We applaud Kimball et al¹ on their report that adalimumab demonstrated clinical improvement in patients with hidradenitis suppurativa (HS) versus placebo in 2 phase 3 trials. Hidradenitis suppurativa is a chronic relapsing condition with painful subcutaneous abscesses, malodorous drainage, sinus tract formation, and scarring that typically occurs in the axillae and anogenital region. It impairs the quality of life for these patients, as evidenced by higher Dermatology Life Quality Index scores compared to psoriasis, pimples, hand rash, atopic eczema, or control.²

The exact pathogenesis of HS is unknown but likely involves a complex interaction of genetic, hormonal, immunologic, and environmental factors.³ The levels of inflammatory cytokines are elevated in HS lesions, specifically IL-1β, tumor necrosis factor α, IL-10, and CXCL9, as well as monokines from IFN-γ, IL-11, and IL-17A. Additionally, the dermis of affected regions contains IL-12– and IL-23–containing macrophages along with IL-17–producing T cells.³ These findings reveal many potential therapeutic targets for the treatment of HS.

PIONEER I and PIONEER II are similarly designed 36-week phase 3 trials of 633 patients with HS who were unresponsive to oral antibiotic treatment.¹ By week 12, a significantly greater proportion of patients receiving adalimumab demonstrated clinical improvement (≥50% reduction in total abscess and nodule count) compared to placebo in both trials (PIONEER I: 41.8% vs 26.0%, P=.003; PIONEER II: 58.9% vs 27.6%, P<.001). Secondary end points (inflammatory-nodule count, pain score, and disease severity) were only achieved in PIONEER II. The difference in clinical improvement between the trials is likely due to higher baseline disease severity in the HS patients in PIONEER I versus PIONEER II. No new safety risks were reported and were in accordance with prior adalimumab trials for other diseases. Notably, 10 paradoxical psoriasislike eruptions were reported.¹

Adalimumab is the first and only US Food and Drug Administration–approved therapy for HS. Further understanding of the pathogenesis of HS may result in additional biologic treatments for HS. We encourage the manufacturers of other biologic therapies, such as infliximab,⁴ ustekinumab,⁵ anakinra,⁶ secukinumab, ixekizumab, and brodalumab, to consider conducting further clinical trials in HS to enhance the therapeutic options available for this debilitating disease.

We applaud Kimball et al¹ on their report that adalimumab demonstrated clinical improvement in patients with hidradenitis suppurativa (HS) versus placebo in 2 phase 3 trials. Hidradenitis suppurativa is a chronic relapsing condition with painful subcutaneous abscesses, malodorous drainage, sinus tract formation, and scarring that typically occurs in the axillae and anogenital region. It impairs the quality of life for these patients, as evidenced by higher Dermatology Life Quality Index scores compared to psoriasis, pimples, hand rash, atopic eczema, or control.²

The exact pathogenesis of HS is unknown but likely involves a complex interaction of genetic, hormonal, immunologic, and environmental factors.³ The levels of inflammatory cytokines are elevated in HS lesions, specifically IL-1β, tumor necrosis factor α, IL-10, and CXCL9, as well as monokines from IFN-γ, IL-11, and IL-17A. Additionally, the dermis of affected regions contains IL-12– and IL-23–containing macrophages along with IL-17–producing T cells.³ These findings reveal many potential therapeutic targets for the treatment of HS.

PIONEER I and PIONEER II are similarly designed 36-week phase 3 trials of 633 patients with HS who were unresponsive to oral antibiotic treatment.¹ By week 12, a significantly greater proportion of patients receiving adalimumab demonstrated clinical improvement (≥50% reduction in total abscess and nodule count) compared to placebo in both trials (PIONEER I: 41.8% vs 26.0%, P=.003; PIONEER II: 58.9% vs 27.6%, P<.001). Secondary end points (inflammatory-nodule count, pain score, and disease severity) were only achieved in PIONEER II. The difference in clinical improvement between the trials is likely due to higher baseline disease severity in the HS patients in PIONEER I versus PIONEER II. No new safety risks were reported and were in accordance with prior adalimumab trials for other diseases. Notably, 10 paradoxical psoriasislike eruptions were reported.¹

Adalimumab is the first and only US Food and Drug Administration–approved therapy for HS. Further understanding of the pathogenesis of HS may result in additional biologic treatments for HS. We encourage the manufacturers of other biologic therapies, such as infliximab,⁴ ustekinumab,⁵ anakinra,⁶ secukinumab, ixekizumab, and brodalumab, to consider conducting further clinical trials in HS to enhance the therapeutic options available for this debilitating disease.

We applaud Kimball et al¹ on their report that adalimumab demonstrated clinical improvement in patients with hidradenitis suppurativa (HS) versus placebo in 2 phase 3 trials. Hidradenitis suppurativa is a chronic relapsing condition with painful subcutaneous abscesses, malodorous drainage, sinus tract formation, and scarring that typically occurs in the axillae and anogenital region. It impairs the quality of life for these patients, as evidenced by higher Dermatology Life Quality Index scores compared to psoriasis, pimples, hand rash, atopic eczema, or control.²

The exact pathogenesis of HS is unknown but likely involves a complex interaction of genetic, hormonal, immunologic, and environmental factors.³ The levels of inflammatory cytokines are elevated in HS lesions, specifically IL-1β, tumor necrosis factor α, IL-10, and CXCL9, as well as monokines from IFN-γ, IL-11, and IL-17A. Additionally, the dermis of affected regions contains IL-12– and IL-23–containing macrophages along with IL-17–producing T cells.³ These findings reveal many potential therapeutic targets for the treatment of HS.

PIONEER I and PIONEER II are similarly designed 36-week phase 3 trials of 633 patients with HS who were unresponsive to oral antibiotic treatment.¹ By week 12, a significantly greater proportion of patients receiving adalimumab demonstrated clinical improvement (≥50% reduction in total abscess and nodule count) compared to placebo in both trials (PIONEER I: 41.8% vs 26.0%, P=.003; PIONEER II: 58.9% vs 27.6%, P<.001). Secondary end points (inflammatory-nodule count, pain score, and disease severity) were only achieved in PIONEER II. The difference in clinical improvement between the trials is likely due to higher baseline disease severity in the HS patients in PIONEER I versus PIONEER II. No new safety risks were reported and were in accordance with prior adalimumab trials for other diseases. Notably, 10 paradoxical psoriasislike eruptions were reported.¹

Adalimumab is the first and only US Food and Drug Administration–approved therapy for HS. Further understanding of the pathogenesis of HS may result in additional biologic treatments for HS. We encourage the manufacturers of other biologic therapies, such as infliximab,⁴ ustekinumab,⁵ anakinra,⁶ secukinumab, ixekizumab, and brodalumab, to consider conducting further clinical trials in HS to enhance the therapeutic options available for this debilitating disease.

Avène A-OXitive

Pierre Fabre Dermo-Cosmetique introduces Avène A-OXitive Antioxidant Defense Serum and Avène A-OXitive Antioxidant Water-Cream to fight against oxidative stress. Stable forms of time-released vitamin E and vitamin C work synergistically to defend against environmental aggressors without irritation. Both products contain hyaluronic acid to visibly plump and firm the skin and soothing Avène thermal spring water to soften and restore the skin’s balance. To preserve stability, each formula comes in an airless pump bottle. For more information, visit www.aveneusa.com.

Orencia

Bristol-Myers Squibb Company announces US Food and Drug Administration approval of Orencia (abatacept) for the treatment of adults with active psoriatic arthritis. Orencia is available in both intravenous and subcutaneous injection formulations. It should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use with other biologic rheumatoid arthritis therapy. Orencia also is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis. For more information, visit www.orenciahcp.com.

Tremfya

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Tremfya is administered as a 100-mg subcutaneous injection every 8 weeks, following 2 starter doses at weeks 0 and 4. Clinical studies documented skin clearance at week 16 and up to week 48. For more information, visit www.tremfyahcp.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Avène A-OXitive

Pierre Fabre Dermo-Cosmetique introduces Avène A-OXitive Antioxidant Defense Serum and Avène A-OXitive Antioxidant Water-Cream to fight against oxidative stress. Stable forms of time-released vitamin E and vitamin C work synergistically to defend against environmental aggressors without irritation. Both products contain hyaluronic acid to visibly plump and firm the skin and soothing Avène thermal spring water to soften and restore the skin’s balance. To preserve stability, each formula comes in an airless pump bottle. For more information, visit www.aveneusa.com.

Orencia

Bristol-Myers Squibb Company announces US Food and Drug Administration approval of Orencia (abatacept) for the treatment of adults with active psoriatic arthritis. Orencia is available in both intravenous and subcutaneous injection formulations. It should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use with other biologic rheumatoid arthritis therapy. Orencia also is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis. For more information, visit www.orenciahcp.com.

Tremfya

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Tremfya is administered as a 100-mg subcutaneous injection every 8 weeks, following 2 starter doses at weeks 0 and 4. Clinical studies documented skin clearance at week 16 and up to week 48. For more information, visit www.tremfyahcp.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Avène A-OXitive

Pierre Fabre Dermo-Cosmetique introduces Avène A-OXitive Antioxidant Defense Serum and Avène A-OXitive Antioxidant Water-Cream to fight against oxidative stress. Stable forms of time-released vitamin E and vitamin C work synergistically to defend against environmental aggressors without irritation. Both products contain hyaluronic acid to visibly plump and firm the skin and soothing Avène thermal spring water to soften and restore the skin’s balance. To preserve stability, each formula comes in an airless pump bottle. For more information, visit www.aveneusa.com.

Orencia

Bristol-Myers Squibb Company announces US Food and Drug Administration approval of Orencia (abatacept) for the treatment of adults with active psoriatic arthritis. Orencia is available in both intravenous and subcutaneous injection formulations. It should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use with other biologic rheumatoid arthritis therapy. Orencia also is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis. For more information, visit www.orenciahcp.com.

Tremfya

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Tremfya is administered as a 100-mg subcutaneous injection every 8 weeks, following 2 starter doses at weeks 0 and 4. Clinical studies documented skin clearance at week 16 and up to week 48. For more information, visit www.tremfyahcp.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Clinicians who have attempted to perform an in-office procedure on infants or young children will recognize the difficulties that arise from the developmental inability to cooperate with procedures.¹ Potential problems mentioned in the literature include but are not limited to anxiety, which is identified in all age groups of patients undergoing dermatologic procedures²; limitation of pain control³; and poor outcomes due to movement by the patient.¹ In one author’s experience (N.B.S.), anxious and scared children can potentially cause injury to themselves, parents/guardians, and health care professionals by flailing and kicking; children are flexible and can wriggle out of even fine grips, and some children, especially toddlers, can be strong.

The usage of topical anesthetics can only give superficial anesthesia. They can ostensibly reduce pain and are useful for anesthesia of curettage, but their use is limited in infants and young children by the minimal amount of drug that is safe for application, as risks of absorption include methemoglobinemia and seizure activity, and especially by lack of cooperation by the child.⁴ Infiltrative anesthesia is needed for adequate pain control in addition to a topical anesthetic for many procedures.³

General anesthesia seems to be the best alternative due to associated amnesia of the events occurring including pain; immobilization and ability to produce more accurate biopsy sampling; better immobilization leading to superior cosmetic results; and reduced risk to patients, parents/guardians, and health care professionals from a flailing child. In the field of pediatric dermatology, general anesthesia often is used for excision of larger lesions and cosmetic repairs. Operating room privileges are not always easy to obtain, but many pediatric dermatologists take advantage of outpatient surgical centers associated with their medical center. A retrospective review of 226 children receiving 681 procedures at a single institution documented low rates of complications.¹

If it was that easy, most children would be anesthetized with general anesthesia. However, there are risks associated with general anesthesia. Parents/guardians often will do what they can to avoid risk and may therefore refuse general anesthesia, but it is not completely avoidable in complicated skin disease. Despite the risks, the benefit is present in a major anomaly correction such as a cleft palate in a 6-month-old but may not be there for the treatment of a wart. When procedures are nonessential or may be conducted without anesthesia, avoidance of general anesthesia is reasonable and a combination of topical and local infiltrative anesthesia can help. In the American Academy of Dermatology guidelines on in-office anesthesia, Kouba et al⁵ states: “Topical agents are recommended as a first-line method of anesthesia for the repair of dermal lacerations in children and for other minor dermatologic procedures, including curettage. For skin biopsy, excision, or other cases where topical agents alone are insufficient, adjunctive use of topical anesthesia to lessen the discomfort of infiltrative anesthetic should be considered.”

A new controversy recently has emerged concerning the potential risks of anesthesia on neurocognitive development in infants and young children. These concerns regardingthe labeling changes of anesthetic and sedation drugs by the US Food and Drug Administration (FDA) in December 2016 specifically focused on these risks in children younger than 3 years with prolonged (>3 hours) and repeated exposures; however, this kind of exposure is unlikely with standard pediatric dermatologic procedures.^6-9

There is compelling evidence from animal studies that exposure to all anesthetic agents in clinical use induces neurotoxicity and long-term adverse neurobehavioral deficits; however, whether these findings are applicable in human infants is unknown.^6-9 Most of the studies in humans showing adverse outcomes have been retrospective observational studies subject to multiple sources of bias. Two recent large clinical studies—the GAS (General Anaesthesia compared to Spinal anaesthesia) trial¹⁰ and the PANDA (Pediatric Anesthesia and Neurodevelopment Assessment) study¹¹—have shown no evidence of abnormal neurocognitive effects with a single brief exposure before 3 years of age (PANDA) or during infancy (GAS) in otherwise-healthy children.^10,11

It is important to note that the FDA labeling change warning specifically stated that “[c]onsistent with animal studies, recent human data suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” Moreover, the FDA emphasized that “Surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary.”¹² Taking these points into consideration, we should offer our patients in-office care when possible and postpone elective procedures when advisable but proceed when necessary for our patients’ physical and emotional health.

Clinicians who have attempted to perform an in-office procedure on infants or young children will recognize the difficulties that arise from the developmental inability to cooperate with procedures.¹ Potential problems mentioned in the literature include but are not limited to anxiety, which is identified in all age groups of patients undergoing dermatologic procedures²; limitation of pain control³; and poor outcomes due to movement by the patient.¹ In one author’s experience (N.B.S.), anxious and scared children can potentially cause injury to themselves, parents/guardians, and health care professionals by flailing and kicking; children are flexible and can wriggle out of even fine grips, and some children, especially toddlers, can be strong.

The usage of topical anesthetics can only give superficial anesthesia. They can ostensibly reduce pain and are useful for anesthesia of curettage, but their use is limited in infants and young children by the minimal amount of drug that is safe for application, as risks of absorption include methemoglobinemia and seizure activity, and especially by lack of cooperation by the child.⁴ Infiltrative anesthesia is needed for adequate pain control in addition to a topical anesthetic for many procedures.³

General anesthesia seems to be the best alternative due to associated amnesia of the events occurring including pain; immobilization and ability to produce more accurate biopsy sampling; better immobilization leading to superior cosmetic results; and reduced risk to patients, parents/guardians, and health care professionals from a flailing child. In the field of pediatric dermatology, general anesthesia often is used for excision of larger lesions and cosmetic repairs. Operating room privileges are not always easy to obtain, but many pediatric dermatologists take advantage of outpatient surgical centers associated with their medical center. A retrospective review of 226 children receiving 681 procedures at a single institution documented low rates of complications.¹

If it was that easy, most children would be anesthetized with general anesthesia. However, there are risks associated with general anesthesia. Parents/guardians often will do what they can to avoid risk and may therefore refuse general anesthesia, but it is not completely avoidable in complicated skin disease. Despite the risks, the benefit is present in a major anomaly correction such as a cleft palate in a 6-month-old but may not be there for the treatment of a wart. When procedures are nonessential or may be conducted without anesthesia, avoidance of general anesthesia is reasonable and a combination of topical and local infiltrative anesthesia can help. In the American Academy of Dermatology guidelines on in-office anesthesia, Kouba et al⁵ states: “Topical agents are recommended as a first-line method of anesthesia for the repair of dermal lacerations in children and for other minor dermatologic procedures, including curettage. For skin biopsy, excision, or other cases where topical agents alone are insufficient, adjunctive use of topical anesthesia to lessen the discomfort of infiltrative anesthetic should be considered.”

A new controversy recently has emerged concerning the potential risks of anesthesia on neurocognitive development in infants and young children. These concerns regardingthe labeling changes of anesthetic and sedation drugs by the US Food and Drug Administration (FDA) in December 2016 specifically focused on these risks in children younger than 3 years with prolonged (>3 hours) and repeated exposures; however, this kind of exposure is unlikely with standard pediatric dermatologic procedures.^6-9

There is compelling evidence from animal studies that exposure to all anesthetic agents in clinical use induces neurotoxicity and long-term adverse neurobehavioral deficits; however, whether these findings are applicable in human infants is unknown.^6-9 Most of the studies in humans showing adverse outcomes have been retrospective observational studies subject to multiple sources of bias. Two recent large clinical studies—the GAS (General Anaesthesia compared to Spinal anaesthesia) trial¹⁰ and the PANDA (Pediatric Anesthesia and Neurodevelopment Assessment) study¹¹—have shown no evidence of abnormal neurocognitive effects with a single brief exposure before 3 years of age (PANDA) or during infancy (GAS) in otherwise-healthy children.^10,11

It is important to note that the FDA labeling change warning specifically stated that “[c]onsistent with animal studies, recent human data suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” Moreover, the FDA emphasized that “Surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary.”¹² Taking these points into consideration, we should offer our patients in-office care when possible and postpone elective procedures when advisable but proceed when necessary for our patients’ physical and emotional health.

Clinicians who have attempted to perform an in-office procedure on infants or young children will recognize the difficulties that arise from the developmental inability to cooperate with procedures.¹ Potential problems mentioned in the literature include but are not limited to anxiety, which is identified in all age groups of patients undergoing dermatologic procedures²; limitation of pain control³; and poor outcomes due to movement by the patient.¹ In one author’s experience (N.B.S.), anxious and scared children can potentially cause injury to themselves, parents/guardians, and health care professionals by flailing and kicking; children are flexible and can wriggle out of even fine grips, and some children, especially toddlers, can be strong.

The usage of topical anesthetics can only give superficial anesthesia. They can ostensibly reduce pain and are useful for anesthesia of curettage, but their use is limited in infants and young children by the minimal amount of drug that is safe for application, as risks of absorption include methemoglobinemia and seizure activity, and especially by lack of cooperation by the child.⁴ Infiltrative anesthesia is needed for adequate pain control in addition to a topical anesthetic for many procedures.³

General anesthesia seems to be the best alternative due to associated amnesia of the events occurring including pain; immobilization and ability to produce more accurate biopsy sampling; better immobilization leading to superior cosmetic results; and reduced risk to patients, parents/guardians, and health care professionals from a flailing child. In the field of pediatric dermatology, general anesthesia often is used for excision of larger lesions and cosmetic repairs. Operating room privileges are not always easy to obtain, but many pediatric dermatologists take advantage of outpatient surgical centers associated with their medical center. A retrospective review of 226 children receiving 681 procedures at a single institution documented low rates of complications.¹

If it was that easy, most children would be anesthetized with general anesthesia. However, there are risks associated with general anesthesia. Parents/guardians often will do what they can to avoid risk and may therefore refuse general anesthesia, but it is not completely avoidable in complicated skin disease. Despite the risks, the benefit is present in a major anomaly correction such as a cleft palate in a 6-month-old but may not be there for the treatment of a wart. When procedures are nonessential or may be conducted without anesthesia, avoidance of general anesthesia is reasonable and a combination of topical and local infiltrative anesthesia can help. In the American Academy of Dermatology guidelines on in-office anesthesia, Kouba et al⁵ states: “Topical agents are recommended as a first-line method of anesthesia for the repair of dermal lacerations in children and for other minor dermatologic procedures, including curettage. For skin biopsy, excision, or other cases where topical agents alone are insufficient, adjunctive use of topical anesthesia to lessen the discomfort of infiltrative anesthetic should be considered.”

A new controversy recently has emerged concerning the potential risks of anesthesia on neurocognitive development in infants and young children. These concerns regardingthe labeling changes of anesthetic and sedation drugs by the US Food and Drug Administration (FDA) in December 2016 specifically focused on these risks in children younger than 3 years with prolonged (>3 hours) and repeated exposures; however, this kind of exposure is unlikely with standard pediatric dermatologic procedures.^6-9

There is compelling evidence from animal studies that exposure to all anesthetic agents in clinical use induces neurotoxicity and long-term adverse neurobehavioral deficits; however, whether these findings are applicable in human infants is unknown.^6-9 Most of the studies in humans showing adverse outcomes have been retrospective observational studies subject to multiple sources of bias. Two recent large clinical studies—the GAS (General Anaesthesia compared to Spinal anaesthesia) trial¹⁰ and the PANDA (Pediatric Anesthesia and Neurodevelopment Assessment) study¹¹—have shown no evidence of abnormal neurocognitive effects with a single brief exposure before 3 years of age (PANDA) or during infancy (GAS) in otherwise-healthy children.^10,11

It is important to note that the FDA labeling change warning specifically stated that “[c]onsistent with animal studies, recent human data suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” Moreover, the FDA emphasized that “Surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary.”¹² Taking these points into consideration, we should offer our patients in-office care when possible and postpone elective procedures when advisable but proceed when necessary for our patients’ physical and emotional health.

Adults who were previously employed are twice as likely to report daily or almost-daily pain than are those who are currently employed, according to the Centers for Disease Control and Prevention.

In an ongoing survey, just over 30% of adults aged 18 years and older who were previously employed reported that they experienced pain on “most days or every day” in the past 6 months, compared with 15% of those who were currently employed and 19% of those classified as never employed, investigators from the CDC estimated (MMWR. 2017 Jul 28;66[29]:796).

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Adults who were previously employed are twice as likely to report daily or almost-daily pain than are those who are currently employed, according to the Centers for Disease Control and Prevention.

In an ongoing survey, just over 30% of adults aged 18 years and older who were previously employed reported that they experienced pain on “most days or every day” in the past 6 months, compared with 15% of those who were currently employed and 19% of those classified as never employed, investigators from the CDC estimated (MMWR. 2017 Jul 28;66[29]:796).

[email protected]

Adults who were previously employed are twice as likely to report daily or almost-daily pain than are those who are currently employed, according to the Centers for Disease Control and Prevention.

In an ongoing survey, just over 30% of adults aged 18 years and older who were previously employed reported that they experienced pain on “most days or every day” in the past 6 months, compared with 15% of those who were currently employed and 19% of those classified as never employed, investigators from the CDC estimated (MMWR. 2017 Jul 28;66[29]:796).

[email protected]

Table of Contents

• The Challenges of Precision Medicine and New Advances in Molecular Diagnostic Testing in Hematolymphoid Malignancies: Impact on the VHA
• Systems Automation for Cancer Surveillance: A Lean Six Sigma Project for Tracking Care of Patients With Head and Neck Cancer
• Open Clinical Trials for Patients With Renal Cell Carcinoma
• Innovations Lead to More Targeted Prostate Cancer Treatments
• Depression Screening and Treatment: A Missed Opportunity in Lung Cancer Care
• Acute Leukemia of Ambiguous Lineage in Elderly Patients: A SEER Medicare Database Analysis
• Treatment and Management of Patients With Non-Small Cell Lung Cancer
• Do Erythropoiesis-Stimulating Agents Have a Risk Evaluation and Mitigation Strategy?

Table of Contents

• The Challenges of Precision Medicine and New Advances in Molecular Diagnostic Testing in Hematolymphoid Malignancies: Impact on the VHA
• Systems Automation for Cancer Surveillance: A Lean Six Sigma Project for Tracking Care of Patients With Head and Neck Cancer
• Open Clinical Trials for Patients With Renal Cell Carcinoma
• Innovations Lead to More Targeted Prostate Cancer Treatments
• Depression Screening and Treatment: A Missed Opportunity in Lung Cancer Care
• Acute Leukemia of Ambiguous Lineage in Elderly Patients: A SEER Medicare Database Analysis
• Treatment and Management of Patients With Non-Small Cell Lung Cancer
• Do Erythropoiesis-Stimulating Agents Have a Risk Evaluation and Mitigation Strategy?

Table of Contents

• The Challenges of Precision Medicine and New Advances in Molecular Diagnostic Testing in Hematolymphoid Malignancies: Impact on the VHA
• Systems Automation for Cancer Surveillance: A Lean Six Sigma Project for Tracking Care of Patients With Head and Neck Cancer
• Open Clinical Trials for Patients With Renal Cell Carcinoma
• Innovations Lead to More Targeted Prostate Cancer Treatments
• Depression Screening and Treatment: A Missed Opportunity in Lung Cancer Care
• Acute Leukemia of Ambiguous Lineage in Elderly Patients: A SEER Medicare Database Analysis
• Treatment and Management of Patients With Non-Small Cell Lung Cancer
• Do Erythropoiesis-Stimulating Agents Have a Risk Evaluation and Mitigation Strategy?

“Chronic Lyme disease” is sometimes a catchall diagnosis for patients with a wide spectrum of musculoskeletal and neuropsychiatric symptoms, fatigue, and generalized pain. That, in turn, has led to a variety of treatments: courses of antibiotics lasting for months to years, IV infusions of hydrogen peroxide, immunoglobulin therapy, even stem cell transplants. Those treatments, though, may not lead to substantial long-term improvement—in fact, they can be harmful.

Clinicians, health departments, and patients have contacted the CDC reporting life-threatening complications resulting from treatment for chronic Lyme disease, including metastatic bacterial infections, septic shock, Clostridium difficile (C diff) colitis, and abscess. An article in Morbidity and Mortality Weekly Report (MMWR) described 5 cases that “highlight the severity and scope” of adverse effects caused by the use of unproven treatments for chronic Lyme disease.

 One patient with fatigue and joint pain, was diagnosed with chronic Lyme disease, babesiosis, and Bartonella infection. When the symptoms worsened despite multiple courses of oral antibiotics, the patient was switched to IV ceftriaxone and cefotaxime. However, the pain did not lessen; the patient became hypotensive and tachycardic and was placed in intensive care. Her condition continued to worsen, and she died. The patient’s death was attributed to septic shock related to central venous catheter–associated bacteremia.

In another case, a woman was first diagnosed with amyotrophic lateral sclerosis, then as a second opinion, with chronic Lyme disease. After 7 months of intensive antimicrobial treatment, the pain improved but she got weaker. She also developed intractable C diff infection that required prolonged treatment. However, the patient died of complications of amyotrophic lateral sclerosis—an example, the researchers say, of a missed opportunity for appropriate treatment due to misdiagnosis.

Antibiotics and immunoglobulin therapies are effective and necessary treatments for many conditions, MMWR emphasized—“however, unnecessary antibiotic and immunoglobulin use provides no benefit to patients while putting them at risk for adverse events.”

“Chronic Lyme disease” is sometimes a catchall diagnosis for patients with a wide spectrum of musculoskeletal and neuropsychiatric symptoms, fatigue, and generalized pain. That, in turn, has led to a variety of treatments: courses of antibiotics lasting for months to years, IV infusions of hydrogen peroxide, immunoglobulin therapy, even stem cell transplants. Those treatments, though, may not lead to substantial long-term improvement—in fact, they can be harmful.

Clinicians, health departments, and patients have contacted the CDC reporting life-threatening complications resulting from treatment for chronic Lyme disease, including metastatic bacterial infections, septic shock, Clostridium difficile (C diff) colitis, and abscess. An article in Morbidity and Mortality Weekly Report (MMWR) described 5 cases that “highlight the severity and scope” of adverse effects caused by the use of unproven treatments for chronic Lyme disease.

 One patient with fatigue and joint pain, was diagnosed with chronic Lyme disease, babesiosis, and Bartonella infection. When the symptoms worsened despite multiple courses of oral antibiotics, the patient was switched to IV ceftriaxone and cefotaxime. However, the pain did not lessen; the patient became hypotensive and tachycardic and was placed in intensive care. Her condition continued to worsen, and she died. The patient’s death was attributed to septic shock related to central venous catheter–associated bacteremia.

In another case, a woman was first diagnosed with amyotrophic lateral sclerosis, then as a second opinion, with chronic Lyme disease. After 7 months of intensive antimicrobial treatment, the pain improved but she got weaker. She also developed intractable C diff infection that required prolonged treatment. However, the patient died of complications of amyotrophic lateral sclerosis—an example, the researchers say, of a missed opportunity for appropriate treatment due to misdiagnosis.

Antibiotics and immunoglobulin therapies are effective and necessary treatments for many conditions, MMWR emphasized—“however, unnecessary antibiotic and immunoglobulin use provides no benefit to patients while putting them at risk for adverse events.”

“Chronic Lyme disease” is sometimes a catchall diagnosis for patients with a wide spectrum of musculoskeletal and neuropsychiatric symptoms, fatigue, and generalized pain. That, in turn, has led to a variety of treatments: courses of antibiotics lasting for months to years, IV infusions of hydrogen peroxide, immunoglobulin therapy, even stem cell transplants. Those treatments, though, may not lead to substantial long-term improvement—in fact, they can be harmful.

Clinicians, health departments, and patients have contacted the CDC reporting life-threatening complications resulting from treatment for chronic Lyme disease, including metastatic bacterial infections, septic shock, Clostridium difficile (C diff) colitis, and abscess. An article in Morbidity and Mortality Weekly Report (MMWR) described 5 cases that “highlight the severity and scope” of adverse effects caused by the use of unproven treatments for chronic Lyme disease.

 One patient with fatigue and joint pain, was diagnosed with chronic Lyme disease, babesiosis, and Bartonella infection. When the symptoms worsened despite multiple courses of oral antibiotics, the patient was switched to IV ceftriaxone and cefotaxime. However, the pain did not lessen; the patient became hypotensive and tachycardic and was placed in intensive care. Her condition continued to worsen, and she died. The patient’s death was attributed to septic shock related to central venous catheter–associated bacteremia.

In another case, a woman was first diagnosed with amyotrophic lateral sclerosis, then as a second opinion, with chronic Lyme disease. After 7 months of intensive antimicrobial treatment, the pain improved but she got weaker. She also developed intractable C diff infection that required prolonged treatment. However, the patient died of complications of amyotrophic lateral sclerosis—an example, the researchers say, of a missed opportunity for appropriate treatment due to misdiagnosis.

Antibiotics and immunoglobulin therapies are effective and necessary treatments for many conditions, MMWR emphasized—“however, unnecessary antibiotic and immunoglobulin use provides no benefit to patients while putting them at risk for adverse events.”

Photo from Business Wire

The US Food and Drug Administration (FDA) has approved marketing of the oral IDH2 inhibitor enasidenib (IDHIFA®).

The drug is now approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) and an IDH2 mutation, as detected by an FDA-approved test.

Enasidenib is available in 50 mg and 100 mg tablets. The recommended dose is 100 mg once daily until disease progression or unacceptable toxicity.

The prescribing information for enasidenib includes a boxed warning that the drug may cause differentiation syndrome, and this adverse event (AE) can be fatal if not treated.

Signs and symptoms of differentiation syndrome may include fever, dyspnea, acute respiratory distress, radiographic pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain, peripheral edema, and hepatic, renal, or multi-organ dysfunction. At first suspicion of symptoms, doctors should treat patients with corticosteroids and monitor patients closely until symptoms resolve.

Companion diagnostic

Enasidenib was approved concurrently with the Abbott RealTime™ IDH2 companion diagnostic test, which was approved as an aid in identifying AML patients for treatment with enasidenib.

The FDA granted approval of enasidenib to Celgene Corporation and approval of the RealTime IDH2 Assay to Abbott Laboratories.

Enasidenib is licensed from Agios Pharmaceuticals.

Trial results

The FDA’s approval of enasidenib and the companion diagnostic test was based on data from a phase 1/2 trial (Study AG221-C-001, NCT01915498).

Data from this trial were recently presented at the ASCO 2017 Annual Meeting. However, the definitive data are included in the prescribing information for enasidenib.

The prescribing information includes efficacy data for 199 adults with relapsed/refractory AML and an IDH2 mutation. IDH2 mutations were identified or confirmed by the Abbott RealTime™ IDH2 test.

The 199 patients received enasidenib at a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage side effects.

The patients’ median age was 68 (range, 19 to 100). They received a median of 2 prior anticancer regimens (range, 1 to 6). More than half (52%) were refractory to previous therapy.

The rate of complete response (CR) or CR with partial hematologic improvement (CRh) was 23% (n=46). The median duration of CR/CRh was 8.2 months (range, 4.3 to 19.4).

For patients who achieved a CR/CRh, the median time to first response was 1.9 months (range, 0.5 to 7.5), and the median time to best response of CR/CRh was 3.7 months (range, 0.6 to 11.2).

Among the 157 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 53 (34%) became independent of RBC and platelet transfusions during any 56-day period post-baseline.

Of the 42 patients who were independent of both RBC and platelet transfusions at baseline, 32 (76%) remained transfusion independent during any 56-day post-baseline period.

Researchers evaluated the safety of enasidenib in 214 patients. The median duration of exposure to enasidenib was 4.3 months (range, 0.3 to 23.6).

The most common AEs of any grade (≥20%) were nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite.

Serious AEs were reported in 77.1% of patients. The most frequent serious AEs (≥2%) were leukocytosis, diarrhea, nausea, vomiting, decreased appetite, tumor lysis syndrome, and differentiation syndrome.

The 30-day and 60-day mortality rates were 4.2% (9/214) and 11.7% (25/214), respectively.

Photo from Business Wire

The US Food and Drug Administration (FDA) has approved marketing of the oral IDH2 inhibitor enasidenib (IDHIFA®).

The drug is now approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) and an IDH2 mutation, as detected by an FDA-approved test.

Enasidenib is available in 50 mg and 100 mg tablets. The recommended dose is 100 mg once daily until disease progression or unacceptable toxicity.

The prescribing information for enasidenib includes a boxed warning that the drug may cause differentiation syndrome, and this adverse event (AE) can be fatal if not treated.

Signs and symptoms of differentiation syndrome may include fever, dyspnea, acute respiratory distress, radiographic pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain, peripheral edema, and hepatic, renal, or multi-organ dysfunction. At first suspicion of symptoms, doctors should treat patients with corticosteroids and monitor patients closely until symptoms resolve.

Companion diagnostic

Enasidenib was approved concurrently with the Abbott RealTime™ IDH2 companion diagnostic test, which was approved as an aid in identifying AML patients for treatment with enasidenib.

The FDA granted approval of enasidenib to Celgene Corporation and approval of the RealTime IDH2 Assay to Abbott Laboratories.

Enasidenib is licensed from Agios Pharmaceuticals.

Trial results

The FDA’s approval of enasidenib and the companion diagnostic test was based on data from a phase 1/2 trial (Study AG221-C-001, NCT01915498).

Data from this trial were recently presented at the ASCO 2017 Annual Meeting. However, the definitive data are included in the prescribing information for enasidenib.

The prescribing information includes efficacy data for 199 adults with relapsed/refractory AML and an IDH2 mutation. IDH2 mutations were identified or confirmed by the Abbott RealTime™ IDH2 test.

The 199 patients received enasidenib at a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage side effects.

The patients’ median age was 68 (range, 19 to 100). They received a median of 2 prior anticancer regimens (range, 1 to 6). More than half (52%) were refractory to previous therapy.

The rate of complete response (CR) or CR with partial hematologic improvement (CRh) was 23% (n=46). The median duration of CR/CRh was 8.2 months (range, 4.3 to 19.4).

For patients who achieved a CR/CRh, the median time to first response was 1.9 months (range, 0.5 to 7.5), and the median time to best response of CR/CRh was 3.7 months (range, 0.6 to 11.2).

Among the 157 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 53 (34%) became independent of RBC and platelet transfusions during any 56-day period post-baseline.

Of the 42 patients who were independent of both RBC and platelet transfusions at baseline, 32 (76%) remained transfusion independent during any 56-day post-baseline period.

Researchers evaluated the safety of enasidenib in 214 patients. The median duration of exposure to enasidenib was 4.3 months (range, 0.3 to 23.6).

The most common AEs of any grade (≥20%) were nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite.

Serious AEs were reported in 77.1% of patients. The most frequent serious AEs (≥2%) were leukocytosis, diarrhea, nausea, vomiting, decreased appetite, tumor lysis syndrome, and differentiation syndrome.

The 30-day and 60-day mortality rates were 4.2% (9/214) and 11.7% (25/214), respectively.

Photo from Business Wire

The US Food and Drug Administration (FDA) has approved marketing of the oral IDH2 inhibitor enasidenib (IDHIFA®).

The drug is now approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) and an IDH2 mutation, as detected by an FDA-approved test.

Enasidenib is available in 50 mg and 100 mg tablets. The recommended dose is 100 mg once daily until disease progression or unacceptable toxicity.

The prescribing information for enasidenib includes a boxed warning that the drug may cause differentiation syndrome, and this adverse event (AE) can be fatal if not treated.

Signs and symptoms of differentiation syndrome may include fever, dyspnea, acute respiratory distress, radiographic pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain, peripheral edema, and hepatic, renal, or multi-organ dysfunction. At first suspicion of symptoms, doctors should treat patients with corticosteroids and monitor patients closely until symptoms resolve.

Companion diagnostic

Enasidenib was approved concurrently with the Abbott RealTime™ IDH2 companion diagnostic test, which was approved as an aid in identifying AML patients for treatment with enasidenib.

The FDA granted approval of enasidenib to Celgene Corporation and approval of the RealTime IDH2 Assay to Abbott Laboratories.

Enasidenib is licensed from Agios Pharmaceuticals.

Trial results

The FDA’s approval of enasidenib and the companion diagnostic test was based on data from a phase 1/2 trial (Study AG221-C-001, NCT01915498).

Data from this trial were recently presented at the ASCO 2017 Annual Meeting. However, the definitive data are included in the prescribing information for enasidenib.

The prescribing information includes efficacy data for 199 adults with relapsed/refractory AML and an IDH2 mutation. IDH2 mutations were identified or confirmed by the Abbott RealTime™ IDH2 test.

The 199 patients received enasidenib at a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage side effects.

The patients’ median age was 68 (range, 19 to 100). They received a median of 2 prior anticancer regimens (range, 1 to 6). More than half (52%) were refractory to previous therapy.

The rate of complete response (CR) or CR with partial hematologic improvement (CRh) was 23% (n=46). The median duration of CR/CRh was 8.2 months (range, 4.3 to 19.4).

For patients who achieved a CR/CRh, the median time to first response was 1.9 months (range, 0.5 to 7.5), and the median time to best response of CR/CRh was 3.7 months (range, 0.6 to 11.2).

Among the 157 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 53 (34%) became independent of RBC and platelet transfusions during any 56-day period post-baseline.

Of the 42 patients who were independent of both RBC and platelet transfusions at baseline, 32 (76%) remained transfusion independent during any 56-day post-baseline period.

Researchers evaluated the safety of enasidenib in 214 patients. The median duration of exposure to enasidenib was 4.3 months (range, 0.3 to 23.6).

The most common AEs of any grade (≥20%) were nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite.

Serious AEs were reported in 77.1% of patients. The most frequent serious AEs (≥2%) were leukocytosis, diarrhea, nausea, vomiting, decreased appetite, tumor lysis syndrome, and differentiation syndrome.

The 30-day and 60-day mortality rates were 4.2% (9/214) and 11.7% (25/214), respectively.

Photo courtesy of the CDC

A diagnosis of delirium during a visit to the emergency department (ED) is a poor prognostic factor for patients with advanced cancer, according to research published in The Oncologist.

The study showed that patients with advanced cancer who were diagnosed with delirium during an ED visit were more likely to be admitted to the hospital or intensive care unit (ICU) and more likely to die earlier than patients without delirium.

This shows the importance of accurately diagnosing delirium in advanced cancer patients, said Ahmed Elsayem, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Previous studies have shown that delirium is associated with poor survival in advanced cancer patients being treated in ICUs or receiving palliative care in hospices, but no one had investigated whether the same was true for patients visiting EDs.

“To the best our knowledge, this is the first study to show the poor survival of advanced cancer patients in the emergency department setting,” Dr Elsayem said.

He and his colleagues previously conducted a study in which they assessed the frequency of delirium in advanced cancer patients visiting the ED at MD Anderson. The researchers tested for delirium using 2 questionnaires—the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).

Questioning 243 patients in total, the team found that 44 patients, or 18%, were suffering with delirium according to at least 1 of the questionnaires.

In the current study, Dr Elsayem and his colleagues determined how many of these cancer patients, with and without delirium, were subsequently admitted to hospital and ICUs, as well as how long the patients lived after their visit to the ED.

Results

The rate of hospitalization was 82% among patients with delirium according to CAM and/or MDAS, 77% among patients with delirium according to MDAS only, and 49% among patients without delirium (P=0.0013). Rates of ICU admission were 18%, 14%, and 2%, respectively (P=0.0004).

The median overall survival was 1.23 months for patients with delirium according to CAM and/or MDAS, 4.70 months for patients with delirium according to MDAS only, and 10.45 months for patients without delirium. The difference between the patients with and without delirium was significant (P<0.0001).

Given the influence delirium appears to have on survival, Dr Elsayem said prompt diagnosis and management in hospital EDs is essential.

He noted that, in many cases, delirium in advanced cancer patients can be resolved by simply stopping or modifying their medication and treating any associated infections.

“Treating the triggers if known—such as stopping medications—is the main treatment for an episode of delirium,” Dr Elsayem said.

He also suggested that further research needs to be done on this topic, including conducting similar studies on delirium in advanced cancer patients in other EDs and with larger groups of patients.

Photo courtesy of the CDC

A diagnosis of delirium during a visit to the emergency department (ED) is a poor prognostic factor for patients with advanced cancer, according to research published in The Oncologist.

The study showed that patients with advanced cancer who were diagnosed with delirium during an ED visit were more likely to be admitted to the hospital or intensive care unit (ICU) and more likely to die earlier than patients without delirium.

This shows the importance of accurately diagnosing delirium in advanced cancer patients, said Ahmed Elsayem, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Previous studies have shown that delirium is associated with poor survival in advanced cancer patients being treated in ICUs or receiving palliative care in hospices, but no one had investigated whether the same was true for patients visiting EDs.

“To the best our knowledge, this is the first study to show the poor survival of advanced cancer patients in the emergency department setting,” Dr Elsayem said.

He and his colleagues previously conducted a study in which they assessed the frequency of delirium in advanced cancer patients visiting the ED at MD Anderson. The researchers tested for delirium using 2 questionnaires—the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).

Questioning 243 patients in total, the team found that 44 patients, or 18%, were suffering with delirium according to at least 1 of the questionnaires.

In the current study, Dr Elsayem and his colleagues determined how many of these cancer patients, with and without delirium, were subsequently admitted to hospital and ICUs, as well as how long the patients lived after their visit to the ED.

Results

The rate of hospitalization was 82% among patients with delirium according to CAM and/or MDAS, 77% among patients with delirium according to MDAS only, and 49% among patients without delirium (P=0.0013). Rates of ICU admission were 18%, 14%, and 2%, respectively (P=0.0004).

The median overall survival was 1.23 months for patients with delirium according to CAM and/or MDAS, 4.70 months for patients with delirium according to MDAS only, and 10.45 months for patients without delirium. The difference between the patients with and without delirium was significant (P<0.0001).

Given the influence delirium appears to have on survival, Dr Elsayem said prompt diagnosis and management in hospital EDs is essential.

He noted that, in many cases, delirium in advanced cancer patients can be resolved by simply stopping or modifying their medication and treating any associated infections.

“Treating the triggers if known—such as stopping medications—is the main treatment for an episode of delirium,” Dr Elsayem said.

He also suggested that further research needs to be done on this topic, including conducting similar studies on delirium in advanced cancer patients in other EDs and with larger groups of patients.

Photo courtesy of the CDC

A diagnosis of delirium during a visit to the emergency department (ED) is a poor prognostic factor for patients with advanced cancer, according to research published in The Oncologist.

The study showed that patients with advanced cancer who were diagnosed with delirium during an ED visit were more likely to be admitted to the hospital or intensive care unit (ICU) and more likely to die earlier than patients without delirium.

This shows the importance of accurately diagnosing delirium in advanced cancer patients, said Ahmed Elsayem, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Previous studies have shown that delirium is associated with poor survival in advanced cancer patients being treated in ICUs or receiving palliative care in hospices, but no one had investigated whether the same was true for patients visiting EDs.

“To the best our knowledge, this is the first study to show the poor survival of advanced cancer patients in the emergency department setting,” Dr Elsayem said.

He and his colleagues previously conducted a study in which they assessed the frequency of delirium in advanced cancer patients visiting the ED at MD Anderson. The researchers tested for delirium using 2 questionnaires—the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).

Questioning 243 patients in total, the team found that 44 patients, or 18%, were suffering with delirium according to at least 1 of the questionnaires.

In the current study, Dr Elsayem and his colleagues determined how many of these cancer patients, with and without delirium, were subsequently admitted to hospital and ICUs, as well as how long the patients lived after their visit to the ED.

Results

The rate of hospitalization was 82% among patients with delirium according to CAM and/or MDAS, 77% among patients with delirium according to MDAS only, and 49% among patients without delirium (P=0.0013). Rates of ICU admission were 18%, 14%, and 2%, respectively (P=0.0004).

The median overall survival was 1.23 months for patients with delirium according to CAM and/or MDAS, 4.70 months for patients with delirium according to MDAS only, and 10.45 months for patients without delirium. The difference between the patients with and without delirium was significant (P<0.0001).

Given the influence delirium appears to have on survival, Dr Elsayem said prompt diagnosis and management in hospital EDs is essential.

He noted that, in many cases, delirium in advanced cancer patients can be resolved by simply stopping or modifying their medication and treating any associated infections.

“Treating the triggers if known—such as stopping medications—is the main treatment for an episode of delirium,” Dr Elsayem said.

He also suggested that further research needs to be done on this topic, including conducting similar studies on delirium in advanced cancer patients in other EDs and with larger groups of patients.

Mantle cell lymphoma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to acalabrutinib, a BTK inhibitor being developed to treat multiple B-cell malignancies.

The breakthrough designation applies to acalabrutinib as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

The FDA granted acalabrutinib breakthrough designation based on data from the drug’s development program, which includes data from the phase 2 ACE-LY-004 trial in patients with relapsed or refractory MCL.

Data from this trial have not yet been released to the public but are expected to be presented at an upcoming medical meeting.

Mantle cell lymphoma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to acalabrutinib, a BTK inhibitor being developed to treat multiple B-cell malignancies.

The breakthrough designation applies to acalabrutinib as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

The FDA granted acalabrutinib breakthrough designation based on data from the drug’s development program, which includes data from the phase 2 ACE-LY-004 trial in patients with relapsed or refractory MCL.

Data from this trial have not yet been released to the public but are expected to be presented at an upcoming medical meeting.

Mantle cell lymphoma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to acalabrutinib, a BTK inhibitor being developed to treat multiple B-cell malignancies.

The breakthrough designation applies to acalabrutinib as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

The FDA granted acalabrutinib breakthrough designation based on data from the drug’s development program, which includes data from the phase 2 ACE-LY-004 trial in patients with relapsed or refractory MCL.

Data from this trial have not yet been released to the public but are expected to be presented at an upcoming medical meeting.

ANSWER

The correct interpretation includes normal sinus rhythm, evidence of a previous inferior MI, an anterior MI, and lateral ischemia (evidenced by ST- and T-wave abnormalities in the lateral chest leads).

Normal sinus rhythm is demonstrated by the presence of a P wave for every QRS complex and a QRS complex for every P wave, with a consistent PR interval of 72 beats/min. The Q waves in leads II, III, and aVF indicate an old inferior MI.

Progression of proximal LAD stenosis and an anterior MI is evidenced by the ST segment elevations in leads V₁ to V₃, and lateral ischemia is represented by ST- and T-wave abnormalities in leads V₄ to V₆. Note that there are also Q waves in leads V₄ to V₆, which suggest a previously undiagnosed lateral MI.

ANSWER

The correct interpretation includes normal sinus rhythm, evidence of a previous inferior MI, an anterior MI, and lateral ischemia (evidenced by ST- and T-wave abnormalities in the lateral chest leads).

Normal sinus rhythm is demonstrated by the presence of a P wave for every QRS complex and a QRS complex for every P wave, with a consistent PR interval of 72 beats/min. The Q waves in leads II, III, and aVF indicate an old inferior MI.

Progression of proximal LAD stenosis and an anterior MI is evidenced by the ST segment elevations in leads V₁ to V₃, and lateral ischemia is represented by ST- and T-wave abnormalities in leads V₄ to V₆. Note that there are also Q waves in leads V₄ to V₆, which suggest a previously undiagnosed lateral MI.

ANSWER

The correct interpretation includes normal sinus rhythm, evidence of a previous inferior MI, an anterior MI, and lateral ischemia (evidenced by ST- and T-wave abnormalities in the lateral chest leads).

Normal sinus rhythm is demonstrated by the presence of a P wave for every QRS complex and a QRS complex for every P wave, with a consistent PR interval of 72 beats/min. The Q waves in leads II, III, and aVF indicate an old inferior MI.

Progression of proximal LAD stenosis and an anterior MI is evidenced by the ST segment elevations in leads V₁ to V₃, and lateral ischemia is represented by ST- and T-wave abnormalities in leads V₄ to V₆. Note that there are also Q waves in leads V₄ to V₆, which suggest a previously undiagnosed lateral MI.