the 1,139 EVALI patients who were discharged on or after Oct. 31, 2019. Of that group, 31 (2.7%) patients were rehospitalized and subsequently discharged and another 7 died after the initial discharge. The median age was 54 years for those who died, 27 years for those who were rehospitalized, and 23 for those who survived without rehospitalization, said Dr. Mikosz of the CDC National Center for Injury Prevention and Control, Atlanta, and associates.

Those findings, along with the rates of one or more comorbidities – 83% for those who died, 71% for those who were rehospitalized, and 26% for those who did not die or get readmitted – prompted the CDC to update its guidance for postdischarge follow-up of EVALI patients.

That update involves six specific recommendations to determine readiness for discharge, which include “confirming no clinically significant fluctuations in vital signs for at least 24-48 hours before discharge [and] preparation for hospital discharge and postdischarge care coordination to reduce risk of rehospitalization and death,” Mary E. Evans, MD, and associates said in a separate CDC communication (MMWR. 2019 Dec. 20. 68[early release]:1-6).

As of Dec. 17, the CDC reports that 2,506 patients have been hospitalized with EVALI since March 31, 2019, and 54 deaths have been confirmed in 27 states and the District of Columbia. The outbreak appears to have peaked in September, but cases are still being reported: 13 during the week of Dec. 1-7 and one case for the week of Dec. 8-14.

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SOURCE: Mikosz CA et al. MMWR. 2019 Dec. 20. 68[early release]:1-7.

The Food and Drug Administration has approved lemborexant (Dayvigo) for the treatment of insomnia in adults. The agency approved the drug for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.

Lemborexant will be available in 5-mg and 10-mg tablets after the Drug Enforcement Administration schedules the drug, which is expected to occur within 90 days, according to a statement from Eisai.

Lemborexant is an orexin receptor antagonist. Its approval is based on two phase 3 studies, SUNRISE 1 and SUNRISE 2, that included approximately 2,000 adults with insomnia. Investigators assessed lemborexant versus active comparators for as long as 1 month and versus placebo for 6 months.

In these studies, lemborexant significantly improved objective and subjective measures of sleep onset and sleep maintenance, compared with placebo. The medication was not associated with rebound insomnia or withdrawal effects after treatment discontinuation.

In the phase 3 trials, somnolence was the most common adverse reaction that occurred in at least 5% of patients who received lemborexant and at twice the rate in patients who received placebo (lemborexant 10 mg, 10%; lemborexant 5 mg, 7%; placebo, 1%).

In a middle-of-the-night safety study, lemborexant was associated with dose-dependent worsening on measures of attention and memory, compared with placebo. Treatment did not meaningfully affect ability to awaken to sound, however.

Previously reported data showed that lemborexant was effective in male and female patients and was well tolerated by both sexes and that the medication did not impair postural stability and driving performance.

[email protected]

The Food and Drug Administration has approved lemborexant (Dayvigo) for the treatment of insomnia in adults. The agency approved the drug for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.

Lemborexant will be available in 5-mg and 10-mg tablets after the Drug Enforcement Administration schedules the drug, which is expected to occur within 90 days, according to a statement from Eisai.

Lemborexant is an orexin receptor antagonist. Its approval is based on two phase 3 studies, SUNRISE 1 and SUNRISE 2, that included approximately 2,000 adults with insomnia. Investigators assessed lemborexant versus active comparators for as long as 1 month and versus placebo for 6 months.

In these studies, lemborexant significantly improved objective and subjective measures of sleep onset and sleep maintenance, compared with placebo. The medication was not associated with rebound insomnia or withdrawal effects after treatment discontinuation.

In the phase 3 trials, somnolence was the most common adverse reaction that occurred in at least 5% of patients who received lemborexant and at twice the rate in patients who received placebo (lemborexant 10 mg, 10%; lemborexant 5 mg, 7%; placebo, 1%).

In a middle-of-the-night safety study, lemborexant was associated with dose-dependent worsening on measures of attention and memory, compared with placebo. Treatment did not meaningfully affect ability to awaken to sound, however.

Previously reported data showed that lemborexant was effective in male and female patients and was well tolerated by both sexes and that the medication did not impair postural stability and driving performance.

[email protected]

The Food and Drug Administration has approved lemborexant (Dayvigo) for the treatment of insomnia in adults. The agency approved the drug for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.

Lemborexant will be available in 5-mg and 10-mg tablets after the Drug Enforcement Administration schedules the drug, which is expected to occur within 90 days, according to a statement from Eisai.

Lemborexant is an orexin receptor antagonist. Its approval is based on two phase 3 studies, SUNRISE 1 and SUNRISE 2, that included approximately 2,000 adults with insomnia. Investigators assessed lemborexant versus active comparators for as long as 1 month and versus placebo for 6 months.

In these studies, lemborexant significantly improved objective and subjective measures of sleep onset and sleep maintenance, compared with placebo. The medication was not associated with rebound insomnia or withdrawal effects after treatment discontinuation.

In the phase 3 trials, somnolence was the most common adverse reaction that occurred in at least 5% of patients who received lemborexant and at twice the rate in patients who received placebo (lemborexant 10 mg, 10%; lemborexant 5 mg, 7%; placebo, 1%).

In a middle-of-the-night safety study, lemborexant was associated with dose-dependent worsening on measures of attention and memory, compared with placebo. Treatment did not meaningfully affect ability to awaken to sound, however.

Previously reported data showed that lemborexant was effective in male and female patients and was well tolerated by both sexes and that the medication did not impair postural stability and driving performance.

[email protected]