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ORLANDO – , and could be approved for the indication soon.
With approval pending, “rituximab is quickly emerging as frontline therapy” for pemphigus, so “we should begin to prepare to answer our patients’ questions. It’s likely they will be interested in its use,” said Carolyn Kushner, a medical student and dermatology research fellow at the University of Pennsylvania, Philadelphia. Rituximab manufacturer Genentech announced the priority review for this indication in a Feb. 2018 press release.
“We get a lot of questions in the clinic,” she said at the International Investigative Dermatology meeting. Patients with pemphigus want to know how well rituximab will work, and if they’ll be able to go off other medications. They wonder if it’s safe, and when they’ll need to be retreated. The goal of the study was to provide information for both clinicians and patients regarding what to expect from the treatment.
Overall, 54 patients (48%) achieved a complete response off therapy (CROT) after their first treatment cycle, meaning they had no new lesions for at least 2 months off of all systemic and topical treatments. The median time to a complete response was 7.4 months, and the median time to relapse was 20.9 months after the first infusion. An additional 15 patients (13%) had a complete remission with minimal therapy after one cycle.
In short, “61% of patients achieved complete healing of their skin after one cycle,” Ms. Kushner said. The number rose to 82% (93 patients) when those who had more than one cycle were included. The maximum in the study was seven. Among all patients, the median time from the first to second rituximab dose was 25.1 months.
When age, sex, and disease duration were controlled for, patients who received lymphoma dosing – 375 mg/m2 weekly for 4 weeks – were 2.7 times more likely to achieve CROT than those on the rheumatoid arthritis dosing, two 1,000 mg IV infusions 2 weeks apart (P = .037). “We almost never use RA dosing now,” she said.
The odds of success also increased with age, with patients 45 years and older 3.5 to almost 7 times more likely to achieve CROT than younger patients, also a statistically significant finding.
There were four serious adverse events across 155 cycles of the lymphoma regimen, and one with 90 cycles of arthritis dosing, all infectious and none fatal. Ms. Kushner cautioned the true rate was probably higher, since their review data might have missed some cases.
Race, sex, and disease duration had no significant effect on response rates. About 60% of the patients were women.
Rituximab, approved in 1997, is a CD20-directed cytolytic antibody.
There was no industry funding for the work, and Ms. Kushner didn’t have any disclosures.
SOURCE: Kushner CJ et al. IID 2018, Abstract 552.
ORLANDO – , and could be approved for the indication soon.
With approval pending, “rituximab is quickly emerging as frontline therapy” for pemphigus, so “we should begin to prepare to answer our patients’ questions. It’s likely they will be interested in its use,” said Carolyn Kushner, a medical student and dermatology research fellow at the University of Pennsylvania, Philadelphia. Rituximab manufacturer Genentech announced the priority review for this indication in a Feb. 2018 press release.
“We get a lot of questions in the clinic,” she said at the International Investigative Dermatology meeting. Patients with pemphigus want to know how well rituximab will work, and if they’ll be able to go off other medications. They wonder if it’s safe, and when they’ll need to be retreated. The goal of the study was to provide information for both clinicians and patients regarding what to expect from the treatment.
Overall, 54 patients (48%) achieved a complete response off therapy (CROT) after their first treatment cycle, meaning they had no new lesions for at least 2 months off of all systemic and topical treatments. The median time to a complete response was 7.4 months, and the median time to relapse was 20.9 months after the first infusion. An additional 15 patients (13%) had a complete remission with minimal therapy after one cycle.
In short, “61% of patients achieved complete healing of their skin after one cycle,” Ms. Kushner said. The number rose to 82% (93 patients) when those who had more than one cycle were included. The maximum in the study was seven. Among all patients, the median time from the first to second rituximab dose was 25.1 months.
When age, sex, and disease duration were controlled for, patients who received lymphoma dosing – 375 mg/m2 weekly for 4 weeks – were 2.7 times more likely to achieve CROT than those on the rheumatoid arthritis dosing, two 1,000 mg IV infusions 2 weeks apart (P = .037). “We almost never use RA dosing now,” she said.
The odds of success also increased with age, with patients 45 years and older 3.5 to almost 7 times more likely to achieve CROT than younger patients, also a statistically significant finding.
There were four serious adverse events across 155 cycles of the lymphoma regimen, and one with 90 cycles of arthritis dosing, all infectious and none fatal. Ms. Kushner cautioned the true rate was probably higher, since their review data might have missed some cases.
Race, sex, and disease duration had no significant effect on response rates. About 60% of the patients were women.
Rituximab, approved in 1997, is a CD20-directed cytolytic antibody.
There was no industry funding for the work, and Ms. Kushner didn’t have any disclosures.
SOURCE: Kushner CJ et al. IID 2018, Abstract 552.
ORLANDO – , and could be approved for the indication soon.
With approval pending, “rituximab is quickly emerging as frontline therapy” for pemphigus, so “we should begin to prepare to answer our patients’ questions. It’s likely they will be interested in its use,” said Carolyn Kushner, a medical student and dermatology research fellow at the University of Pennsylvania, Philadelphia. Rituximab manufacturer Genentech announced the priority review for this indication in a Feb. 2018 press release.
“We get a lot of questions in the clinic,” she said at the International Investigative Dermatology meeting. Patients with pemphigus want to know how well rituximab will work, and if they’ll be able to go off other medications. They wonder if it’s safe, and when they’ll need to be retreated. The goal of the study was to provide information for both clinicians and patients regarding what to expect from the treatment.
Overall, 54 patients (48%) achieved a complete response off therapy (CROT) after their first treatment cycle, meaning they had no new lesions for at least 2 months off of all systemic and topical treatments. The median time to a complete response was 7.4 months, and the median time to relapse was 20.9 months after the first infusion. An additional 15 patients (13%) had a complete remission with minimal therapy after one cycle.
In short, “61% of patients achieved complete healing of their skin after one cycle,” Ms. Kushner said. The number rose to 82% (93 patients) when those who had more than one cycle were included. The maximum in the study was seven. Among all patients, the median time from the first to second rituximab dose was 25.1 months.
When age, sex, and disease duration were controlled for, patients who received lymphoma dosing – 375 mg/m2 weekly for 4 weeks – were 2.7 times more likely to achieve CROT than those on the rheumatoid arthritis dosing, two 1,000 mg IV infusions 2 weeks apart (P = .037). “We almost never use RA dosing now,” she said.
The odds of success also increased with age, with patients 45 years and older 3.5 to almost 7 times more likely to achieve CROT than younger patients, also a statistically significant finding.
There were four serious adverse events across 155 cycles of the lymphoma regimen, and one with 90 cycles of arthritis dosing, all infectious and none fatal. Ms. Kushner cautioned the true rate was probably higher, since their review data might have missed some cases.
Race, sex, and disease duration had no significant effect on response rates. About 60% of the patients were women.
Rituximab, approved in 1997, is a CD20-directed cytolytic antibody.
There was no industry funding for the work, and Ms. Kushner didn’t have any disclosures.
SOURCE: Kushner CJ et al. IID 2018, Abstract 552.
REPORTING FROM IID 2018
Key clinical point: Rituximab puts the majority of pemphigus patients in remission, with a median time between doses of about 2 years.
Major finding: Sixty-one percent of patients achieved complete healing of their skin after one cycle, increasing to 82% when those who had more than one cycle were included.
Study details: A single-center review of 113 patients
Disclosures: There was no industry funding, and the lead investigator had no disclosures.
Source: Kushner CJ et al. IID 2018, Abstract 552.