Lichen striatus (LS) is a common benign skin condition that presents in children between the ages of 5 and 15 years.¹ The rash is typically unilateral and most frequently on the extremities, although it may appear on the face, trunk, or buttocks. The lesions start as pink or skin-colored asymptomatic papules in a linear orientation following the lines of Blaschko. Lesions usually evolve over several weeks, and typically resolve in 6-12 months. There may be residual postinflammatory hypo- or hyperpigmentation which often improves within a few years.

Of note, there are subsets of lichen striatus: Hypopigmented lichen striatus with minimal papules has been termed “lichen striatus albus.” Nail lichen striatus may present as onycholysis or fissuring of nails, present as an isolated finding, or more commonly in association with concurrent affected skin. Nail lichen striatus typically resolves on its own, however there are case reports of improvement with intralesional steroids.²

There is no established etiology for LS. Autoimmune disease, viruses, immunizations, medications, and hypersensitivity reactions have been associated with triggering LS in various case reports, although strength of the associations is low. Children have been reported to have LS following scarlet fever and Candida vulvitis.³ Diagnosis usually is clinical, although biopsy may be helpful for histopathologic confirmation. No work-up for associated infections or conditions is warranted.

The differential for linear papular lesions includes inflammatory linear verrucous epidermal nevus (ILVEN), blaschkitis, or linear morphea. ILVEN is a hamartoma that usually is congenital or presents in early childhood; presents with linear or whorled, hyperkeratotic papules and plaque in similar linear “line of Blaschko” patterns; and represents cutaneous mosaicism. It is often difficult to differentiate between lichen striatus and ILVEN, however lichen striatus is not congenital, and is a self-limited condition. Under dermoscopy (polarized light systems) findings of LS more frequently demonstrate gray granular pigmentation. ILVEN is more frequently associated with cerebriform pattern.⁴ Blaschkitis is a term for a blaschkoid inflammation of the skin that presents with more eczematous findings and histology of spongiosis, unlike the lichenoid findings of LS. It is typically accompanied by noticeable pruritus and broader bands of involved area, and has older age of onset than LS. Linear morphea is a deeper inflammatory process of the dermis or subcutaneous fat, presenting with sclerotic skin, and typically has associated atrophy.

Treatment need not be pursued for lichen striatus because it is a benign condition. The lesions typically self-resolve without any residual scarring. If patients have associated pruritus then low- to midpotency topical steroids can be used for symptomatic relief.
 

Dr. Kaushik is with the division of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, and Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. There are no conflicts of interest or financial disclosures for Dr. Kaushik or Dr. Eichenfield. Email them at pdnews@mdedge.com.

References

1. Gupta D, Mathes E. Lichen Striatus. (Levy ML ed.) 2019: UpToDate.

2. Dermatol Ther. 2018 Nov;31(6):e12713.

3. Int J Dermatol. 2018 Sep;57(9):1118-9.

4. J Dermatol. 2017 Dec;44(12):e355-6.

Lichen striatus (LS) is a common benign skin condition that presents in children between the ages of 5 and 15 years.¹ The rash is typically unilateral and most frequently on the extremities, although it may appear on the face, trunk, or buttocks. The lesions start as pink or skin-colored asymptomatic papules in a linear orientation following the lines of Blaschko. Lesions usually evolve over several weeks, and typically resolve in 6-12 months. There may be residual postinflammatory hypo- or hyperpigmentation which often improves within a few years.

Of note, there are subsets of lichen striatus: Hypopigmented lichen striatus with minimal papules has been termed “lichen striatus albus.” Nail lichen striatus may present as onycholysis or fissuring of nails, present as an isolated finding, or more commonly in association with concurrent affected skin. Nail lichen striatus typically resolves on its own, however there are case reports of improvement with intralesional steroids.²

There is no established etiology for LS. Autoimmune disease, viruses, immunizations, medications, and hypersensitivity reactions have been associated with triggering LS in various case reports, although strength of the associations is low. Children have been reported to have LS following scarlet fever and Candida vulvitis.³ Diagnosis usually is clinical, although biopsy may be helpful for histopathologic confirmation. No work-up for associated infections or conditions is warranted.

The differential for linear papular lesions includes inflammatory linear verrucous epidermal nevus (ILVEN), blaschkitis, or linear morphea. ILVEN is a hamartoma that usually is congenital or presents in early childhood; presents with linear or whorled, hyperkeratotic papules and plaque in similar linear “line of Blaschko” patterns; and represents cutaneous mosaicism. It is often difficult to differentiate between lichen striatus and ILVEN, however lichen striatus is not congenital, and is a self-limited condition. Under dermoscopy (polarized light systems) findings of LS more frequently demonstrate gray granular pigmentation. ILVEN is more frequently associated with cerebriform pattern.⁴ Blaschkitis is a term for a blaschkoid inflammation of the skin that presents with more eczematous findings and histology of spongiosis, unlike the lichenoid findings of LS. It is typically accompanied by noticeable pruritus and broader bands of involved area, and has older age of onset than LS. Linear morphea is a deeper inflammatory process of the dermis or subcutaneous fat, presenting with sclerotic skin, and typically has associated atrophy.

Treatment need not be pursued for lichen striatus because it is a benign condition. The lesions typically self-resolve without any residual scarring. If patients have associated pruritus then low- to midpotency topical steroids can be used for symptomatic relief.
 

Dr. Kaushik is with the division of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, and Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. There are no conflicts of interest or financial disclosures for Dr. Kaushik or Dr. Eichenfield. Email them at pdnews@mdedge.com.

References

1. Gupta D, Mathes E. Lichen Striatus. (Levy ML ed.) 2019: UpToDate.

2. Dermatol Ther. 2018 Nov;31(6):e12713.

3. Int J Dermatol. 2018 Sep;57(9):1118-9.

4. J Dermatol. 2017 Dec;44(12):e355-6.

Lichen striatus (LS) is a common benign skin condition that presents in children between the ages of 5 and 15 years.¹ The rash is typically unilateral and most frequently on the extremities, although it may appear on the face, trunk, or buttocks. The lesions start as pink or skin-colored asymptomatic papules in a linear orientation following the lines of Blaschko. Lesions usually evolve over several weeks, and typically resolve in 6-12 months. There may be residual postinflammatory hypo- or hyperpigmentation which often improves within a few years.

Of note, there are subsets of lichen striatus: Hypopigmented lichen striatus with minimal papules has been termed “lichen striatus albus.” Nail lichen striatus may present as onycholysis or fissuring of nails, present as an isolated finding, or more commonly in association with concurrent affected skin. Nail lichen striatus typically resolves on its own, however there are case reports of improvement with intralesional steroids.²

There is no established etiology for LS. Autoimmune disease, viruses, immunizations, medications, and hypersensitivity reactions have been associated with triggering LS in various case reports, although strength of the associations is low. Children have been reported to have LS following scarlet fever and Candida vulvitis.³ Diagnosis usually is clinical, although biopsy may be helpful for histopathologic confirmation. No work-up for associated infections or conditions is warranted.

The differential for linear papular lesions includes inflammatory linear verrucous epidermal nevus (ILVEN), blaschkitis, or linear morphea. ILVEN is a hamartoma that usually is congenital or presents in early childhood; presents with linear or whorled, hyperkeratotic papules and plaque in similar linear “line of Blaschko” patterns; and represents cutaneous mosaicism. It is often difficult to differentiate between lichen striatus and ILVEN, however lichen striatus is not congenital, and is a self-limited condition. Under dermoscopy (polarized light systems) findings of LS more frequently demonstrate gray granular pigmentation. ILVEN is more frequently associated with cerebriform pattern.⁴ Blaschkitis is a term for a blaschkoid inflammation of the skin that presents with more eczematous findings and histology of spongiosis, unlike the lichenoid findings of LS. It is typically accompanied by noticeable pruritus and broader bands of involved area, and has older age of onset than LS. Linear morphea is a deeper inflammatory process of the dermis or subcutaneous fat, presenting with sclerotic skin, and typically has associated atrophy.

Treatment need not be pursued for lichen striatus because it is a benign condition. The lesions typically self-resolve without any residual scarring. If patients have associated pruritus then low- to midpotency topical steroids can be used for symptomatic relief.
 

Dr. Kaushik is with the division of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, and Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. There are no conflicts of interest or financial disclosures for Dr. Kaushik or Dr. Eichenfield. Email them at pdnews@mdedge.com.

References

1. Gupta D, Mathes E. Lichen Striatus. (Levy ML ed.) 2019: UpToDate.

2. Dermatol Ther. 2018 Nov;31(6):e12713.

3. Int J Dermatol. 2018 Sep;57(9):1118-9.

4. J Dermatol. 2017 Dec;44(12):e355-6.

Although epidermal growth factor receptor–mutant lung cancers generally don’t benefit from checkpoint inhibitors, there may be some subtypes that do respond, results of a large, multi-institution analysis suggest.

Compared with wild-type lung cancer cases, tumors with epidermal growth factor receptor (EGFR) exon 19 deletion did indeed have worse outcomes after progressive death-1/progressive death–ligand 1 (PD-1/PD-L1) blockade; however, tumors harboring EGFR L858R mutations had comparable response rates and overall survival.

These findings don’t change clinical practice, but do serve as a “foundation” for more research into which patients with EGFR-mutant disease might benefit from immunotherapy, according to Katherine Hastings, PhD, of Yale University, New Haven, Conn., and associates.

“We unequivocally support the guidance that EGFR TKIs should be the preferred first-line treatment option for patients with EGFR-mutant lung cancer,” Dr. Hastings and coauthors wrote in Annals of Oncology.

To date, clinical investigations of immune checkpoint inhibitors in patients with EGFR-mutant lung cancers have largely been discouraging, the authors wrote. However, there have been some exceptions, including a phase 2 study where third-line durvalumab showed activity in some patients with EGFR-positive, PD-L1-expressing advanced non–small cell lung cancer (NSCLC).

Accordingly, the investigators sought to determine whether specific molecular features made a difference. They looked at a total of 171 EGFR-mutant lung cancers that had been treated with PD-1/PD-L1 inhibitors, alone or in combination with a cytotoxic T-lymphocyte antigen 4 inhibitor.

In their analysis, they drilled down on the most common EGFR tyrosine kinase inhibitor–sensitizing alleles: EGFR exon 19 deletions, which represented 76 cases, and EGFR L858R, which represented 44 cases. For comparison, they looked at a cohort of 212 patients with EGFR wild-type NSCLC who had also been treated with immune checkpoint inhibitors.

EGFR exon 19 deletion cases had a significantly lower overall response rate versus EGFR wild-type tumors, at 7% versus 22%, respectively (P = .002), the investigators found. Likewise, overall survival was significantly reduced, with a hazard ratio of 0.69 (95% confidence interval, 0.493-0.965; P = .03).

By contrast, EGFR L858R tumors had similar response rates versus EGFR wild type, at 16% and 22%, respectively (P = .42); overall survival also was similar, with a hazard ratio of 0.917 (95% CI, 0.597-1.409; P = .69).

Of note, progression-free survival was reduced in both EGFR L858R and EGFR exon 19 deletion cases as compared with EGFR wild-type cases, though the investigators wrote that discrepancy might be related to variations in scanning intervals between different institutions that contributed cases to the study.

“Overall, these data suggest that patients with EGFR exon 19–mutant tumors, in particular, have a significantly reduced benefit upon treatment with immune checkpoint inhibitors,” the authors noted.

In a separate but related analysis of 383 patients with EGFR-mutant lung cancer, tumor mutation burden was lower in EGFR exon 19 deletion cases as compared with the EGFR L858R cases. That finding lined up with the immunotherapy response data, the investigators wrote, though it’s unclear what might be driving the differences in tumor burden between these two groups.

There were no differences in response to immune checkpoint blockade based on whether or not tumors harbored the EGFR T790M mutation, the investigators added. Similarly, PD-L1 expression did not impact response.

The study authors reported disclosures related to Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Calithera Biosciences, Daiichi, Eli Lilly, Merck, Mirati Therapeutics, Novartis, Pfizer, Roche, and Takeda, among others.

SOURCE: Hastings K et al. Ann Oncol. 2019 May 14. doi: 10.1093/annonc/mdz141.

Although epidermal growth factor receptor–mutant lung cancers generally don’t benefit from checkpoint inhibitors, there may be some subtypes that do respond, results of a large, multi-institution analysis suggest.

Compared with wild-type lung cancer cases, tumors with epidermal growth factor receptor (EGFR) exon 19 deletion did indeed have worse outcomes after progressive death-1/progressive death–ligand 1 (PD-1/PD-L1) blockade; however, tumors harboring EGFR L858R mutations had comparable response rates and overall survival.

These findings don’t change clinical practice, but do serve as a “foundation” for more research into which patients with EGFR-mutant disease might benefit from immunotherapy, according to Katherine Hastings, PhD, of Yale University, New Haven, Conn., and associates.

“We unequivocally support the guidance that EGFR TKIs should be the preferred first-line treatment option for patients with EGFR-mutant lung cancer,” Dr. Hastings and coauthors wrote in Annals of Oncology.

To date, clinical investigations of immune checkpoint inhibitors in patients with EGFR-mutant lung cancers have largely been discouraging, the authors wrote. However, there have been some exceptions, including a phase 2 study where third-line durvalumab showed activity in some patients with EGFR-positive, PD-L1-expressing advanced non–small cell lung cancer (NSCLC).

Accordingly, the investigators sought to determine whether specific molecular features made a difference. They looked at a total of 171 EGFR-mutant lung cancers that had been treated with PD-1/PD-L1 inhibitors, alone or in combination with a cytotoxic T-lymphocyte antigen 4 inhibitor.

In their analysis, they drilled down on the most common EGFR tyrosine kinase inhibitor–sensitizing alleles: EGFR exon 19 deletions, which represented 76 cases, and EGFR L858R, which represented 44 cases. For comparison, they looked at a cohort of 212 patients with EGFR wild-type NSCLC who had also been treated with immune checkpoint inhibitors.

EGFR exon 19 deletion cases had a significantly lower overall response rate versus EGFR wild-type tumors, at 7% versus 22%, respectively (P = .002), the investigators found. Likewise, overall survival was significantly reduced, with a hazard ratio of 0.69 (95% confidence interval, 0.493-0.965; P = .03).

By contrast, EGFR L858R tumors had similar response rates versus EGFR wild type, at 16% and 22%, respectively (P = .42); overall survival also was similar, with a hazard ratio of 0.917 (95% CI, 0.597-1.409; P = .69).

Of note, progression-free survival was reduced in both EGFR L858R and EGFR exon 19 deletion cases as compared with EGFR wild-type cases, though the investigators wrote that discrepancy might be related to variations in scanning intervals between different institutions that contributed cases to the study.

“Overall, these data suggest that patients with EGFR exon 19–mutant tumors, in particular, have a significantly reduced benefit upon treatment with immune checkpoint inhibitors,” the authors noted.

In a separate but related analysis of 383 patients with EGFR-mutant lung cancer, tumor mutation burden was lower in EGFR exon 19 deletion cases as compared with the EGFR L858R cases. That finding lined up with the immunotherapy response data, the investigators wrote, though it’s unclear what might be driving the differences in tumor burden between these two groups.

There were no differences in response to immune checkpoint blockade based on whether or not tumors harbored the EGFR T790M mutation, the investigators added. Similarly, PD-L1 expression did not impact response.

The study authors reported disclosures related to Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Calithera Biosciences, Daiichi, Eli Lilly, Merck, Mirati Therapeutics, Novartis, Pfizer, Roche, and Takeda, among others.

SOURCE: Hastings K et al. Ann Oncol. 2019 May 14. doi: 10.1093/annonc/mdz141.

Although epidermal growth factor receptor–mutant lung cancers generally don’t benefit from checkpoint inhibitors, there may be some subtypes that do respond, results of a large, multi-institution analysis suggest.

Compared with wild-type lung cancer cases, tumors with epidermal growth factor receptor (EGFR) exon 19 deletion did indeed have worse outcomes after progressive death-1/progressive death–ligand 1 (PD-1/PD-L1) blockade; however, tumors harboring EGFR L858R mutations had comparable response rates and overall survival.

These findings don’t change clinical practice, but do serve as a “foundation” for more research into which patients with EGFR-mutant disease might benefit from immunotherapy, according to Katherine Hastings, PhD, of Yale University, New Haven, Conn., and associates.

“We unequivocally support the guidance that EGFR TKIs should be the preferred first-line treatment option for patients with EGFR-mutant lung cancer,” Dr. Hastings and coauthors wrote in Annals of Oncology.

To date, clinical investigations of immune checkpoint inhibitors in patients with EGFR-mutant lung cancers have largely been discouraging, the authors wrote. However, there have been some exceptions, including a phase 2 study where third-line durvalumab showed activity in some patients with EGFR-positive, PD-L1-expressing advanced non–small cell lung cancer (NSCLC).

Accordingly, the investigators sought to determine whether specific molecular features made a difference. They looked at a total of 171 EGFR-mutant lung cancers that had been treated with PD-1/PD-L1 inhibitors, alone or in combination with a cytotoxic T-lymphocyte antigen 4 inhibitor.

In their analysis, they drilled down on the most common EGFR tyrosine kinase inhibitor–sensitizing alleles: EGFR exon 19 deletions, which represented 76 cases, and EGFR L858R, which represented 44 cases. For comparison, they looked at a cohort of 212 patients with EGFR wild-type NSCLC who had also been treated with immune checkpoint inhibitors.

EGFR exon 19 deletion cases had a significantly lower overall response rate versus EGFR wild-type tumors, at 7% versus 22%, respectively (P = .002), the investigators found. Likewise, overall survival was significantly reduced, with a hazard ratio of 0.69 (95% confidence interval, 0.493-0.965; P = .03).

By contrast, EGFR L858R tumors had similar response rates versus EGFR wild type, at 16% and 22%, respectively (P = .42); overall survival also was similar, with a hazard ratio of 0.917 (95% CI, 0.597-1.409; P = .69).

Of note, progression-free survival was reduced in both EGFR L858R and EGFR exon 19 deletion cases as compared with EGFR wild-type cases, though the investigators wrote that discrepancy might be related to variations in scanning intervals between different institutions that contributed cases to the study.

“Overall, these data suggest that patients with EGFR exon 19–mutant tumors, in particular, have a significantly reduced benefit upon treatment with immune checkpoint inhibitors,” the authors noted.

In a separate but related analysis of 383 patients with EGFR-mutant lung cancer, tumor mutation burden was lower in EGFR exon 19 deletion cases as compared with the EGFR L858R cases. That finding lined up with the immunotherapy response data, the investigators wrote, though it’s unclear what might be driving the differences in tumor burden between these two groups.

There were no differences in response to immune checkpoint blockade based on whether or not tumors harbored the EGFR T790M mutation, the investigators added. Similarly, PD-L1 expression did not impact response.

The study authors reported disclosures related to Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Calithera Biosciences, Daiichi, Eli Lilly, Merck, Mirati Therapeutics, Novartis, Pfizer, Roche, and Takeda, among others.

SOURCE: Hastings K et al. Ann Oncol. 2019 May 14. doi: 10.1093/annonc/mdz141.

Neither baseline Th17-associated cytokines nor C-reactive protein levels were predictive of response to ustekinumab in patients with psoriatic arthritis, despite significant reductions following treatment, according to Stefan Siebert, PhD, of the University of Glasgow (Scotland) and associates.

In a study published in Arthritis & Rheumatology, the authors retrospectively analyzed serum samples collected from 927 patients with psoriatic arthritis who participated in the phase 3 PSUMMIT trials. Patients received ustekinumab (Stelara) or placebo, and samples were collected at baseline, 4 weeks, and 24 weeks.

At baseline, interleukin-17A, -17F, and -23 levels were associated with skin disease scores, but neither these nor C-reactive protein (CRP) were associated with joint disease scores. While IL-17A, IL-17F, and CRP were reduced in patients who responded to ustekinumab, baseline levels of IL-17A, IL-17F, IL-23, and CRP were not associated with ustekinumab response in either skin or joints.

In patients who achieved a 75% reduction in their Psoriasis Area and Severity Index scores or a 20% reduction in their American College of Rheumatology response score after 24 weeks, CRP levels were significantly lower than in patients who did not achieve these scores (51%-58% vs. 32%-33%; P less than .05). However, IL-17A and IL-17F levels were not significantly different in these patients.

“While the biomarkers studied in the PSUMMIT program did not translate into therapeutic utility, it is important that relevant biomarker studies associated with phase 3 clinical trial programs are published in order to increase our understanding of this complex disease and further dissect the role of the IL-23/IL-17 pathway,” the investigators concluded.

The study was funded by Janssen; four coauthors reported being employed with Janssen.

lfranki@mdedge.com

SOURCE: Siebert S et al. Arthritis Rheumatol. 2019 May 9. doi: 10.1002/art.40921.

Neither baseline Th17-associated cytokines nor C-reactive protein levels were predictive of response to ustekinumab in patients with psoriatic arthritis, despite significant reductions following treatment, according to Stefan Siebert, PhD, of the University of Glasgow (Scotland) and associates.

In a study published in Arthritis & Rheumatology, the authors retrospectively analyzed serum samples collected from 927 patients with psoriatic arthritis who participated in the phase 3 PSUMMIT trials. Patients received ustekinumab (Stelara) or placebo, and samples were collected at baseline, 4 weeks, and 24 weeks.

At baseline, interleukin-17A, -17F, and -23 levels were associated with skin disease scores, but neither these nor C-reactive protein (CRP) were associated with joint disease scores. While IL-17A, IL-17F, and CRP were reduced in patients who responded to ustekinumab, baseline levels of IL-17A, IL-17F, IL-23, and CRP were not associated with ustekinumab response in either skin or joints.

In patients who achieved a 75% reduction in their Psoriasis Area and Severity Index scores or a 20% reduction in their American College of Rheumatology response score after 24 weeks, CRP levels were significantly lower than in patients who did not achieve these scores (51%-58% vs. 32%-33%; P less than .05). However, IL-17A and IL-17F levels were not significantly different in these patients.

“While the biomarkers studied in the PSUMMIT program did not translate into therapeutic utility, it is important that relevant biomarker studies associated with phase 3 clinical trial programs are published in order to increase our understanding of this complex disease and further dissect the role of the IL-23/IL-17 pathway,” the investigators concluded.

The study was funded by Janssen; four coauthors reported being employed with Janssen.

lfranki@mdedge.com

SOURCE: Siebert S et al. Arthritis Rheumatol. 2019 May 9. doi: 10.1002/art.40921.

Neither baseline Th17-associated cytokines nor C-reactive protein levels were predictive of response to ustekinumab in patients with psoriatic arthritis, despite significant reductions following treatment, according to Stefan Siebert, PhD, of the University of Glasgow (Scotland) and associates.

In a study published in Arthritis & Rheumatology, the authors retrospectively analyzed serum samples collected from 927 patients with psoriatic arthritis who participated in the phase 3 PSUMMIT trials. Patients received ustekinumab (Stelara) or placebo, and samples were collected at baseline, 4 weeks, and 24 weeks.

At baseline, interleukin-17A, -17F, and -23 levels were associated with skin disease scores, but neither these nor C-reactive protein (CRP) were associated with joint disease scores. While IL-17A, IL-17F, and CRP were reduced in patients who responded to ustekinumab, baseline levels of IL-17A, IL-17F, IL-23, and CRP were not associated with ustekinumab response in either skin or joints.

In patients who achieved a 75% reduction in their Psoriasis Area and Severity Index scores or a 20% reduction in their American College of Rheumatology response score after 24 weeks, CRP levels were significantly lower than in patients who did not achieve these scores (51%-58% vs. 32%-33%; P less than .05). However, IL-17A and IL-17F levels were not significantly different in these patients.

“While the biomarkers studied in the PSUMMIT program did not translate into therapeutic utility, it is important that relevant biomarker studies associated with phase 3 clinical trial programs are published in order to increase our understanding of this complex disease and further dissect the role of the IL-23/IL-17 pathway,” the investigators concluded.

The study was funded by Janssen; four coauthors reported being employed with Janssen.

lfranki@mdedge.com

SOURCE: Siebert S et al. Arthritis Rheumatol. 2019 May 9. doi: 10.1002/art.40921.

Disease severity and family history appear to play a significant role in the age of diagnosis for women with congenital bleeding disorders, according to recent survey findings.

A European multinational survey has identified delays in diagnosis and other challenges faced by girls and women with congenital bleeding disorders.

“The aim of this survey, carried out by the European Haemophilia Consortium (EHC), was to provide the patient voice of their lived experiences with congenital bleeding disorders,” wrote Declan Noone of the EHC in Brussels, and colleagues. The findings were published in Haemophilia.

The researchers conducted a survey of 709 girls and women with various congenital bleeding disorders from 32 countries, primarily located in Western Europe. Most respondents were adults, with just 3.8% under age 18 years.

The questionnaire was administered to eligible patients at various hemophilia treatment centers. More than half of respondents were hemophilia carriers and nearly 28% had von Willebrand disease.

The survey explored the effects of bleeding disorders on several activities of daily life, including symptoms, physical activity, and reproductive ability.

After analysis, the researchers found that overall the median age at diagnosis of a bleeding disorder was 16 years (range, 2-28 years) among respondents. Having a family history of a bleeding disorder resulted in a significantly younger median age at diagnosis (6 years; range, 0-26 years) versus those without a family history (17 years; range 5-28 years; P less than .01).

Disease severity also appears to play a role. Women with type 3 von Willebrand disease had a median age of diagnosis of 1 year old, compared with 19.3 years old for type 2 disease (P less than .01).

Respondents reported a substantial disease burden on activities of daily life, especially for women with platelet function disorders and other factor deficiency.

Women without a known family history of a bleeding disorders reported a significantly greater impact on their physical life, social life, and romantic life (P less than .01 for all domains), compared with women with a family history of bleeding disorders.

There were no statistically significant differences across types of bleeding disorders on questions related to reproductive life. However, the researchers reported that “surprisingly,” 25% of women reported that having a bleeding disorder “has had a severe impact on their decision or has prevented them from having children.

“The bleeding symptom of biggest impact on daily life is [heavy menstrual bleeding], reported by 55% of women,” the researchers wrote.

The researchers acknowledged that a key limitation of the survey was the composition of the sample: predominantly of patients from Western Europe. As a result, the findings may not be generalizable to all patient populations.

No funding sources were reported. The authors reported having no conflicts of interest.

SOURCE: Noone D et al. Haemophilia. 2019 Apr 29. doi: 10.1111/hae.13722.

Disease severity and family history appear to play a significant role in the age of diagnosis for women with congenital bleeding disorders, according to recent survey findings.

A European multinational survey has identified delays in diagnosis and other challenges faced by girls and women with congenital bleeding disorders.

“The aim of this survey, carried out by the European Haemophilia Consortium (EHC), was to provide the patient voice of their lived experiences with congenital bleeding disorders,” wrote Declan Noone of the EHC in Brussels, and colleagues. The findings were published in Haemophilia.

The researchers conducted a survey of 709 girls and women with various congenital bleeding disorders from 32 countries, primarily located in Western Europe. Most respondents were adults, with just 3.8% under age 18 years.

The questionnaire was administered to eligible patients at various hemophilia treatment centers. More than half of respondents were hemophilia carriers and nearly 28% had von Willebrand disease.

The survey explored the effects of bleeding disorders on several activities of daily life, including symptoms, physical activity, and reproductive ability.

After analysis, the researchers found that overall the median age at diagnosis of a bleeding disorder was 16 years (range, 2-28 years) among respondents. Having a family history of a bleeding disorder resulted in a significantly younger median age at diagnosis (6 years; range, 0-26 years) versus those without a family history (17 years; range 5-28 years; P less than .01).

Disease severity also appears to play a role. Women with type 3 von Willebrand disease had a median age of diagnosis of 1 year old, compared with 19.3 years old for type 2 disease (P less than .01).

Respondents reported a substantial disease burden on activities of daily life, especially for women with platelet function disorders and other factor deficiency.

Women without a known family history of a bleeding disorders reported a significantly greater impact on their physical life, social life, and romantic life (P less than .01 for all domains), compared with women with a family history of bleeding disorders.

There were no statistically significant differences across types of bleeding disorders on questions related to reproductive life. However, the researchers reported that “surprisingly,” 25% of women reported that having a bleeding disorder “has had a severe impact on their decision or has prevented them from having children.

“The bleeding symptom of biggest impact on daily life is [heavy menstrual bleeding], reported by 55% of women,” the researchers wrote.

The researchers acknowledged that a key limitation of the survey was the composition of the sample: predominantly of patients from Western Europe. As a result, the findings may not be generalizable to all patient populations.

No funding sources were reported. The authors reported having no conflicts of interest.

SOURCE: Noone D et al. Haemophilia. 2019 Apr 29. doi: 10.1111/hae.13722.

Disease severity and family history appear to play a significant role in the age of diagnosis for women with congenital bleeding disorders, according to recent survey findings.

A European multinational survey has identified delays in diagnosis and other challenges faced by girls and women with congenital bleeding disorders.

“The aim of this survey, carried out by the European Haemophilia Consortium (EHC), was to provide the patient voice of their lived experiences with congenital bleeding disorders,” wrote Declan Noone of the EHC in Brussels, and colleagues. The findings were published in Haemophilia.

The researchers conducted a survey of 709 girls and women with various congenital bleeding disorders from 32 countries, primarily located in Western Europe. Most respondents were adults, with just 3.8% under age 18 years.

The questionnaire was administered to eligible patients at various hemophilia treatment centers. More than half of respondents were hemophilia carriers and nearly 28% had von Willebrand disease.

The survey explored the effects of bleeding disorders on several activities of daily life, including symptoms, physical activity, and reproductive ability.

After analysis, the researchers found that overall the median age at diagnosis of a bleeding disorder was 16 years (range, 2-28 years) among respondents. Having a family history of a bleeding disorder resulted in a significantly younger median age at diagnosis (6 years; range, 0-26 years) versus those without a family history (17 years; range 5-28 years; P less than .01).

Disease severity also appears to play a role. Women with type 3 von Willebrand disease had a median age of diagnosis of 1 year old, compared with 19.3 years old for type 2 disease (P less than .01).

Respondents reported a substantial disease burden on activities of daily life, especially for women with platelet function disorders and other factor deficiency.

Women without a known family history of a bleeding disorders reported a significantly greater impact on their physical life, social life, and romantic life (P less than .01 for all domains), compared with women with a family history of bleeding disorders.

There were no statistically significant differences across types of bleeding disorders on questions related to reproductive life. However, the researchers reported that “surprisingly,” 25% of women reported that having a bleeding disorder “has had a severe impact on their decision or has prevented them from having children.

“The bleeding symptom of biggest impact on daily life is [heavy menstrual bleeding], reported by 55% of women,” the researchers wrote.

The researchers acknowledged that a key limitation of the survey was the composition of the sample: predominantly of patients from Western Europe. As a result, the findings may not be generalizable to all patient populations.

No funding sources were reported. The authors reported having no conflicts of interest.

SOURCE: Noone D et al. Haemophilia. 2019 Apr 29. doi: 10.1111/hae.13722.

NEW ORLEANS – Next-generation sequencing of peripheral blood is at least as effective as flow cytometry of bone marrow for assessing minimal residual disease, according to a new study.

Researchers compared bone marrow flow cytometry (FC) and peripheral blood next-generation sequencing (NGS) for minimal residual disease (MRD) assessment in pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who received treatment with tisagenlecleucel. There was a high level of concordance between the assays, but the NGS assay detected more MRD-positive samples and NGS results provided a longer lead time to relapse.

Michael A. Pulsipher, MD, of the Children’s Hospital Los Angeles, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.

The researchers analyzed samples from pediatric and young adult patients aged 2-25 years who had relapsed or refractory B-ALL and received treatment with tisagenlecleucel on the ELIANA or ENSIGN trials.

The patients had received at least two prior lines of therapy and were ineligible for allogeneic transplant. They received a single dose of tisagenlecleucel. MRD was assessed before tisagenlecleucel infusion, at various time points after infusion, and at relapse.

Dr. Pulsipher and his colleagues compared MRD results from an NGS assay – Adaptive Biotechnologies’ clonoSEQ – using peripheral blood and results from FC of bone marrow. NGS and FC results were available for 237 samples from 83 patients.

After treatment, NGS detected more MRD-positive samples at each sensitivity level tested (10^-4, 10^-5, and 10^-6). At 10^-6, NGS detected 18% more MRD-positive samples than did FC – 50% and 32%, respectively.

Detection of MRD positivity prior to relapse was faster with NGS than with FC. In 17 of 34 patients with morphological relapse, NGS provided a median lead time of 67 days. FC provided a median lead time of 39 days in 11 of the 34 patients.

About 80% of patients who had an MRD status of zero by NGS at day 28 remained relapse-free for up to 3 years.

Among complete responders (n = 50), the duration of response was significantly longer in patients who had an MRD status of zero at day 28 by NGS than in patients who had an MRD status greater than zero (P = .0003). Overall survival was significantly better among patients with an MRD status of zero as well (P = .0004).

Dr. Pulsipher said additional studies are needed to confirm these findings and determine the best way to know if a patient has been cured or needs additional therapy after tisagenlecleucel.

Dr. Pulsipher reported relationships with Adaptive Biotech, Novartis, Incyte, Amgen, Bellicum Pharmaceuticals, Medac Pharma, and Miltenyi Biotec. ELIANA and ENSIGN were funded by Novartis, which markets tisagenlecleucel as Kymriah.

jensmith@mdedge.com

SOURCE: Pulsipher MA et al. ASPHO 2019, Abstract 2001.

NEW ORLEANS – Next-generation sequencing of peripheral blood is at least as effective as flow cytometry of bone marrow for assessing minimal residual disease, according to a new study.

Researchers compared bone marrow flow cytometry (FC) and peripheral blood next-generation sequencing (NGS) for minimal residual disease (MRD) assessment in pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who received treatment with tisagenlecleucel. There was a high level of concordance between the assays, but the NGS assay detected more MRD-positive samples and NGS results provided a longer lead time to relapse.

Michael A. Pulsipher, MD, of the Children’s Hospital Los Angeles, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.

The researchers analyzed samples from pediatric and young adult patients aged 2-25 years who had relapsed or refractory B-ALL and received treatment with tisagenlecleucel on the ELIANA or ENSIGN trials.

The patients had received at least two prior lines of therapy and were ineligible for allogeneic transplant. They received a single dose of tisagenlecleucel. MRD was assessed before tisagenlecleucel infusion, at various time points after infusion, and at relapse.

Dr. Pulsipher and his colleagues compared MRD results from an NGS assay – Adaptive Biotechnologies’ clonoSEQ – using peripheral blood and results from FC of bone marrow. NGS and FC results were available for 237 samples from 83 patients.

After treatment, NGS detected more MRD-positive samples at each sensitivity level tested (10^-4, 10^-5, and 10^-6). At 10^-6, NGS detected 18% more MRD-positive samples than did FC – 50% and 32%, respectively.

Detection of MRD positivity prior to relapse was faster with NGS than with FC. In 17 of 34 patients with morphological relapse, NGS provided a median lead time of 67 days. FC provided a median lead time of 39 days in 11 of the 34 patients.

About 80% of patients who had an MRD status of zero by NGS at day 28 remained relapse-free for up to 3 years.

Among complete responders (n = 50), the duration of response was significantly longer in patients who had an MRD status of zero at day 28 by NGS than in patients who had an MRD status greater than zero (P = .0003). Overall survival was significantly better among patients with an MRD status of zero as well (P = .0004).

Dr. Pulsipher said additional studies are needed to confirm these findings and determine the best way to know if a patient has been cured or needs additional therapy after tisagenlecleucel.

Dr. Pulsipher reported relationships with Adaptive Biotech, Novartis, Incyte, Amgen, Bellicum Pharmaceuticals, Medac Pharma, and Miltenyi Biotec. ELIANA and ENSIGN were funded by Novartis, which markets tisagenlecleucel as Kymriah.

jensmith@mdedge.com

SOURCE: Pulsipher MA et al. ASPHO 2019, Abstract 2001.

NEW ORLEANS – Next-generation sequencing of peripheral blood is at least as effective as flow cytometry of bone marrow for assessing minimal residual disease, according to a new study.

Researchers compared bone marrow flow cytometry (FC) and peripheral blood next-generation sequencing (NGS) for minimal residual disease (MRD) assessment in pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who received treatment with tisagenlecleucel. There was a high level of concordance between the assays, but the NGS assay detected more MRD-positive samples and NGS results provided a longer lead time to relapse.

Michael A. Pulsipher, MD, of the Children’s Hospital Los Angeles, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.

The researchers analyzed samples from pediatric and young adult patients aged 2-25 years who had relapsed or refractory B-ALL and received treatment with tisagenlecleucel on the ELIANA or ENSIGN trials.

The patients had received at least two prior lines of therapy and were ineligible for allogeneic transplant. They received a single dose of tisagenlecleucel. MRD was assessed before tisagenlecleucel infusion, at various time points after infusion, and at relapse.

Dr. Pulsipher and his colleagues compared MRD results from an NGS assay – Adaptive Biotechnologies’ clonoSEQ – using peripheral blood and results from FC of bone marrow. NGS and FC results were available for 237 samples from 83 patients.

After treatment, NGS detected more MRD-positive samples at each sensitivity level tested (10^-4, 10^-5, and 10^-6). At 10^-6, NGS detected 18% more MRD-positive samples than did FC – 50% and 32%, respectively.

Detection of MRD positivity prior to relapse was faster with NGS than with FC. In 17 of 34 patients with morphological relapse, NGS provided a median lead time of 67 days. FC provided a median lead time of 39 days in 11 of the 34 patients.

About 80% of patients who had an MRD status of zero by NGS at day 28 remained relapse-free for up to 3 years.

Among complete responders (n = 50), the duration of response was significantly longer in patients who had an MRD status of zero at day 28 by NGS than in patients who had an MRD status greater than zero (P = .0003). Overall survival was significantly better among patients with an MRD status of zero as well (P = .0004).

Dr. Pulsipher said additional studies are needed to confirm these findings and determine the best way to know if a patient has been cured or needs additional therapy after tisagenlecleucel.

Dr. Pulsipher reported relationships with Adaptive Biotech, Novartis, Incyte, Amgen, Bellicum Pharmaceuticals, Medac Pharma, and Miltenyi Biotec. ELIANA and ENSIGN were funded by Novartis, which markets tisagenlecleucel as Kymriah.

jensmith@mdedge.com

SOURCE: Pulsipher MA et al. ASPHO 2019, Abstract 2001.

The introduction of the Affordable Care Act was associated with an increase in health insurance among cancer survivors, but cost still remains a barrier to insurance, particularly among certain groups, research suggests.

Researchers conducted an analysis of National Health Interview Survey data from 17,806 survey participants who reported a cancer diagnosis. The findings are in JAMA Oncology.

Around one in ten of those surveyed did not have health insurance, but this rate was significantly higher before the introduction of the Affordable Care Act compared to the 3-year period after its implementation in 2014 (10.6% vs. 6.2%, P less than .001).

While cost was the most common reason for not having health insurance, the survey showed that the proportion of noninsured cancer survivors who cited cost as the reason for noninsurance decreased significantly after implementation of the Affordable Care Act (49.6% vs. 37.6%, P = .003).

Unemployment was the second-most common reason for noninsurance, but this also decreased in the 2014-2017 period compared with 2000-2013 (37.1% vs. 28.5%, P = .005).

Younger cancer survivors – aged below the mean age of 50.9 years – were 84% more likely to be uninsured, compared with those above the mean age of the study population, and those with a family income below the poverty threshold were nearly twice as likely not to be insured.

Participants of Hispanic ethnicity, noncitizens, and current smokers were significantly more likely to be uninsured.

Before the implementation of the Affordable Care Act, black patients were 29% more likely to be uninsured compared with nonblack patients. But after the ACA was introduced, this difference disappeared.

Nina N. Sanford, MD, of the University of Texas, Dallas, and coauthors wrote that, to their knowledge, this was the first study to look at reasons for noninsurance among cancer survivors, and highlighted that efforts to improve insurance coverage would require “diverse policy initiatives.

“Despite these improvements [after the Affordable Care Act], our study identified several demographic subgroups who appear to continue to be at risk for not having insurance even after the ACA, which may contribute to worse cancer-specific outcomes, decreased quality of life, and greater mortality,” they wrote. “Policymakers should be aware of these disparities when proposing legislation to either augment or limit health care coverage.”

They expressed concern about the association between smoking and a lack of health insurance, noting that the Affordable Care Act allows insurers to impose a surcharge premium on smokers. However they pointed out that this initiative has not decreased rates of smoking, and may instead have led to higher rates of noninsurance among cancer survivors who continue to smoke.

One author was supported by the American Society of Radiation Oncology and the Prostate Cancer Foundation, and one author declared funding from the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Sanford N et al. JAMA Oncology 2019, May 15. doi: 10.1001/jamaoncol.2019.1973.

The introduction of the Affordable Care Act was associated with an increase in health insurance among cancer survivors, but cost still remains a barrier to insurance, particularly among certain groups, research suggests.

Researchers conducted an analysis of National Health Interview Survey data from 17,806 survey participants who reported a cancer diagnosis. The findings are in JAMA Oncology.

Around one in ten of those surveyed did not have health insurance, but this rate was significantly higher before the introduction of the Affordable Care Act compared to the 3-year period after its implementation in 2014 (10.6% vs. 6.2%, P less than .001).

While cost was the most common reason for not having health insurance, the survey showed that the proportion of noninsured cancer survivors who cited cost as the reason for noninsurance decreased significantly after implementation of the Affordable Care Act (49.6% vs. 37.6%, P = .003).

Unemployment was the second-most common reason for noninsurance, but this also decreased in the 2014-2017 period compared with 2000-2013 (37.1% vs. 28.5%, P = .005).

Younger cancer survivors – aged below the mean age of 50.9 years – were 84% more likely to be uninsured, compared with those above the mean age of the study population, and those with a family income below the poverty threshold were nearly twice as likely not to be insured.

Participants of Hispanic ethnicity, noncitizens, and current smokers were significantly more likely to be uninsured.

Before the implementation of the Affordable Care Act, black patients were 29% more likely to be uninsured compared with nonblack patients. But after the ACA was introduced, this difference disappeared.

Nina N. Sanford, MD, of the University of Texas, Dallas, and coauthors wrote that, to their knowledge, this was the first study to look at reasons for noninsurance among cancer survivors, and highlighted that efforts to improve insurance coverage would require “diverse policy initiatives.

“Despite these improvements [after the Affordable Care Act], our study identified several demographic subgroups who appear to continue to be at risk for not having insurance even after the ACA, which may contribute to worse cancer-specific outcomes, decreased quality of life, and greater mortality,” they wrote. “Policymakers should be aware of these disparities when proposing legislation to either augment or limit health care coverage.”

They expressed concern about the association between smoking and a lack of health insurance, noting that the Affordable Care Act allows insurers to impose a surcharge premium on smokers. However they pointed out that this initiative has not decreased rates of smoking, and may instead have led to higher rates of noninsurance among cancer survivors who continue to smoke.

One author was supported by the American Society of Radiation Oncology and the Prostate Cancer Foundation, and one author declared funding from the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Sanford N et al. JAMA Oncology 2019, May 15. doi: 10.1001/jamaoncol.2019.1973.

The introduction of the Affordable Care Act was associated with an increase in health insurance among cancer survivors, but cost still remains a barrier to insurance, particularly among certain groups, research suggests.

Researchers conducted an analysis of National Health Interview Survey data from 17,806 survey participants who reported a cancer diagnosis. The findings are in JAMA Oncology.

Around one in ten of those surveyed did not have health insurance, but this rate was significantly higher before the introduction of the Affordable Care Act compared to the 3-year period after its implementation in 2014 (10.6% vs. 6.2%, P less than .001).

While cost was the most common reason for not having health insurance, the survey showed that the proportion of noninsured cancer survivors who cited cost as the reason for noninsurance decreased significantly after implementation of the Affordable Care Act (49.6% vs. 37.6%, P = .003).

Unemployment was the second-most common reason for noninsurance, but this also decreased in the 2014-2017 period compared with 2000-2013 (37.1% vs. 28.5%, P = .005).

Younger cancer survivors – aged below the mean age of 50.9 years – were 84% more likely to be uninsured, compared with those above the mean age of the study population, and those with a family income below the poverty threshold were nearly twice as likely not to be insured.

Participants of Hispanic ethnicity, noncitizens, and current smokers were significantly more likely to be uninsured.

Before the implementation of the Affordable Care Act, black patients were 29% more likely to be uninsured compared with nonblack patients. But after the ACA was introduced, this difference disappeared.

Nina N. Sanford, MD, of the University of Texas, Dallas, and coauthors wrote that, to their knowledge, this was the first study to look at reasons for noninsurance among cancer survivors, and highlighted that efforts to improve insurance coverage would require “diverse policy initiatives.

“Despite these improvements [after the Affordable Care Act], our study identified several demographic subgroups who appear to continue to be at risk for not having insurance even after the ACA, which may contribute to worse cancer-specific outcomes, decreased quality of life, and greater mortality,” they wrote. “Policymakers should be aware of these disparities when proposing legislation to either augment or limit health care coverage.”

They expressed concern about the association between smoking and a lack of health insurance, noting that the Affordable Care Act allows insurers to impose a surcharge premium on smokers. However they pointed out that this initiative has not decreased rates of smoking, and may instead have led to higher rates of noninsurance among cancer survivors who continue to smoke.

One author was supported by the American Society of Radiation Oncology and the Prostate Cancer Foundation, and one author declared funding from the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Sanford N et al. JAMA Oncology 2019, May 15. doi: 10.1001/jamaoncol.2019.1973.

As many as one in eight patients with uterine cancer who undergo adjuvant radiation therapy may have been treated with doses that are inconsistent with standard practice, a new study suggests.

Writing in JCO Clinical Cancer Informatics, Corbin D. Jacobs, MD, of Duke University, Durham, N.C., and coauthors analyzed National Cancer Database data from 14,298 women with stage IIIC1-C2 uterine cancer who underwent adjuvant radiation therapy after hysterectomy. The analysis included information on radiation therapy site, modality, dose, fractions, timing, duration, and stage, as well as details about the facilities at which the treatment was given.

Overall, 16% of the women had at least one ‘anomalous’ entry in their records of radiation therapy. The most common anomalies were that the combined total radiation therapy dose was insufficient, or there was an insufficient number of external beam radiation therapy fractions, both of which may have represented an incomplete course of radiation therapy.

Other anomalies were excessive brachytherapy fractions, inconsistency in the staging, and less than 100 days of radiation therapy.

The study showed that the 5-year overall survival rate in individuals who had at least one anomalous data entry was 51.3% compared with 58% among individuals without any anomalous entries (P less than .001). The difference in survival rates was entirely accounted for by insufficient, excessive, or unknown radiation therapy dose.

More than half of patients in the study had missing or unknown data for at least one entry, and this was associated with lower 5-year survival compared with patients with complete data entries.

The researchers also looked at facility-specific factors, such as the type of facility, its location, and its distance from the patient’s home, and how these impacted the frequency of anomalous data. They found that comprehensive community cancer programs had the lowest incidence of anomalous data (14.7%) compared with non–comprehensive community cancer programs, which had an incidence of 17.1%.

The incidence of anomalous data was highest in facilities in the south Atlantic, east south central and west south central regions of the United States. The further away from a patient’s home the reporting facility was, the higher the presence of anomalous data.

“Because an insufficient RT dose or fewer than 20 fractions accounted for such a large proportion of the anomalies, patients may potentially be more likely to have an incomplete RT course or complete RT in a hypofractionated manner when the facility is farther from their home,” the authors wrote.

One author was an employee of Bioventus, and three declared research funding from the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Jacobs C et al. JCO Clin Cancer Inform. 2019, May 3. doi: 10.1200/CCI.18.00118.

As many as one in eight patients with uterine cancer who undergo adjuvant radiation therapy may have been treated with doses that are inconsistent with standard practice, a new study suggests.

Writing in JCO Clinical Cancer Informatics, Corbin D. Jacobs, MD, of Duke University, Durham, N.C., and coauthors analyzed National Cancer Database data from 14,298 women with stage IIIC1-C2 uterine cancer who underwent adjuvant radiation therapy after hysterectomy. The analysis included information on radiation therapy site, modality, dose, fractions, timing, duration, and stage, as well as details about the facilities at which the treatment was given.

Overall, 16% of the women had at least one ‘anomalous’ entry in their records of radiation therapy. The most common anomalies were that the combined total radiation therapy dose was insufficient, or there was an insufficient number of external beam radiation therapy fractions, both of which may have represented an incomplete course of radiation therapy.

Other anomalies were excessive brachytherapy fractions, inconsistency in the staging, and less than 100 days of radiation therapy.

The study showed that the 5-year overall survival rate in individuals who had at least one anomalous data entry was 51.3% compared with 58% among individuals without any anomalous entries (P less than .001). The difference in survival rates was entirely accounted for by insufficient, excessive, or unknown radiation therapy dose.

More than half of patients in the study had missing or unknown data for at least one entry, and this was associated with lower 5-year survival compared with patients with complete data entries.

The researchers also looked at facility-specific factors, such as the type of facility, its location, and its distance from the patient’s home, and how these impacted the frequency of anomalous data. They found that comprehensive community cancer programs had the lowest incidence of anomalous data (14.7%) compared with non–comprehensive community cancer programs, which had an incidence of 17.1%.

The incidence of anomalous data was highest in facilities in the south Atlantic, east south central and west south central regions of the United States. The further away from a patient’s home the reporting facility was, the higher the presence of anomalous data.

“Because an insufficient RT dose or fewer than 20 fractions accounted for such a large proportion of the anomalies, patients may potentially be more likely to have an incomplete RT course or complete RT in a hypofractionated manner when the facility is farther from their home,” the authors wrote.

One author was an employee of Bioventus, and three declared research funding from the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Jacobs C et al. JCO Clin Cancer Inform. 2019, May 3. doi: 10.1200/CCI.18.00118.

As many as one in eight patients with uterine cancer who undergo adjuvant radiation therapy may have been treated with doses that are inconsistent with standard practice, a new study suggests.

Writing in JCO Clinical Cancer Informatics, Corbin D. Jacobs, MD, of Duke University, Durham, N.C., and coauthors analyzed National Cancer Database data from 14,298 women with stage IIIC1-C2 uterine cancer who underwent adjuvant radiation therapy after hysterectomy. The analysis included information on radiation therapy site, modality, dose, fractions, timing, duration, and stage, as well as details about the facilities at which the treatment was given.

Overall, 16% of the women had at least one ‘anomalous’ entry in their records of radiation therapy. The most common anomalies were that the combined total radiation therapy dose was insufficient, or there was an insufficient number of external beam radiation therapy fractions, both of which may have represented an incomplete course of radiation therapy.

Other anomalies were excessive brachytherapy fractions, inconsistency in the staging, and less than 100 days of radiation therapy.

The study showed that the 5-year overall survival rate in individuals who had at least one anomalous data entry was 51.3% compared with 58% among individuals without any anomalous entries (P less than .001). The difference in survival rates was entirely accounted for by insufficient, excessive, or unknown radiation therapy dose.

More than half of patients in the study had missing or unknown data for at least one entry, and this was associated with lower 5-year survival compared with patients with complete data entries.

The researchers also looked at facility-specific factors, such as the type of facility, its location, and its distance from the patient’s home, and how these impacted the frequency of anomalous data. They found that comprehensive community cancer programs had the lowest incidence of anomalous data (14.7%) compared with non–comprehensive community cancer programs, which had an incidence of 17.1%.

The incidence of anomalous data was highest in facilities in the south Atlantic, east south central and west south central regions of the United States. The further away from a patient’s home the reporting facility was, the higher the presence of anomalous data.

“Because an insufficient RT dose or fewer than 20 fractions accounted for such a large proportion of the anomalies, patients may potentially be more likely to have an incomplete RT course or complete RT in a hypofractionated manner when the facility is farther from their home,” the authors wrote.

One author was an employee of Bioventus, and three declared research funding from the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Jacobs C et al. JCO Clin Cancer Inform. 2019, May 3. doi: 10.1200/CCI.18.00118.

A low-dose chemotherapy regimen appears safe and effective for older and frail patients with advanced gastroesophageal cancer.

In a phase 3 trial, progression-free survival in patients who received the lowest dose of oxaliplatin and capecitabine was noninferior to progression-free survival in patients who received two higher doses of the combination.

The lowest dose also was associated with better overall treatment utility, which is a composite of clinical benefit, tolerability, quality of life, and patient value.

“[T]his is the largest randomized, controlled trial to date specifically investigating frail or elderly patients with advanced gastroesophageal cancer,” said study investigator Peter S. Hall, PhD, of the University of Edinburgh. “We found that the lowest dose tested was noninferior in terms of progression-free survival, it produced less toxicity, and it had better overall treatment utility.”

These findings are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology. Dr. Hall discussed the findings during a press briefing in advance of the meeting.

The phase 3 trial (ISRCTN44687907) enrolled older and frail patients, aged 51-96 years, with advanced gastroesophageal cancer. Dr. Hall presented data on 514 patients randomized to receive oxaliplatin and capecitabine at one of three dose levels. Dose level A consisted of oxaliplatin given at 130 mg/m² once every 21 days and capecitabine given at 625 mg/m² twice a day every day. Dose level B was 80% of the level A dosage, and dose level C was 60% of the level A dosage. Patients with decreased kidney function received 75% of the allocated capecitabine dose.

The trial’s primary endpoint was noninferiority of progression-free survival at 12 months. Noninferiority was confirmed for level B, compared with level A, with a hazard ratio of 1.09, and for level C, compared with level A, with a hazard ratio of 1.10.

“The lowest dose, the level C dose, had the best overall treatment utility … compared to patients either on level A or level B, and this was due to lower side effects and better quality of life,” Dr. Hall said.

Overall treatment utility outcomes were “good” in 35% of the dose A group, 36% of the dose B group, and 43% of the dose C group. Outcomes were “poor” in 31%, 38%, and 29%, respectively, and outcomes were “intermediate” in 34%, 26%, and 27%, respectively.

To achieve “good” overall treatment utility, patients had to achieve the following six domains: cancer doesn’t progress on scans, oncologist assesses a benefit of treatment, lack of severe toxicity, patient’s global quality of life scores aren’t deteriorating, patient scores the treatment as worthwhile, and the patient says the treatment doesn’t interfere with daily activities.

These results suggest low-dose chemotherapy is feasible for older and frail patients with advanced gastroesophageal cancer, according to Dr. Hall.

“[L]ow-dose treatment may be offered to patients who are suitable for chemotherapy but considered too frail or elderly for a full-dose standard regime, in the confidence that it can produce superior outcomes without compromising cancer control or survival,” Dr. Hall said.

Dr. Hall reported relationships with Eisai, Pfizer, Roche, AstraZeneca, Daiichi Sankyo, and Novartis. The trial was funded by Cancer Research UK and sponsored by the University of Leeds (England).

jensmith@mdedge.com

SOURCE: Hall PS et al. ASCO 2019, Abstract 4006.

A low-dose chemotherapy regimen appears safe and effective for older and frail patients with advanced gastroesophageal cancer.

In a phase 3 trial, progression-free survival in patients who received the lowest dose of oxaliplatin and capecitabine was noninferior to progression-free survival in patients who received two higher doses of the combination.

The lowest dose also was associated with better overall treatment utility, which is a composite of clinical benefit, tolerability, quality of life, and patient value.

“[T]his is the largest randomized, controlled trial to date specifically investigating frail or elderly patients with advanced gastroesophageal cancer,” said study investigator Peter S. Hall, PhD, of the University of Edinburgh. “We found that the lowest dose tested was noninferior in terms of progression-free survival, it produced less toxicity, and it had better overall treatment utility.”

These findings are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology. Dr. Hall discussed the findings during a press briefing in advance of the meeting.

The phase 3 trial (ISRCTN44687907) enrolled older and frail patients, aged 51-96 years, with advanced gastroesophageal cancer. Dr. Hall presented data on 514 patients randomized to receive oxaliplatin and capecitabine at one of three dose levels. Dose level A consisted of oxaliplatin given at 130 mg/m² once every 21 days and capecitabine given at 625 mg/m² twice a day every day. Dose level B was 80% of the level A dosage, and dose level C was 60% of the level A dosage. Patients with decreased kidney function received 75% of the allocated capecitabine dose.

The trial’s primary endpoint was noninferiority of progression-free survival at 12 months. Noninferiority was confirmed for level B, compared with level A, with a hazard ratio of 1.09, and for level C, compared with level A, with a hazard ratio of 1.10.

“The lowest dose, the level C dose, had the best overall treatment utility … compared to patients either on level A or level B, and this was due to lower side effects and better quality of life,” Dr. Hall said.

Overall treatment utility outcomes were “good” in 35% of the dose A group, 36% of the dose B group, and 43% of the dose C group. Outcomes were “poor” in 31%, 38%, and 29%, respectively, and outcomes were “intermediate” in 34%, 26%, and 27%, respectively.

To achieve “good” overall treatment utility, patients had to achieve the following six domains: cancer doesn’t progress on scans, oncologist assesses a benefit of treatment, lack of severe toxicity, patient’s global quality of life scores aren’t deteriorating, patient scores the treatment as worthwhile, and the patient says the treatment doesn’t interfere with daily activities.

These results suggest low-dose chemotherapy is feasible for older and frail patients with advanced gastroesophageal cancer, according to Dr. Hall.

“[L]ow-dose treatment may be offered to patients who are suitable for chemotherapy but considered too frail or elderly for a full-dose standard regime, in the confidence that it can produce superior outcomes without compromising cancer control or survival,” Dr. Hall said.

Dr. Hall reported relationships with Eisai, Pfizer, Roche, AstraZeneca, Daiichi Sankyo, and Novartis. The trial was funded by Cancer Research UK and sponsored by the University of Leeds (England).

jensmith@mdedge.com

SOURCE: Hall PS et al. ASCO 2019, Abstract 4006.

A low-dose chemotherapy regimen appears safe and effective for older and frail patients with advanced gastroesophageal cancer.

In a phase 3 trial, progression-free survival in patients who received the lowest dose of oxaliplatin and capecitabine was noninferior to progression-free survival in patients who received two higher doses of the combination.

The lowest dose also was associated with better overall treatment utility, which is a composite of clinical benefit, tolerability, quality of life, and patient value.

“[T]his is the largest randomized, controlled trial to date specifically investigating frail or elderly patients with advanced gastroesophageal cancer,” said study investigator Peter S. Hall, PhD, of the University of Edinburgh. “We found that the lowest dose tested was noninferior in terms of progression-free survival, it produced less toxicity, and it had better overall treatment utility.”

These findings are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology. Dr. Hall discussed the findings during a press briefing in advance of the meeting.

The phase 3 trial (ISRCTN44687907) enrolled older and frail patients, aged 51-96 years, with advanced gastroesophageal cancer. Dr. Hall presented data on 514 patients randomized to receive oxaliplatin and capecitabine at one of three dose levels. Dose level A consisted of oxaliplatin given at 130 mg/m² once every 21 days and capecitabine given at 625 mg/m² twice a day every day. Dose level B was 80% of the level A dosage, and dose level C was 60% of the level A dosage. Patients with decreased kidney function received 75% of the allocated capecitabine dose.

The trial’s primary endpoint was noninferiority of progression-free survival at 12 months. Noninferiority was confirmed for level B, compared with level A, with a hazard ratio of 1.09, and for level C, compared with level A, with a hazard ratio of 1.10.

“The lowest dose, the level C dose, had the best overall treatment utility … compared to patients either on level A or level B, and this was due to lower side effects and better quality of life,” Dr. Hall said.

Overall treatment utility outcomes were “good” in 35% of the dose A group, 36% of the dose B group, and 43% of the dose C group. Outcomes were “poor” in 31%, 38%, and 29%, respectively, and outcomes were “intermediate” in 34%, 26%, and 27%, respectively.

To achieve “good” overall treatment utility, patients had to achieve the following six domains: cancer doesn’t progress on scans, oncologist assesses a benefit of treatment, lack of severe toxicity, patient’s global quality of life scores aren’t deteriorating, patient scores the treatment as worthwhile, and the patient says the treatment doesn’t interfere with daily activities.

These results suggest low-dose chemotherapy is feasible for older and frail patients with advanced gastroesophageal cancer, according to Dr. Hall.

“[L]ow-dose treatment may be offered to patients who are suitable for chemotherapy but considered too frail or elderly for a full-dose standard regime, in the confidence that it can produce superior outcomes without compromising cancer control or survival,” Dr. Hall said.

Dr. Hall reported relationships with Eisai, Pfizer, Roche, AstraZeneca, Daiichi Sankyo, and Novartis. The trial was funded by Cancer Research UK and sponsored by the University of Leeds (England).

jensmith@mdedge.com

SOURCE: Hall PS et al. ASCO 2019, Abstract 4006.

SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.

Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.

She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.

Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.

EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.

Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).

The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.

mzoler@mdedge.com

SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.

SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.

Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.

She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.

Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.

EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.

Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).

The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.

mzoler@mdedge.com

SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.

SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.

Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.

She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.

Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.

EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.

Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).

The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.

mzoler@mdedge.com

SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients at high risk of blood clots in the lungs should not be prescribed the 10-mg, twice-daily dose of tofacitinib (Xeljanz).

The PRAC recommendation is based on results from an ongoing study of patients with rheumatoid arthritis (RA), which has shown that patients receiving the 10-mg, twice-daily dose – twice the approved dose for RA – are at an increased risk of blood clots in the lungs and death.

Patients at risk include those with heart failure, cancer, inherited blood clotting disorders, or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy, or are undergoing major surgery. In addition, age, obesity, smoking, or immobilization should also be considered as risk factors.

In Europe, tofacitinib is indicated for the treatment of RA, psoriatic arthritis, and severe ulcerative colitis. Because the 10-mg dose is the only indicated treatment for ulcerative colitis, patients with the disease and who are at high risk should not be started on tofacitinib, and patients who are already taking the drug should be switched to a different treatment.

“The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5-mg, twice-daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded,” according to the European Medicines Agency.

Find the full press release on the European Medicines Agency website.

lfranki@mdedge.com

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients at high risk of blood clots in the lungs should not be prescribed the 10-mg, twice-daily dose of tofacitinib (Xeljanz).

The PRAC recommendation is based on results from an ongoing study of patients with rheumatoid arthritis (RA), which has shown that patients receiving the 10-mg, twice-daily dose – twice the approved dose for RA – are at an increased risk of blood clots in the lungs and death.

Patients at risk include those with heart failure, cancer, inherited blood clotting disorders, or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy, or are undergoing major surgery. In addition, age, obesity, smoking, or immobilization should also be considered as risk factors.

In Europe, tofacitinib is indicated for the treatment of RA, psoriatic arthritis, and severe ulcerative colitis. Because the 10-mg dose is the only indicated treatment for ulcerative colitis, patients with the disease and who are at high risk should not be started on tofacitinib, and patients who are already taking the drug should be switched to a different treatment.

“The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5-mg, twice-daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded,” according to the European Medicines Agency.

Find the full press release on the European Medicines Agency website.

lfranki@mdedge.com

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients at high risk of blood clots in the lungs should not be prescribed the 10-mg, twice-daily dose of tofacitinib (Xeljanz).

The PRAC recommendation is based on results from an ongoing study of patients with rheumatoid arthritis (RA), which has shown that patients receiving the 10-mg, twice-daily dose – twice the approved dose for RA – are at an increased risk of blood clots in the lungs and death.

Patients at risk include those with heart failure, cancer, inherited blood clotting disorders, or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy, or are undergoing major surgery. In addition, age, obesity, smoking, or immobilization should also be considered as risk factors.

In Europe, tofacitinib is indicated for the treatment of RA, psoriatic arthritis, and severe ulcerative colitis. Because the 10-mg dose is the only indicated treatment for ulcerative colitis, patients with the disease and who are at high risk should not be started on tofacitinib, and patients who are already taking the drug should be switched to a different treatment.

“The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5-mg, twice-daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded,” according to the European Medicines Agency.

Find the full press release on the European Medicines Agency website.

lfranki@mdedge.com