Patients with relapsed or refractory B-cell non-Hodgkin lymphomas who are not candidates for hematopoietic stem cell transplant have a generally poor prognosis and few treatment options, but an experimental combination of the antibody-drug conjugate naratuximab with rituximab showed promising efficacy and acceptable safety in these patients in a phase 2 trial.

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) the combination was associated with a 44.7% overall response rate, including 31.6% complete responses, and two-thirds of patients had responses lasting more than 12 months, reported Moshe Yair Levy, MD, from Texas Oncology–Baylor Charles A Sammons Cancer Center in Dallas.

“This is, in my viewpoint, very exciting therapy,” he said in a question-and-answer session following his presentation of the data in a late-breaking abstract session during the European Hematology Association annual congress. (Abstract LB1903).

Naratuximab emtansine is an investigational antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody against CD37, a surface marker on B lymphocytes that is highly expressed in non-Hodgkin lymphoma (NHL), conjugated to a cytotoxic derivative of maitansine.

CD37 is also an internalizable cell-surface antigen, making it an attractive candidate for an ADC approach.

In a phase 1 trial, naratuximab monotherapy showed a good safety profile and a 22% overall response rate, Dr. Levy noted.

“What they found is that, if you coadminister this ADC with rituximab, you’re actually going to get more internalization of the CD37 monoclonal, therefore more payload delivered to your target cells,” he said.

He reported results of a multicenter, adaptive phase 2 study of the combination in patients with DLBCL and other relapsed/refractory NHL.
 

DLBCL and others

The trial was divided into two parts, with the first consisting of a safety run-in phase with expansion in patients with confirmed diagnoses of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Patients with double- or triple-hit disease (with translocations in MYC plus either BCL2 and/or BCL6), bulky disease, or transformed lymphoma were eligible.

The second part consisted of two cohorts of patients with DLBCL treated with naratuximab and rituximab either weekly or every 3 weeks.

All patients in the study had received one to six prior lines of therapy, and had Eastern Cooperative Oncology Group performance status of 0-2. Patients with CNS lymphomas or prior anti-CD37 targeting therapy were excluded.

The safety population included 50 patients with DLBCL assigned to therapy every 3 weeks, 30 assigned to weekly therapy, and 20 patients with other NHL.
 

DLBCL efficacy

A total of 76 patients with DLBCL were evaluable for efficacy.

The ORR was 44% for patients in both the weekly and every 3 week cohorts, with 31.6% having complete responses.

Among 61 patients with nonbulky disease (longest diameter 7.5 cm or less), the ORR was 50.8%, and among 28 patients who had three or more prior lines of therapy the ORR was 46.4%, with 32.1% having a complete response.

Among responders followed for a median of 15 months, the median duration of response was not reached, and 66% had responses lasting beyond 12 months.

In the weekly dosing DLBCL cohort, 53.3% of patients discontinued treatment of both study drugs because of disease progression, as did 58% of those in the every 3 week cohort, and 30% of patients with other lymphomas. Only eight patients discontinued the combination because of treatment-emergent adverse events. Six patients had treatment-emergent adverse events leading to naratuximab dose reduction.

The most common grade 3 or 4 adverse events were neutropenia, leukopenia, lymphopenia and thrombocytopenias. Dr. Levy commented that the use of granulocyte colony-stimulating factor, which was not mandatory in the study, would likely have lowered the incidence of cytopenias.

There were 10 deaths during the study, 2 of which were considered to be treatment related, occurring in 1 patient each in the DLBCL dosing cohorts; 1 of the patients died from pneumonitis, and the other from left ventricular heart failure.

Other patients deaths were attributed to non–treatment-related cardiac arrest, acute renal failure, exacerbation of chronic heart failure, respiratory failure, multiorgan failure, lung infection, or colon adenocarcinoma.
 

Q 3 weeks suffices

In the question-and-answer session following the presentation, Kenny Lei, MD, from the Chinese University of Hong Kong asked Dr. Levy what the half-life of naratuximab is, and what was the investigator’s rationale for testing a weekly dosing schedule.

“I think the reason they checked the two different regimens, the Q week and the Q 3-week group, is that they noted that [naratuximab] was cleared relatively quickly, and they wanted to see whether or not, by giving Q weekly, when you get a continuous CD37 site occupancy if they would have a better outcome. But as you saw, in the groups there was really no clinically relevant difference in outcome,” Dr. Levy said.

Andrew Davies, MD, PhD, from the University of Southampton (England), asked whether the neutropenia seen in the study was related to myeloid expression of the target of from the off-target deconjugated payload.

“I don’t know that I necessarily have the answer to that,” Dr. Levy replied. “Remember there is the CD20 monoclonal rituximab which we know can cause neutropenia, as well as the CD37 and the target payload. I don’t know if we have enough information to attribute it to one specific component of the therapy,” he said.

The study was funded by Debiopharm International. Dr. Levy disclosed speaker activities for multiple companies, not including Debiopharm. Dr. Lei and Dr. Davies had no disclosures relevant to the study.

Patients with relapsed or refractory B-cell non-Hodgkin lymphomas who are not candidates for hematopoietic stem cell transplant have a generally poor prognosis and few treatment options, but an experimental combination of the antibody-drug conjugate naratuximab with rituximab showed promising efficacy and acceptable safety in these patients in a phase 2 trial.

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) the combination was associated with a 44.7% overall response rate, including 31.6% complete responses, and two-thirds of patients had responses lasting more than 12 months, reported Moshe Yair Levy, MD, from Texas Oncology–Baylor Charles A Sammons Cancer Center in Dallas.

“This is, in my viewpoint, very exciting therapy,” he said in a question-and-answer session following his presentation of the data in a late-breaking abstract session during the European Hematology Association annual congress. (Abstract LB1903).

Naratuximab emtansine is an investigational antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody against CD37, a surface marker on B lymphocytes that is highly expressed in non-Hodgkin lymphoma (NHL), conjugated to a cytotoxic derivative of maitansine.

CD37 is also an internalizable cell-surface antigen, making it an attractive candidate for an ADC approach.

In a phase 1 trial, naratuximab monotherapy showed a good safety profile and a 22% overall response rate, Dr. Levy noted.

“What they found is that, if you coadminister this ADC with rituximab, you’re actually going to get more internalization of the CD37 monoclonal, therefore more payload delivered to your target cells,” he said.

He reported results of a multicenter, adaptive phase 2 study of the combination in patients with DLBCL and other relapsed/refractory NHL.
 

DLBCL and others

The trial was divided into two parts, with the first consisting of a safety run-in phase with expansion in patients with confirmed diagnoses of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Patients with double- or triple-hit disease (with translocations in MYC plus either BCL2 and/or BCL6), bulky disease, or transformed lymphoma were eligible.

The second part consisted of two cohorts of patients with DLBCL treated with naratuximab and rituximab either weekly or every 3 weeks.

All patients in the study had received one to six prior lines of therapy, and had Eastern Cooperative Oncology Group performance status of 0-2. Patients with CNS lymphomas or prior anti-CD37 targeting therapy were excluded.

The safety population included 50 patients with DLBCL assigned to therapy every 3 weeks, 30 assigned to weekly therapy, and 20 patients with other NHL.
 

DLBCL efficacy

A total of 76 patients with DLBCL were evaluable for efficacy.

The ORR was 44% for patients in both the weekly and every 3 week cohorts, with 31.6% having complete responses.

Among 61 patients with nonbulky disease (longest diameter 7.5 cm or less), the ORR was 50.8%, and among 28 patients who had three or more prior lines of therapy the ORR was 46.4%, with 32.1% having a complete response.

Among responders followed for a median of 15 months, the median duration of response was not reached, and 66% had responses lasting beyond 12 months.

In the weekly dosing DLBCL cohort, 53.3% of patients discontinued treatment of both study drugs because of disease progression, as did 58% of those in the every 3 week cohort, and 30% of patients with other lymphomas. Only eight patients discontinued the combination because of treatment-emergent adverse events. Six patients had treatment-emergent adverse events leading to naratuximab dose reduction.

The most common grade 3 or 4 adverse events were neutropenia, leukopenia, lymphopenia and thrombocytopenias. Dr. Levy commented that the use of granulocyte colony-stimulating factor, which was not mandatory in the study, would likely have lowered the incidence of cytopenias.

There were 10 deaths during the study, 2 of which were considered to be treatment related, occurring in 1 patient each in the DLBCL dosing cohorts; 1 of the patients died from pneumonitis, and the other from left ventricular heart failure.

Other patients deaths were attributed to non–treatment-related cardiac arrest, acute renal failure, exacerbation of chronic heart failure, respiratory failure, multiorgan failure, lung infection, or colon adenocarcinoma.
 

Q 3 weeks suffices

In the question-and-answer session following the presentation, Kenny Lei, MD, from the Chinese University of Hong Kong asked Dr. Levy what the half-life of naratuximab is, and what was the investigator’s rationale for testing a weekly dosing schedule.

“I think the reason they checked the two different regimens, the Q week and the Q 3-week group, is that they noted that [naratuximab] was cleared relatively quickly, and they wanted to see whether or not, by giving Q weekly, when you get a continuous CD37 site occupancy if they would have a better outcome. But as you saw, in the groups there was really no clinically relevant difference in outcome,” Dr. Levy said.

Andrew Davies, MD, PhD, from the University of Southampton (England), asked whether the neutropenia seen in the study was related to myeloid expression of the target of from the off-target deconjugated payload.

“I don’t know that I necessarily have the answer to that,” Dr. Levy replied. “Remember there is the CD20 monoclonal rituximab which we know can cause neutropenia, as well as the CD37 and the target payload. I don’t know if we have enough information to attribute it to one specific component of the therapy,” he said.

The study was funded by Debiopharm International. Dr. Levy disclosed speaker activities for multiple companies, not including Debiopharm. Dr. Lei and Dr. Davies had no disclosures relevant to the study.

Patients with relapsed or refractory B-cell non-Hodgkin lymphomas who are not candidates for hematopoietic stem cell transplant have a generally poor prognosis and few treatment options, but an experimental combination of the antibody-drug conjugate naratuximab with rituximab showed promising efficacy and acceptable safety in these patients in a phase 2 trial.

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) the combination was associated with a 44.7% overall response rate, including 31.6% complete responses, and two-thirds of patients had responses lasting more than 12 months, reported Moshe Yair Levy, MD, from Texas Oncology–Baylor Charles A Sammons Cancer Center in Dallas.

“This is, in my viewpoint, very exciting therapy,” he said in a question-and-answer session following his presentation of the data in a late-breaking abstract session during the European Hematology Association annual congress. (Abstract LB1903).

Naratuximab emtansine is an investigational antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody against CD37, a surface marker on B lymphocytes that is highly expressed in non-Hodgkin lymphoma (NHL), conjugated to a cytotoxic derivative of maitansine.

CD37 is also an internalizable cell-surface antigen, making it an attractive candidate for an ADC approach.

In a phase 1 trial, naratuximab monotherapy showed a good safety profile and a 22% overall response rate, Dr. Levy noted.

“What they found is that, if you coadminister this ADC with rituximab, you’re actually going to get more internalization of the CD37 monoclonal, therefore more payload delivered to your target cells,” he said.

He reported results of a multicenter, adaptive phase 2 study of the combination in patients with DLBCL and other relapsed/refractory NHL.
 

DLBCL and others

The trial was divided into two parts, with the first consisting of a safety run-in phase with expansion in patients with confirmed diagnoses of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Patients with double- or triple-hit disease (with translocations in MYC plus either BCL2 and/or BCL6), bulky disease, or transformed lymphoma were eligible.

The second part consisted of two cohorts of patients with DLBCL treated with naratuximab and rituximab either weekly or every 3 weeks.

All patients in the study had received one to six prior lines of therapy, and had Eastern Cooperative Oncology Group performance status of 0-2. Patients with CNS lymphomas or prior anti-CD37 targeting therapy were excluded.

The safety population included 50 patients with DLBCL assigned to therapy every 3 weeks, 30 assigned to weekly therapy, and 20 patients with other NHL.
 

DLBCL efficacy

A total of 76 patients with DLBCL were evaluable for efficacy.

The ORR was 44% for patients in both the weekly and every 3 week cohorts, with 31.6% having complete responses.

Among 61 patients with nonbulky disease (longest diameter 7.5 cm or less), the ORR was 50.8%, and among 28 patients who had three or more prior lines of therapy the ORR was 46.4%, with 32.1% having a complete response.

Among responders followed for a median of 15 months, the median duration of response was not reached, and 66% had responses lasting beyond 12 months.

In the weekly dosing DLBCL cohort, 53.3% of patients discontinued treatment of both study drugs because of disease progression, as did 58% of those in the every 3 week cohort, and 30% of patients with other lymphomas. Only eight patients discontinued the combination because of treatment-emergent adverse events. Six patients had treatment-emergent adverse events leading to naratuximab dose reduction.

The most common grade 3 or 4 adverse events were neutropenia, leukopenia, lymphopenia and thrombocytopenias. Dr. Levy commented that the use of granulocyte colony-stimulating factor, which was not mandatory in the study, would likely have lowered the incidence of cytopenias.

There were 10 deaths during the study, 2 of which were considered to be treatment related, occurring in 1 patient each in the DLBCL dosing cohorts; 1 of the patients died from pneumonitis, and the other from left ventricular heart failure.

Other patients deaths were attributed to non–treatment-related cardiac arrest, acute renal failure, exacerbation of chronic heart failure, respiratory failure, multiorgan failure, lung infection, or colon adenocarcinoma.
 

Q 3 weeks suffices

In the question-and-answer session following the presentation, Kenny Lei, MD, from the Chinese University of Hong Kong asked Dr. Levy what the half-life of naratuximab is, and what was the investigator’s rationale for testing a weekly dosing schedule.

“I think the reason they checked the two different regimens, the Q week and the Q 3-week group, is that they noted that [naratuximab] was cleared relatively quickly, and they wanted to see whether or not, by giving Q weekly, when you get a continuous CD37 site occupancy if they would have a better outcome. But as you saw, in the groups there was really no clinically relevant difference in outcome,” Dr. Levy said.

Andrew Davies, MD, PhD, from the University of Southampton (England), asked whether the neutropenia seen in the study was related to myeloid expression of the target of from the off-target deconjugated payload.

“I don’t know that I necessarily have the answer to that,” Dr. Levy replied. “Remember there is the CD20 monoclonal rituximab which we know can cause neutropenia, as well as the CD37 and the target payload. I don’t know if we have enough information to attribute it to one specific component of the therapy,” he said.

The study was funded by Debiopharm International. Dr. Levy disclosed speaker activities for multiple companies, not including Debiopharm. Dr. Lei and Dr. Davies had no disclosures relevant to the study.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

Key clinical point: Ustekinumab induced and maintained steroid-free clinical remission to 1 year in a significant proportion of children with extensive and treatment-refractory ulcerative colitis (UC).

Major finding: At week 52, 44% of children who received ustekinumab achieved steroid-free remission. This included 69% of those previously treated with antitumor necrosis factor (anti-TNF) only vs. 17% of those who previously failed vedolizumab (P = .008). No adverse events were reported.

Study details: Data come from an open-label prospective cohort study of 25 children with anti-TNF refractory UC who were treated with intravenous ustekinumab. All patients had failed prior infliximab therapy, whereas 12 patients also failed vedolizumab.

Disclosures: The study was funded by the Canadian Institutes of Health Research and Children's Intestinal and Liver Disease Foundation. Some of the authors reported serving as a consultant, speaker, advisory board member for and receiving speaker/consultation fees, honoraria, and/or research support from multiple sources.

Source: Dhaliwal J et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16388.

Key clinical point: Ustekinumab induced and maintained steroid-free clinical remission to 1 year in a significant proportion of children with extensive and treatment-refractory ulcerative colitis (UC).

Major finding: At week 52, 44% of children who received ustekinumab achieved steroid-free remission. This included 69% of those previously treated with antitumor necrosis factor (anti-TNF) only vs. 17% of those who previously failed vedolizumab (P = .008). No adverse events were reported.

Study details: Data come from an open-label prospective cohort study of 25 children with anti-TNF refractory UC who were treated with intravenous ustekinumab. All patients had failed prior infliximab therapy, whereas 12 patients also failed vedolizumab.

Disclosures: The study was funded by the Canadian Institutes of Health Research and Children's Intestinal and Liver Disease Foundation. Some of the authors reported serving as a consultant, speaker, advisory board member for and receiving speaker/consultation fees, honoraria, and/or research support from multiple sources.

Source: Dhaliwal J et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16388.

Key clinical point: Ustekinumab induced and maintained steroid-free clinical remission to 1 year in a significant proportion of children with extensive and treatment-refractory ulcerative colitis (UC).

Major finding: At week 52, 44% of children who received ustekinumab achieved steroid-free remission. This included 69% of those previously treated with antitumor necrosis factor (anti-TNF) only vs. 17% of those who previously failed vedolizumab (P = .008). No adverse events were reported.

Study details: Data come from an open-label prospective cohort study of 25 children with anti-TNF refractory UC who were treated with intravenous ustekinumab. All patients had failed prior infliximab therapy, whereas 12 patients also failed vedolizumab.

Disclosures: The study was funded by the Canadian Institutes of Health Research and Children's Intestinal and Liver Disease Foundation. Some of the authors reported serving as a consultant, speaker, advisory board member for and receiving speaker/consultation fees, honoraria, and/or research support from multiple sources.

Source: Dhaliwal J et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16388.

Key clinical point: Sarcopenia is predictive of the clinical course and postoperative outcomes of acute severe ulcerative colitis (ASUC).

Major finding: Sarcopenia was an independent risk factor for intravenous corticosteroid failure (odds ratio [OR], 3.130; P = .001), colectomy after medical rescue therapy failure (OR, 3.401; P = .033), and postoperative complications after colectomy (OR, 4.157; P = .012).

Study details: Findings are from a retrospective cohort study of 233 patients with ASUC.

Disclosures: The work was supported by the National Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation. The authors declared no conflicts of interest.

Source: Ge X et al. Dig Liver Dis. 2021 Apr 29. doi: 10.1016/j.dld.2021.03.031.

Key clinical point: Sarcopenia is predictive of the clinical course and postoperative outcomes of acute severe ulcerative colitis (ASUC).

Major finding: Sarcopenia was an independent risk factor for intravenous corticosteroid failure (odds ratio [OR], 3.130; P = .001), colectomy after medical rescue therapy failure (OR, 3.401; P = .033), and postoperative complications after colectomy (OR, 4.157; P = .012).

Study details: Findings are from a retrospective cohort study of 233 patients with ASUC.

Disclosures: The work was supported by the National Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation. The authors declared no conflicts of interest.

Source: Ge X et al. Dig Liver Dis. 2021 Apr 29. doi: 10.1016/j.dld.2021.03.031.

Key clinical point: Sarcopenia is predictive of the clinical course and postoperative outcomes of acute severe ulcerative colitis (ASUC).

Major finding: Sarcopenia was an independent risk factor for intravenous corticosteroid failure (odds ratio [OR], 3.130; P = .001), colectomy after medical rescue therapy failure (OR, 3.401; P = .033), and postoperative complications after colectomy (OR, 4.157; P = .012).

Study details: Findings are from a retrospective cohort study of 233 patients with ASUC.

Disclosures: The work was supported by the National Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation. The authors declared no conflicts of interest.

Source: Ge X et al. Dig Liver Dis. 2021 Apr 29. doi: 10.1016/j.dld.2021.03.031.

Key clinical point: Inflammatory bowel disease (IBD) may be a risk factor for stroke.

Major finding: IBD was associated with an increased risk for stroke (odds ratio/relative risk [OR/RR], 1.21; P less than .001). Additionally, both Crohn's disease (OR/RR, 1.25; P less than .001) and ulcerative colitis (OR/RR, 1.09; P = .051) were associated with an increased risk for stroke.

Study details: Findings are from a meta-analysis of 9 studies involving 791,010 patients with IBD or stroke.

Disclosures: The study was supported by the General Project of Chongqing Natural Science Foundation and the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Chen Y et al. Brain Behav. 2021 May 7. doi: 10.1002/brb3.2159.

Key clinical point: Inflammatory bowel disease (IBD) may be a risk factor for stroke.

Major finding: IBD was associated with an increased risk for stroke (odds ratio/relative risk [OR/RR], 1.21; P less than .001). Additionally, both Crohn's disease (OR/RR, 1.25; P less than .001) and ulcerative colitis (OR/RR, 1.09; P = .051) were associated with an increased risk for stroke.

Study details: Findings are from a meta-analysis of 9 studies involving 791,010 patients with IBD or stroke.

Disclosures: The study was supported by the General Project of Chongqing Natural Science Foundation and the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Chen Y et al. Brain Behav. 2021 May 7. doi: 10.1002/brb3.2159.

Key clinical point: Inflammatory bowel disease (IBD) may be a risk factor for stroke.

Major finding: IBD was associated with an increased risk for stroke (odds ratio/relative risk [OR/RR], 1.21; P less than .001). Additionally, both Crohn's disease (OR/RR, 1.25; P less than .001) and ulcerative colitis (OR/RR, 1.09; P = .051) were associated with an increased risk for stroke.

Study details: Findings are from a meta-analysis of 9 studies involving 791,010 patients with IBD or stroke.

Disclosures: The study was supported by the General Project of Chongqing Natural Science Foundation and the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Chen Y et al. Brain Behav. 2021 May 7. doi: 10.1002/brb3.2159.

Key clinical point: Prenatal exposure to tobacco smoke and antibiotics and early life otitis media were risk factors for inflammatory bowel disease (IBD).

Major finding: Prenatal exposure to tobacco smoke (odds ratio [OR], 1.49; 95% confidence interval [CI], 1.17-1.90) and antibiotics (OR, 1.75; 95% CI, 1.22-2.51), and early life otitis media (OR, 2.11; 95% CI, 1.22-3.62) were positively associated with IBD.

Study details: Findings are from a meta-analysis of 39 studies that evaluated the association between early life (prenatal life to 5 years of age) exposures and subsequent risk for IBD.

Disclosures: The study did not receive any funding. Some of the authors reported receiving grants, speaker fees, advisory board fees, personal fees, consultancy, and/or lectures, and/or honoraria from multiple sources. All other authors had no disclosures.

Source: Agrawal M et al. EClinicalMedicine. 2021 May 15. doi: 10.1016/j.eclinm.2021.100884.

Key clinical point: Prenatal exposure to tobacco smoke and antibiotics and early life otitis media were risk factors for inflammatory bowel disease (IBD).

Major finding: Prenatal exposure to tobacco smoke (odds ratio [OR], 1.49; 95% confidence interval [CI], 1.17-1.90) and antibiotics (OR, 1.75; 95% CI, 1.22-2.51), and early life otitis media (OR, 2.11; 95% CI, 1.22-3.62) were positively associated with IBD.

Study details: Findings are from a meta-analysis of 39 studies that evaluated the association between early life (prenatal life to 5 years of age) exposures and subsequent risk for IBD.

Disclosures: The study did not receive any funding. Some of the authors reported receiving grants, speaker fees, advisory board fees, personal fees, consultancy, and/or lectures, and/or honoraria from multiple sources. All other authors had no disclosures.

Source: Agrawal M et al. EClinicalMedicine. 2021 May 15. doi: 10.1016/j.eclinm.2021.100884.

Key clinical point: Prenatal exposure to tobacco smoke and antibiotics and early life otitis media were risk factors for inflammatory bowel disease (IBD).

Major finding: Prenatal exposure to tobacco smoke (odds ratio [OR], 1.49; 95% confidence interval [CI], 1.17-1.90) and antibiotics (OR, 1.75; 95% CI, 1.22-2.51), and early life otitis media (OR, 2.11; 95% CI, 1.22-3.62) were positively associated with IBD.

Study details: Findings are from a meta-analysis of 39 studies that evaluated the association between early life (prenatal life to 5 years of age) exposures and subsequent risk for IBD.

Disclosures: The study did not receive any funding. Some of the authors reported receiving grants, speaker fees, advisory board fees, personal fees, consultancy, and/or lectures, and/or honoraria from multiple sources. All other authors had no disclosures.

Source: Agrawal M et al. EClinicalMedicine. 2021 May 15. doi: 10.1016/j.eclinm.2021.100884.

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

Key clinical point: Ustekinumab showed higher short- and long-term efficacy than vedolizumab in patients with Crohn's disease with prior antitumor necrosis factor (TNF) therapy failure.

Major finding: Ustekinumab vs. vedolizumab was more effective in achieving corticosteroid-free clinical remission at week 54 (50.6% vs. 40.6%; P = .047) and deep remission at week 14 (17.9% vs. 5.7%; P = .047). Patients treated with ustekinumab vs. vedolizumab had a lower rate of primary nonresponse (6.7% vs. 14.8%, P = .034), a longer time to therapeutic escalation (hazard ratio [HR], 1.35; P = .043), and lower risk for drug discontinuation (HR, 1.53; P = .029).

Study details: This was a retrospective cohort study of 312 patients with Crohn's disease treated with ustekinumab (n=224) or vedolizumab (n=88) after exposure to at least 1 anti-TNF agent.

Disclosures: No information on funding was available. A Buisson reported receiving consulting and lecture fees from multiple sources. The other authors had no disclosures.

Source: Manlay L et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16377.

Key clinical point: Ustekinumab showed higher short- and long-term efficacy than vedolizumab in patients with Crohn's disease with prior antitumor necrosis factor (TNF) therapy failure.

Major finding: Ustekinumab vs. vedolizumab was more effective in achieving corticosteroid-free clinical remission at week 54 (50.6% vs. 40.6%; P = .047) and deep remission at week 14 (17.9% vs. 5.7%; P = .047). Patients treated with ustekinumab vs. vedolizumab had a lower rate of primary nonresponse (6.7% vs. 14.8%, P = .034), a longer time to therapeutic escalation (hazard ratio [HR], 1.35; P = .043), and lower risk for drug discontinuation (HR, 1.53; P = .029).

Study details: This was a retrospective cohort study of 312 patients with Crohn's disease treated with ustekinumab (n=224) or vedolizumab (n=88) after exposure to at least 1 anti-TNF agent.

Disclosures: No information on funding was available. A Buisson reported receiving consulting and lecture fees from multiple sources. The other authors had no disclosures.

Source: Manlay L et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16377.

Key clinical point: Ustekinumab showed higher short- and long-term efficacy than vedolizumab in patients with Crohn's disease with prior antitumor necrosis factor (TNF) therapy failure.

Major finding: Ustekinumab vs. vedolizumab was more effective in achieving corticosteroid-free clinical remission at week 54 (50.6% vs. 40.6%; P = .047) and deep remission at week 14 (17.9% vs. 5.7%; P = .047). Patients treated with ustekinumab vs. vedolizumab had a lower rate of primary nonresponse (6.7% vs. 14.8%, P = .034), a longer time to therapeutic escalation (hazard ratio [HR], 1.35; P = .043), and lower risk for drug discontinuation (HR, 1.53; P = .029).

Study details: This was a retrospective cohort study of 312 patients with Crohn's disease treated with ustekinumab (n=224) or vedolizumab (n=88) after exposure to at least 1 anti-TNF agent.

Disclosures: No information on funding was available. A Buisson reported receiving consulting and lecture fees from multiple sources. The other authors had no disclosures.

Source: Manlay L et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16377.

Key clinical point: Patients with Crohn’s disease (CD) who responded to antitumor necrosis factor (anti-TNF) treatment showed partial restoration of intestinal microbiome characteristics of healthy individuals.

Major finding: Patients with CD vs. healthy cohort showed a decrease in genera of the class Clostridia and an increase in the phylum Proteobacteria (P less than .01). Anti-TNF treatment allowed restoration of bacteria belonging to the class Clostridia in responders. The genus Escherichia/Shigella reduced significantly vs. baseline but did not reach statistical significance in responders vs. healthy control.

Study details: Data come from a prospective multicenter observational study of 27 patients with CD who initiated anti-TNF treatment and 16 healthy individuals. Based on inflammatory activity, patients were classified into responders and nonresponders.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Sanchis-Artero L et al. Sci Rep. 2021 May 11. doi: 10.1038/s41598-021-88823-2.

Key clinical point: Patients with Crohn’s disease (CD) who responded to antitumor necrosis factor (anti-TNF) treatment showed partial restoration of intestinal microbiome characteristics of healthy individuals.

Major finding: Patients with CD vs. healthy cohort showed a decrease in genera of the class Clostridia and an increase in the phylum Proteobacteria (P less than .01). Anti-TNF treatment allowed restoration of bacteria belonging to the class Clostridia in responders. The genus Escherichia/Shigella reduced significantly vs. baseline but did not reach statistical significance in responders vs. healthy control.

Study details: Data come from a prospective multicenter observational study of 27 patients with CD who initiated anti-TNF treatment and 16 healthy individuals. Based on inflammatory activity, patients were classified into responders and nonresponders.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Sanchis-Artero L et al. Sci Rep. 2021 May 11. doi: 10.1038/s41598-021-88823-2.

Key clinical point: Patients with Crohn’s disease (CD) who responded to antitumor necrosis factor (anti-TNF) treatment showed partial restoration of intestinal microbiome characteristics of healthy individuals.

Major finding: Patients with CD vs. healthy cohort showed a decrease in genera of the class Clostridia and an increase in the phylum Proteobacteria (P less than .01). Anti-TNF treatment allowed restoration of bacteria belonging to the class Clostridia in responders. The genus Escherichia/Shigella reduced significantly vs. baseline but did not reach statistical significance in responders vs. healthy control.

Study details: Data come from a prospective multicenter observational study of 27 patients with CD who initiated anti-TNF treatment and 16 healthy individuals. Based on inflammatory activity, patients were classified into responders and nonresponders.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Sanchis-Artero L et al. Sci Rep. 2021 May 11. doi: 10.1038/s41598-021-88823-2.