Why are you bothering to read this? What could I offer that could possibly be useful to you? In fact, I was invited to write this column simply because I happened to be at the right conference at the right time. Soon, if not already, you’ll discover I’m actually not that clever. I’m an impostor.

I’ve thought this while staring at the blank page that is to be my article for the month. Reflecting on it, I realize you’ve probably had the same feelings of fraud at one time or another. Impostor syndrome is common. It is the experience of believing you don’t deserve a role or success despite evidence to the contrary. It often occurs at moments of transition, such as when you were accepted into medical school or matched into a competitive specialty. Looking at your peers, watching how your colleagues perform, you feel you just aren’t smart enough to be there; either someone made a mistake or you just got lucky.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Why are you bothering to read this? What could I offer that could possibly be useful to you? In fact, I was invited to write this column simply because I happened to be at the right conference at the right time. Soon, if not already, you’ll discover I’m actually not that clever. I’m an impostor.

I’ve thought this while staring at the blank page that is to be my article for the month. Reflecting on it, I realize you’ve probably had the same feelings of fraud at one time or another. Impostor syndrome is common. It is the experience of believing you don’t deserve a role or success despite evidence to the contrary. It often occurs at moments of transition, such as when you were accepted into medical school or matched into a competitive specialty. Looking at your peers, watching how your colleagues perform, you feel you just aren’t smart enough to be there; either someone made a mistake or you just got lucky.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Why are you bothering to read this? What could I offer that could possibly be useful to you? In fact, I was invited to write this column simply because I happened to be at the right conference at the right time. Soon, if not already, you’ll discover I’m actually not that clever. I’m an impostor.

I’ve thought this while staring at the blank page that is to be my article for the month. Reflecting on it, I realize you’ve probably had the same feelings of fraud at one time or another. Impostor syndrome is common. It is the experience of believing you don’t deserve a role or success despite evidence to the contrary. It often occurs at moments of transition, such as when you were accepted into medical school or matched into a competitive specialty. Looking at your peers, watching how your colleagues perform, you feel you just aren’t smart enough to be there; either someone made a mistake or you just got lucky.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

The Diagnosis: Hypopigmented Mycosis Fungoides

The patient was started on clobetasol dipropionate cream 0.05% twice daily, which she did not tolerate due to a burning sensation on application. She then was started on narrowband UVB phototherapy 2 to 3 times weekly, and the hypopigmented areas began to improve. Narrowband UVB phototherapy was discontinued after 7 weeks due to the high cost to the patient, but the hypopigmented patches on the left thigh appeared to remit, and the patient did not return to the clinic for 6 months. She returned when the areas on the left thigh reappeared, along with new areas on the right buttock and right medial upper arm. Serial biopsies of the new patches also revealed a CD8⁺ atypical lymphocytic infiltrate consistent with hypopigmented patch-stage mycosis fungoides (MF). She was started on halobetasol ointment 0.05% twice daily to affected areas, which she tolerated well. Complete blood count and peripheral blood smear were unremarkable, and the patient continued to deny systemic symptoms. Over the next year, the patient's cutaneous findings continued to wax and wane with topical treatment, and she was referred to a regional cancer treatment center for a second opinion from a hematopathologist. Hematopathologic and dermatopathologic review of the case, including hematoxylin and eosin and immunohistochemical staining, was highly consistent with hypopigmented MF (Figures 1-3).

Mycosis fungoides is an uncommon disease characterized by atypical clonal T cells exhibiting epidermotropism. Most commonly, MF is characterized by a CD4⁺ lymphocytic infiltrate. Mycosis fungoides can be difficult to diagnose in its early stages, as it may resemble benign inflammatory conditions (eg, chronic atopic dermatitis, nummular eczema) and often requires biopsy and additional studies, such as immunohistochemistry, to secure a diagnosis. Hypopigmented MF is regarded as a subtype of MF, as it can exhibit different clinical and pathologic characteristics from classical MF. In particular, the lymphocytic phenotype in hypopigmented MF is more likely to be CD8⁺. 

In general, the progression of MF is characterized as stage IA (patches or plaques involving less than 10% body surface area [BSA]), IB (patches or plaques involving ≥10% BSA without lymph node or visceral involvement), IIA (patches or plaques of any percentage of BSA with lymph node involvement), IIB (cutaneous tumors with or without lymph node involvement), III (erythroderma with low blood tumor burden), or IV (erythroderma with high blood tumor burden with or without visceral involvement). Hypopigmented MF generally presents in early patch stage and rarely progresses past stage IB, and thus generally has a favorable prognosis.^1,2 Kim et al³ demonstrated that evolution from patch to plaque stage MF is accompanied by a shift in lymphocytes from the T helper 1 (Th1) to T helper 2 phenotype; therefore the Th1 phenotype, CD8⁺ T cells are associated with lower risk for disease progression. Other investigators also have hypothesized that predominance of Th1 phenotype, CD8⁺ T cells may have an immunoregulatory effect, thus preventing evolution of disease from patch to plaque stage and explaining why hypopigmented MF, with a predominantly CD8⁺ phenotype, confers better prognosis with less chance for disease progression than classical MF.^4,5 The patch- or plaque-stage lesions of classical MF have a predilection for non-sun exposed areas (eg, buttocks, medial thighs, breasts),² whereas hypopigmented MF tends to present with hypopigmented or depigmented lesions mainly distributed on the trunk, arms, and legs. These lesions may become more visible following sun exposure.¹ The size of the hypopigmented lesions can vary, and patients may complain of pruritus with variable intensity.

Hypopigmented MF presents more commonly in younger populations, in contrast to classical MF.^6-8 However, like classical MF, hypopigmented MF appears to more frequently affect individuals with darker Fitzpatrick skin types.^1,9,10 Although it generally is accepted that hypopigmented MF does not favor either sex, some studies suggest that hypopigmented MF has a female predominance.^6,10

Classical MF is characterized by an epidermotropic infiltrate of CD4⁺ T helper cells,¹⁰ whereas CD8⁺ epidermotropism is considered hallmark in hypopigmented MF.^10-12 The other typical histopathologic features of hypopigmented MF generally are identical to those of classical MF, with solitary or small groups of atypical haloed lymphocytes within the basal layer, exocytosis of lymphocytes out of proportion to spongiosis, and papillary dermal fibrosis. Immunohistochemistry generally is helpful in distinguishing between classical MF and hypopigmented MF.

The clinical differential diagnosis for hypopigmented MF includes the early (inflammatory) stage of vitiligo, postinflammatory hypopigmentation, lichen sclerosus, pityriasis alba, and leprosy.

First-line treatment for hypopigmented MF consists of phototherapy/photochemotherapy and topical steroids.^9,13 Narrowband UVB phototherapy has been used with good success in pediatric patients.¹⁴ However, narrowband UVB may not be as effective in darker-skinned individuals; it has been hypothesized that this lack of efficacy could be due to the protective effects of increased melanin in the skin.¹ Other topical therapies may include topical carmustine and topical nitrogen mustard.

The Diagnosis: Hypopigmented Mycosis Fungoides

The patient was started on clobetasol dipropionate cream 0.05% twice daily, which she did not tolerate due to a burning sensation on application. She then was started on narrowband UVB phototherapy 2 to 3 times weekly, and the hypopigmented areas began to improve. Narrowband UVB phototherapy was discontinued after 7 weeks due to the high cost to the patient, but the hypopigmented patches on the left thigh appeared to remit, and the patient did not return to the clinic for 6 months. She returned when the areas on the left thigh reappeared, along with new areas on the right buttock and right medial upper arm. Serial biopsies of the new patches also revealed a CD8⁺ atypical lymphocytic infiltrate consistent with hypopigmented patch-stage mycosis fungoides (MF). She was started on halobetasol ointment 0.05% twice daily to affected areas, which she tolerated well. Complete blood count and peripheral blood smear were unremarkable, and the patient continued to deny systemic symptoms. Over the next year, the patient's cutaneous findings continued to wax and wane with topical treatment, and she was referred to a regional cancer treatment center for a second opinion from a hematopathologist. Hematopathologic and dermatopathologic review of the case, including hematoxylin and eosin and immunohistochemical staining, was highly consistent with hypopigmented MF (Figures 1-3).

Mycosis fungoides is an uncommon disease characterized by atypical clonal T cells exhibiting epidermotropism. Most commonly, MF is characterized by a CD4⁺ lymphocytic infiltrate. Mycosis fungoides can be difficult to diagnose in its early stages, as it may resemble benign inflammatory conditions (eg, chronic atopic dermatitis, nummular eczema) and often requires biopsy and additional studies, such as immunohistochemistry, to secure a diagnosis. Hypopigmented MF is regarded as a subtype of MF, as it can exhibit different clinical and pathologic characteristics from classical MF. In particular, the lymphocytic phenotype in hypopigmented MF is more likely to be CD8⁺. 

In general, the progression of MF is characterized as stage IA (patches or plaques involving less than 10% body surface area [BSA]), IB (patches or plaques involving ≥10% BSA without lymph node or visceral involvement), IIA (patches or plaques of any percentage of BSA with lymph node involvement), IIB (cutaneous tumors with or without lymph node involvement), III (erythroderma with low blood tumor burden), or IV (erythroderma with high blood tumor burden with or without visceral involvement). Hypopigmented MF generally presents in early patch stage and rarely progresses past stage IB, and thus generally has a favorable prognosis.^1,2 Kim et al³ demonstrated that evolution from patch to plaque stage MF is accompanied by a shift in lymphocytes from the T helper 1 (Th1) to T helper 2 phenotype; therefore the Th1 phenotype, CD8⁺ T cells are associated with lower risk for disease progression. Other investigators also have hypothesized that predominance of Th1 phenotype, CD8⁺ T cells may have an immunoregulatory effect, thus preventing evolution of disease from patch to plaque stage and explaining why hypopigmented MF, with a predominantly CD8⁺ phenotype, confers better prognosis with less chance for disease progression than classical MF.^4,5 The patch- or plaque-stage lesions of classical MF have a predilection for non-sun exposed areas (eg, buttocks, medial thighs, breasts),² whereas hypopigmented MF tends to present with hypopigmented or depigmented lesions mainly distributed on the trunk, arms, and legs. These lesions may become more visible following sun exposure.¹ The size of the hypopigmented lesions can vary, and patients may complain of pruritus with variable intensity.

Hypopigmented MF presents more commonly in younger populations, in contrast to classical MF.^6-8 However, like classical MF, hypopigmented MF appears to more frequently affect individuals with darker Fitzpatrick skin types.^1,9,10 Although it generally is accepted that hypopigmented MF does not favor either sex, some studies suggest that hypopigmented MF has a female predominance.^6,10

Classical MF is characterized by an epidermotropic infiltrate of CD4⁺ T helper cells,¹⁰ whereas CD8⁺ epidermotropism is considered hallmark in hypopigmented MF.^10-12 The other typical histopathologic features of hypopigmented MF generally are identical to those of classical MF, with solitary or small groups of atypical haloed lymphocytes within the basal layer, exocytosis of lymphocytes out of proportion to spongiosis, and papillary dermal fibrosis. Immunohistochemistry generally is helpful in distinguishing between classical MF and hypopigmented MF.

The clinical differential diagnosis for hypopigmented MF includes the early (inflammatory) stage of vitiligo, postinflammatory hypopigmentation, lichen sclerosus, pityriasis alba, and leprosy.

First-line treatment for hypopigmented MF consists of phototherapy/photochemotherapy and topical steroids.^9,13 Narrowband UVB phototherapy has been used with good success in pediatric patients.¹⁴ However, narrowband UVB may not be as effective in darker-skinned individuals; it has been hypothesized that this lack of efficacy could be due to the protective effects of increased melanin in the skin.¹ Other topical therapies may include topical carmustine and topical nitrogen mustard.

The Diagnosis: Hypopigmented Mycosis Fungoides

The patient was started on clobetasol dipropionate cream 0.05% twice daily, which she did not tolerate due to a burning sensation on application. She then was started on narrowband UVB phototherapy 2 to 3 times weekly, and the hypopigmented areas began to improve. Narrowband UVB phototherapy was discontinued after 7 weeks due to the high cost to the patient, but the hypopigmented patches on the left thigh appeared to remit, and the patient did not return to the clinic for 6 months. She returned when the areas on the left thigh reappeared, along with new areas on the right buttock and right medial upper arm. Serial biopsies of the new patches also revealed a CD8⁺ atypical lymphocytic infiltrate consistent with hypopigmented patch-stage mycosis fungoides (MF). She was started on halobetasol ointment 0.05% twice daily to affected areas, which she tolerated well. Complete blood count and peripheral blood smear were unremarkable, and the patient continued to deny systemic symptoms. Over the next year, the patient's cutaneous findings continued to wax and wane with topical treatment, and she was referred to a regional cancer treatment center for a second opinion from a hematopathologist. Hematopathologic and dermatopathologic review of the case, including hematoxylin and eosin and immunohistochemical staining, was highly consistent with hypopigmented MF (Figures 1-3).

Mycosis fungoides is an uncommon disease characterized by atypical clonal T cells exhibiting epidermotropism. Most commonly, MF is characterized by a CD4⁺ lymphocytic infiltrate. Mycosis fungoides can be difficult to diagnose in its early stages, as it may resemble benign inflammatory conditions (eg, chronic atopic dermatitis, nummular eczema) and often requires biopsy and additional studies, such as immunohistochemistry, to secure a diagnosis. Hypopigmented MF is regarded as a subtype of MF, as it can exhibit different clinical and pathologic characteristics from classical MF. In particular, the lymphocytic phenotype in hypopigmented MF is more likely to be CD8⁺. 

In general, the progression of MF is characterized as stage IA (patches or plaques involving less than 10% body surface area [BSA]), IB (patches or plaques involving ≥10% BSA without lymph node or visceral involvement), IIA (patches or plaques of any percentage of BSA with lymph node involvement), IIB (cutaneous tumors with or without lymph node involvement), III (erythroderma with low blood tumor burden), or IV (erythroderma with high blood tumor burden with or without visceral involvement). Hypopigmented MF generally presents in early patch stage and rarely progresses past stage IB, and thus generally has a favorable prognosis.^1,2 Kim et al³ demonstrated that evolution from patch to plaque stage MF is accompanied by a shift in lymphocytes from the T helper 1 (Th1) to T helper 2 phenotype; therefore the Th1 phenotype, CD8⁺ T cells are associated with lower risk for disease progression. Other investigators also have hypothesized that predominance of Th1 phenotype, CD8⁺ T cells may have an immunoregulatory effect, thus preventing evolution of disease from patch to plaque stage and explaining why hypopigmented MF, with a predominantly CD8⁺ phenotype, confers better prognosis with less chance for disease progression than classical MF.^4,5 The patch- or plaque-stage lesions of classical MF have a predilection for non-sun exposed areas (eg, buttocks, medial thighs, breasts),² whereas hypopigmented MF tends to present with hypopigmented or depigmented lesions mainly distributed on the trunk, arms, and legs. These lesions may become more visible following sun exposure.¹ The size of the hypopigmented lesions can vary, and patients may complain of pruritus with variable intensity.

Hypopigmented MF presents more commonly in younger populations, in contrast to classical MF.^6-8 However, like classical MF, hypopigmented MF appears to more frequently affect individuals with darker Fitzpatrick skin types.^1,9,10 Although it generally is accepted that hypopigmented MF does not favor either sex, some studies suggest that hypopigmented MF has a female predominance.^6,10

Classical MF is characterized by an epidermotropic infiltrate of CD4⁺ T helper cells,¹⁰ whereas CD8⁺ epidermotropism is considered hallmark in hypopigmented MF.^10-12 The other typical histopathologic features of hypopigmented MF generally are identical to those of classical MF, with solitary or small groups of atypical haloed lymphocytes within the basal layer, exocytosis of lymphocytes out of proportion to spongiosis, and papillary dermal fibrosis. Immunohistochemistry generally is helpful in distinguishing between classical MF and hypopigmented MF.

The clinical differential diagnosis for hypopigmented MF includes the early (inflammatory) stage of vitiligo, postinflammatory hypopigmentation, lichen sclerosus, pityriasis alba, and leprosy.

First-line treatment for hypopigmented MF consists of phototherapy/photochemotherapy and topical steroids.^9,13 Narrowband UVB phototherapy has been used with good success in pediatric patients.¹⁴ However, narrowband UVB may not be as effective in darker-skinned individuals; it has been hypothesized that this lack of efficacy could be due to the protective effects of increased melanin in the skin.¹ Other topical therapies may include topical carmustine and topical nitrogen mustard.

KAUAI, HAWAII – The novel interleukin-17 inhibitor bimekizumab achieved “remarkable” outcomes for moderate to severe plaque psoriasis in the phase 2b BE ABLE study.

And that’s not all: Much the same was true in patients with psoriatic arthritis in the parallel phase 2b BE ACTIVE study and for ankylosing spondylitis in the BE AGILE study. BE ABLE was a double-blind, 12-week, multicenter, five-arm, placebo-controlled, dose-ranging study of 250 psoriasis patients randomized to various doses of subcutaneous bimekizumab or placebo every 4 weeks. The primary outcome – the PASI 90 response rate at 12 weeks, rather than the lower-bar PASI 75 endpoint more typically used in clinical trials – was 79% at the optimal dose. The PASI 100 rate – complete clearance of disease – at 12 weeks was 60%, Craig L. Leonardi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
 

Bruce Jancin/Frontline Medical News

[email protected]

KAUAI, HAWAII – The novel interleukin-17 inhibitor bimekizumab achieved “remarkable” outcomes for moderate to severe plaque psoriasis in the phase 2b BE ABLE study.

And that’s not all: Much the same was true in patients with psoriatic arthritis in the parallel phase 2b BE ACTIVE study and for ankylosing spondylitis in the BE AGILE study. BE ABLE was a double-blind, 12-week, multicenter, five-arm, placebo-controlled, dose-ranging study of 250 psoriasis patients randomized to various doses of subcutaneous bimekizumab or placebo every 4 weeks. The primary outcome – the PASI 90 response rate at 12 weeks, rather than the lower-bar PASI 75 endpoint more typically used in clinical trials – was 79% at the optimal dose. The PASI 100 rate – complete clearance of disease – at 12 weeks was 60%, Craig L. Leonardi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
 

Bruce Jancin/Frontline Medical News

[email protected]

KAUAI, HAWAII – The novel interleukin-17 inhibitor bimekizumab achieved “remarkable” outcomes for moderate to severe plaque psoriasis in the phase 2b BE ABLE study.

And that’s not all: Much the same was true in patients with psoriatic arthritis in the parallel phase 2b BE ACTIVE study and for ankylosing spondylitis in the BE AGILE study. BE ABLE was a double-blind, 12-week, multicenter, five-arm, placebo-controlled, dose-ranging study of 250 psoriasis patients randomized to various doses of subcutaneous bimekizumab or placebo every 4 weeks. The primary outcome – the PASI 90 response rate at 12 weeks, rather than the lower-bar PASI 75 endpoint more typically used in clinical trials – was 79% at the optimal dose. The PASI 100 rate – complete clearance of disease – at 12 weeks was 60%, Craig L. Leonardi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
 

Bruce Jancin/Frontline Medical News

[email protected]

Virtual reality–based cognitive-behavioral therapy could help reduce momentary paranoia and anxiety, and improve social cognition in individuals with psychotic disorders.

Researchers reported the results of a randomized controlled trial of personalized virtual reality-based cognitive-behavioral therapy in 116 patients with a DSM IV–diagnosed psychotic disorder and paranoid ideation in an article published online Feb. 8 in Lancet Psychiatry.

SOURCE: Lancet Psychiatry. 2018 Feb 8. doi: 10.1016/S2215-0366(18)30053-1.

Virtual reality–based cognitive-behavioral therapy could help reduce momentary paranoia and anxiety, and improve social cognition in individuals with psychotic disorders.

Researchers reported the results of a randomized controlled trial of personalized virtual reality-based cognitive-behavioral therapy in 116 patients with a DSM IV–diagnosed psychotic disorder and paranoid ideation in an article published online Feb. 8 in Lancet Psychiatry.

SOURCE: Lancet Psychiatry. 2018 Feb 8. doi: 10.1016/S2215-0366(18)30053-1.

Virtual reality–based cognitive-behavioral therapy could help reduce momentary paranoia and anxiety, and improve social cognition in individuals with psychotic disorders.

Researchers reported the results of a randomized controlled trial of personalized virtual reality-based cognitive-behavioral therapy in 116 patients with a DSM IV–diagnosed psychotic disorder and paranoid ideation in an article published online Feb. 8 in Lancet Psychiatry.

SOURCE: Lancet Psychiatry. 2018 Feb 8. doi: 10.1016/S2215-0366(18)30053-1.

LAS VEGAS – In the clinical opinion of Edward V. Loftus Jr., MD, biologics for inflammatory bowel disease (IBD) patients are best positioned based on age, personal medical history, and the presence of extraintestinal manifestations.

“An algorithmic treatment regimen guided by biomarkers of inflammation in addition to symptoms results in higher rates of endoscopic healing, and is the way to go if you’re trying to change the trajectory of illness,” Dr. Loftus said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

In general, patients who are younger at diagnosis are going to have more severe disease than patients diagnosed older, said Dr. Loftus, professor of medicine at the Mayo Clinic, Rochester, Minn. “For CD [Crohn’s disease], the presence of fistulizing disease, especially internal fistulas, and to a lesser extent perianal fistulas, and then the presence of small-bowel disease or proximal GI disease, are all harbingers of more aggressive disease,” he said. “Multiple studies show that the time interval between diagnosis and development of intestinal complications is shorter in patients with small-bowel disease relative to colonic disease. When you add up those factors, you’re talking about 70% of CD patients, if not more. Most Crohn’s patients are going to be high-risk patients.”

For ulcerative colitis (UC), being male is a risk factor for hospitalization, surgery, and for developing colon cancer. On average, males are twice as likely as females to require surgery, and they’re twice as likely to develop colon cancer. Other predictors in UC for high-risk disease include early need for hospitalization, early need for corticosteroids, and extensive colitis at diagnosis. “You’re thinking about these things because how you’re going to treat these patients is going to differ,” he said.

According to Dr. Loftus, aminosalicylate (5-ASA) drugs are the frontline drugs of choice for low-risk UC patients with mild symptoms. “If they’re having moderate symptoms, you might initially start with a corticosteroid taper,” he noted. “That can be either prednisone or budesonide MMX. In a patient with really active symptoms, they’re going to go to IV steroids or maybe directly to anti-TNF [tumor necrosis factor] therapy.” For low-risk CD patients, consider budesonide taper then observation. “If they don’t flare again, maybe monitor that patient periodically,” he advised. “For high-risk patients, consider biologic therapy with or without thiopurine or methotrexate.”

A recent analysis of Medicare and Medicaid data from 2006 to 2013 found a significantly higher rate of mortality in IBD patients treated with prolonged corticosteroids than that seen in those treated with anti-TNF therapy (Am J Gastroenterol. Jan 16, 2018. doi: 10.1038/ajg2017.479). “That should give you pause,” Dr. Loftus said. “Don’t just put your patient on prednisone because you think it’s the easiest and safest thing to do. It’s not. It’s much more dangerous and has implications [for] the patient’s life expectancy.”

Some data are beginning to emerge about the use of biosimilars in IBD, mostly from Europe. Investigators of one randomized, controlled trial of biosimilar CT-P13 vs. originator infliximab in CD presented at the 2017 Digestive Disease Week meeting; they found in their trial that at week 6 all clinical endpoints were similar between the two agents. “If you’re forced to change your patient to this particular biosimilar, I wouldn’t be too worried about it,” Dr. Loftus said. “Of course, I’m not necessarily going to switch unless my institution or a particular third-party payer mandate it.”

In a published study funded by the Norwegian government, researchers conducted a prospective trial of switching from infliximab to CT-P13 in patients with a variety of conditions (Lancet. 2017;389:2304-16). Overall, the clinical failure rate was the same for both agents. Among CD patients, the researchers observed a nonsignificant trend toward disease worsening among those on the biosimilar, “but there was essentially no difference,” Dr. Loftus said.

He went on to discuss vedolizumab, a monoclonal antibody to alpha₄beta₇ integrin approved in 2014 for patients with moderate to severely active UC or CD. Phase 3 data from GEMINI I in moderate to severe UC found that relevant clinical endpoints were met by week 6 and they persisted at week 52 at both doses (N Engl J Med. 2013;369[8]:699-710). “For CD, the use of vedolizumab is a bit of a mixed picture,” Dr. Loftus said. “In GEMINI II, some of the primary endpoints were met at week 6, but at least one was missed (N Engl J Med. 2013;369[8]:711-21). The same thing was seen in GEMINI III. There’s a sense here that vedolizumab takes a little bit longer to work in CD.”

Integrated safety analyses of the GEMINI trials found no signal for increased rates of serious adverse events, and no cases of progressive multifocal leukoencephalopathy have been reported (J Crohns Colitis. 2017;11[2]:185-90). “The risk factors for serious infections were prior anti-TNF failure and opioid analgesic use in UC patients and younger age, steroid use, and opioid analgesic use in CD patients,” Dr. Loftus said.

In a trial of CD patients failing anti-TNF therapy, researchers observed a robust clinical response with ustekinumab, compared with placebo, at week 6 (N Engl J Med. 2016;375:1946-60). Even greater effects were observed in UNITI-2, a trial of ustekinumab in CD patients who hadn’t failed anti-TNFs.

Dr. Loftus cautioned that elderly and immunocompromised patients face an increased risk for infections when they’re placed on anti-TNF therapy. At the same time, researchers used a French database to determine the risk of lymphoma in IBD patients stratified by medication. For patients unexposed to such therapies, the risk of lymphoma was 1:4,000. For patients on thiopurine monotherapy, the risk was about 1:2,000; it was about 1:2,500 for those on anti-TNF monotherapy and about 1:1,000 for those on combination therapy (JAMA. 2017;318:1679-86). “One of the messages in this study is we can reassure our more risk-averse patients that the absolute risk of lymphoma is very low, even among patients on combination therapy,” he said.

Dr. Loftus called for head-to-head trials comparing the individual biologic agents and shared his recommendations on how to position currently available therapies. “I would say that for the average ‘bread and butter’ Crohn’s patient, anti-TNF therapy is the way to go,” he said. “For perianal fistulizing patients, I’m going to go with anti-TNF therapy, such as infliximab or adalimumab. For a patient with active extraintestinal manifestations, such as spondyloarthropathy, uveitis, and pyoderma, anti-TNF therapy is the way to go. However, with an elderly or immunosuppressed patient, consider vedolizumab or ustekinumab. For patients with a personal history of malignancy, an anti-TNF is very reasonable, but it may be easier to convince them to consider vedolizumab or ustekinumab.”

Recommendations for UC are largely similar, he continued. “However, I think we have enough data from GEMINI I and the integrated safety data with vedolizumab to say that, for the average ‘bread and butter’ UC patient, anti-TNF therapy or vedolizumab are appropriate. For a patient with extraintestinal manifestations I would avoid vedolizumab initially and try anti-TNF therapy. For patients with acute severe colitis, we have the bulk of evidence for efficacy resting with infliximab, so I would go with that. For the elderly or immunosuppressed patient, I would go with vedolizumab. For the person with a history of malignancy, an anti-TNF agent is reasonable, but consider vedolizumab.”

Dr. Loftus disclosed that he has consulted for AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Eli Lilly, Celltrion Healthcare, Napo Pharmaceuticals. He has also received research support from AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Genentech, Seres Pharmaceuticals, MedImmune, Allergan, and Robarts Clinical Trials.

*This story was updated on 3/26.

[email protected]

LAS VEGAS – In the clinical opinion of Edward V. Loftus Jr., MD, biologics for inflammatory bowel disease (IBD) patients are best positioned based on age, personal medical history, and the presence of extraintestinal manifestations.

“An algorithmic treatment regimen guided by biomarkers of inflammation in addition to symptoms results in higher rates of endoscopic healing, and is the way to go if you’re trying to change the trajectory of illness,” Dr. Loftus said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

In general, patients who are younger at diagnosis are going to have more severe disease than patients diagnosed older, said Dr. Loftus, professor of medicine at the Mayo Clinic, Rochester, Minn. “For CD [Crohn’s disease], the presence of fistulizing disease, especially internal fistulas, and to a lesser extent perianal fistulas, and then the presence of small-bowel disease or proximal GI disease, are all harbingers of more aggressive disease,” he said. “Multiple studies show that the time interval between diagnosis and development of intestinal complications is shorter in patients with small-bowel disease relative to colonic disease. When you add up those factors, you’re talking about 70% of CD patients, if not more. Most Crohn’s patients are going to be high-risk patients.”

For ulcerative colitis (UC), being male is a risk factor for hospitalization, surgery, and for developing colon cancer. On average, males are twice as likely as females to require surgery, and they’re twice as likely to develop colon cancer. Other predictors in UC for high-risk disease include early need for hospitalization, early need for corticosteroids, and extensive colitis at diagnosis. “You’re thinking about these things because how you’re going to treat these patients is going to differ,” he said.

According to Dr. Loftus, aminosalicylate (5-ASA) drugs are the frontline drugs of choice for low-risk UC patients with mild symptoms. “If they’re having moderate symptoms, you might initially start with a corticosteroid taper,” he noted. “That can be either prednisone or budesonide MMX. In a patient with really active symptoms, they’re going to go to IV steroids or maybe directly to anti-TNF [tumor necrosis factor] therapy.” For low-risk CD patients, consider budesonide taper then observation. “If they don’t flare again, maybe monitor that patient periodically,” he advised. “For high-risk patients, consider biologic therapy with or without thiopurine or methotrexate.”

A recent analysis of Medicare and Medicaid data from 2006 to 2013 found a significantly higher rate of mortality in IBD patients treated with prolonged corticosteroids than that seen in those treated with anti-TNF therapy (Am J Gastroenterol. Jan 16, 2018. doi: 10.1038/ajg2017.479). “That should give you pause,” Dr. Loftus said. “Don’t just put your patient on prednisone because you think it’s the easiest and safest thing to do. It’s not. It’s much more dangerous and has implications [for] the patient’s life expectancy.”

Some data are beginning to emerge about the use of biosimilars in IBD, mostly from Europe. Investigators of one randomized, controlled trial of biosimilar CT-P13 vs. originator infliximab in CD presented at the 2017 Digestive Disease Week meeting; they found in their trial that at week 6 all clinical endpoints were similar between the two agents. “If you’re forced to change your patient to this particular biosimilar, I wouldn’t be too worried about it,” Dr. Loftus said. “Of course, I’m not necessarily going to switch unless my institution or a particular third-party payer mandate it.”

In a published study funded by the Norwegian government, researchers conducted a prospective trial of switching from infliximab to CT-P13 in patients with a variety of conditions (Lancet. 2017;389:2304-16). Overall, the clinical failure rate was the same for both agents. Among CD patients, the researchers observed a nonsignificant trend toward disease worsening among those on the biosimilar, “but there was essentially no difference,” Dr. Loftus said.

He went on to discuss vedolizumab, a monoclonal antibody to alpha₄beta₇ integrin approved in 2014 for patients with moderate to severely active UC or CD. Phase 3 data from GEMINI I in moderate to severe UC found that relevant clinical endpoints were met by week 6 and they persisted at week 52 at both doses (N Engl J Med. 2013;369[8]:699-710). “For CD, the use of vedolizumab is a bit of a mixed picture,” Dr. Loftus said. “In GEMINI II, some of the primary endpoints were met at week 6, but at least one was missed (N Engl J Med. 2013;369[8]:711-21). The same thing was seen in GEMINI III. There’s a sense here that vedolizumab takes a little bit longer to work in CD.”

Integrated safety analyses of the GEMINI trials found no signal for increased rates of serious adverse events, and no cases of progressive multifocal leukoencephalopathy have been reported (J Crohns Colitis. 2017;11[2]:185-90). “The risk factors for serious infections were prior anti-TNF failure and opioid analgesic use in UC patients and younger age, steroid use, and opioid analgesic use in CD patients,” Dr. Loftus said.

In a trial of CD patients failing anti-TNF therapy, researchers observed a robust clinical response with ustekinumab, compared with placebo, at week 6 (N Engl J Med. 2016;375:1946-60). Even greater effects were observed in UNITI-2, a trial of ustekinumab in CD patients who hadn’t failed anti-TNFs.

Dr. Loftus cautioned that elderly and immunocompromised patients face an increased risk for infections when they’re placed on anti-TNF therapy. At the same time, researchers used a French database to determine the risk of lymphoma in IBD patients stratified by medication. For patients unexposed to such therapies, the risk of lymphoma was 1:4,000. For patients on thiopurine monotherapy, the risk was about 1:2,000; it was about 1:2,500 for those on anti-TNF monotherapy and about 1:1,000 for those on combination therapy (JAMA. 2017;318:1679-86). “One of the messages in this study is we can reassure our more risk-averse patients that the absolute risk of lymphoma is very low, even among patients on combination therapy,” he said.

Dr. Loftus called for head-to-head trials comparing the individual biologic agents and shared his recommendations on how to position currently available therapies. “I would say that for the average ‘bread and butter’ Crohn’s patient, anti-TNF therapy is the way to go,” he said. “For perianal fistulizing patients, I’m going to go with anti-TNF therapy, such as infliximab or adalimumab. For a patient with active extraintestinal manifestations, such as spondyloarthropathy, uveitis, and pyoderma, anti-TNF therapy is the way to go. However, with an elderly or immunosuppressed patient, consider vedolizumab or ustekinumab. For patients with a personal history of malignancy, an anti-TNF is very reasonable, but it may be easier to convince them to consider vedolizumab or ustekinumab.”

Recommendations for UC are largely similar, he continued. “However, I think we have enough data from GEMINI I and the integrated safety data with vedolizumab to say that, for the average ‘bread and butter’ UC patient, anti-TNF therapy or vedolizumab are appropriate. For a patient with extraintestinal manifestations I would avoid vedolizumab initially and try anti-TNF therapy. For patients with acute severe colitis, we have the bulk of evidence for efficacy resting with infliximab, so I would go with that. For the elderly or immunosuppressed patient, I would go with vedolizumab. For the person with a history of malignancy, an anti-TNF agent is reasonable, but consider vedolizumab.”

Dr. Loftus disclosed that he has consulted for AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Eli Lilly, Celltrion Healthcare, Napo Pharmaceuticals. He has also received research support from AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Genentech, Seres Pharmaceuticals, MedImmune, Allergan, and Robarts Clinical Trials.

*This story was updated on 3/26.

[email protected]

LAS VEGAS – In the clinical opinion of Edward V. Loftus Jr., MD, biologics for inflammatory bowel disease (IBD) patients are best positioned based on age, personal medical history, and the presence of extraintestinal manifestations.

“An algorithmic treatment regimen guided by biomarkers of inflammation in addition to symptoms results in higher rates of endoscopic healing, and is the way to go if you’re trying to change the trajectory of illness,” Dr. Loftus said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

In general, patients who are younger at diagnosis are going to have more severe disease than patients diagnosed older, said Dr. Loftus, professor of medicine at the Mayo Clinic, Rochester, Minn. “For CD [Crohn’s disease], the presence of fistulizing disease, especially internal fistulas, and to a lesser extent perianal fistulas, and then the presence of small-bowel disease or proximal GI disease, are all harbingers of more aggressive disease,” he said. “Multiple studies show that the time interval between diagnosis and development of intestinal complications is shorter in patients with small-bowel disease relative to colonic disease. When you add up those factors, you’re talking about 70% of CD patients, if not more. Most Crohn’s patients are going to be high-risk patients.”

For ulcerative colitis (UC), being male is a risk factor for hospitalization, surgery, and for developing colon cancer. On average, males are twice as likely as females to require surgery, and they’re twice as likely to develop colon cancer. Other predictors in UC for high-risk disease include early need for hospitalization, early need for corticosteroids, and extensive colitis at diagnosis. “You’re thinking about these things because how you’re going to treat these patients is going to differ,” he said.

According to Dr. Loftus, aminosalicylate (5-ASA) drugs are the frontline drugs of choice for low-risk UC patients with mild symptoms. “If they’re having moderate symptoms, you might initially start with a corticosteroid taper,” he noted. “That can be either prednisone or budesonide MMX. In a patient with really active symptoms, they’re going to go to IV steroids or maybe directly to anti-TNF [tumor necrosis factor] therapy.” For low-risk CD patients, consider budesonide taper then observation. “If they don’t flare again, maybe monitor that patient periodically,” he advised. “For high-risk patients, consider biologic therapy with or without thiopurine or methotrexate.”

A recent analysis of Medicare and Medicaid data from 2006 to 2013 found a significantly higher rate of mortality in IBD patients treated with prolonged corticosteroids than that seen in those treated with anti-TNF therapy (Am J Gastroenterol. Jan 16, 2018. doi: 10.1038/ajg2017.479). “That should give you pause,” Dr. Loftus said. “Don’t just put your patient on prednisone because you think it’s the easiest and safest thing to do. It’s not. It’s much more dangerous and has implications [for] the patient’s life expectancy.”

Some data are beginning to emerge about the use of biosimilars in IBD, mostly from Europe. Investigators of one randomized, controlled trial of biosimilar CT-P13 vs. originator infliximab in CD presented at the 2017 Digestive Disease Week meeting; they found in their trial that at week 6 all clinical endpoints were similar between the two agents. “If you’re forced to change your patient to this particular biosimilar, I wouldn’t be too worried about it,” Dr. Loftus said. “Of course, I’m not necessarily going to switch unless my institution or a particular third-party payer mandate it.”

In a published study funded by the Norwegian government, researchers conducted a prospective trial of switching from infliximab to CT-P13 in patients with a variety of conditions (Lancet. 2017;389:2304-16). Overall, the clinical failure rate was the same for both agents. Among CD patients, the researchers observed a nonsignificant trend toward disease worsening among those on the biosimilar, “but there was essentially no difference,” Dr. Loftus said.

He went on to discuss vedolizumab, a monoclonal antibody to alpha₄beta₇ integrin approved in 2014 for patients with moderate to severely active UC or CD. Phase 3 data from GEMINI I in moderate to severe UC found that relevant clinical endpoints were met by week 6 and they persisted at week 52 at both doses (N Engl J Med. 2013;369[8]:699-710). “For CD, the use of vedolizumab is a bit of a mixed picture,” Dr. Loftus said. “In GEMINI II, some of the primary endpoints were met at week 6, but at least one was missed (N Engl J Med. 2013;369[8]:711-21). The same thing was seen in GEMINI III. There’s a sense here that vedolizumab takes a little bit longer to work in CD.”

Integrated safety analyses of the GEMINI trials found no signal for increased rates of serious adverse events, and no cases of progressive multifocal leukoencephalopathy have been reported (J Crohns Colitis. 2017;11[2]:185-90). “The risk factors for serious infections were prior anti-TNF failure and opioid analgesic use in UC patients and younger age, steroid use, and opioid analgesic use in CD patients,” Dr. Loftus said.

In a trial of CD patients failing anti-TNF therapy, researchers observed a robust clinical response with ustekinumab, compared with placebo, at week 6 (N Engl J Med. 2016;375:1946-60). Even greater effects were observed in UNITI-2, a trial of ustekinumab in CD patients who hadn’t failed anti-TNFs.

Dr. Loftus cautioned that elderly and immunocompromised patients face an increased risk for infections when they’re placed on anti-TNF therapy. At the same time, researchers used a French database to determine the risk of lymphoma in IBD patients stratified by medication. For patients unexposed to such therapies, the risk of lymphoma was 1:4,000. For patients on thiopurine monotherapy, the risk was about 1:2,000; it was about 1:2,500 for those on anti-TNF monotherapy and about 1:1,000 for those on combination therapy (JAMA. 2017;318:1679-86). “One of the messages in this study is we can reassure our more risk-averse patients that the absolute risk of lymphoma is very low, even among patients on combination therapy,” he said.

Dr. Loftus called for head-to-head trials comparing the individual biologic agents and shared his recommendations on how to position currently available therapies. “I would say that for the average ‘bread and butter’ Crohn’s patient, anti-TNF therapy is the way to go,” he said. “For perianal fistulizing patients, I’m going to go with anti-TNF therapy, such as infliximab or adalimumab. For a patient with active extraintestinal manifestations, such as spondyloarthropathy, uveitis, and pyoderma, anti-TNF therapy is the way to go. However, with an elderly or immunosuppressed patient, consider vedolizumab or ustekinumab. For patients with a personal history of malignancy, an anti-TNF is very reasonable, but it may be easier to convince them to consider vedolizumab or ustekinumab.”

Recommendations for UC are largely similar, he continued. “However, I think we have enough data from GEMINI I and the integrated safety data with vedolizumab to say that, for the average ‘bread and butter’ UC patient, anti-TNF therapy or vedolizumab are appropriate. For a patient with extraintestinal manifestations I would avoid vedolizumab initially and try anti-TNF therapy. For patients with acute severe colitis, we have the bulk of evidence for efficacy resting with infliximab, so I would go with that. For the elderly or immunosuppressed patient, I would go with vedolizumab. For the person with a history of malignancy, an anti-TNF agent is reasonable, but consider vedolizumab.”

Dr. Loftus disclosed that he has consulted for AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Eli Lilly, Celltrion Healthcare, Napo Pharmaceuticals. He has also received research support from AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Genentech, Seres Pharmaceuticals, MedImmune, Allergan, and Robarts Clinical Trials.

*This story was updated on 3/26.

[email protected]

SAN FRANCISCO – The androgen receptor inhibitor enzalutamide is efficacious for treating nonmetastatic castration-resistant prostate cancer accompanied by a rapidly rising prostate-specific antigen (PSA) level, according to results of the phase 3 PROSPER trial.

“Nonmetastatic castration-resistant prostate cancer is an area of unmet need with no currently approved therapies. The development of metastases is predictable in this group of patients and is associated with increasing baseline PSA and a PSA doubling time of less than 10 months,” said lead author Maha Hussain, MBChB, deputy director at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago. “Delaying time to all metastases, which is a very clinically relevant endpoint because that is the terminal phase of the disease, is important, with the potential to delay cancer-related morbidity and also prolong overall survival.”

The PROSPER investigators enrolled 1,401 men with nonmetastatic castration-resistant prostate cancer and a PSA doubling time of 10 months or less despite castrate levels of testosterone. They were randomized 2:1 to enzalutamide (Xtandi) or placebo, with continuation of androgen deprivation therapy in both groups. (At present, enzalutamide is approved by the Food and Drug Administration for untreated and docetaxel-treated metastatic castration-resistant prostate cancer).

With a median follow-up of 22 months, median metastasis-free survival (based on radiographic progression or death) was about 22 months longer with enzalutamide versus placebo, according to results reported at the 2018 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. The difference translated to a 71% reduction in risk of events.

Relative to peers in the placebo group, patients in the enzalutamide group also had dramatically longer time to PSA progression (93% risk reduction) and time to first use of new antineoplastic therapy (79% risk reduction). An interim analysis showed a trend toward better overall survival with the drug as well, and it was well tolerated.

Susan London/Frontline Medical News

Although progression on PROSPER was ascertained by conventional imaging, advent of new, more sensitive imaging modalities, such as fluciclovine and prostate-specific membrane antigen PET, are unlikely to change the calculus, according to Dr. Hussain. “These patients have micrometastatic disease. The fact that we have imaging criteria right now that are not very sensitive does not mean we don’t think the patients have micromets. With the newer technologies, certainly, a good chunk of these patients could have physical metastatic disease,” she elaborated. And cancer treatments often achieve greater benefits when moved earlier in the disease course.

Approved indications aside, oncologists will likely take a tailored approach when deciding to treat nonmetastatic castration-resistant prostate cancer with enzalutamide or a similar agent, Dr. Hussain said. “Like anything else, the issue is going to boil down to a shared decision with the patient, pros and cons, and then making a decision together.”

The findings with enzalutamide in the PROSPER trial are also noteworthy in that they largely mirror those obtained with apalutamide in the SPARTAN trial, which were reported in the same session at the symposium.

 

Weighing the evidence

The 2-year prolongation of metastasis-free survival with apalutamide and enzalutamide is “very impressive,” said invited discussant Philip Kantoff, MD, a medical oncologist and chair of the department of medicine, Memorial Sloan Kettering Cancer Center in New York. “These drugs are very biologically active. This potentially gives us options for men with M0 castration-resistant prostate cancer. It’s something I would like to see as a clinician, but we have to be a little bit cautious. Treating asymptomatic patients carries a certain burden of proof wherein benefit must clearly outweigh risk.”

Clinical benefit of a drug in this patient population could be shown in three ways, he said: curing disease (which is unlikely), prolonging survival (which is as yet unproven), and improving quality of life by, for example, reducing anxiety over rising PSA levels and preventing skeletal-related adverse events (which is hinted at by SPARTAN data showing that enzalutamide delayed time to symptomatic progression).

“Clinical benefit, to me, is not fully demonstrated in these two studies, and there are some untoward effects that need to be better defined,” Dr. Kantoff maintained. In particular, apalutamide was associated with higher (albeit still low) rates of grade 3 or worse falls, fractures, and rash, and enzalutamide with more deaths in the absence of radiographic progression, for unclear reasons.

Susan London/Frontline Medical News

“My confidence in declaring victory would be greater with further scrutiny of the toxicities and understanding how the care patterns in these studies compare with actual practice, specifically, the timing of initiation of alternative therapies in these trials as opposed to what’s going on in the community,” he said.

It is too early to determine whether one drug is superior, according to Dr. Kantoff. “These were not comparative trials, so we don’t have enough information to say one versus the other. There’s a hint of different toxicity profiles. It isn’t clear that the efficacy is different.” And when it comes to adoption by community oncology, the FDA will have a role, sifting through the data for both drugs and rendering decisions, he said.
 

Study details

Median metastasis-free survival in PROSPER was 36.6 months with enzalutamide and 14.7 months with placebo (hazard ratio, 0.29; P less than .0001), Dr. Hussain reported. Benefit was similar across a range of patient subgroups, including patients with PSA doubling times of less than and greater than 6 months.

Patients in the enzalutamide group had half the rate of progression events when compared with peers in the placebo group (23% vs. 49%). Among those with a metastasis-free survival event, the rate of deaths without documented radiographic progression after stopping study treatment was higher with enzalutamide (15% vs. 2%); there were somewhat more cardiovascular deaths with the drug within this subset, but no single cause was clearly predominant, she said.

Median time to PSA progression was 37.2 months with enzalutamide and merely 3.9 months with placebo (HR, 0.07; P less than .0001). Median time to first use of new antineoplastic therapy was 39.6 months and 17.7 months, respectively (HR, 0.21; P less than .0001).

Median overall survival was not yet reached in either group, but tended to be longer with enzalutamide (HR, 0.80).

“Therapy overall was well tolerated. Adverse events were generally consistent with those reported in prior clinical trials in men with castration-resistant disease,” Dr. Hussain said. The rate of grade 3 or worse events was 31% with enzalutamide and 23% with placebo. The enzalutamide group more commonly experienced grade 3 or worse hypertension (5% vs. 2%) and fatigue (3% vs. 1%).

The rate of adverse events leading to study discontinuation was 9% with enzalutamide and 6% with placebo, and that of death due to adverse events was 3% and 1%, respectively.

Dr. Hussain disclosed that she receives honoraria from OncLive; has a consulting or advisory role with Abbvie, Bayer, and Genentech/Roche; has patents, royalties, or other intellectual property pertaining to dual inhibition of MET and VEGF for the treatment of castration-resistant prostate cancer; and receives travel, accommodations, or expenses from Abbvie, Bayer, and Genentech. In addition, her institution receives research funding from AstraZeneca, Genentech, PCCTC, and Pfizer. The trial was sponsored by Pfizer, with collaboration of Astellas Pharma Inc. and Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

SOURCE: Hussain M et al. Abstract 3.

SAN FRANCISCO – The androgen receptor inhibitor enzalutamide is efficacious for treating nonmetastatic castration-resistant prostate cancer accompanied by a rapidly rising prostate-specific antigen (PSA) level, according to results of the phase 3 PROSPER trial.

“Nonmetastatic castration-resistant prostate cancer is an area of unmet need with no currently approved therapies. The development of metastases is predictable in this group of patients and is associated with increasing baseline PSA and a PSA doubling time of less than 10 months,” said lead author Maha Hussain, MBChB, deputy director at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago. “Delaying time to all metastases, which is a very clinically relevant endpoint because that is the terminal phase of the disease, is important, with the potential to delay cancer-related morbidity and also prolong overall survival.”

The PROSPER investigators enrolled 1,401 men with nonmetastatic castration-resistant prostate cancer and a PSA doubling time of 10 months or less despite castrate levels of testosterone. They were randomized 2:1 to enzalutamide (Xtandi) or placebo, with continuation of androgen deprivation therapy in both groups. (At present, enzalutamide is approved by the Food and Drug Administration for untreated and docetaxel-treated metastatic castration-resistant prostate cancer).

With a median follow-up of 22 months, median metastasis-free survival (based on radiographic progression or death) was about 22 months longer with enzalutamide versus placebo, according to results reported at the 2018 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. The difference translated to a 71% reduction in risk of events.

Relative to peers in the placebo group, patients in the enzalutamide group also had dramatically longer time to PSA progression (93% risk reduction) and time to first use of new antineoplastic therapy (79% risk reduction). An interim analysis showed a trend toward better overall survival with the drug as well, and it was well tolerated.

Susan London/Frontline Medical News

Although progression on PROSPER was ascertained by conventional imaging, advent of new, more sensitive imaging modalities, such as fluciclovine and prostate-specific membrane antigen PET, are unlikely to change the calculus, according to Dr. Hussain. “These patients have micrometastatic disease. The fact that we have imaging criteria right now that are not very sensitive does not mean we don’t think the patients have micromets. With the newer technologies, certainly, a good chunk of these patients could have physical metastatic disease,” she elaborated. And cancer treatments often achieve greater benefits when moved earlier in the disease course.

Approved indications aside, oncologists will likely take a tailored approach when deciding to treat nonmetastatic castration-resistant prostate cancer with enzalutamide or a similar agent, Dr. Hussain said. “Like anything else, the issue is going to boil down to a shared decision with the patient, pros and cons, and then making a decision together.”

The findings with enzalutamide in the PROSPER trial are also noteworthy in that they largely mirror those obtained with apalutamide in the SPARTAN trial, which were reported in the same session at the symposium.

 

Weighing the evidence

The 2-year prolongation of metastasis-free survival with apalutamide and enzalutamide is “very impressive,” said invited discussant Philip Kantoff, MD, a medical oncologist and chair of the department of medicine, Memorial Sloan Kettering Cancer Center in New York. “These drugs are very biologically active. This potentially gives us options for men with M0 castration-resistant prostate cancer. It’s something I would like to see as a clinician, but we have to be a little bit cautious. Treating asymptomatic patients carries a certain burden of proof wherein benefit must clearly outweigh risk.”

Clinical benefit of a drug in this patient population could be shown in three ways, he said: curing disease (which is unlikely), prolonging survival (which is as yet unproven), and improving quality of life by, for example, reducing anxiety over rising PSA levels and preventing skeletal-related adverse events (which is hinted at by SPARTAN data showing that enzalutamide delayed time to symptomatic progression).

“Clinical benefit, to me, is not fully demonstrated in these two studies, and there are some untoward effects that need to be better defined,” Dr. Kantoff maintained. In particular, apalutamide was associated with higher (albeit still low) rates of grade 3 or worse falls, fractures, and rash, and enzalutamide with more deaths in the absence of radiographic progression, for unclear reasons.

Susan London/Frontline Medical News

“My confidence in declaring victory would be greater with further scrutiny of the toxicities and understanding how the care patterns in these studies compare with actual practice, specifically, the timing of initiation of alternative therapies in these trials as opposed to what’s going on in the community,” he said.

It is too early to determine whether one drug is superior, according to Dr. Kantoff. “These were not comparative trials, so we don’t have enough information to say one versus the other. There’s a hint of different toxicity profiles. It isn’t clear that the efficacy is different.” And when it comes to adoption by community oncology, the FDA will have a role, sifting through the data for both drugs and rendering decisions, he said.
 

Study details

Median metastasis-free survival in PROSPER was 36.6 months with enzalutamide and 14.7 months with placebo (hazard ratio, 0.29; P less than .0001), Dr. Hussain reported. Benefit was similar across a range of patient subgroups, including patients with PSA doubling times of less than and greater than 6 months.

Patients in the enzalutamide group had half the rate of progression events when compared with peers in the placebo group (23% vs. 49%). Among those with a metastasis-free survival event, the rate of deaths without documented radiographic progression after stopping study treatment was higher with enzalutamide (15% vs. 2%); there were somewhat more cardiovascular deaths with the drug within this subset, but no single cause was clearly predominant, she said.

Median time to PSA progression was 37.2 months with enzalutamide and merely 3.9 months with placebo (HR, 0.07; P less than .0001). Median time to first use of new antineoplastic therapy was 39.6 months and 17.7 months, respectively (HR, 0.21; P less than .0001).

Median overall survival was not yet reached in either group, but tended to be longer with enzalutamide (HR, 0.80).

“Therapy overall was well tolerated. Adverse events were generally consistent with those reported in prior clinical trials in men with castration-resistant disease,” Dr. Hussain said. The rate of grade 3 or worse events was 31% with enzalutamide and 23% with placebo. The enzalutamide group more commonly experienced grade 3 or worse hypertension (5% vs. 2%) and fatigue (3% vs. 1%).

The rate of adverse events leading to study discontinuation was 9% with enzalutamide and 6% with placebo, and that of death due to adverse events was 3% and 1%, respectively.

Dr. Hussain disclosed that she receives honoraria from OncLive; has a consulting or advisory role with Abbvie, Bayer, and Genentech/Roche; has patents, royalties, or other intellectual property pertaining to dual inhibition of MET and VEGF for the treatment of castration-resistant prostate cancer; and receives travel, accommodations, or expenses from Abbvie, Bayer, and Genentech. In addition, her institution receives research funding from AstraZeneca, Genentech, PCCTC, and Pfizer. The trial was sponsored by Pfizer, with collaboration of Astellas Pharma Inc. and Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

SOURCE: Hussain M et al. Abstract 3.

SAN FRANCISCO – The androgen receptor inhibitor enzalutamide is efficacious for treating nonmetastatic castration-resistant prostate cancer accompanied by a rapidly rising prostate-specific antigen (PSA) level, according to results of the phase 3 PROSPER trial.

“Nonmetastatic castration-resistant prostate cancer is an area of unmet need with no currently approved therapies. The development of metastases is predictable in this group of patients and is associated with increasing baseline PSA and a PSA doubling time of less than 10 months,” said lead author Maha Hussain, MBChB, deputy director at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago. “Delaying time to all metastases, which is a very clinically relevant endpoint because that is the terminal phase of the disease, is important, with the potential to delay cancer-related morbidity and also prolong overall survival.”

The PROSPER investigators enrolled 1,401 men with nonmetastatic castration-resistant prostate cancer and a PSA doubling time of 10 months or less despite castrate levels of testosterone. They were randomized 2:1 to enzalutamide (Xtandi) or placebo, with continuation of androgen deprivation therapy in both groups. (At present, enzalutamide is approved by the Food and Drug Administration for untreated and docetaxel-treated metastatic castration-resistant prostate cancer).

With a median follow-up of 22 months, median metastasis-free survival (based on radiographic progression or death) was about 22 months longer with enzalutamide versus placebo, according to results reported at the 2018 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. The difference translated to a 71% reduction in risk of events.

Relative to peers in the placebo group, patients in the enzalutamide group also had dramatically longer time to PSA progression (93% risk reduction) and time to first use of new antineoplastic therapy (79% risk reduction). An interim analysis showed a trend toward better overall survival with the drug as well, and it was well tolerated.

Susan London/Frontline Medical News

Although progression on PROSPER was ascertained by conventional imaging, advent of new, more sensitive imaging modalities, such as fluciclovine and prostate-specific membrane antigen PET, are unlikely to change the calculus, according to Dr. Hussain. “These patients have micrometastatic disease. The fact that we have imaging criteria right now that are not very sensitive does not mean we don’t think the patients have micromets. With the newer technologies, certainly, a good chunk of these patients could have physical metastatic disease,” she elaborated. And cancer treatments often achieve greater benefits when moved earlier in the disease course.

Approved indications aside, oncologists will likely take a tailored approach when deciding to treat nonmetastatic castration-resistant prostate cancer with enzalutamide or a similar agent, Dr. Hussain said. “Like anything else, the issue is going to boil down to a shared decision with the patient, pros and cons, and then making a decision together.”

The findings with enzalutamide in the PROSPER trial are also noteworthy in that they largely mirror those obtained with apalutamide in the SPARTAN trial, which were reported in the same session at the symposium.

 

Weighing the evidence

The 2-year prolongation of metastasis-free survival with apalutamide and enzalutamide is “very impressive,” said invited discussant Philip Kantoff, MD, a medical oncologist and chair of the department of medicine, Memorial Sloan Kettering Cancer Center in New York. “These drugs are very biologically active. This potentially gives us options for men with M0 castration-resistant prostate cancer. It’s something I would like to see as a clinician, but we have to be a little bit cautious. Treating asymptomatic patients carries a certain burden of proof wherein benefit must clearly outweigh risk.”

Clinical benefit of a drug in this patient population could be shown in three ways, he said: curing disease (which is unlikely), prolonging survival (which is as yet unproven), and improving quality of life by, for example, reducing anxiety over rising PSA levels and preventing skeletal-related adverse events (which is hinted at by SPARTAN data showing that enzalutamide delayed time to symptomatic progression).

“Clinical benefit, to me, is not fully demonstrated in these two studies, and there are some untoward effects that need to be better defined,” Dr. Kantoff maintained. In particular, apalutamide was associated with higher (albeit still low) rates of grade 3 or worse falls, fractures, and rash, and enzalutamide with more deaths in the absence of radiographic progression, for unclear reasons.

Susan London/Frontline Medical News

“My confidence in declaring victory would be greater with further scrutiny of the toxicities and understanding how the care patterns in these studies compare with actual practice, specifically, the timing of initiation of alternative therapies in these trials as opposed to what’s going on in the community,” he said.

It is too early to determine whether one drug is superior, according to Dr. Kantoff. “These were not comparative trials, so we don’t have enough information to say one versus the other. There’s a hint of different toxicity profiles. It isn’t clear that the efficacy is different.” And when it comes to adoption by community oncology, the FDA will have a role, sifting through the data for both drugs and rendering decisions, he said.
 

Study details

Median metastasis-free survival in PROSPER was 36.6 months with enzalutamide and 14.7 months with placebo (hazard ratio, 0.29; P less than .0001), Dr. Hussain reported. Benefit was similar across a range of patient subgroups, including patients with PSA doubling times of less than and greater than 6 months.

Patients in the enzalutamide group had half the rate of progression events when compared with peers in the placebo group (23% vs. 49%). Among those with a metastasis-free survival event, the rate of deaths without documented radiographic progression after stopping study treatment was higher with enzalutamide (15% vs. 2%); there were somewhat more cardiovascular deaths with the drug within this subset, but no single cause was clearly predominant, she said.

Median time to PSA progression was 37.2 months with enzalutamide and merely 3.9 months with placebo (HR, 0.07; P less than .0001). Median time to first use of new antineoplastic therapy was 39.6 months and 17.7 months, respectively (HR, 0.21; P less than .0001).

Median overall survival was not yet reached in either group, but tended to be longer with enzalutamide (HR, 0.80).

“Therapy overall was well tolerated. Adverse events were generally consistent with those reported in prior clinical trials in men with castration-resistant disease,” Dr. Hussain said. The rate of grade 3 or worse events was 31% with enzalutamide and 23% with placebo. The enzalutamide group more commonly experienced grade 3 or worse hypertension (5% vs. 2%) and fatigue (3% vs. 1%).

The rate of adverse events leading to study discontinuation was 9% with enzalutamide and 6% with placebo, and that of death due to adverse events was 3% and 1%, respectively.

Dr. Hussain disclosed that she receives honoraria from OncLive; has a consulting or advisory role with Abbvie, Bayer, and Genentech/Roche; has patents, royalties, or other intellectual property pertaining to dual inhibition of MET and VEGF for the treatment of castration-resistant prostate cancer; and receives travel, accommodations, or expenses from Abbvie, Bayer, and Genentech. In addition, her institution receives research funding from AstraZeneca, Genentech, PCCTC, and Pfizer. The trial was sponsored by Pfizer, with collaboration of Astellas Pharma Inc. and Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

SOURCE: Hussain M et al. Abstract 3.

Compared with a longer hospital stay, next-day discharge (NDD) after minimalist transcatheter aortic valve replacement (TAVR) appears safe, according to a recently reported analysis of patients treated at a single center.

The composite endpoint of mortality and readmission at 30 days was similar for NDD, compared with later discharges among patients who had a procedure that met minimalist criteria, defined in this study as transfemoral TAVR under conscious sedation and local anesthesia.

Mortality and readmission at 1 year was lower in the NDD group, mainly because of a lower risk of noncardiovascular readmissions, study authors reported in JACC: Cardiovascular Interventions. “Although superior NDD outcomes are likely attributed to selected patient characteristics, NDD in patients without in-hospital complications may be appropriate after transfemoral balloon-expandable TAVR,” wrote Norihiko Kamioka, MD, division of cardiology, Emory University, Atlanta, and associates.

The retrospective, observational analysis included 663 consecutive patients who underwent elective balloon-expandable TAVR during July 2014–July 2016. Cases with complications after the procedure were excluded.

The final analysis, which included 150 patients who had NDD and 210 discharged later, showed no difference between groups in the composite endpoint of mortality, and that 30-day readmissions were similar between groups (hazard ratio, 0.62; 95% confidence interval, 0.20-1.91).

Mortality and readmission at 1 year, the primary endpoint chosen for the study, favored the NDD group (HR, 0.47; 95% CI, 0.27-0.81), but “this finding probably reflects a healthier cohort in the NDD group,” the investigators noted. Furthermore, “although the reason for the discrepancy in the composite outcome at 1 year is mainly driven by noncardiovascular readmission, other confounding variables cannot be entirely ruled out,” Dr. Kamioka and colleagues said in the report.

Predictors of NDD included male sex, no atrial fibrillation, lower serum creatinine level, and younger age, researchers also found.

A validation cohort would be needed to confirm the findings of this study, including predictors of favorable outcomes, and to apply NDD to a wider population, study authors said.

Dr. Kamioka reported no relationships relevant to the study. Study coauthors reported disclosures related to Edwards Lifesciences, Abbott Vascular, Medtronic, Gore Vascular, and Boston Scientific.

[email protected]

SOURCE: JACC: Cardiovascular Interventions. 2018 Jan 22. doi: 10.1016/j.jcin.2017.10.021.

Compared with a longer hospital stay, next-day discharge (NDD) after minimalist transcatheter aortic valve replacement (TAVR) appears safe, according to a recently reported analysis of patients treated at a single center.

The composite endpoint of mortality and readmission at 30 days was similar for NDD, compared with later discharges among patients who had a procedure that met minimalist criteria, defined in this study as transfemoral TAVR under conscious sedation and local anesthesia.

Mortality and readmission at 1 year was lower in the NDD group, mainly because of a lower risk of noncardiovascular readmissions, study authors reported in JACC: Cardiovascular Interventions. “Although superior NDD outcomes are likely attributed to selected patient characteristics, NDD in patients without in-hospital complications may be appropriate after transfemoral balloon-expandable TAVR,” wrote Norihiko Kamioka, MD, division of cardiology, Emory University, Atlanta, and associates.

The retrospective, observational analysis included 663 consecutive patients who underwent elective balloon-expandable TAVR during July 2014–July 2016. Cases with complications after the procedure were excluded.

The final analysis, which included 150 patients who had NDD and 210 discharged later, showed no difference between groups in the composite endpoint of mortality, and that 30-day readmissions were similar between groups (hazard ratio, 0.62; 95% confidence interval, 0.20-1.91).

Mortality and readmission at 1 year, the primary endpoint chosen for the study, favored the NDD group (HR, 0.47; 95% CI, 0.27-0.81), but “this finding probably reflects a healthier cohort in the NDD group,” the investigators noted. Furthermore, “although the reason for the discrepancy in the composite outcome at 1 year is mainly driven by noncardiovascular readmission, other confounding variables cannot be entirely ruled out,” Dr. Kamioka and colleagues said in the report.

Predictors of NDD included male sex, no atrial fibrillation, lower serum creatinine level, and younger age, researchers also found.

A validation cohort would be needed to confirm the findings of this study, including predictors of favorable outcomes, and to apply NDD to a wider population, study authors said.

Dr. Kamioka reported no relationships relevant to the study. Study coauthors reported disclosures related to Edwards Lifesciences, Abbott Vascular, Medtronic, Gore Vascular, and Boston Scientific.

[email protected]

SOURCE: JACC: Cardiovascular Interventions. 2018 Jan 22. doi: 10.1016/j.jcin.2017.10.021.

Compared with a longer hospital stay, next-day discharge (NDD) after minimalist transcatheter aortic valve replacement (TAVR) appears safe, according to a recently reported analysis of patients treated at a single center.

The composite endpoint of mortality and readmission at 30 days was similar for NDD, compared with later discharges among patients who had a procedure that met minimalist criteria, defined in this study as transfemoral TAVR under conscious sedation and local anesthesia.

Mortality and readmission at 1 year was lower in the NDD group, mainly because of a lower risk of noncardiovascular readmissions, study authors reported in JACC: Cardiovascular Interventions. “Although superior NDD outcomes are likely attributed to selected patient characteristics, NDD in patients without in-hospital complications may be appropriate after transfemoral balloon-expandable TAVR,” wrote Norihiko Kamioka, MD, division of cardiology, Emory University, Atlanta, and associates.

The retrospective, observational analysis included 663 consecutive patients who underwent elective balloon-expandable TAVR during July 2014–July 2016. Cases with complications after the procedure were excluded.

The final analysis, which included 150 patients who had NDD and 210 discharged later, showed no difference between groups in the composite endpoint of mortality, and that 30-day readmissions were similar between groups (hazard ratio, 0.62; 95% confidence interval, 0.20-1.91).

Mortality and readmission at 1 year, the primary endpoint chosen for the study, favored the NDD group (HR, 0.47; 95% CI, 0.27-0.81), but “this finding probably reflects a healthier cohort in the NDD group,” the investigators noted. Furthermore, “although the reason for the discrepancy in the composite outcome at 1 year is mainly driven by noncardiovascular readmission, other confounding variables cannot be entirely ruled out,” Dr. Kamioka and colleagues said in the report.

Predictors of NDD included male sex, no atrial fibrillation, lower serum creatinine level, and younger age, researchers also found.

A validation cohort would be needed to confirm the findings of this study, including predictors of favorable outcomes, and to apply NDD to a wider population, study authors said.

Dr. Kamioka reported no relationships relevant to the study. Study coauthors reported disclosures related to Edwards Lifesciences, Abbott Vascular, Medtronic, Gore Vascular, and Boston Scientific.

[email protected]

SOURCE: JACC: Cardiovascular Interventions. 2018 Jan 22. doi: 10.1016/j.jcin.2017.10.021.

Recently, there was a lot of hoopla in the popular press caused by the report by Philip A. May, PhD, and his team showing that the rates of fetal alcohol spectrum disorder (FASD) ran between 1.1 to 5.0% in first graders in four U.S. communities (JAMA. 2018;319[5]:474-82). This publication and the press it received made my heart sing because the findings made national news – meaning the issue would be in the public’s consciousness for a day or two. That is progress.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago; a clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago; a former president/CEO of Community Mental Health Council; and a former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.

Recently, there was a lot of hoopla in the popular press caused by the report by Philip A. May, PhD, and his team showing that the rates of fetal alcohol spectrum disorder (FASD) ran between 1.1 to 5.0% in first graders in four U.S. communities (JAMA. 2018;319[5]:474-82). This publication and the press it received made my heart sing because the findings made national news – meaning the issue would be in the public’s consciousness for a day or two. That is progress.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago; a clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago; a former president/CEO of Community Mental Health Council; and a former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.

Recently, there was a lot of hoopla in the popular press caused by the report by Philip A. May, PhD, and his team showing that the rates of fetal alcohol spectrum disorder (FASD) ran between 1.1 to 5.0% in first graders in four U.S. communities (JAMA. 2018;319[5]:474-82). This publication and the press it received made my heart sing because the findings made national news – meaning the issue would be in the public’s consciousness for a day or two. That is progress.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago; a clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago; a former president/CEO of Community Mental Health Council; and a former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.

Pediatrician blogs frequently provide accurate information to parents concerning vaccines, although some blogs do provide information inconsistent with Centers for Disease Control and Prevention guidelines, a study found.

“Nearly all vaccine information on active pediatrician blogs was consistent with online information from the CDC. However, we identified two exceptions in which pediatrician blogs conveyed extremely inaccurate, antivaccine information,” wrote Mersine A. Bryan, MD, of the University of Washington, Seattle, and her colleagues. “These two extreme blogs were the only blogs that contained any information that was not consistent with CDC information. This finding is important because pediatricians are viewed by parents as a trusted source of information about vaccines.”

©Wavebreak Media/Thinkstockphotos.com

The authors had no relevant financial disclosures.

[email protected]

SOURCE: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.

Pediatrician blogs frequently provide accurate information to parents concerning vaccines, although some blogs do provide information inconsistent with Centers for Disease Control and Prevention guidelines, a study found.

“Nearly all vaccine information on active pediatrician blogs was consistent with online information from the CDC. However, we identified two exceptions in which pediatrician blogs conveyed extremely inaccurate, antivaccine information,” wrote Mersine A. Bryan, MD, of the University of Washington, Seattle, and her colleagues. “These two extreme blogs were the only blogs that contained any information that was not consistent with CDC information. This finding is important because pediatricians are viewed by parents as a trusted source of information about vaccines.”

©Wavebreak Media/Thinkstockphotos.com

The authors had no relevant financial disclosures.

[email protected]

SOURCE: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.

Pediatrician blogs frequently provide accurate information to parents concerning vaccines, although some blogs do provide information inconsistent with Centers for Disease Control and Prevention guidelines, a study found.

“Nearly all vaccine information on active pediatrician blogs was consistent with online information from the CDC. However, we identified two exceptions in which pediatrician blogs conveyed extremely inaccurate, antivaccine information,” wrote Mersine A. Bryan, MD, of the University of Washington, Seattle, and her colleagues. “These two extreme blogs were the only blogs that contained any information that was not consistent with CDC information. This finding is important because pediatricians are viewed by parents as a trusted source of information about vaccines.”

©Wavebreak Media/Thinkstockphotos.com

The authors had no relevant financial disclosures.

[email protected]

SOURCE: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in San Diego. Look for the latest news and video interviews from the meeting in medical, surgical, and aesthetic dermatology at edermatologynews.com starting Friday February 16.

Coverage will include the late-breaker sessions, which will be presented on Saturday February 17.

f11photo/Thinkstock

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in San Diego. Look for the latest news and video interviews from the meeting in medical, surgical, and aesthetic dermatology at edermatologynews.com starting Friday February 16.

Coverage will include the late-breaker sessions, which will be presented on Saturday February 17.

f11photo/Thinkstock

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in San Diego. Look for the latest news and video interviews from the meeting in medical, surgical, and aesthetic dermatology at edermatologynews.com starting Friday February 16.

Coverage will include the late-breaker sessions, which will be presented on Saturday February 17.

f11photo/Thinkstock