On car trips with our kids, we used to listen to comedy tapes. (Cassette tapes. Look them up.) One of our favorite comics was Steven Wright, who made it to the Tonight Show with Johnny Carson. (Google him.)

Wright’s offbeat humor was quirky and a bit philosophical, and was delivered in a deadpan, mumbled monotone. For instance:

When I got to school, the teacher said, “The socks you’re wearing don’t match. They’re two different colors.”

I said, “I go by thickness.”

That punchline goes pop in your head, like a shy little firecracker: How come it never occurred to me to look at it that way?

I thought of Steven Wright recently while I was enrolling Stacy, a 20-year-old, in the iPledge program for a planned course of isotretinoin. Stacy told me she is sexually active and has an IUD.

“When you start the medicine next month,” I told her, “you’ll need to pick a second form of contraception.”

Stacy looked bewildered. When I’ve made that statement to a thousand previous patients, none of them ever looked bewildered.

“I mean,” I said, “besides the IUD, you’ll need to use a second type of contraception, to be sure you don’t get pregnant. You could choose condoms, or one of the other types listed in the booklet I gave you.”

That didn’t seem to help. Stacey hemmed a bit. “Does that mean I have to tell you ... ?”

“Yes, you have to pick another form of birth control and tell me which one it is.”

“I have to tell you every time?”

My go-by-thickness moment – I finally got it. “NO,” I said. “You do NOT have to tell me which second contraceptive you use every time you have sex!”

Steven Wright would be proud of Stacy. Isotretinoin came out in 1982, but nobody ever thought of “choose a second type of contraception” that way before. Stacy goes by retail.

That case reminded of another out-of-left field question I heard for the first – and only – time almost 40 years ago. I had prescribed a cream for a young man.

“Can I get it refilled?” he asked.

“Sure,” I said.

“How do I refill it?” he asked.

“You take it back to the pharmacy, and they refill it for you,” I said.

“But how do they refill it?”

“You show them what you need, and they refill it.”

“But how?”

“Why do you keep asking me that?”

“The tube is going to be all scrunched up from my squeezing it,” he said. “How do they get the new cream back in?”

Well son of a gun, “refill” could mean that, couldn’t it? If you go by thickness.

In idle moments I like to let novel perspectives such as those roll around in my head. The other day I accompanied a relative to an emergency department. While waiting in triage for 5 hours, I looked up and saw a sign on the wall, in big, blue letters: “Support ED Research!”

That puzzled me. I know it can be an important problem, but why the dickens would someone come to an emergency department for erectile dysfunction?

I go by acronyms.
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

On car trips with our kids, we used to listen to comedy tapes. (Cassette tapes. Look them up.) One of our favorite comics was Steven Wright, who made it to the Tonight Show with Johnny Carson. (Google him.)

Wright’s offbeat humor was quirky and a bit philosophical, and was delivered in a deadpan, mumbled monotone. For instance:

When I got to school, the teacher said, “The socks you’re wearing don’t match. They’re two different colors.”

I said, “I go by thickness.”

That punchline goes pop in your head, like a shy little firecracker: How come it never occurred to me to look at it that way?

I thought of Steven Wright recently while I was enrolling Stacy, a 20-year-old, in the iPledge program for a planned course of isotretinoin. Stacy told me she is sexually active and has an IUD.

“When you start the medicine next month,” I told her, “you’ll need to pick a second form of contraception.”

Stacy looked bewildered. When I’ve made that statement to a thousand previous patients, none of them ever looked bewildered.

“I mean,” I said, “besides the IUD, you’ll need to use a second type of contraception, to be sure you don’t get pregnant. You could choose condoms, or one of the other types listed in the booklet I gave you.”

That didn’t seem to help. Stacey hemmed a bit. “Does that mean I have to tell you ... ?”

“Yes, you have to pick another form of birth control and tell me which one it is.”

“I have to tell you every time?”

My go-by-thickness moment – I finally got it. “NO,” I said. “You do NOT have to tell me which second contraceptive you use every time you have sex!”

Steven Wright would be proud of Stacy. Isotretinoin came out in 1982, but nobody ever thought of “choose a second type of contraception” that way before. Stacy goes by retail.

That case reminded of another out-of-left field question I heard for the first – and only – time almost 40 years ago. I had prescribed a cream for a young man.

“Can I get it refilled?” he asked.

“Sure,” I said.

“How do I refill it?” he asked.

“You take it back to the pharmacy, and they refill it for you,” I said.

“But how do they refill it?”

“You show them what you need, and they refill it.”

“But how?”

“Why do you keep asking me that?”

“The tube is going to be all scrunched up from my squeezing it,” he said. “How do they get the new cream back in?”

Well son of a gun, “refill” could mean that, couldn’t it? If you go by thickness.

In idle moments I like to let novel perspectives such as those roll around in my head. The other day I accompanied a relative to an emergency department. While waiting in triage for 5 hours, I looked up and saw a sign on the wall, in big, blue letters: “Support ED Research!”

That puzzled me. I know it can be an important problem, but why the dickens would someone come to an emergency department for erectile dysfunction?

I go by acronyms.
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

On car trips with our kids, we used to listen to comedy tapes. (Cassette tapes. Look them up.) One of our favorite comics was Steven Wright, who made it to the Tonight Show with Johnny Carson. (Google him.)

Wright’s offbeat humor was quirky and a bit philosophical, and was delivered in a deadpan, mumbled monotone. For instance:

When I got to school, the teacher said, “The socks you’re wearing don’t match. They’re two different colors.”

I said, “I go by thickness.”

That punchline goes pop in your head, like a shy little firecracker: How come it never occurred to me to look at it that way?

I thought of Steven Wright recently while I was enrolling Stacy, a 20-year-old, in the iPledge program for a planned course of isotretinoin. Stacy told me she is sexually active and has an IUD.

“When you start the medicine next month,” I told her, “you’ll need to pick a second form of contraception.”

Stacy looked bewildered. When I’ve made that statement to a thousand previous patients, none of them ever looked bewildered.

“I mean,” I said, “besides the IUD, you’ll need to use a second type of contraception, to be sure you don’t get pregnant. You could choose condoms, or one of the other types listed in the booklet I gave you.”

That didn’t seem to help. Stacey hemmed a bit. “Does that mean I have to tell you ... ?”

“Yes, you have to pick another form of birth control and tell me which one it is.”

“I have to tell you every time?”

My go-by-thickness moment – I finally got it. “NO,” I said. “You do NOT have to tell me which second contraceptive you use every time you have sex!”

Steven Wright would be proud of Stacy. Isotretinoin came out in 1982, but nobody ever thought of “choose a second type of contraception” that way before. Stacy goes by retail.

That case reminded of another out-of-left field question I heard for the first – and only – time almost 40 years ago. I had prescribed a cream for a young man.

“Can I get it refilled?” he asked.

“Sure,” I said.

“How do I refill it?” he asked.

“You take it back to the pharmacy, and they refill it for you,” I said.

“But how do they refill it?”

“You show them what you need, and they refill it.”

“But how?”

“Why do you keep asking me that?”

“The tube is going to be all scrunched up from my squeezing it,” he said. “How do they get the new cream back in?”

Well son of a gun, “refill” could mean that, couldn’t it? If you go by thickness.

In idle moments I like to let novel perspectives such as those roll around in my head. The other day I accompanied a relative to an emergency department. While waiting in triage for 5 hours, I looked up and saw a sign on the wall, in big, blue letters: “Support ED Research!”

That puzzled me. I know it can be an important problem, but why the dickens would someone come to an emergency department for erectile dysfunction?

I go by acronyms.
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Favorable results from a phase 2 trial have prompted further development of polatuzumab vedotin in non-Hodgkin lymphoma.

In the ROMULUS trial, polatuzumab vedotin plus rituximab (R-pola) produced more durable responses than did pinatuzumab vedotin plus rituximab (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).

Researchers also observed a more favorable benefit-risk profile with R-pola.

Franck Morschhauser, MD, of Centre Hospitalier Régional Universitaire de Lille, France, and his colleagues described these findings in the Lancet Haematology.

The ROMULUS trial included 81 DLBCL patients and 42 FL patients. They were randomized to receive R-pola or R-pina (rituximab at 375 mg/m² plus either antibody-drug conjugate at 2.4 mg/kg) every 21 days until disease progression or unacceptable toxicity for up to 1 year.

Among DLBCL patients, the median age was 69 years in the R-pina arm and 68 years in the R-pola arm. Among FL patients, the median age was 59 years in the R-pina arm and 67 years in the R-pola arm.

Seventy-six percent of DLBCL patients randomized to R-pina were refractory to their last treatment, as were 80% of DLBCL patients assigned to R-pola, 52% of FL patients assigned to R-pina, and 35% of FL patients assigned to R-pola.

The median number of prior systemic therapies was three in the R-pina DLBCL arm, the R-pola DLBCL arm, and the R-pina FL arm. The median number of prior therapies was two in the R-pola FL arm.

Response and survival

Among the DLBCL patients, R-pina produced an objective response rate (ORR) of 60% and a complete response (CR) rate of 26%. R-pola produced an ORR of 54% and a CR rate of 21%. The median duration of response was 6.2 months in the R-pina arm and 13.4 months in the R-pola arm.

The median progression-free survival in the DLBCL cohort was 5.4 months for the R-pina arm and 5.6 months for the R-pola arm. The median overall survival was 16.5 months and 20.1 months, respectively.

In the FL cohort, R-pina produced an ORR of 62% and a CR rate of 5%. R-pola produced an ORR of 70% and a CR rate of 45%. The median duration of response was 6.5 months in the R-pina arm and 9.4 months in the R-pola arm.

The median progression-free survival in the FL cohort was 12.7 months for the R-pina arm and 15.3 months for the R-pola arm. The 2-year overall survival rate was 90.5% and 87.8%, respectively. The median overall survival was not reached in either arm.

“Patients treated with R-pola tended to have longer durations of response than those receiving R-pina (particularly those with relapsed or refractory diffuse large B-cell lymphoma), and the results for R-pola compared favorably with other novel antilymphoma agents,” Dr. Morschhauser and his colleagues wrote.

Safety

Among DLBCL patients, serious adverse events (AEs) occurred in 50.0% of those in the R-pina arm and 35.9% of those in the R-pola arm. Among FL patients, serious AEs occurred in 28.6% of those the R-pina arm and 35.0% of those in the R-pola arm.

Ten grade 5 AEs occurred in nine DLBCL patients who received R-pina (21.4%). These events included two cases of sepsis, influenza and pneumonia in the same patient, general physical health deterioration including one death attributed to disease progression, and one case each of Clostridium difficile sepsis, respiratory failure, urosepsis, and sudden death.

There was one grade 5 AE in a FL patient who received R-pola. The 84-year-old patient died of pulmonary congestion 64 days after the last of 12 cycles of treatment.

There were no fatal AEs in the other arms.

“These findings make pola a promising novel candidate for further clinical evaluation in combination regimens in treatment-refractory patients and also in a first-line setting in B-cell non-Hodgkin lymphoma,” Dr. Morschhauser and his colleagues wrote.

Polatuzumab vedotin was chosen by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response, compared with pinatuzumab vedotin.

Polatuzumab vedotin is currently under investigation in the phase 3 POLARIX study. The drug is being combined with rituximab, cyclophosphamide, doxorubicin, and prednisone and compared to rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL.

The ROMULUS study was funded by F Hoffmann-La Roche. The study authors reported relationships with Roche and other companies.

jensmith@mdedge.com

SOURCE: Morschhauser F et al. Lancet Haematol. 2019 Mar 29. doi: 10.1016/S2352-3026(19)30026-2.

Favorable results from a phase 2 trial have prompted further development of polatuzumab vedotin in non-Hodgkin lymphoma.

In the ROMULUS trial, polatuzumab vedotin plus rituximab (R-pola) produced more durable responses than did pinatuzumab vedotin plus rituximab (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).

Researchers also observed a more favorable benefit-risk profile with R-pola.

Franck Morschhauser, MD, of Centre Hospitalier Régional Universitaire de Lille, France, and his colleagues described these findings in the Lancet Haematology.

The ROMULUS trial included 81 DLBCL patients and 42 FL patients. They were randomized to receive R-pola or R-pina (rituximab at 375 mg/m² plus either antibody-drug conjugate at 2.4 mg/kg) every 21 days until disease progression or unacceptable toxicity for up to 1 year.

Among DLBCL patients, the median age was 69 years in the R-pina arm and 68 years in the R-pola arm. Among FL patients, the median age was 59 years in the R-pina arm and 67 years in the R-pola arm.

Seventy-six percent of DLBCL patients randomized to R-pina were refractory to their last treatment, as were 80% of DLBCL patients assigned to R-pola, 52% of FL patients assigned to R-pina, and 35% of FL patients assigned to R-pola.

The median number of prior systemic therapies was three in the R-pina DLBCL arm, the R-pola DLBCL arm, and the R-pina FL arm. The median number of prior therapies was two in the R-pola FL arm.

Response and survival

Among the DLBCL patients, R-pina produced an objective response rate (ORR) of 60% and a complete response (CR) rate of 26%. R-pola produced an ORR of 54% and a CR rate of 21%. The median duration of response was 6.2 months in the R-pina arm and 13.4 months in the R-pola arm.

The median progression-free survival in the DLBCL cohort was 5.4 months for the R-pina arm and 5.6 months for the R-pola arm. The median overall survival was 16.5 months and 20.1 months, respectively.

In the FL cohort, R-pina produced an ORR of 62% and a CR rate of 5%. R-pola produced an ORR of 70% and a CR rate of 45%. The median duration of response was 6.5 months in the R-pina arm and 9.4 months in the R-pola arm.

The median progression-free survival in the FL cohort was 12.7 months for the R-pina arm and 15.3 months for the R-pola arm. The 2-year overall survival rate was 90.5% and 87.8%, respectively. The median overall survival was not reached in either arm.

“Patients treated with R-pola tended to have longer durations of response than those receiving R-pina (particularly those with relapsed or refractory diffuse large B-cell lymphoma), and the results for R-pola compared favorably with other novel antilymphoma agents,” Dr. Morschhauser and his colleagues wrote.

Safety

Among DLBCL patients, serious adverse events (AEs) occurred in 50.0% of those in the R-pina arm and 35.9% of those in the R-pola arm. Among FL patients, serious AEs occurred in 28.6% of those the R-pina arm and 35.0% of those in the R-pola arm.

Ten grade 5 AEs occurred in nine DLBCL patients who received R-pina (21.4%). These events included two cases of sepsis, influenza and pneumonia in the same patient, general physical health deterioration including one death attributed to disease progression, and one case each of Clostridium difficile sepsis, respiratory failure, urosepsis, and sudden death.

There was one grade 5 AE in a FL patient who received R-pola. The 84-year-old patient died of pulmonary congestion 64 days after the last of 12 cycles of treatment.

There were no fatal AEs in the other arms.

“These findings make pola a promising novel candidate for further clinical evaluation in combination regimens in treatment-refractory patients and also in a first-line setting in B-cell non-Hodgkin lymphoma,” Dr. Morschhauser and his colleagues wrote.

Polatuzumab vedotin was chosen by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response, compared with pinatuzumab vedotin.

Polatuzumab vedotin is currently under investigation in the phase 3 POLARIX study. The drug is being combined with rituximab, cyclophosphamide, doxorubicin, and prednisone and compared to rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL.

The ROMULUS study was funded by F Hoffmann-La Roche. The study authors reported relationships with Roche and other companies.

jensmith@mdedge.com

SOURCE: Morschhauser F et al. Lancet Haematol. 2019 Mar 29. doi: 10.1016/S2352-3026(19)30026-2.

Favorable results from a phase 2 trial have prompted further development of polatuzumab vedotin in non-Hodgkin lymphoma.

In the ROMULUS trial, polatuzumab vedotin plus rituximab (R-pola) produced more durable responses than did pinatuzumab vedotin plus rituximab (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).

Researchers also observed a more favorable benefit-risk profile with R-pola.

Franck Morschhauser, MD, of Centre Hospitalier Régional Universitaire de Lille, France, and his colleagues described these findings in the Lancet Haematology.

The ROMULUS trial included 81 DLBCL patients and 42 FL patients. They were randomized to receive R-pola or R-pina (rituximab at 375 mg/m² plus either antibody-drug conjugate at 2.4 mg/kg) every 21 days until disease progression or unacceptable toxicity for up to 1 year.

Among DLBCL patients, the median age was 69 years in the R-pina arm and 68 years in the R-pola arm. Among FL patients, the median age was 59 years in the R-pina arm and 67 years in the R-pola arm.

Seventy-six percent of DLBCL patients randomized to R-pina were refractory to their last treatment, as were 80% of DLBCL patients assigned to R-pola, 52% of FL patients assigned to R-pina, and 35% of FL patients assigned to R-pola.

The median number of prior systemic therapies was three in the R-pina DLBCL arm, the R-pola DLBCL arm, and the R-pina FL arm. The median number of prior therapies was two in the R-pola FL arm.

Response and survival

Among the DLBCL patients, R-pina produced an objective response rate (ORR) of 60% and a complete response (CR) rate of 26%. R-pola produced an ORR of 54% and a CR rate of 21%. The median duration of response was 6.2 months in the R-pina arm and 13.4 months in the R-pola arm.

The median progression-free survival in the DLBCL cohort was 5.4 months for the R-pina arm and 5.6 months for the R-pola arm. The median overall survival was 16.5 months and 20.1 months, respectively.

In the FL cohort, R-pina produced an ORR of 62% and a CR rate of 5%. R-pola produced an ORR of 70% and a CR rate of 45%. The median duration of response was 6.5 months in the R-pina arm and 9.4 months in the R-pola arm.

The median progression-free survival in the FL cohort was 12.7 months for the R-pina arm and 15.3 months for the R-pola arm. The 2-year overall survival rate was 90.5% and 87.8%, respectively. The median overall survival was not reached in either arm.

“Patients treated with R-pola tended to have longer durations of response than those receiving R-pina (particularly those with relapsed or refractory diffuse large B-cell lymphoma), and the results for R-pola compared favorably with other novel antilymphoma agents,” Dr. Morschhauser and his colleagues wrote.

Safety

Among DLBCL patients, serious adverse events (AEs) occurred in 50.0% of those in the R-pina arm and 35.9% of those in the R-pola arm. Among FL patients, serious AEs occurred in 28.6% of those the R-pina arm and 35.0% of those in the R-pola arm.

Ten grade 5 AEs occurred in nine DLBCL patients who received R-pina (21.4%). These events included two cases of sepsis, influenza and pneumonia in the same patient, general physical health deterioration including one death attributed to disease progression, and one case each of Clostridium difficile sepsis, respiratory failure, urosepsis, and sudden death.

There was one grade 5 AE in a FL patient who received R-pola. The 84-year-old patient died of pulmonary congestion 64 days after the last of 12 cycles of treatment.

There were no fatal AEs in the other arms.

“These findings make pola a promising novel candidate for further clinical evaluation in combination regimens in treatment-refractory patients and also in a first-line setting in B-cell non-Hodgkin lymphoma,” Dr. Morschhauser and his colleagues wrote.

Polatuzumab vedotin was chosen by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response, compared with pinatuzumab vedotin.

Polatuzumab vedotin is currently under investigation in the phase 3 POLARIX study. The drug is being combined with rituximab, cyclophosphamide, doxorubicin, and prednisone and compared to rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL.

The ROMULUS study was funded by F Hoffmann-La Roche. The study authors reported relationships with Roche and other companies.

jensmith@mdedge.com

SOURCE: Morschhauser F et al. Lancet Haematol. 2019 Mar 29. doi: 10.1016/S2352-3026(19)30026-2.

An ingestible electronic capsule that measures intestinal gas. A talented toilet. Obesity subtype biomarkers, improved endoscopies, and an IBD wellness app. Could any of these five innovations transform medicine and lead to gastrointestinal glory?

Five companies will present their innovations to a panel of experts at this week's AGA Tech Summit Shark Tank event, brought to you by the AGA Center for GI Innovation and Technology. Stay tuned to GI & Hepatology News for the AGA Tech Summit Report, where we will provide more information on each product and announce the winner as decided by a panel of judges and the AGA Tech Summit audience. But first, check out the contestants and their products:

1. TrueLoo: Excreta-examining toilet

“TrueLoo is a replacement for a conventional toilet seat,” said Vikram Kashyap, CEO of Toi Labs. “The device acquires time-lapse images of a bowel movement or urination event automatically and under controlled conditions. These images are transmitted to a remote cloud server and analyzed to measure various properties related to the toilet event.”

According to Mr. Kashyap, the firm is developing a way to conduct fecal occult blood tests on the platform without requiring contact or direct sample handling.

2. Ultivision: Video endoscopy booster

“The Ultivision technology will be integrated seamlessly into the endoscopy workflow and provide feedback in real-time,” said University of California at Irvine gastroenterologist Jason B. Samarasena, MD, cofounder of DocBot. “As the endoscopist is performing the upper endoscopy, a lag-free video overlay will display boxes over suspicious lesions that the endoscopist should draw their attention to. When the area is more closely examined, the algorithm will deliver a prediction as to the likelihood that this tissue harbors dysplasia.”



3. Pheno Test: Know your obesity subtype

The Pheno Test aims to unveil obesity biomarkers which “are supported by a diagnostic algorithm... which has already been validated to predict weight response to obesity pharmacotherapy,” said Phenomix Sciences CEO Andres J. Acosta, MD, PhD, assistant professor of medicine and consultant in gastroenterology and hepatology at Mayo Clinic.

According to Dr. Acosta, a separate trial tracked patients with obesity, including some who were treated differently based on their phenotype. Those patients lost more than double their body weight compared with those who received standard of care and had fewer adverse effects linked to treatment.
 

4. Oshi: Meet the “all in one” IBD app

The Oshi app, which is now available for Apple iOS and Android, allows patients with IBD to track their symptoms and “uncover hidden patterns affecting wellness,” said Dan Weinstein, MBA, CEO of Oshi Health.

Patients can also read about IBD news, hear from other patients about their experiences, and ask questions of health professionals. “We are expanding to include proven digital tools to enhance IBD care such as medication adherence, treatment history logs, at-home fecal calprotectin testing, and more,” Mr. Weinstein said.
 

5. Atmo Gas Capsule: Swallow your way to GI insights

An ingestible electronic capsule the size of a large vitamin tablet gathers “digital health data in the form of gas concentrations as it passes through the gut for the screening and diagnosis of gastrointestinal disorders and for assessing effects of dietary treatments on the gut,” said Malcolm Hebblewhite, MBA, CEO of Atmo Biosciences.

The capsule transmits data to a small receiver and on to a smartphone, Mr. Hebblewhite said. “The real-time data is displayed for the user with more complex information accessible by the practitioner remotely via the cloud.”

An ingestible electronic capsule that measures intestinal gas. A talented toilet. Obesity subtype biomarkers, improved endoscopies, and an IBD wellness app. Could any of these five innovations transform medicine and lead to gastrointestinal glory?

Five companies will present their innovations to a panel of experts at this week's AGA Tech Summit Shark Tank event, brought to you by the AGA Center for GI Innovation and Technology. Stay tuned to GI & Hepatology News for the AGA Tech Summit Report, where we will provide more information on each product and announce the winner as decided by a panel of judges and the AGA Tech Summit audience. But first, check out the contestants and their products:

1. TrueLoo: Excreta-examining toilet

“TrueLoo is a replacement for a conventional toilet seat,” said Vikram Kashyap, CEO of Toi Labs. “The device acquires time-lapse images of a bowel movement or urination event automatically and under controlled conditions. These images are transmitted to a remote cloud server and analyzed to measure various properties related to the toilet event.”

According to Mr. Kashyap, the firm is developing a way to conduct fecal occult blood tests on the platform without requiring contact or direct sample handling.

2. Ultivision: Video endoscopy booster

“The Ultivision technology will be integrated seamlessly into the endoscopy workflow and provide feedback in real-time,” said University of California at Irvine gastroenterologist Jason B. Samarasena, MD, cofounder of DocBot. “As the endoscopist is performing the upper endoscopy, a lag-free video overlay will display boxes over suspicious lesions that the endoscopist should draw their attention to. When the area is more closely examined, the algorithm will deliver a prediction as to the likelihood that this tissue harbors dysplasia.”



3. Pheno Test: Know your obesity subtype

The Pheno Test aims to unveil obesity biomarkers which “are supported by a diagnostic algorithm... which has already been validated to predict weight response to obesity pharmacotherapy,” said Phenomix Sciences CEO Andres J. Acosta, MD, PhD, assistant professor of medicine and consultant in gastroenterology and hepatology at Mayo Clinic.

According to Dr. Acosta, a separate trial tracked patients with obesity, including some who were treated differently based on their phenotype. Those patients lost more than double their body weight compared with those who received standard of care and had fewer adverse effects linked to treatment.
 

4. Oshi: Meet the “all in one” IBD app

The Oshi app, which is now available for Apple iOS and Android, allows patients with IBD to track their symptoms and “uncover hidden patterns affecting wellness,” said Dan Weinstein, MBA, CEO of Oshi Health.

Patients can also read about IBD news, hear from other patients about their experiences, and ask questions of health professionals. “We are expanding to include proven digital tools to enhance IBD care such as medication adherence, treatment history logs, at-home fecal calprotectin testing, and more,” Mr. Weinstein said.
 

5. Atmo Gas Capsule: Swallow your way to GI insights

An ingestible electronic capsule the size of a large vitamin tablet gathers “digital health data in the form of gas concentrations as it passes through the gut for the screening and diagnosis of gastrointestinal disorders and for assessing effects of dietary treatments on the gut,” said Malcolm Hebblewhite, MBA, CEO of Atmo Biosciences.

The capsule transmits data to a small receiver and on to a smartphone, Mr. Hebblewhite said. “The real-time data is displayed for the user with more complex information accessible by the practitioner remotely via the cloud.”

An ingestible electronic capsule that measures intestinal gas. A talented toilet. Obesity subtype biomarkers, improved endoscopies, and an IBD wellness app. Could any of these five innovations transform medicine and lead to gastrointestinal glory?

Five companies will present their innovations to a panel of experts at this week's AGA Tech Summit Shark Tank event, brought to you by the AGA Center for GI Innovation and Technology. Stay tuned to GI & Hepatology News for the AGA Tech Summit Report, where we will provide more information on each product and announce the winner as decided by a panel of judges and the AGA Tech Summit audience. But first, check out the contestants and their products:

1. TrueLoo: Excreta-examining toilet

“TrueLoo is a replacement for a conventional toilet seat,” said Vikram Kashyap, CEO of Toi Labs. “The device acquires time-lapse images of a bowel movement or urination event automatically and under controlled conditions. These images are transmitted to a remote cloud server and analyzed to measure various properties related to the toilet event.”

According to Mr. Kashyap, the firm is developing a way to conduct fecal occult blood tests on the platform without requiring contact or direct sample handling.

2. Ultivision: Video endoscopy booster

“The Ultivision technology will be integrated seamlessly into the endoscopy workflow and provide feedback in real-time,” said University of California at Irvine gastroenterologist Jason B. Samarasena, MD, cofounder of DocBot. “As the endoscopist is performing the upper endoscopy, a lag-free video overlay will display boxes over suspicious lesions that the endoscopist should draw their attention to. When the area is more closely examined, the algorithm will deliver a prediction as to the likelihood that this tissue harbors dysplasia.”



3. Pheno Test: Know your obesity subtype

The Pheno Test aims to unveil obesity biomarkers which “are supported by a diagnostic algorithm... which has already been validated to predict weight response to obesity pharmacotherapy,” said Phenomix Sciences CEO Andres J. Acosta, MD, PhD, assistant professor of medicine and consultant in gastroenterology and hepatology at Mayo Clinic.

According to Dr. Acosta, a separate trial tracked patients with obesity, including some who were treated differently based on their phenotype. Those patients lost more than double their body weight compared with those who received standard of care and had fewer adverse effects linked to treatment.
 

4. Oshi: Meet the “all in one” IBD app

The Oshi app, which is now available for Apple iOS and Android, allows patients with IBD to track their symptoms and “uncover hidden patterns affecting wellness,” said Dan Weinstein, MBA, CEO of Oshi Health.

Patients can also read about IBD news, hear from other patients about their experiences, and ask questions of health professionals. “We are expanding to include proven digital tools to enhance IBD care such as medication adherence, treatment history logs, at-home fecal calprotectin testing, and more,” Mr. Weinstein said.
 

5. Atmo Gas Capsule: Swallow your way to GI insights

An ingestible electronic capsule the size of a large vitamin tablet gathers “digital health data in the form of gas concentrations as it passes through the gut for the screening and diagnosis of gastrointestinal disorders and for assessing effects of dietary treatments on the gut,” said Malcolm Hebblewhite, MBA, CEO of Atmo Biosciences.

The capsule transmits data to a small receiver and on to a smartphone, Mr. Hebblewhite said. “The real-time data is displayed for the user with more complex information accessible by the practitioner remotely via the cloud.”

SEATTLE – Almost a third of patients who developed HIV while on pre-exposure prophylaxis (PrEP) had strains that were resistant to emtricitabine – a component of the PrEP medication Truvada along with tenofovir – at time of diagnosis, compared with just 2% of those not on PrEP, in a review of more than 3,500 newly diagnosed HIV cases in New York.

M. Alexander Otto/MDedge News

The finding points to a growing concern as use of PrEP becomes more common: the induction of resistance to HIV treatments.

PrEP is highly effective, so it’s likely that the PrEP patients already had HIV when they started treatment. Nucleic acid amplification testing (NAAT) is the only way to rule it out definitively, but only 5% of PrEP users in the study were screened with NAAT within 2 days of initiation.

The usual test – HIV antibody screening – returns a false negative in the window between HIV exposure and active infection, when antibodies turn positive, which can take months. NAAT, on the other hand, looks for evidence of the virus directly.

The findings led the investigators to urge routine NAAT screening before PrEP, something that New York State guidelines currently recommend only if patients present with symptoms of acute HIV infection or report condomless sex in the previous 4 weeks.

To prevent drug resistance, “rigorous screening that includes NAAT is critical.” It reduces “the likelihood of PrEP start during undetected HIV infection,” said lead investigator Kavita Misra, PhD, MPH, a senior epidemiologist at the New York City Department of Health and Mental Hygiene.

Her team reviewed 3,685 people in New York who were diagnosed with HIV from November 2015 to August 2017; 91 had been on PrEP beforehand for a median of 106 days.

Postdiagnosis genotyping was available for 75% of PrEP users and 63% in the no-PrEP group. Resistance mutations to emtricitabine were significantly more prevalent with PrEP than without (29% versus 2%, respectively; P less than .0001). None of the PrEP users, but four in the no-PrEP group, had resistance to the other component of Truvada, tenofovir.

PrEP users were more likely to be diagnosed with HIV in the acute phase of infection than were those not using PrEP (33% versus 9%; P less than .0001), probably because they were also more likely to have regular office visits while on PrEP.

Skeptics at the Conference on Retroviruses and Opportunistic Infections, where the study was presented, wondered whether emtricitabine resistance would have been more common in the no-PrEP group if the infection had been picked up earlier because resistance fades as the infection progresses.

Dr. Misra said it was a good question and that her team will look into it. However, she stood by her conclusions.

PrEP use was most common among white men who have sex with men and among people under 30 years old.

There was no external funding, and the investigators didn’t have any disclosures.

aotto@mdedge.com

SOURCE: Misra K et al. 2019 CROI, Abstract 107.

SEATTLE – Almost a third of patients who developed HIV while on pre-exposure prophylaxis (PrEP) had strains that were resistant to emtricitabine – a component of the PrEP medication Truvada along with tenofovir – at time of diagnosis, compared with just 2% of those not on PrEP, in a review of more than 3,500 newly diagnosed HIV cases in New York.

M. Alexander Otto/MDedge News

The finding points to a growing concern as use of PrEP becomes more common: the induction of resistance to HIV treatments.

PrEP is highly effective, so it’s likely that the PrEP patients already had HIV when they started treatment. Nucleic acid amplification testing (NAAT) is the only way to rule it out definitively, but only 5% of PrEP users in the study were screened with NAAT within 2 days of initiation.

The usual test – HIV antibody screening – returns a false negative in the window between HIV exposure and active infection, when antibodies turn positive, which can take months. NAAT, on the other hand, looks for evidence of the virus directly.

The findings led the investigators to urge routine NAAT screening before PrEP, something that New York State guidelines currently recommend only if patients present with symptoms of acute HIV infection or report condomless sex in the previous 4 weeks.

To prevent drug resistance, “rigorous screening that includes NAAT is critical.” It reduces “the likelihood of PrEP start during undetected HIV infection,” said lead investigator Kavita Misra, PhD, MPH, a senior epidemiologist at the New York City Department of Health and Mental Hygiene.

Her team reviewed 3,685 people in New York who were diagnosed with HIV from November 2015 to August 2017; 91 had been on PrEP beforehand for a median of 106 days.

Postdiagnosis genotyping was available for 75% of PrEP users and 63% in the no-PrEP group. Resistance mutations to emtricitabine were significantly more prevalent with PrEP than without (29% versus 2%, respectively; P less than .0001). None of the PrEP users, but four in the no-PrEP group, had resistance to the other component of Truvada, tenofovir.

PrEP users were more likely to be diagnosed with HIV in the acute phase of infection than were those not using PrEP (33% versus 9%; P less than .0001), probably because they were also more likely to have regular office visits while on PrEP.

Skeptics at the Conference on Retroviruses and Opportunistic Infections, where the study was presented, wondered whether emtricitabine resistance would have been more common in the no-PrEP group if the infection had been picked up earlier because resistance fades as the infection progresses.

Dr. Misra said it was a good question and that her team will look into it. However, she stood by her conclusions.

PrEP use was most common among white men who have sex with men and among people under 30 years old.

There was no external funding, and the investigators didn’t have any disclosures.

aotto@mdedge.com

SOURCE: Misra K et al. 2019 CROI, Abstract 107.

SEATTLE – Almost a third of patients who developed HIV while on pre-exposure prophylaxis (PrEP) had strains that were resistant to emtricitabine – a component of the PrEP medication Truvada along with tenofovir – at time of diagnosis, compared with just 2% of those not on PrEP, in a review of more than 3,500 newly diagnosed HIV cases in New York.

M. Alexander Otto/MDedge News

The finding points to a growing concern as use of PrEP becomes more common: the induction of resistance to HIV treatments.

PrEP is highly effective, so it’s likely that the PrEP patients already had HIV when they started treatment. Nucleic acid amplification testing (NAAT) is the only way to rule it out definitively, but only 5% of PrEP users in the study were screened with NAAT within 2 days of initiation.

The usual test – HIV antibody screening – returns a false negative in the window between HIV exposure and active infection, when antibodies turn positive, which can take months. NAAT, on the other hand, looks for evidence of the virus directly.

The findings led the investigators to urge routine NAAT screening before PrEP, something that New York State guidelines currently recommend only if patients present with symptoms of acute HIV infection or report condomless sex in the previous 4 weeks.

To prevent drug resistance, “rigorous screening that includes NAAT is critical.” It reduces “the likelihood of PrEP start during undetected HIV infection,” said lead investigator Kavita Misra, PhD, MPH, a senior epidemiologist at the New York City Department of Health and Mental Hygiene.

Her team reviewed 3,685 people in New York who were diagnosed with HIV from November 2015 to August 2017; 91 had been on PrEP beforehand for a median of 106 days.

Postdiagnosis genotyping was available for 75% of PrEP users and 63% in the no-PrEP group. Resistance mutations to emtricitabine were significantly more prevalent with PrEP than without (29% versus 2%, respectively; P less than .0001). None of the PrEP users, but four in the no-PrEP group, had resistance to the other component of Truvada, tenofovir.

PrEP users were more likely to be diagnosed with HIV in the acute phase of infection than were those not using PrEP (33% versus 9%; P less than .0001), probably because they were also more likely to have regular office visits while on PrEP.

Skeptics at the Conference on Retroviruses and Opportunistic Infections, where the study was presented, wondered whether emtricitabine resistance would have been more common in the no-PrEP group if the infection had been picked up earlier because resistance fades as the infection progresses.

Dr. Misra said it was a good question and that her team will look into it. However, she stood by her conclusions.

PrEP use was most common among white men who have sex with men and among people under 30 years old.

There was no external funding, and the investigators didn’t have any disclosures.

aotto@mdedge.com

SOURCE: Misra K et al. 2019 CROI, Abstract 107.

Although the gastroenterology specialty relies heavily on technology, only incremental advances have been made in this space in the last several decades. “While the potential for innovation is huge, we need to overcome structural and conceptual barriers to realize its true potential,” said Pankaj Jay Pasricha, MD, vice chair of the department of medicine at Johns Hopkins University, Baltimore. Dr. Pasricha will discuss what barriers exist and how to overcome them in his keynote presentation at 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Some barriers are risk aversion, reimbursement challenges, and failure to understand true unmet needs. “We need to find practical solutions that are technologically innovative that can get to market,” he said. The general concepts that Dr. Pasricha talks about will be discussed in detail with specific examples during the summit’s sessions.

When looking to bring innovative ideas to market, Dr. Pasricha recommends learning from individuals who have already done this successfully and from those who have tried and failed. One way to do this is to connect with inventors, entrepreneurs, investors, health care providers and institutions, and regulatory and reimbursement stakeholders through the AGA Center for GI Innovation & Technology (CGIT), which he helped found 10 years ago and served as the center's first chair.

The center supports innovation and developing new technology in gastroenterology, hepatology, nutrition, and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process, according to CGIT’s website. It serves as a key resource for industry and physician innovators developing new technology in gastroenterology, and provides guidance to the Food and Drug Administration and other regulatory groups to expedite the device development process.

“CGIT’s purpose is to provide education on how to identify needs, find solutions, and provide roadmaps for connecting ideas and bringing them to the real world,” Dr. Pasricha said. “We need to create disruptive technologies that will address unmet needs at every level from the average gastroenterologist in practice, to advanced endoscopists, and even advanced surgeons who perform gastroenterology procedures.”

CGIT also provides guidance for bringing new technologies into clinical trials through the creation of registries and other means. You can learn more about the center at www.gastro.org/CGIT. 

Regarding recent advances in technologies, Dr. Pasricha said there are now better ways to ablate tissue, do tissue anastomosis, prevent reflux, promote weight loss, and resect locally advanced cancer. “Platform” technologies such as new ways to deliver energy, flexible robotics, and artificial intelligence are also beginning to emerge in our specialty.

Dr. Pasricha is quite experienced in bringing new technologies to market. He holds more than 50 patents that have either been issued or are in process by The United States Patent and Trademark Office and has cofounded several companies within both the medtech/endoscopy and biotech gastroenterology spaces.

His contributions to endoscopy include the use of botulinum toxin for gastroenterology disorders, cryotherapy, novel stents, and the POEM procedure. He is currently working with Galvani Bioelectronics to develop a novel neuromodulation therapy for type 2 diabetes, which has become a worldwide scourge.

Dr. Pasricha discloses being a consultant for several pharmaceutical companies.

Although the gastroenterology specialty relies heavily on technology, only incremental advances have been made in this space in the last several decades. “While the potential for innovation is huge, we need to overcome structural and conceptual barriers to realize its true potential,” said Pankaj Jay Pasricha, MD, vice chair of the department of medicine at Johns Hopkins University, Baltimore. Dr. Pasricha will discuss what barriers exist and how to overcome them in his keynote presentation at 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Some barriers are risk aversion, reimbursement challenges, and failure to understand true unmet needs. “We need to find practical solutions that are technologically innovative that can get to market,” he said. The general concepts that Dr. Pasricha talks about will be discussed in detail with specific examples during the summit’s sessions.

When looking to bring innovative ideas to market, Dr. Pasricha recommends learning from individuals who have already done this successfully and from those who have tried and failed. One way to do this is to connect with inventors, entrepreneurs, investors, health care providers and institutions, and regulatory and reimbursement stakeholders through the AGA Center for GI Innovation & Technology (CGIT), which he helped found 10 years ago and served as the center's first chair.

The center supports innovation and developing new technology in gastroenterology, hepatology, nutrition, and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process, according to CGIT’s website. It serves as a key resource for industry and physician innovators developing new technology in gastroenterology, and provides guidance to the Food and Drug Administration and other regulatory groups to expedite the device development process.

“CGIT’s purpose is to provide education on how to identify needs, find solutions, and provide roadmaps for connecting ideas and bringing them to the real world,” Dr. Pasricha said. “We need to create disruptive technologies that will address unmet needs at every level from the average gastroenterologist in practice, to advanced endoscopists, and even advanced surgeons who perform gastroenterology procedures.”

CGIT also provides guidance for bringing new technologies into clinical trials through the creation of registries and other means. You can learn more about the center at www.gastro.org/CGIT. 

Regarding recent advances in technologies, Dr. Pasricha said there are now better ways to ablate tissue, do tissue anastomosis, prevent reflux, promote weight loss, and resect locally advanced cancer. “Platform” technologies such as new ways to deliver energy, flexible robotics, and artificial intelligence are also beginning to emerge in our specialty.

Dr. Pasricha is quite experienced in bringing new technologies to market. He holds more than 50 patents that have either been issued or are in process by The United States Patent and Trademark Office and has cofounded several companies within both the medtech/endoscopy and biotech gastroenterology spaces.

His contributions to endoscopy include the use of botulinum toxin for gastroenterology disorders, cryotherapy, novel stents, and the POEM procedure. He is currently working with Galvani Bioelectronics to develop a novel neuromodulation therapy for type 2 diabetes, which has become a worldwide scourge.

Dr. Pasricha discloses being a consultant for several pharmaceutical companies.

Although the gastroenterology specialty relies heavily on technology, only incremental advances have been made in this space in the last several decades. “While the potential for innovation is huge, we need to overcome structural and conceptual barriers to realize its true potential,” said Pankaj Jay Pasricha, MD, vice chair of the department of medicine at Johns Hopkins University, Baltimore. Dr. Pasricha will discuss what barriers exist and how to overcome them in his keynote presentation at 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Some barriers are risk aversion, reimbursement challenges, and failure to understand true unmet needs. “We need to find practical solutions that are technologically innovative that can get to market,” he said. The general concepts that Dr. Pasricha talks about will be discussed in detail with specific examples during the summit’s sessions.

When looking to bring innovative ideas to market, Dr. Pasricha recommends learning from individuals who have already done this successfully and from those who have tried and failed. One way to do this is to connect with inventors, entrepreneurs, investors, health care providers and institutions, and regulatory and reimbursement stakeholders through the AGA Center for GI Innovation & Technology (CGIT), which he helped found 10 years ago and served as the center's first chair.

The center supports innovation and developing new technology in gastroenterology, hepatology, nutrition, and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process, according to CGIT’s website. It serves as a key resource for industry and physician innovators developing new technology in gastroenterology, and provides guidance to the Food and Drug Administration and other regulatory groups to expedite the device development process.

“CGIT’s purpose is to provide education on how to identify needs, find solutions, and provide roadmaps for connecting ideas and bringing them to the real world,” Dr. Pasricha said. “We need to create disruptive technologies that will address unmet needs at every level from the average gastroenterologist in practice, to advanced endoscopists, and even advanced surgeons who perform gastroenterology procedures.”

CGIT also provides guidance for bringing new technologies into clinical trials through the creation of registries and other means. You can learn more about the center at www.gastro.org/CGIT. 

Regarding recent advances in technologies, Dr. Pasricha said there are now better ways to ablate tissue, do tissue anastomosis, prevent reflux, promote weight loss, and resect locally advanced cancer. “Platform” technologies such as new ways to deliver energy, flexible robotics, and artificial intelligence are also beginning to emerge in our specialty.

Dr. Pasricha is quite experienced in bringing new technologies to market. He holds more than 50 patents that have either been issued or are in process by The United States Patent and Trademark Office and has cofounded several companies within both the medtech/endoscopy and biotech gastroenterology spaces.

His contributions to endoscopy include the use of botulinum toxin for gastroenterology disorders, cryotherapy, novel stents, and the POEM procedure. He is currently working with Galvani Bioelectronics to develop a novel neuromodulation therapy for type 2 diabetes, which has become a worldwide scourge.

Dr. Pasricha discloses being a consultant for several pharmaceutical companies.

The Food and Drug Administration has identified 40 angiotensin II receptor blockers (ARBs) that do not contain the environmental contaminants, nitrosamines.

This marks the first time the FDA has released a list of nitrosamine-free ARBs since impurities in these antihypertensive drugs were discovered last summer, according to a statement from the regulatory agency.

Among the drugs on this list are Accord Healthcare’s amlodipine and olmesartan medoxomil, Alembic Pharmaceuticals’ valsartan and hydrochlorothiazide, and Hisun Pharmaceuticals USA’s telmisartan.

Despite the FDA’s findings, the agency recommends patients continue taking the ARBs they have been prescribed until their pharmacists or physicians change their prescriptions to a safe replacement or different treatment option.

“We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medications far outweighs the low risk associated with continuing the medications with these impurities,” says the statement.

The FDA noted that it is “continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits,” and that this effort has resulted in shortages of valsartan products. In anticipation of more shortages, the FDA “is not objecting to temporary distribution” of specific lots of losartan containing impurities at levels exceeding the regulatory agency’s aforementioned standards.

The FDA’s scientists said that using ARBs with impurity levels above the interim acceptable intake limits over the time it should take to get impurity-free losartan to market will not result in an increased risk for cancer.

More information, including the full statement, is available on the FDA’s website.

cpalmer@mdedge.com

The Food and Drug Administration has identified 40 angiotensin II receptor blockers (ARBs) that do not contain the environmental contaminants, nitrosamines.

This marks the first time the FDA has released a list of nitrosamine-free ARBs since impurities in these antihypertensive drugs were discovered last summer, according to a statement from the regulatory agency.

Among the drugs on this list are Accord Healthcare’s amlodipine and olmesartan medoxomil, Alembic Pharmaceuticals’ valsartan and hydrochlorothiazide, and Hisun Pharmaceuticals USA’s telmisartan.

Despite the FDA’s findings, the agency recommends patients continue taking the ARBs they have been prescribed until their pharmacists or physicians change their prescriptions to a safe replacement or different treatment option.

“We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medications far outweighs the low risk associated with continuing the medications with these impurities,” says the statement.

The FDA noted that it is “continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits,” and that this effort has resulted in shortages of valsartan products. In anticipation of more shortages, the FDA “is not objecting to temporary distribution” of specific lots of losartan containing impurities at levels exceeding the regulatory agency’s aforementioned standards.

The FDA’s scientists said that using ARBs with impurity levels above the interim acceptable intake limits over the time it should take to get impurity-free losartan to market will not result in an increased risk for cancer.

More information, including the full statement, is available on the FDA’s website.

cpalmer@mdedge.com

The Food and Drug Administration has identified 40 angiotensin II receptor blockers (ARBs) that do not contain the environmental contaminants, nitrosamines.

This marks the first time the FDA has released a list of nitrosamine-free ARBs since impurities in these antihypertensive drugs were discovered last summer, according to a statement from the regulatory agency.

Among the drugs on this list are Accord Healthcare’s amlodipine and olmesartan medoxomil, Alembic Pharmaceuticals’ valsartan and hydrochlorothiazide, and Hisun Pharmaceuticals USA’s telmisartan.

Despite the FDA’s findings, the agency recommends patients continue taking the ARBs they have been prescribed until their pharmacists or physicians change their prescriptions to a safe replacement or different treatment option.

“We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medications far outweighs the low risk associated with continuing the medications with these impurities,” says the statement.

The FDA noted that it is “continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits,” and that this effort has resulted in shortages of valsartan products. In anticipation of more shortages, the FDA “is not objecting to temporary distribution” of specific lots of losartan containing impurities at levels exceeding the regulatory agency’s aforementioned standards.

The FDA’s scientists said that using ARBs with impurity levels above the interim acceptable intake limits over the time it should take to get impurity-free losartan to market will not result in an increased risk for cancer.

More information, including the full statement, is available on the FDA’s website.

cpalmer@mdedge.com

GLASGOW – Patients with relapsed or refractory mantle cell lymphoma (MCL) who experience disease progression on a Bruton’s tyrosine kinase inhibitor (BTKi) may respond best to a combination of rituximab, bendamustine, and cytarabine (R-BAC), based on early results from an ongoing retrospective study.

Will Pass/MDedge News

Findings from the study, which were presented at the annual meeting of the British Society for Haematology, showed that R-BAC after BTKi failure had an overall response rate (ORR) of 90.5%.

This is a “remarkable response rate” according to the investigators, who cited previously reported response rates for other treatments ranging from 29% to 53%.

Treatment of relapsed/refractory MCL patients in the post-BTKi setting is an area of unmet clinical need, said senior author Simon Rule, MD, of the University of Plymouth, England. He noted that there is currently no consensus regarding best treatment strategy for this patient population.

Dr. Rule said that he and his colleagues have collected data on 30 patients so far, of which 22 were included in this early data release.

All patients received R-BAC between 2016 and 2018 at treatment centers in Italy and the United Kingdom. Treatment consisted of rituximab (375 mg/m² or 500 mg) on day 1, bendamustine 70 mg/m² on days 1 and 2, and cytarabine 500 mg/m² on days 1 through 3, given in a 28-day cycle.

Patients received R-BAC immediately after BTKi failure. Data were drawn from hospital records.

Analysis showed that the median patient age was 65 years, with a range from 43 to 79 years. Most patients were men (81.8%), 55.0% were high risk based on the Mantle Cell Lymphoma International Prognostic Index, and 22.7% had blastoid morphology.

Patients had a median of two prior systemic therapies, with a range from one to six lines. First-line therapies included rituximab in combination with HDAC (high-dose cytarabine containing regimen), CHOP, CVP, or ibrutinib. Nine patients (42.9%) had allogeneic stem cell transplantation (ASCT) after induction treatment.

For BTKi therapy, most patients received ibrutinib (n = 18), while the remainder received acalabrutinib, tirabrutinib or M7583. Most patients discontinued BTKi therapy because of disease progression (90.9%); two patients stopped because of a lack of response (9.1%).

The median number of R-BAC cycles received was four. Two patients started with attenuated doses and seven patients reduced doses after the first cycle. More than 70% of patients completed R-BAC treatment.

The estimated median progression-free survival was 7.3 months and estimated median overall survival was 11.2 months.

Although the investigators reported a complete response rate of 57.1%, they noted that this figure “may be exaggerated” because of a lack of bone marrow biopsy; however, they suggested that the overall response rate (90.5%) “should be accurate.”

During the course of treatment, 31.8% of patients required inpatient admission, 22.7% developed neutropenic fever, and 77.8% required transfusion support. No treatment-related deaths occurred.

“This population, enriched for patients with high risk features, showed remarkable response rates to R-BAC,” the investigators wrote. “The treatment had acceptable toxicity, maintained efficacy at attenuated doses, and was used successfully as a bridge to ASCT in over 20% of patients.”

The investigators suggested that R-BAC should be considered a new standard of care in the United Kingdom for bendamustine-naive patients who are unable to be enrolled in clinical trials. “The high response rate makes it particularly appealing for patients considered candidates for consolidation ASCT,” they wrote.

In an interview, Dr. Rule added perspective to these findings.

“There’s been an obsession with venetoclax, that that’s the answer, but it really isn’t,” Dr. Rule said. “So people are looking for a new drug. I guess what I do differently to most people is I use CHOP frontline rather than bendamustine. To me, that’s the best way of sequencing the therapies, whereas if you use [bendamustine and rituximab] up front, which a lot of people do, particularly in the [United] States, your R-BAC might not be so effective.”

However, Dr. Rule said that first-line therapies appear to have minimal impact on R-BAC efficacy. “Even if you’ve had bendamustine, even if you’ve had high-dose cytarabine, even if you’ve had an allogeneic stem cell transplant, [R-BAC] still works,” he said.

Where patients have issues with tolerability, Dr. Rule noted that dose reductions are possible without sacrificing efficacy.

He offered an example of such a scenario. “My oldest patient was about 80 with blastoid disease, relapsing,” Dr. Rule said. “After ibrutinib, I gave him just a single dose of bendamustine at 70 mg, a single dose of cytarabine at 500 mg, just 1 day, and he had that six times, probably 3 weeks apart. He’s been in complete remission for over a year.”

With data on 30 patients collected, Dr. Rule said that he and his colleagues plan to present more extensive findings at the European Hematology Association Congress, held June 13-16 in Amsterdam.

The investigators reported having no conflicts of interest.
 

GLASGOW – Patients with relapsed or refractory mantle cell lymphoma (MCL) who experience disease progression on a Bruton’s tyrosine kinase inhibitor (BTKi) may respond best to a combination of rituximab, bendamustine, and cytarabine (R-BAC), based on early results from an ongoing retrospective study.

Will Pass/MDedge News

Findings from the study, which were presented at the annual meeting of the British Society for Haematology, showed that R-BAC after BTKi failure had an overall response rate (ORR) of 90.5%.

This is a “remarkable response rate” according to the investigators, who cited previously reported response rates for other treatments ranging from 29% to 53%.

Treatment of relapsed/refractory MCL patients in the post-BTKi setting is an area of unmet clinical need, said senior author Simon Rule, MD, of the University of Plymouth, England. He noted that there is currently no consensus regarding best treatment strategy for this patient population.

Dr. Rule said that he and his colleagues have collected data on 30 patients so far, of which 22 were included in this early data release.

All patients received R-BAC between 2016 and 2018 at treatment centers in Italy and the United Kingdom. Treatment consisted of rituximab (375 mg/m² or 500 mg) on day 1, bendamustine 70 mg/m² on days 1 and 2, and cytarabine 500 mg/m² on days 1 through 3, given in a 28-day cycle.

Patients received R-BAC immediately after BTKi failure. Data were drawn from hospital records.

Analysis showed that the median patient age was 65 years, with a range from 43 to 79 years. Most patients were men (81.8%), 55.0% were high risk based on the Mantle Cell Lymphoma International Prognostic Index, and 22.7% had blastoid morphology.

Patients had a median of two prior systemic therapies, with a range from one to six lines. First-line therapies included rituximab in combination with HDAC (high-dose cytarabine containing regimen), CHOP, CVP, or ibrutinib. Nine patients (42.9%) had allogeneic stem cell transplantation (ASCT) after induction treatment.

For BTKi therapy, most patients received ibrutinib (n = 18), while the remainder received acalabrutinib, tirabrutinib or M7583. Most patients discontinued BTKi therapy because of disease progression (90.9%); two patients stopped because of a lack of response (9.1%).

The median number of R-BAC cycles received was four. Two patients started with attenuated doses and seven patients reduced doses after the first cycle. More than 70% of patients completed R-BAC treatment.

The estimated median progression-free survival was 7.3 months and estimated median overall survival was 11.2 months.

Although the investigators reported a complete response rate of 57.1%, they noted that this figure “may be exaggerated” because of a lack of bone marrow biopsy; however, they suggested that the overall response rate (90.5%) “should be accurate.”

During the course of treatment, 31.8% of patients required inpatient admission, 22.7% developed neutropenic fever, and 77.8% required transfusion support. No treatment-related deaths occurred.

“This population, enriched for patients with high risk features, showed remarkable response rates to R-BAC,” the investigators wrote. “The treatment had acceptable toxicity, maintained efficacy at attenuated doses, and was used successfully as a bridge to ASCT in over 20% of patients.”

The investigators suggested that R-BAC should be considered a new standard of care in the United Kingdom for bendamustine-naive patients who are unable to be enrolled in clinical trials. “The high response rate makes it particularly appealing for patients considered candidates for consolidation ASCT,” they wrote.

In an interview, Dr. Rule added perspective to these findings.

“There’s been an obsession with venetoclax, that that’s the answer, but it really isn’t,” Dr. Rule said. “So people are looking for a new drug. I guess what I do differently to most people is I use CHOP frontline rather than bendamustine. To me, that’s the best way of sequencing the therapies, whereas if you use [bendamustine and rituximab] up front, which a lot of people do, particularly in the [United] States, your R-BAC might not be so effective.”

However, Dr. Rule said that first-line therapies appear to have minimal impact on R-BAC efficacy. “Even if you’ve had bendamustine, even if you’ve had high-dose cytarabine, even if you’ve had an allogeneic stem cell transplant, [R-BAC] still works,” he said.

Where patients have issues with tolerability, Dr. Rule noted that dose reductions are possible without sacrificing efficacy.

He offered an example of such a scenario. “My oldest patient was about 80 with blastoid disease, relapsing,” Dr. Rule said. “After ibrutinib, I gave him just a single dose of bendamustine at 70 mg, a single dose of cytarabine at 500 mg, just 1 day, and he had that six times, probably 3 weeks apart. He’s been in complete remission for over a year.”

With data on 30 patients collected, Dr. Rule said that he and his colleagues plan to present more extensive findings at the European Hematology Association Congress, held June 13-16 in Amsterdam.

The investigators reported having no conflicts of interest.
 

GLASGOW – Patients with relapsed or refractory mantle cell lymphoma (MCL) who experience disease progression on a Bruton’s tyrosine kinase inhibitor (BTKi) may respond best to a combination of rituximab, bendamustine, and cytarabine (R-BAC), based on early results from an ongoing retrospective study.

Will Pass/MDedge News

Findings from the study, which were presented at the annual meeting of the British Society for Haematology, showed that R-BAC after BTKi failure had an overall response rate (ORR) of 90.5%.

This is a “remarkable response rate” according to the investigators, who cited previously reported response rates for other treatments ranging from 29% to 53%.

Treatment of relapsed/refractory MCL patients in the post-BTKi setting is an area of unmet clinical need, said senior author Simon Rule, MD, of the University of Plymouth, England. He noted that there is currently no consensus regarding best treatment strategy for this patient population.

Dr. Rule said that he and his colleagues have collected data on 30 patients so far, of which 22 were included in this early data release.

All patients received R-BAC between 2016 and 2018 at treatment centers in Italy and the United Kingdom. Treatment consisted of rituximab (375 mg/m² or 500 mg) on day 1, bendamustine 70 mg/m² on days 1 and 2, and cytarabine 500 mg/m² on days 1 through 3, given in a 28-day cycle.

Patients received R-BAC immediately after BTKi failure. Data were drawn from hospital records.

Analysis showed that the median patient age was 65 years, with a range from 43 to 79 years. Most patients were men (81.8%), 55.0% were high risk based on the Mantle Cell Lymphoma International Prognostic Index, and 22.7% had blastoid morphology.

Patients had a median of two prior systemic therapies, with a range from one to six lines. First-line therapies included rituximab in combination with HDAC (high-dose cytarabine containing regimen), CHOP, CVP, or ibrutinib. Nine patients (42.9%) had allogeneic stem cell transplantation (ASCT) after induction treatment.

For BTKi therapy, most patients received ibrutinib (n = 18), while the remainder received acalabrutinib, tirabrutinib or M7583. Most patients discontinued BTKi therapy because of disease progression (90.9%); two patients stopped because of a lack of response (9.1%).

The median number of R-BAC cycles received was four. Two patients started with attenuated doses and seven patients reduced doses after the first cycle. More than 70% of patients completed R-BAC treatment.

The estimated median progression-free survival was 7.3 months and estimated median overall survival was 11.2 months.

Although the investigators reported a complete response rate of 57.1%, they noted that this figure “may be exaggerated” because of a lack of bone marrow biopsy; however, they suggested that the overall response rate (90.5%) “should be accurate.”

During the course of treatment, 31.8% of patients required inpatient admission, 22.7% developed neutropenic fever, and 77.8% required transfusion support. No treatment-related deaths occurred.

“This population, enriched for patients with high risk features, showed remarkable response rates to R-BAC,” the investigators wrote. “The treatment had acceptable toxicity, maintained efficacy at attenuated doses, and was used successfully as a bridge to ASCT in over 20% of patients.”

The investigators suggested that R-BAC should be considered a new standard of care in the United Kingdom for bendamustine-naive patients who are unable to be enrolled in clinical trials. “The high response rate makes it particularly appealing for patients considered candidates for consolidation ASCT,” they wrote.

In an interview, Dr. Rule added perspective to these findings.

“There’s been an obsession with venetoclax, that that’s the answer, but it really isn’t,” Dr. Rule said. “So people are looking for a new drug. I guess what I do differently to most people is I use CHOP frontline rather than bendamustine. To me, that’s the best way of sequencing the therapies, whereas if you use [bendamustine and rituximab] up front, which a lot of people do, particularly in the [United] States, your R-BAC might not be so effective.”

However, Dr. Rule said that first-line therapies appear to have minimal impact on R-BAC efficacy. “Even if you’ve had bendamustine, even if you’ve had high-dose cytarabine, even if you’ve had an allogeneic stem cell transplant, [R-BAC] still works,” he said.

Where patients have issues with tolerability, Dr. Rule noted that dose reductions are possible without sacrificing efficacy.

He offered an example of such a scenario. “My oldest patient was about 80 with blastoid disease, relapsing,” Dr. Rule said. “After ibrutinib, I gave him just a single dose of bendamustine at 70 mg, a single dose of cytarabine at 500 mg, just 1 day, and he had that six times, probably 3 weeks apart. He’s been in complete remission for over a year.”

With data on 30 patients collected, Dr. Rule said that he and his colleagues plan to present more extensive findings at the European Hematology Association Congress, held June 13-16 in Amsterdam.

The investigators reported having no conflicts of interest.
 

Concerns about abatacept (Orencia)-related lung disease in patients with rheumatoid arthritis appear to be unfounded, a large U.S. database review has determined.

designer491/Thinkstock

Safety signals seen in a small subset of patients in the 2006 ASSURE study likely arose from chance, Samy Suissa, PhD, and his colleagues wrote in Seminars in Arthritis & Rheumatism. Patients in that study with preexisting chronic obstructive pulmonary disease (COPD) were 84% more likely to develop an exacerbation or other lung disorder than were those taking a placebo comparator.

The new database study contradicted that finding.

“Our study suggests that these numerical differences in ASSURE are expected results of random variation and thus compatible with chance,” Dr. Suissa of Jewish General Hospital and McGill University, both in Montreal, and his coauthors wrote. “Moreover, our findings are consistent with two studies of the safety of abatacept in the context of interstitial lung disease, albeit a different respiratory disease than COPD.”

The year-long ASSURE trial reported on the safety of abatacept in 959 patients versus 482 assigned to placebo. The safety signal arose in a subgroup of 54 patients with COPD, 37 of whom were assigned to abatacept and 17 to placebo. Among these were four serious respiratory adverse events (COPD exacerbation, worsening of COPD, bronchitis, and pneumonia) in four patients taking abatacept and none in the placebo arm.

“It is useful to note that this difference of 11% versus 0% rate is compatible with chance [exact P = .31], while the exact 95% confidence interval for the odds ratio is wide and includes unity ... The trial also reported more mild-moderate respiratory events with abatacept than with placebo [43.2% vs. 23.5%], including cough, rhonchi, COPD exacerbation, COPD, dyspnea, and nasal congestion. This difference resulted in an odds ration of 1.84,” with a wide confidence interval that included unity (0.48-8.63).

Nevertheless, these findings led to the addition of a warning in the prescribing insert: “Adult COPD patients treated with Orencia developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. Use of Orencia in patients with RA and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status.”

Dr. Suissa’s team used the U.S. MarketScan prescribing database to asses the risk of respiratory adverse events associated with abatacept, compared with other biologic disease-modifying antirheumatic drugs (DMARDs) in a real-world setting.

The cohort comprised 1,807 patients with rheumatoid arthritis and COPD who started a new prescription for abatacept, matched in time to 3,547 who initiated another biologic DMARD. The primary endpoint was the combined risk of hospitalization for COPD exacerbation, bronchitis, and hospitalized pneumonia or influenza.

The most common comparator biologic DMARDs were etanercept, adalimumab, rituximab, and infliximab.

For patients with COPD and comparator patients, the incidence rates for COPD exacerbation were 1.2 per 100 person-years with abatacept and 2.1 per 100 person-years with a different biologic DMARD; for bronchitis, the respective rates were 4.2 and 5.3; for hospitalized pneumonia or influenza, 3.6 and 2.6; and for outpatient pneumonia or flu, 14.7 and 14.4. For the combined endpoint, the incidence rate was 8.7 per 100 person-years with abatacept and 9.9 per 100 person-years with other biologic DMARDs.

The adjusted hazard ratio of the combined endpoint with abatacept versus that with other biologic DMARDs was a nonsignificant risk of 0.87. The hazard ratio with abatacept was 0.60 for hospitalized COPD; 0.80 for bronchitis; 1.39 for hospitalized pneumonia and flu; and 1.05 for outpatient pneumonia and flu. None of these associations was statistically significant.

“One exception was the risk of hospitalization for pneumonia or influenza, which was higher with abatacept among patients with more severe COPD,” at 6.99, than it was with other biologic DMARDs, the authors noted.

Dr. Suissa disclosed relationships with AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Novartis.

msullivan@mdedge.com

SOURCE: Suissa S et al. Semin Arthritis Rheum. 2019 Mar 16. doi: 10.1016j.semarthrit.2019.03.007.
 

Concerns about abatacept (Orencia)-related lung disease in patients with rheumatoid arthritis appear to be unfounded, a large U.S. database review has determined.

designer491/Thinkstock

Safety signals seen in a small subset of patients in the 2006 ASSURE study likely arose from chance, Samy Suissa, PhD, and his colleagues wrote in Seminars in Arthritis & Rheumatism. Patients in that study with preexisting chronic obstructive pulmonary disease (COPD) were 84% more likely to develop an exacerbation or other lung disorder than were those taking a placebo comparator.

The new database study contradicted that finding.

“Our study suggests that these numerical differences in ASSURE are expected results of random variation and thus compatible with chance,” Dr. Suissa of Jewish General Hospital and McGill University, both in Montreal, and his coauthors wrote. “Moreover, our findings are consistent with two studies of the safety of abatacept in the context of interstitial lung disease, albeit a different respiratory disease than COPD.”

The year-long ASSURE trial reported on the safety of abatacept in 959 patients versus 482 assigned to placebo. The safety signal arose in a subgroup of 54 patients with COPD, 37 of whom were assigned to abatacept and 17 to placebo. Among these were four serious respiratory adverse events (COPD exacerbation, worsening of COPD, bronchitis, and pneumonia) in four patients taking abatacept and none in the placebo arm.

“It is useful to note that this difference of 11% versus 0% rate is compatible with chance [exact P = .31], while the exact 95% confidence interval for the odds ratio is wide and includes unity ... The trial also reported more mild-moderate respiratory events with abatacept than with placebo [43.2% vs. 23.5%], including cough, rhonchi, COPD exacerbation, COPD, dyspnea, and nasal congestion. This difference resulted in an odds ration of 1.84,” with a wide confidence interval that included unity (0.48-8.63).

Nevertheless, these findings led to the addition of a warning in the prescribing insert: “Adult COPD patients treated with Orencia developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. Use of Orencia in patients with RA and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status.”

Dr. Suissa’s team used the U.S. MarketScan prescribing database to asses the risk of respiratory adverse events associated with abatacept, compared with other biologic disease-modifying antirheumatic drugs (DMARDs) in a real-world setting.

The cohort comprised 1,807 patients with rheumatoid arthritis and COPD who started a new prescription for abatacept, matched in time to 3,547 who initiated another biologic DMARD. The primary endpoint was the combined risk of hospitalization for COPD exacerbation, bronchitis, and hospitalized pneumonia or influenza.

The most common comparator biologic DMARDs were etanercept, adalimumab, rituximab, and infliximab.

For patients with COPD and comparator patients, the incidence rates for COPD exacerbation were 1.2 per 100 person-years with abatacept and 2.1 per 100 person-years with a different biologic DMARD; for bronchitis, the respective rates were 4.2 and 5.3; for hospitalized pneumonia or influenza, 3.6 and 2.6; and for outpatient pneumonia or flu, 14.7 and 14.4. For the combined endpoint, the incidence rate was 8.7 per 100 person-years with abatacept and 9.9 per 100 person-years with other biologic DMARDs.

The adjusted hazard ratio of the combined endpoint with abatacept versus that with other biologic DMARDs was a nonsignificant risk of 0.87. The hazard ratio with abatacept was 0.60 for hospitalized COPD; 0.80 for bronchitis; 1.39 for hospitalized pneumonia and flu; and 1.05 for outpatient pneumonia and flu. None of these associations was statistically significant.

“One exception was the risk of hospitalization for pneumonia or influenza, which was higher with abatacept among patients with more severe COPD,” at 6.99, than it was with other biologic DMARDs, the authors noted.

Dr. Suissa disclosed relationships with AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Novartis.

msullivan@mdedge.com

SOURCE: Suissa S et al. Semin Arthritis Rheum. 2019 Mar 16. doi: 10.1016j.semarthrit.2019.03.007.
 

Concerns about abatacept (Orencia)-related lung disease in patients with rheumatoid arthritis appear to be unfounded, a large U.S. database review has determined.

designer491/Thinkstock

Safety signals seen in a small subset of patients in the 2006 ASSURE study likely arose from chance, Samy Suissa, PhD, and his colleagues wrote in Seminars in Arthritis & Rheumatism. Patients in that study with preexisting chronic obstructive pulmonary disease (COPD) were 84% more likely to develop an exacerbation or other lung disorder than were those taking a placebo comparator.

The new database study contradicted that finding.

“Our study suggests that these numerical differences in ASSURE are expected results of random variation and thus compatible with chance,” Dr. Suissa of Jewish General Hospital and McGill University, both in Montreal, and his coauthors wrote. “Moreover, our findings are consistent with two studies of the safety of abatacept in the context of interstitial lung disease, albeit a different respiratory disease than COPD.”

The year-long ASSURE trial reported on the safety of abatacept in 959 patients versus 482 assigned to placebo. The safety signal arose in a subgroup of 54 patients with COPD, 37 of whom were assigned to abatacept and 17 to placebo. Among these were four serious respiratory adverse events (COPD exacerbation, worsening of COPD, bronchitis, and pneumonia) in four patients taking abatacept and none in the placebo arm.

“It is useful to note that this difference of 11% versus 0% rate is compatible with chance [exact P = .31], while the exact 95% confidence interval for the odds ratio is wide and includes unity ... The trial also reported more mild-moderate respiratory events with abatacept than with placebo [43.2% vs. 23.5%], including cough, rhonchi, COPD exacerbation, COPD, dyspnea, and nasal congestion. This difference resulted in an odds ration of 1.84,” with a wide confidence interval that included unity (0.48-8.63).

Nevertheless, these findings led to the addition of a warning in the prescribing insert: “Adult COPD patients treated with Orencia developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. Use of Orencia in patients with RA and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status.”

Dr. Suissa’s team used the U.S. MarketScan prescribing database to asses the risk of respiratory adverse events associated with abatacept, compared with other biologic disease-modifying antirheumatic drugs (DMARDs) in a real-world setting.

The cohort comprised 1,807 patients with rheumatoid arthritis and COPD who started a new prescription for abatacept, matched in time to 3,547 who initiated another biologic DMARD. The primary endpoint was the combined risk of hospitalization for COPD exacerbation, bronchitis, and hospitalized pneumonia or influenza.

The most common comparator biologic DMARDs were etanercept, adalimumab, rituximab, and infliximab.

For patients with COPD and comparator patients, the incidence rates for COPD exacerbation were 1.2 per 100 person-years with abatacept and 2.1 per 100 person-years with a different biologic DMARD; for bronchitis, the respective rates were 4.2 and 5.3; for hospitalized pneumonia or influenza, 3.6 and 2.6; and for outpatient pneumonia or flu, 14.7 and 14.4. For the combined endpoint, the incidence rate was 8.7 per 100 person-years with abatacept and 9.9 per 100 person-years with other biologic DMARDs.

The adjusted hazard ratio of the combined endpoint with abatacept versus that with other biologic DMARDs was a nonsignificant risk of 0.87. The hazard ratio with abatacept was 0.60 for hospitalized COPD; 0.80 for bronchitis; 1.39 for hospitalized pneumonia and flu; and 1.05 for outpatient pneumonia and flu. None of these associations was statistically significant.

“One exception was the risk of hospitalization for pneumonia or influenza, which was higher with abatacept among patients with more severe COPD,” at 6.99, than it was with other biologic DMARDs, the authors noted.

Dr. Suissa disclosed relationships with AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Novartis.

msullivan@mdedge.com

SOURCE: Suissa S et al. Semin Arthritis Rheum. 2019 Mar 16. doi: 10.1016j.semarthrit.2019.03.007.
 

The American College of Rheumatology has issued a series of policy recommendations aimed at improving access to pharmaceuticals. The position statements cover two broad topics: drug pricing and step therapy.

“We continue to emphasize these topics because they are so critical to the well-being of millions of Americans living with rheumatic diseases, some of which can be quite debilitating and even lead to death,” Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the ACR’s Committee on Rheumatologic Care, said in a statement. “The need for patients to have access to prompt, affordable, and medically necessary treatments is ongoing and should be considered at every step of the policy making process.”

The position statement on drug pricing calls for transparency in the policies used by pharmaceutical manufacturers, pharmacy benefit managers, and health insurance companies that determine drug prices.

To illustrate the need for transparency, the ACR pointed to the cost of adalimumab (Humira), a biologic medication that is used to treat a number of rheumatologic and other inflammatory conditions, which has seen its list price increase more than 100% during the past 5 years.


“The yearly price hike has dramatically outpaced inflation despite the lack of clinically significant modifications to the medication or major changes in the production process. The overall process of pricing and contracting is hidden from public view, such that the exact nature and profit margin taken by those involved is not disclosed to the largest stakeholder in the process, the patient,” the ACR stated.

The statement also calls for continued work on a safe and efficient biosimilar approval pathway and marketplace, which it says will help to improve access to drugs through lower costs.

“Any comprehensive proposal to deal with rising drug prices must simultaneously address these primary concerns: cost to the health care system, continuity of care, and out-of-pocket affordability to patients,” the position statement on drug pricing noted, adding that the organization “supports rational policies that mitigate rapid escalations in pricing of rheumatologic drugs.”

Kenishirotie/Thinkstock

The position statement on step therapy notes that the ACR “does not support step therapy, fail-first policies, or tiering of medications based solely on cost,” and that access to drugs “should be timely and not impeded or delayed by unnecessary barriers.”

The organization noted that unregulated step therapy policies for targeted immune modulating agents (TIMs) “have hijacked the otherwise thoughtful and highly complex process that patients and their providers navigate when choosing appropriate therapy. While TIMs within a class may have similar effectiveness in large populations, responses by individual patients vary dramatically.”

The ACR called for transparency in the formulary decision-making process and for pharmacy review committees to include rheumatologists to help to develop formularies.

“The ACR welcomes the opportunity to provide expertise regarding rheumatic therapies to insurers,” the position statement said.

The organization also called for an end to nonmedical switching.

“Nonmedical switching between branded products and across therapeutic classes in a medically stable patient solely for cost savings and without the consent of the patient and his/her provider is inappropriate and potentially harmful to patients’ health,” the ACR said.

It expanded upon this position, noting that nonmedical switching occurs frequently and results in “adverse effects on treatment. In these situations, patients may unexpectedly be subjected to new step therapy requirements, forcing them to switch from their current medication to whatever agent is ‘preferred.’ ”

The ACR said the appeals process can take between 4 and 8 weeks and can be labor intensive, all the while putting the patient at harm for disease progression and physical damage.

gtwachtman@mdedge.com

The American College of Rheumatology has issued a series of policy recommendations aimed at improving access to pharmaceuticals. The position statements cover two broad topics: drug pricing and step therapy.

“We continue to emphasize these topics because they are so critical to the well-being of millions of Americans living with rheumatic diseases, some of which can be quite debilitating and even lead to death,” Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the ACR’s Committee on Rheumatologic Care, said in a statement. “The need for patients to have access to prompt, affordable, and medically necessary treatments is ongoing and should be considered at every step of the policy making process.”

The position statement on drug pricing calls for transparency in the policies used by pharmaceutical manufacturers, pharmacy benefit managers, and health insurance companies that determine drug prices.

To illustrate the need for transparency, the ACR pointed to the cost of adalimumab (Humira), a biologic medication that is used to treat a number of rheumatologic and other inflammatory conditions, which has seen its list price increase more than 100% during the past 5 years.


“The yearly price hike has dramatically outpaced inflation despite the lack of clinically significant modifications to the medication or major changes in the production process. The overall process of pricing and contracting is hidden from public view, such that the exact nature and profit margin taken by those involved is not disclosed to the largest stakeholder in the process, the patient,” the ACR stated.

The statement also calls for continued work on a safe and efficient biosimilar approval pathway and marketplace, which it says will help to improve access to drugs through lower costs.

“Any comprehensive proposal to deal with rising drug prices must simultaneously address these primary concerns: cost to the health care system, continuity of care, and out-of-pocket affordability to patients,” the position statement on drug pricing noted, adding that the organization “supports rational policies that mitigate rapid escalations in pricing of rheumatologic drugs.”

Kenishirotie/Thinkstock

The position statement on step therapy notes that the ACR “does not support step therapy, fail-first policies, or tiering of medications based solely on cost,” and that access to drugs “should be timely and not impeded or delayed by unnecessary barriers.”

The organization noted that unregulated step therapy policies for targeted immune modulating agents (TIMs) “have hijacked the otherwise thoughtful and highly complex process that patients and their providers navigate when choosing appropriate therapy. While TIMs within a class may have similar effectiveness in large populations, responses by individual patients vary dramatically.”

The ACR called for transparency in the formulary decision-making process and for pharmacy review committees to include rheumatologists to help to develop formularies.

“The ACR welcomes the opportunity to provide expertise regarding rheumatic therapies to insurers,” the position statement said.

The organization also called for an end to nonmedical switching.

“Nonmedical switching between branded products and across therapeutic classes in a medically stable patient solely for cost savings and without the consent of the patient and his/her provider is inappropriate and potentially harmful to patients’ health,” the ACR said.

It expanded upon this position, noting that nonmedical switching occurs frequently and results in “adverse effects on treatment. In these situations, patients may unexpectedly be subjected to new step therapy requirements, forcing them to switch from their current medication to whatever agent is ‘preferred.’ ”

The ACR said the appeals process can take between 4 and 8 weeks and can be labor intensive, all the while putting the patient at harm for disease progression and physical damage.

gtwachtman@mdedge.com

The American College of Rheumatology has issued a series of policy recommendations aimed at improving access to pharmaceuticals. The position statements cover two broad topics: drug pricing and step therapy.

“We continue to emphasize these topics because they are so critical to the well-being of millions of Americans living with rheumatic diseases, some of which can be quite debilitating and even lead to death,” Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the ACR’s Committee on Rheumatologic Care, said in a statement. “The need for patients to have access to prompt, affordable, and medically necessary treatments is ongoing and should be considered at every step of the policy making process.”

The position statement on drug pricing calls for transparency in the policies used by pharmaceutical manufacturers, pharmacy benefit managers, and health insurance companies that determine drug prices.

To illustrate the need for transparency, the ACR pointed to the cost of adalimumab (Humira), a biologic medication that is used to treat a number of rheumatologic and other inflammatory conditions, which has seen its list price increase more than 100% during the past 5 years.


“The yearly price hike has dramatically outpaced inflation despite the lack of clinically significant modifications to the medication or major changes in the production process. The overall process of pricing and contracting is hidden from public view, such that the exact nature and profit margin taken by those involved is not disclosed to the largest stakeholder in the process, the patient,” the ACR stated.

The statement also calls for continued work on a safe and efficient biosimilar approval pathway and marketplace, which it says will help to improve access to drugs through lower costs.

“Any comprehensive proposal to deal with rising drug prices must simultaneously address these primary concerns: cost to the health care system, continuity of care, and out-of-pocket affordability to patients,” the position statement on drug pricing noted, adding that the organization “supports rational policies that mitigate rapid escalations in pricing of rheumatologic drugs.”

Kenishirotie/Thinkstock

The position statement on step therapy notes that the ACR “does not support step therapy, fail-first policies, or tiering of medications based solely on cost,” and that access to drugs “should be timely and not impeded or delayed by unnecessary barriers.”

The organization noted that unregulated step therapy policies for targeted immune modulating agents (TIMs) “have hijacked the otherwise thoughtful and highly complex process that patients and their providers navigate when choosing appropriate therapy. While TIMs within a class may have similar effectiveness in large populations, responses by individual patients vary dramatically.”

The ACR called for transparency in the formulary decision-making process and for pharmacy review committees to include rheumatologists to help to develop formularies.

“The ACR welcomes the opportunity to provide expertise regarding rheumatic therapies to insurers,” the position statement said.

The organization also called for an end to nonmedical switching.

“Nonmedical switching between branded products and across therapeutic classes in a medically stable patient solely for cost savings and without the consent of the patient and his/her provider is inappropriate and potentially harmful to patients’ health,” the ACR said.

It expanded upon this position, noting that nonmedical switching occurs frequently and results in “adverse effects on treatment. In these situations, patients may unexpectedly be subjected to new step therapy requirements, forcing them to switch from their current medication to whatever agent is ‘preferred.’ ”

The ACR said the appeals process can take between 4 and 8 weeks and can be labor intensive, all the while putting the patient at harm for disease progression and physical damage.

gtwachtman@mdedge.com

Clinical question: Are the same doses of aspirin equally effective in preventing cardiovascular (CV) events and long-term colorectal risk reduction in patients of various body sizes?

Background: Strong evidence for the one-dose-fits-all approach to use of aspirin in long-term prevention of CV events is lacking. Aspirin effect may be dependent on patient’s body size. Excess dosing of aspirin in patients of small body size might negatively affect their outcomes.

Study design: Meta-analysis.

Setting: Trials from the Antithrombotic Trialists’ Collaboration, other systematic reviews of trials of aspirin, and from the Cochrane Database of Systematic Reviews.

Synopsis: The authors included 10 trials (117,279 participants altogether) and analyzed the association of body weight with the effectiveness of aspirin doses on CV event and colon cancer prevention. The greatest benefit of low-dose aspirin (75-100 mg) in reducing CV events was seen in patients weighing 50-69 kg (hazard ratio, 0.75; 95% confidence interval, 0.65-0.85; P less than .0001), with CV events increasing with increasing weights (P interaction = .0072). There was an increased rate of fatality with low-dose aspirin among patients at body weights greater than 70 kg (HR, 1.33; 95% CI, 1.08-1.64; P = .0082) or less than 50 kg (HR, 1.52; 95% CI, 1.04-2.21; P = .031). Higher doses of aspirin were more effective at higher body weights (P interaction = .017). Similar weight-dependent effects were seen in the 20-year risk of colorectal cancer.

While findings are consistent across trials looking at dose-dependent aspirin effects in patients of various body sizes, limitations included lack of generalizability of the results in secondary prevention trials, inclusion of older trials, variability of participants’ characteristics, and aspirin compliance across trials.

Bottom line: Weight-based aspirin dosing may be required for prevention of CV events, sudden cardiac death, and cancer. Based on the results of this meta-analysis, one-dose-fits-all aspirin administration strategy may not be advisable.

Citation: Rothwell PM et al. Effects of aspirin on risks of vascular events and cancer according to body weight and dose: Analysis of individual patient data from randomized trials. Lancet. 2018;392:387-99.
 

Dr. Burklin is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Are the same doses of aspirin equally effective in preventing cardiovascular (CV) events and long-term colorectal risk reduction in patients of various body sizes?

Background: Strong evidence for the one-dose-fits-all approach to use of aspirin in long-term prevention of CV events is lacking. Aspirin effect may be dependent on patient’s body size. Excess dosing of aspirin in patients of small body size might negatively affect their outcomes.

Study design: Meta-analysis.

Setting: Trials from the Antithrombotic Trialists’ Collaboration, other systematic reviews of trials of aspirin, and from the Cochrane Database of Systematic Reviews.

Synopsis: The authors included 10 trials (117,279 participants altogether) and analyzed the association of body weight with the effectiveness of aspirin doses on CV event and colon cancer prevention. The greatest benefit of low-dose aspirin (75-100 mg) in reducing CV events was seen in patients weighing 50-69 kg (hazard ratio, 0.75; 95% confidence interval, 0.65-0.85; P less than .0001), with CV events increasing with increasing weights (P interaction = .0072). There was an increased rate of fatality with low-dose aspirin among patients at body weights greater than 70 kg (HR, 1.33; 95% CI, 1.08-1.64; P = .0082) or less than 50 kg (HR, 1.52; 95% CI, 1.04-2.21; P = .031). Higher doses of aspirin were more effective at higher body weights (P interaction = .017). Similar weight-dependent effects were seen in the 20-year risk of colorectal cancer.

While findings are consistent across trials looking at dose-dependent aspirin effects in patients of various body sizes, limitations included lack of generalizability of the results in secondary prevention trials, inclusion of older trials, variability of participants’ characteristics, and aspirin compliance across trials.

Bottom line: Weight-based aspirin dosing may be required for prevention of CV events, sudden cardiac death, and cancer. Based on the results of this meta-analysis, one-dose-fits-all aspirin administration strategy may not be advisable.

Citation: Rothwell PM et al. Effects of aspirin on risks of vascular events and cancer according to body weight and dose: Analysis of individual patient data from randomized trials. Lancet. 2018;392:387-99.
 

Dr. Burklin is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Clinical question: Are the same doses of aspirin equally effective in preventing cardiovascular (CV) events and long-term colorectal risk reduction in patients of various body sizes?

Background: Strong evidence for the one-dose-fits-all approach to use of aspirin in long-term prevention of CV events is lacking. Aspirin effect may be dependent on patient’s body size. Excess dosing of aspirin in patients of small body size might negatively affect their outcomes.

Study design: Meta-analysis.

Setting: Trials from the Antithrombotic Trialists’ Collaboration, other systematic reviews of trials of aspirin, and from the Cochrane Database of Systematic Reviews.

Synopsis: The authors included 10 trials (117,279 participants altogether) and analyzed the association of body weight with the effectiveness of aspirin doses on CV event and colon cancer prevention. The greatest benefit of low-dose aspirin (75-100 mg) in reducing CV events was seen in patients weighing 50-69 kg (hazard ratio, 0.75; 95% confidence interval, 0.65-0.85; P less than .0001), with CV events increasing with increasing weights (P interaction = .0072). There was an increased rate of fatality with low-dose aspirin among patients at body weights greater than 70 kg (HR, 1.33; 95% CI, 1.08-1.64; P = .0082) or less than 50 kg (HR, 1.52; 95% CI, 1.04-2.21; P = .031). Higher doses of aspirin were more effective at higher body weights (P interaction = .017). Similar weight-dependent effects were seen in the 20-year risk of colorectal cancer.

While findings are consistent across trials looking at dose-dependent aspirin effects in patients of various body sizes, limitations included lack of generalizability of the results in secondary prevention trials, inclusion of older trials, variability of participants’ characteristics, and aspirin compliance across trials.

Bottom line: Weight-based aspirin dosing may be required for prevention of CV events, sudden cardiac death, and cancer. Based on the results of this meta-analysis, one-dose-fits-all aspirin administration strategy may not be advisable.

Citation: Rothwell PM et al. Effects of aspirin on risks of vascular events and cancer according to body weight and dose: Analysis of individual patient data from randomized trials. Lancet. 2018;392:387-99.
 

Dr. Burklin is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.