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Low infliximab start dose appears effective in psoriatic arthritis
Median starting doses of infliximab in psoriatic arthritis patients in two nationwide registries were below the recommended dose of 5 mg/kg every 8 weeks, but outcomes suggest that a low starting dose with subsequent step-up is an effective treatment strategy, according to an observational cohort study based on the registries.
In 376 Danish patients in the Danish Rheumatologic Database (DANBIO) registry and 86 Icelandic patients in the Center for Rheumatology Research (ICEBIO) registry, starting infliximab doses were less than 3 mg/kg in 29% and 74%, respectively, 3-5 mg/kg in 42% and 27%, respectively, and greater than 5 mg/kg in 10% and 0%, respectively (starting doses in the remaining patients were not registered). In those cohorts, median starting doses were 3.1 mg/kg and 2.3 mg/kg, respectively, Dr. Bente Glintborg of the Copenhagen Center for Arthritis Research and Glostrup (Denmark) Hospital and her colleagues reported (Rheumatology 2014 June 17 [doi:10.1093/rheumatology/keu252]).
Treatment was maintained after 12 months in 58% and 66% of the Danish and Icelandic patients, respectively (and was highest in those taking concomitant methotrexate). At 12 months, the median doses were 3.3 and 2.9 mg/kg, respectively, and time until dose escalation, response rates, drug survival, and disease activity at 12 months did not differ based on starting dose. Dosing was sustained at below the recommended level in more than 70% of the patients, the investigators found.
Recommended starting doses of infliximab are higher for psoriatic arthritis than for rheumatoid arthritis (5 mg/kg vs. 3 mg/kg) based on randomized trial data, but data on the effectiveness of lower doses are lacking. The current findings suggest that the approach often used in RA – a lower starting dose with gradual escalation – is also effective in psoriatic arthritis, they concluded.
Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.
Median starting doses of infliximab in psoriatic arthritis patients in two nationwide registries were below the recommended dose of 5 mg/kg every 8 weeks, but outcomes suggest that a low starting dose with subsequent step-up is an effective treatment strategy, according to an observational cohort study based on the registries.
In 376 Danish patients in the Danish Rheumatologic Database (DANBIO) registry and 86 Icelandic patients in the Center for Rheumatology Research (ICEBIO) registry, starting infliximab doses were less than 3 mg/kg in 29% and 74%, respectively, 3-5 mg/kg in 42% and 27%, respectively, and greater than 5 mg/kg in 10% and 0%, respectively (starting doses in the remaining patients were not registered). In those cohorts, median starting doses were 3.1 mg/kg and 2.3 mg/kg, respectively, Dr. Bente Glintborg of the Copenhagen Center for Arthritis Research and Glostrup (Denmark) Hospital and her colleagues reported (Rheumatology 2014 June 17 [doi:10.1093/rheumatology/keu252]).
Treatment was maintained after 12 months in 58% and 66% of the Danish and Icelandic patients, respectively (and was highest in those taking concomitant methotrexate). At 12 months, the median doses were 3.3 and 2.9 mg/kg, respectively, and time until dose escalation, response rates, drug survival, and disease activity at 12 months did not differ based on starting dose. Dosing was sustained at below the recommended level in more than 70% of the patients, the investigators found.
Recommended starting doses of infliximab are higher for psoriatic arthritis than for rheumatoid arthritis (5 mg/kg vs. 3 mg/kg) based on randomized trial data, but data on the effectiveness of lower doses are lacking. The current findings suggest that the approach often used in RA – a lower starting dose with gradual escalation – is also effective in psoriatic arthritis, they concluded.
Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.
Median starting doses of infliximab in psoriatic arthritis patients in two nationwide registries were below the recommended dose of 5 mg/kg every 8 weeks, but outcomes suggest that a low starting dose with subsequent step-up is an effective treatment strategy, according to an observational cohort study based on the registries.
In 376 Danish patients in the Danish Rheumatologic Database (DANBIO) registry and 86 Icelandic patients in the Center for Rheumatology Research (ICEBIO) registry, starting infliximab doses were less than 3 mg/kg in 29% and 74%, respectively, 3-5 mg/kg in 42% and 27%, respectively, and greater than 5 mg/kg in 10% and 0%, respectively (starting doses in the remaining patients were not registered). In those cohorts, median starting doses were 3.1 mg/kg and 2.3 mg/kg, respectively, Dr. Bente Glintborg of the Copenhagen Center for Arthritis Research and Glostrup (Denmark) Hospital and her colleagues reported (Rheumatology 2014 June 17 [doi:10.1093/rheumatology/keu252]).
Treatment was maintained after 12 months in 58% and 66% of the Danish and Icelandic patients, respectively (and was highest in those taking concomitant methotrexate). At 12 months, the median doses were 3.3 and 2.9 mg/kg, respectively, and time until dose escalation, response rates, drug survival, and disease activity at 12 months did not differ based on starting dose. Dosing was sustained at below the recommended level in more than 70% of the patients, the investigators found.
Recommended starting doses of infliximab are higher for psoriatic arthritis than for rheumatoid arthritis (5 mg/kg vs. 3 mg/kg) based on randomized trial data, but data on the effectiveness of lower doses are lacking. The current findings suggest that the approach often used in RA – a lower starting dose with gradual escalation – is also effective in psoriatic arthritis, they concluded.
Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.
FROM RHEUMATOLOGY
Key clinical point: Most patients with psoriatic arthritis fare well on a lower than recommended starting dose.
Major finding: Median starting doses were 3.1 and 2.3 mg/kg every 8 weeks in the Danish and Icelandic patients, respectively.
Data source: An observational cohort study of 462 psoriatic arthritis patients.
Disclosures: Dr. Glintborg reported having no disclosures. Other study authors reported receiving research grants, serving on a speakers’ bureau, providing consultancy, or serving as an adviser or investigator to a variety of manufacturers of biologic drugs.
TNF-alpha antagonists did not increase cancer risk in IBD
The tumor necrosis factor–alpha antagonists infliximab, adalimumab, and certolizumab did not raise the risk of cancer in a nationwide Danish cohort study of patients with inflammatory bowel disease who were followed for approximately 10 years, according to a report published online June 17 in JAMA.
At present, the effectiveness of these agents in inflammatory bowel disease (IBD) must be weighed against their potential adverse effects, which include immunosuppression that is suspected to increase the risk of cancer. But few studies have examined this risk, and those that have done so have had short (less than 1 year) exposure and follow-up times, said Dr. Nynne Nyboe Andersen of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.
They assessed the risks of any cancer and of 11 individual cancers in 56,146 IBD patients aged 15 and older living in Denmark in 1999-2012, of whom 4,553 took TNF-alpha antagonists. Median follow-up was 9.3 years, and median duration of therapy with TNF-alpha antagonists was 3.7 years. The two study groups were propensity matched for year of birth, sex, socioeconomic status, comorbidities, use of other medications, subtype of IBD, and history of gastrointestinal or anal fistula, abscess, fissure, or surgery.
A total of 6.7% of the patients who never took TNF-alpha antagonists developed cancer during follow-up, compared with 1.8% of patients who took the drugs, indicating no increase in cancer risk associated with TNF-alpha antagonists. Further analyses of the data found no association between use of these agents and the risk of overall cancer, regardless of the patient’s sex, age, the duration of therapy, or the cumulative dose, and sensitivity analyses confirmed these results, the investigators said (JAMA 2014 June 17 [doi:10.1001/jama.2014.5613]).
There also was no association between use of TNF-alpha antagonists and any individual cancer. "However, it should be noted that because of the relatively small sample size and the small number of cancer cases in our study, statistical power was limited in subgroup analyses of site-specific cancers," Dr. Andersen and her associates said.
"Stratifying for cancer risk according to years since first exposure, no specific time-dependent pattern was observed in our study. However, considering the often protracted progression of cancer, an increased risk in the long term cannot be excluded, and future studies with longer follow-up are needed," they added.
The Lundbeck Foundation, Danish Cancer Society, Crohn’s and Colitis Association of Denmark, and Danish Council of Independent Research supported the study. Dr. Andersen reported receiving funding from Merck Sharp & Dohme; her associates reported ties to Merck Sharp & Dohme, Tillotts, Calpro, Ferring, and AbbVie.
The tumor necrosis factor–alpha antagonists infliximab, adalimumab, and certolizumab did not raise the risk of cancer in a nationwide Danish cohort study of patients with inflammatory bowel disease who were followed for approximately 10 years, according to a report published online June 17 in JAMA.
At present, the effectiveness of these agents in inflammatory bowel disease (IBD) must be weighed against their potential adverse effects, which include immunosuppression that is suspected to increase the risk of cancer. But few studies have examined this risk, and those that have done so have had short (less than 1 year) exposure and follow-up times, said Dr. Nynne Nyboe Andersen of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.
They assessed the risks of any cancer and of 11 individual cancers in 56,146 IBD patients aged 15 and older living in Denmark in 1999-2012, of whom 4,553 took TNF-alpha antagonists. Median follow-up was 9.3 years, and median duration of therapy with TNF-alpha antagonists was 3.7 years. The two study groups were propensity matched for year of birth, sex, socioeconomic status, comorbidities, use of other medications, subtype of IBD, and history of gastrointestinal or anal fistula, abscess, fissure, or surgery.
A total of 6.7% of the patients who never took TNF-alpha antagonists developed cancer during follow-up, compared with 1.8% of patients who took the drugs, indicating no increase in cancer risk associated with TNF-alpha antagonists. Further analyses of the data found no association between use of these agents and the risk of overall cancer, regardless of the patient’s sex, age, the duration of therapy, or the cumulative dose, and sensitivity analyses confirmed these results, the investigators said (JAMA 2014 June 17 [doi:10.1001/jama.2014.5613]).
There also was no association between use of TNF-alpha antagonists and any individual cancer. "However, it should be noted that because of the relatively small sample size and the small number of cancer cases in our study, statistical power was limited in subgroup analyses of site-specific cancers," Dr. Andersen and her associates said.
"Stratifying for cancer risk according to years since first exposure, no specific time-dependent pattern was observed in our study. However, considering the often protracted progression of cancer, an increased risk in the long term cannot be excluded, and future studies with longer follow-up are needed," they added.
The Lundbeck Foundation, Danish Cancer Society, Crohn’s and Colitis Association of Denmark, and Danish Council of Independent Research supported the study. Dr. Andersen reported receiving funding from Merck Sharp & Dohme; her associates reported ties to Merck Sharp & Dohme, Tillotts, Calpro, Ferring, and AbbVie.
The tumor necrosis factor–alpha antagonists infliximab, adalimumab, and certolizumab did not raise the risk of cancer in a nationwide Danish cohort study of patients with inflammatory bowel disease who were followed for approximately 10 years, according to a report published online June 17 in JAMA.
At present, the effectiveness of these agents in inflammatory bowel disease (IBD) must be weighed against their potential adverse effects, which include immunosuppression that is suspected to increase the risk of cancer. But few studies have examined this risk, and those that have done so have had short (less than 1 year) exposure and follow-up times, said Dr. Nynne Nyboe Andersen of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.
They assessed the risks of any cancer and of 11 individual cancers in 56,146 IBD patients aged 15 and older living in Denmark in 1999-2012, of whom 4,553 took TNF-alpha antagonists. Median follow-up was 9.3 years, and median duration of therapy with TNF-alpha antagonists was 3.7 years. The two study groups were propensity matched for year of birth, sex, socioeconomic status, comorbidities, use of other medications, subtype of IBD, and history of gastrointestinal or anal fistula, abscess, fissure, or surgery.
A total of 6.7% of the patients who never took TNF-alpha antagonists developed cancer during follow-up, compared with 1.8% of patients who took the drugs, indicating no increase in cancer risk associated with TNF-alpha antagonists. Further analyses of the data found no association between use of these agents and the risk of overall cancer, regardless of the patient’s sex, age, the duration of therapy, or the cumulative dose, and sensitivity analyses confirmed these results, the investigators said (JAMA 2014 June 17 [doi:10.1001/jama.2014.5613]).
There also was no association between use of TNF-alpha antagonists and any individual cancer. "However, it should be noted that because of the relatively small sample size and the small number of cancer cases in our study, statistical power was limited in subgroup analyses of site-specific cancers," Dr. Andersen and her associates said.
"Stratifying for cancer risk according to years since first exposure, no specific time-dependent pattern was observed in our study. However, considering the often protracted progression of cancer, an increased risk in the long term cannot be excluded, and future studies with longer follow-up are needed," they added.
The Lundbeck Foundation, Danish Cancer Society, Crohn’s and Colitis Association of Denmark, and Danish Council of Independent Research supported the study. Dr. Andersen reported receiving funding from Merck Sharp & Dohme; her associates reported ties to Merck Sharp & Dohme, Tillotts, Calpro, Ferring, and AbbVie.
FROM JAMA
Major finding: A total of 6.7% of patients who never took TNF-alpha antagonists developed cancer during follow-up, compared with 1.8% of patients who took the drugs, indicating no increase in cancer risk associated with these agents.
Data source: A nationwide prospective cohort study involving 56,146 IBD patients aged 15 and older, of whom 4,553 took TNF-alpha antagonists, who were followed for approximately 10 years for the development of cancer.
Disclosures: The Lundbeck Foundation, Danish Cancer Society, Crohn’s and Colitis Association of Denmark, and Danish Council of Independent Research supported the study. Dr. Andersen reported receiving funding from Merck Sharp & Dohme; her associates reported ties to Merck Sharp & Dohme, Tillotts, Calpro, Ferring, and AbbVie.
Treat to target shows durable improvements in psoriatic arthritis
Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.
Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.
But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.
At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.
"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."
Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.
About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.
Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.
"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."
Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.
Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.
Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.
Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.
But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.
At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.
"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."
Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.
About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.
Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.
"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."
Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.
Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.
Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.
Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.
But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.
At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.
"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."
Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.
About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.
Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.
"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."
Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.
Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.
FROM THE EULAR CONGRESS 2014
Brodalumab outperformed placebo for psoriatic arthritis
Psoriatic arthritis patients treated with brodalumab improved by approximately 20%, compared with those on placebo, achieving the primary endpoint in a phase II trial, investigators reported online June 11 in the New England Journal of Medicine.
Brodalumab is a human monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA). At week 12 of the 40-week randomized trial, 37%-39% of brodalumab patients had improved by at least 20% based on the American College of Rheumatology response criteria (ACR 20), compared with only 18% of the placebo patients (P = .03 and .02, respectively), reported Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, and his associates.
Rates of 50% improvement in response criteria, or ACR 50, also exceeded placebo in both treatment arms (14%, compared with 4% for placebo; P = .05).
The researchers randomized 168 adults with psoriatic arthritis, of whom 159 finished the double-blind phase and 134 completed 40 weeks of the open-label extension (N. Engl. J. Med. 2014;370:2295-306 [doi: 10.1056/NEJMoa1315231]). By week 24, ACR 20 response rates were 51% for the 140-mg group, 64% for the 280-mg group, and 44% in placebo patients who switched to open-label brodalumab, said the researchers. Patients improved similarly whether they were treatment naive or had received previous biologic therapy, the investigators added.
Adverse events were comparable between the treatment and placebo groups, with no opportunistic infections or deaths, the investigators reported. Two patients tested positive for antibodies to brodalumab. "No significant neutropenic events were reported – an important safety outcome, since interleukin-17 is involved in neutrophil homeostasis," the researchers said. They noted, however, that larger trials would be needed to detect rare adverse events.
Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.
The study findings also were scheduled for presentation in a poster at EULAR 2014.
Psoriatic arthritis patients treated with brodalumab improved by approximately 20%, compared with those on placebo, achieving the primary endpoint in a phase II trial, investigators reported online June 11 in the New England Journal of Medicine.
Brodalumab is a human monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA). At week 12 of the 40-week randomized trial, 37%-39% of brodalumab patients had improved by at least 20% based on the American College of Rheumatology response criteria (ACR 20), compared with only 18% of the placebo patients (P = .03 and .02, respectively), reported Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, and his associates.
Rates of 50% improvement in response criteria, or ACR 50, also exceeded placebo in both treatment arms (14%, compared with 4% for placebo; P = .05).
The researchers randomized 168 adults with psoriatic arthritis, of whom 159 finished the double-blind phase and 134 completed 40 weeks of the open-label extension (N. Engl. J. Med. 2014;370:2295-306 [doi: 10.1056/NEJMoa1315231]). By week 24, ACR 20 response rates were 51% for the 140-mg group, 64% for the 280-mg group, and 44% in placebo patients who switched to open-label brodalumab, said the researchers. Patients improved similarly whether they were treatment naive or had received previous biologic therapy, the investigators added.
Adverse events were comparable between the treatment and placebo groups, with no opportunistic infections or deaths, the investigators reported. Two patients tested positive for antibodies to brodalumab. "No significant neutropenic events were reported – an important safety outcome, since interleukin-17 is involved in neutrophil homeostasis," the researchers said. They noted, however, that larger trials would be needed to detect rare adverse events.
Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.
The study findings also were scheduled for presentation in a poster at EULAR 2014.
Psoriatic arthritis patients treated with brodalumab improved by approximately 20%, compared with those on placebo, achieving the primary endpoint in a phase II trial, investigators reported online June 11 in the New England Journal of Medicine.
Brodalumab is a human monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA). At week 12 of the 40-week randomized trial, 37%-39% of brodalumab patients had improved by at least 20% based on the American College of Rheumatology response criteria (ACR 20), compared with only 18% of the placebo patients (P = .03 and .02, respectively), reported Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, and his associates.
Rates of 50% improvement in response criteria, or ACR 50, also exceeded placebo in both treatment arms (14%, compared with 4% for placebo; P = .05).
The researchers randomized 168 adults with psoriatic arthritis, of whom 159 finished the double-blind phase and 134 completed 40 weeks of the open-label extension (N. Engl. J. Med. 2014;370:2295-306 [doi: 10.1056/NEJMoa1315231]). By week 24, ACR 20 response rates were 51% for the 140-mg group, 64% for the 280-mg group, and 44% in placebo patients who switched to open-label brodalumab, said the researchers. Patients improved similarly whether they were treatment naive or had received previous biologic therapy, the investigators added.
Adverse events were comparable between the treatment and placebo groups, with no opportunistic infections or deaths, the investigators reported. Two patients tested positive for antibodies to brodalumab. "No significant neutropenic events were reported – an important safety outcome, since interleukin-17 is involved in neutrophil homeostasis," the researchers said. They noted, however, that larger trials would be needed to detect rare adverse events.
Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.
The study findings also were scheduled for presentation in a poster at EULAR 2014.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Interleukin-17 receptor A is a potential treatment target in psoriatic arthritis patients, whether or not they have received other biologic therapies.
Major finding: At week 12, patients who received 140 or 280 mg of brodalumab weekly had ACR 20 response rates of 37% (P = .03) and 39% (P = .02), respectively, compared with 18% for placebo.
Data source: Randomized clinical trial of 168 patients with psoriatic arthritis. Patients received brodalumab (140 or 280 mg subcutaneously) or placebo on day 1 and at weeks 1, 2, 4, 6, 8, and 10.
Disclosures: Amgen, a maker of brodalumab, funded the study. Dr. Mease and his coauthors reported employment with or receiving grants from Amgen.
Psoriasis patients on adalimumab show significant improvement by body region
Roughly half of psoriasis patients on adalimumab showed complete resolution in specific body regions after 16 weeks, according to an analysis of the phase III CHAMPION trial reported in the May issue of the Journal of Drugs in Dermatology.
Breaking down the Psoriasis Area Severity Index (PASI) scores by body regions allows for a more clinically relevant assessment of the outcomes, said Dr. Alexander A. Navarini of King’s College, London, and his colleagues.
Adalimumab patients averaged significant improvements in PASI scores from baseline for each body region, compared with scores with methotrexate and placebo. The average improvements for the head were 81%, 57%, and 27% for the adalimumab, methotrexate, and placebo groups, respectively. Improvements for the trunk were 86%, 51%, and 20%, respectively; improvements for the upper extremities were 79%, 53%, and 15%; and improvements for the lower extremities were 78%, 53%, and 15%.
Overall, 50% of adalimumab patients achieved a PASI 100 for the head and trunk regions, compared with 23% of methotrexate patients and 17% of placebo patients (J. Drugs Dermatol. 2014;13:554-62).
The complexity of calculating a PASI score makes it difficult to interpret, said Dr. Navarini and his colleagues.
"The score has difficulty expressing a significant reduction of erythema, scaling, and infiltration of the lesions when no modification of the affected area is observed," they wrote. "Body area is the last parameter to be affected by treatment." In a post-hoc analysis of the CHAMPION study, which showed the safety and effectiveness of adalimumab, compared with methotrexate and placebo, the researchers calculated PASI scores by body regions and by PASI components (J. Drugs Dermatol. 2014;13:554-62).
The study included adults aged 18 years and older with stable, moderate to severe chronic plaque psoriasis. A total of 108 patients were randomized to adalimumab, 110 to methotrexate, and 53 to placebo.
The researchers also reviewed data based on PASI component scores for erythema, induration, desquamation, and surface area.
"For all PASI components, the mean percent improvement in PASI score was significantly greater (P less than .05) for adalimumab-treated patients, compared with methotrexate and placebo-treated patients, at all time points, with the exception of week 1," the researchers wrote.
In addition, improvements in disease quality of life scores correlated with improvements in PASI body region scores and PASI component scores.
The analysis of PASI body region scores and PASI component scores has not been published for other treatments, the researchers noted. However, this strategy "allows for a more thorough evaluation and tracking of a patient’s disease severity as well as response to treatment, no matter how extensive or localized the disease manifestations may be," they added.
Roughly half of psoriasis patients on adalimumab showed complete resolution in specific body regions after 16 weeks, according to an analysis of the phase III CHAMPION trial reported in the May issue of the Journal of Drugs in Dermatology.
Breaking down the Psoriasis Area Severity Index (PASI) scores by body regions allows for a more clinically relevant assessment of the outcomes, said Dr. Alexander A. Navarini of King’s College, London, and his colleagues.
Adalimumab patients averaged significant improvements in PASI scores from baseline for each body region, compared with scores with methotrexate and placebo. The average improvements for the head were 81%, 57%, and 27% for the adalimumab, methotrexate, and placebo groups, respectively. Improvements for the trunk were 86%, 51%, and 20%, respectively; improvements for the upper extremities were 79%, 53%, and 15%; and improvements for the lower extremities were 78%, 53%, and 15%.
Overall, 50% of adalimumab patients achieved a PASI 100 for the head and trunk regions, compared with 23% of methotrexate patients and 17% of placebo patients (J. Drugs Dermatol. 2014;13:554-62).
The complexity of calculating a PASI score makes it difficult to interpret, said Dr. Navarini and his colleagues.
"The score has difficulty expressing a significant reduction of erythema, scaling, and infiltration of the lesions when no modification of the affected area is observed," they wrote. "Body area is the last parameter to be affected by treatment." In a post-hoc analysis of the CHAMPION study, which showed the safety and effectiveness of adalimumab, compared with methotrexate and placebo, the researchers calculated PASI scores by body regions and by PASI components (J. Drugs Dermatol. 2014;13:554-62).
The study included adults aged 18 years and older with stable, moderate to severe chronic plaque psoriasis. A total of 108 patients were randomized to adalimumab, 110 to methotrexate, and 53 to placebo.
The researchers also reviewed data based on PASI component scores for erythema, induration, desquamation, and surface area.
"For all PASI components, the mean percent improvement in PASI score was significantly greater (P less than .05) for adalimumab-treated patients, compared with methotrexate and placebo-treated patients, at all time points, with the exception of week 1," the researchers wrote.
In addition, improvements in disease quality of life scores correlated with improvements in PASI body region scores and PASI component scores.
The analysis of PASI body region scores and PASI component scores has not been published for other treatments, the researchers noted. However, this strategy "allows for a more thorough evaluation and tracking of a patient’s disease severity as well as response to treatment, no matter how extensive or localized the disease manifestations may be," they added.
Roughly half of psoriasis patients on adalimumab showed complete resolution in specific body regions after 16 weeks, according to an analysis of the phase III CHAMPION trial reported in the May issue of the Journal of Drugs in Dermatology.
Breaking down the Psoriasis Area Severity Index (PASI) scores by body regions allows for a more clinically relevant assessment of the outcomes, said Dr. Alexander A. Navarini of King’s College, London, and his colleagues.
Adalimumab patients averaged significant improvements in PASI scores from baseline for each body region, compared with scores with methotrexate and placebo. The average improvements for the head were 81%, 57%, and 27% for the adalimumab, methotrexate, and placebo groups, respectively. Improvements for the trunk were 86%, 51%, and 20%, respectively; improvements for the upper extremities were 79%, 53%, and 15%; and improvements for the lower extremities were 78%, 53%, and 15%.
Overall, 50% of adalimumab patients achieved a PASI 100 for the head and trunk regions, compared with 23% of methotrexate patients and 17% of placebo patients (J. Drugs Dermatol. 2014;13:554-62).
The complexity of calculating a PASI score makes it difficult to interpret, said Dr. Navarini and his colleagues.
"The score has difficulty expressing a significant reduction of erythema, scaling, and infiltration of the lesions when no modification of the affected area is observed," they wrote. "Body area is the last parameter to be affected by treatment." In a post-hoc analysis of the CHAMPION study, which showed the safety and effectiveness of adalimumab, compared with methotrexate and placebo, the researchers calculated PASI scores by body regions and by PASI components (J. Drugs Dermatol. 2014;13:554-62).
The study included adults aged 18 years and older with stable, moderate to severe chronic plaque psoriasis. A total of 108 patients were randomized to adalimumab, 110 to methotrexate, and 53 to placebo.
The researchers also reviewed data based on PASI component scores for erythema, induration, desquamation, and surface area.
"For all PASI components, the mean percent improvement in PASI score was significantly greater (P less than .05) for adalimumab-treated patients, compared with methotrexate and placebo-treated patients, at all time points, with the exception of week 1," the researchers wrote.
In addition, improvements in disease quality of life scores correlated with improvements in PASI body region scores and PASI component scores.
The analysis of PASI body region scores and PASI component scores has not been published for other treatments, the researchers noted. However, this strategy "allows for a more thorough evaluation and tracking of a patient’s disease severity as well as response to treatment, no matter how extensive or localized the disease manifestations may be," they added.
FROM THE JOURNAL OF DRUGS IN DERMATOLOGY
Key clinical point: The rate of PASI 100 response by body region in patients on adalimumab was more than twice that of patients on methotrexate or placebo.
Major finding: Half of patients on adalimumab attained a PASI 100 response in the head and trunk after 16 weeks.
Data source: A post hoc analysis of data taken from the CHAMPION study, a randomized phase III trial of adults with moderate to severe psoriasis.
Disclosures: The study was funded by AbbVie, and one of the authors is employed by AbbeVie. The other researchers had no financial conflicts to disclose.
About Time
As dermatologists we are all aware of the serious nature of psoriasis and its impact on the quality of life of patients. In the last decade we have more clearly recognized the comorbidities of the condition, including increased risk for cardiovascular disease and malignancy. However, there are many people, within and outside the medical community, who are not aware of the potentially serious nature of this disease.
Hopefully the tide is turning. According to News Medical, at the recent 67th World Health Assembly, the World Health Organization member states adopted a resolution on psoriasis, recognizing it as “a chronic, non-communicable, painful, disfiguring, and disabling disease for which there is no cure.” This resolution also acknowledged the psychosocial burden of the disease as well as the fact that many people with psoriasis suffer due to lack of awareness and access to sufficient treatment.
On this occasion, Wolfram Sterry, MD, president of the International League of Dermatological Societies, commented with the following:
“As a dermatologist I have seen first-hand how deeply psoriasis affects people in their daily lives, as have the many members of our worldwide organization. Together with the psoriasis patient associations, we have been able to educate policy makers on the impact this disease has and what can be done to ease its burden. This resolution gives us a platform from which we can engage even further with policy makers to help improve access to the treatment and care that people with psoriasis need and deserve.”
For many years, dermatologic societies and the National Psoriasis Foundation have been active in raising awareness about the impact of psoriasis, but it is gratifying to see a more global body take steps to increase public awareness of the disease.
What’s the issue?
Awareness of psoriasis is not at the level where it should be, which is especially true among the patients with the disease who often do not know where to find care and are unaware of the treatment options available in 2014. This acknowledgment by the World Health Organization is a nice step in the right direction. What will you do to increase awareness in your community?
As dermatologists we are all aware of the serious nature of psoriasis and its impact on the quality of life of patients. In the last decade we have more clearly recognized the comorbidities of the condition, including increased risk for cardiovascular disease and malignancy. However, there are many people, within and outside the medical community, who are not aware of the potentially serious nature of this disease.
Hopefully the tide is turning. According to News Medical, at the recent 67th World Health Assembly, the World Health Organization member states adopted a resolution on psoriasis, recognizing it as “a chronic, non-communicable, painful, disfiguring, and disabling disease for which there is no cure.” This resolution also acknowledged the psychosocial burden of the disease as well as the fact that many people with psoriasis suffer due to lack of awareness and access to sufficient treatment.
On this occasion, Wolfram Sterry, MD, president of the International League of Dermatological Societies, commented with the following:
“As a dermatologist I have seen first-hand how deeply psoriasis affects people in their daily lives, as have the many members of our worldwide organization. Together with the psoriasis patient associations, we have been able to educate policy makers on the impact this disease has and what can be done to ease its burden. This resolution gives us a platform from which we can engage even further with policy makers to help improve access to the treatment and care that people with psoriasis need and deserve.”
For many years, dermatologic societies and the National Psoriasis Foundation have been active in raising awareness about the impact of psoriasis, but it is gratifying to see a more global body take steps to increase public awareness of the disease.
What’s the issue?
Awareness of psoriasis is not at the level where it should be, which is especially true among the patients with the disease who often do not know where to find care and are unaware of the treatment options available in 2014. This acknowledgment by the World Health Organization is a nice step in the right direction. What will you do to increase awareness in your community?
As dermatologists we are all aware of the serious nature of psoriasis and its impact on the quality of life of patients. In the last decade we have more clearly recognized the comorbidities of the condition, including increased risk for cardiovascular disease and malignancy. However, there are many people, within and outside the medical community, who are not aware of the potentially serious nature of this disease.
Hopefully the tide is turning. According to News Medical, at the recent 67th World Health Assembly, the World Health Organization member states adopted a resolution on psoriasis, recognizing it as “a chronic, non-communicable, painful, disfiguring, and disabling disease for which there is no cure.” This resolution also acknowledged the psychosocial burden of the disease as well as the fact that many people with psoriasis suffer due to lack of awareness and access to sufficient treatment.
On this occasion, Wolfram Sterry, MD, president of the International League of Dermatological Societies, commented with the following:
“As a dermatologist I have seen first-hand how deeply psoriasis affects people in their daily lives, as have the many members of our worldwide organization. Together with the psoriasis patient associations, we have been able to educate policy makers on the impact this disease has and what can be done to ease its burden. This resolution gives us a platform from which we can engage even further with policy makers to help improve access to the treatment and care that people with psoriasis need and deserve.”
For many years, dermatologic societies and the National Psoriasis Foundation have been active in raising awareness about the impact of psoriasis, but it is gratifying to see a more global body take steps to increase public awareness of the disease.
What’s the issue?
Awareness of psoriasis is not at the level where it should be, which is especially true among the patients with the disease who often do not know where to find care and are unaware of the treatment options available in 2014. This acknowledgment by the World Health Organization is a nice step in the right direction. What will you do to increase awareness in your community?
Protein may link psoriasis to metabolic comorbidities
The concentration of a protein known to be involved in insulin resistance was significantly higher in serum of both lean and obese psoriasis patients, based on data from 80 adults.
The protein – known as wingless-type MMTV integration site Family, Member 5a (wnt5a) – also is upregulated in psoriatic skin lesions, noted Dr. Sascha Gerdes of the University Medical Center Schleswig-Holstein, Kiel, Germany, and colleagues.
"We investigated whether wnt5a and its counterpart, secreted frizzled-related protein 5, are altered in the circulation of lean and obese patients with psoriasis compared with lean and obese healthy volunteers by measuring serum concentrations of both proteins," they wrote (Experimental Dermatology 2014;23:439-40).
The mean serum concentration of wnt5a was significantly higher in 20 lean psoriasis patients, compared with 20 lean healthy controls (0.096 ng/mL vs. 0.020 ng/mL, respectively, P less than or equal to .01). The difference was even more pronounced in the serum samples from 20 obese psoriasis patients, compared with 20 obese healthy controls (0.177 ng/mL vs. 0.011 ng/mL, respectively, P less than or equal to .001).
There was no significant difference in the mean serum concentration of secreted frizzled-related protein 5 (sFRP5) in lean psoriasis patients, compared with lean controls. However, obese psoriasis patients had significantly higher concentrations of sFRP5, compared with obese controls (14.358 ng/mL vs. 6.389 ng/mL, respectively).
A second set of experiments on the serum samples of 50 psoriasis patients ranging from lean to obese showed that wnt5a levels increased as body mass index increased and was statistically significant in patients with a body mass index between 35 and less than 40 kg/m2, compared with lean patients who had a BMI between 20 and less than 25 kg/m2 (0.337 ng/mL vs. 0.125 ng/mL, respectively).
"We hypothesize that the expression of wnt5a in psoriatic lesions subsequently leads to an increase in wnt5a in the circulation, which could partly explain why metabolic comorbidity such as insulin resistance and diabetes mellitus type 2 develops in psoriasis patients with and without obesity," the researchers noted.
Although the findings suggest a role for wnt5a in the interaction of psoriasis and metabolic comorbidities, additional studies are needed to determine how psoriasis treatment and/or weight management might impact both wnt5a and sFRP5 in psoriasis patients, they added.
The researchers had no financial conflicts to disclose.
The concentration of a protein known to be involved in insulin resistance was significantly higher in serum of both lean and obese psoriasis patients, based on data from 80 adults.
The protein – known as wingless-type MMTV integration site Family, Member 5a (wnt5a) – also is upregulated in psoriatic skin lesions, noted Dr. Sascha Gerdes of the University Medical Center Schleswig-Holstein, Kiel, Germany, and colleagues.
"We investigated whether wnt5a and its counterpart, secreted frizzled-related protein 5, are altered in the circulation of lean and obese patients with psoriasis compared with lean and obese healthy volunteers by measuring serum concentrations of both proteins," they wrote (Experimental Dermatology 2014;23:439-40).
The mean serum concentration of wnt5a was significantly higher in 20 lean psoriasis patients, compared with 20 lean healthy controls (0.096 ng/mL vs. 0.020 ng/mL, respectively, P less than or equal to .01). The difference was even more pronounced in the serum samples from 20 obese psoriasis patients, compared with 20 obese healthy controls (0.177 ng/mL vs. 0.011 ng/mL, respectively, P less than or equal to .001).
There was no significant difference in the mean serum concentration of secreted frizzled-related protein 5 (sFRP5) in lean psoriasis patients, compared with lean controls. However, obese psoriasis patients had significantly higher concentrations of sFRP5, compared with obese controls (14.358 ng/mL vs. 6.389 ng/mL, respectively).
A second set of experiments on the serum samples of 50 psoriasis patients ranging from lean to obese showed that wnt5a levels increased as body mass index increased and was statistically significant in patients with a body mass index between 35 and less than 40 kg/m2, compared with lean patients who had a BMI between 20 and less than 25 kg/m2 (0.337 ng/mL vs. 0.125 ng/mL, respectively).
"We hypothesize that the expression of wnt5a in psoriatic lesions subsequently leads to an increase in wnt5a in the circulation, which could partly explain why metabolic comorbidity such as insulin resistance and diabetes mellitus type 2 develops in psoriasis patients with and without obesity," the researchers noted.
Although the findings suggest a role for wnt5a in the interaction of psoriasis and metabolic comorbidities, additional studies are needed to determine how psoriasis treatment and/or weight management might impact both wnt5a and sFRP5 in psoriasis patients, they added.
The researchers had no financial conflicts to disclose.
The concentration of a protein known to be involved in insulin resistance was significantly higher in serum of both lean and obese psoriasis patients, based on data from 80 adults.
The protein – known as wingless-type MMTV integration site Family, Member 5a (wnt5a) – also is upregulated in psoriatic skin lesions, noted Dr. Sascha Gerdes of the University Medical Center Schleswig-Holstein, Kiel, Germany, and colleagues.
"We investigated whether wnt5a and its counterpart, secreted frizzled-related protein 5, are altered in the circulation of lean and obese patients with psoriasis compared with lean and obese healthy volunteers by measuring serum concentrations of both proteins," they wrote (Experimental Dermatology 2014;23:439-40).
The mean serum concentration of wnt5a was significantly higher in 20 lean psoriasis patients, compared with 20 lean healthy controls (0.096 ng/mL vs. 0.020 ng/mL, respectively, P less than or equal to .01). The difference was even more pronounced in the serum samples from 20 obese psoriasis patients, compared with 20 obese healthy controls (0.177 ng/mL vs. 0.011 ng/mL, respectively, P less than or equal to .001).
There was no significant difference in the mean serum concentration of secreted frizzled-related protein 5 (sFRP5) in lean psoriasis patients, compared with lean controls. However, obese psoriasis patients had significantly higher concentrations of sFRP5, compared with obese controls (14.358 ng/mL vs. 6.389 ng/mL, respectively).
A second set of experiments on the serum samples of 50 psoriasis patients ranging from lean to obese showed that wnt5a levels increased as body mass index increased and was statistically significant in patients with a body mass index between 35 and less than 40 kg/m2, compared with lean patients who had a BMI between 20 and less than 25 kg/m2 (0.337 ng/mL vs. 0.125 ng/mL, respectively).
"We hypothesize that the expression of wnt5a in psoriatic lesions subsequently leads to an increase in wnt5a in the circulation, which could partly explain why metabolic comorbidity such as insulin resistance and diabetes mellitus type 2 develops in psoriasis patients with and without obesity," the researchers noted.
Although the findings suggest a role for wnt5a in the interaction of psoriasis and metabolic comorbidities, additional studies are needed to determine how psoriasis treatment and/or weight management might impact both wnt5a and sFRP5 in psoriasis patients, they added.
The researchers had no financial conflicts to disclose.
FROM EXPERIMENTAL DERMATOLOGY
Key clinical point: Expression of the protein wnt5a in psoriatic lesions may increase wnt5a in the circulation, which might contribute to the development of metabolic comorbidities in psoriasis patients.
Major finding: The mean serum concentration of wnt5a was significantly higher in serum samples from 20 obese psoriasis patients, compared with 20 obese healthy controls (0.177 ng/mL vs. 0.011 ng/mL, respectively, P less than or equal to .001).
Data source: 40 adults with psoriasis and 40 controls.
Disclosures: The researchers had no financial conflicts to disclose.
FDA approves blood test for membranous glomerulonephritis
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
Systemic Agents on the Horizon for Psoriasis
For more information, read Dr. Han's Resident Corner column from March 2014, "In the Pipeline for Psoriasis: Upcoming Psoriasis Treatments."
For more information, read Dr. Han's Resident Corner column from March 2014, "In the Pipeline for Psoriasis: Upcoming Psoriasis Treatments."
For more information, read Dr. Han's Resident Corner column from March 2014, "In the Pipeline for Psoriasis: Upcoming Psoriasis Treatments."
Is There a Potential Benefit of Expressive Writing for Dermatology Patients?
A diagnosis of a chronic and/or serious medical condition can be a traumatic experience. Patients may experience not only intrusive thoughts but also avoidance behaviors. The affected individuals can express these trauma-associated symptoms as depression, fatigue, and sleep disturbance.
Milbury et al (J Clin Oncol. 2014;32:663-670) included 277 patients who had been diagnosed with renal cell carcinoma in a study to evaluate if writing about their deepest thoughts and feelings regarding their cancer (expressive writing) offered a quality-of-life benefit compared to writing about neutral topics (neutral writing). They found that expressive writing not only reduced the patients’ cancer-related symptoms but also improved their physical functioning.
What’s the issue?
Many of the conditions that affect dermatology patients are chronic, serious, or both. For example, psoriasis is a chronic skin condition with the potential for serious associated rheumatologic or metabolic sequelae. In addition, skin malignancies (eg, basal cell carcinoma, squamous cell carcinoma, malignant melanoma) and cutaneous lymphoma (eg, mycosis fungoides) are conditions that require chronic surveillance and possibly may have serious consequences.
Expressive writing for dermatology patients might result in remarkable improvement in emotional and physical health. Perhaps dermatologists should recommend this intervention for their patients.
A diagnosis of a chronic and/or serious medical condition can be a traumatic experience. Patients may experience not only intrusive thoughts but also avoidance behaviors. The affected individuals can express these trauma-associated symptoms as depression, fatigue, and sleep disturbance.
Milbury et al (J Clin Oncol. 2014;32:663-670) included 277 patients who had been diagnosed with renal cell carcinoma in a study to evaluate if writing about their deepest thoughts and feelings regarding their cancer (expressive writing) offered a quality-of-life benefit compared to writing about neutral topics (neutral writing). They found that expressive writing not only reduced the patients’ cancer-related symptoms but also improved their physical functioning.
What’s the issue?
Many of the conditions that affect dermatology patients are chronic, serious, or both. For example, psoriasis is a chronic skin condition with the potential for serious associated rheumatologic or metabolic sequelae. In addition, skin malignancies (eg, basal cell carcinoma, squamous cell carcinoma, malignant melanoma) and cutaneous lymphoma (eg, mycosis fungoides) are conditions that require chronic surveillance and possibly may have serious consequences.
Expressive writing for dermatology patients might result in remarkable improvement in emotional and physical health. Perhaps dermatologists should recommend this intervention for their patients.
A diagnosis of a chronic and/or serious medical condition can be a traumatic experience. Patients may experience not only intrusive thoughts but also avoidance behaviors. The affected individuals can express these trauma-associated symptoms as depression, fatigue, and sleep disturbance.
Milbury et al (J Clin Oncol. 2014;32:663-670) included 277 patients who had been diagnosed with renal cell carcinoma in a study to evaluate if writing about their deepest thoughts and feelings regarding their cancer (expressive writing) offered a quality-of-life benefit compared to writing about neutral topics (neutral writing). They found that expressive writing not only reduced the patients’ cancer-related symptoms but also improved their physical functioning.
What’s the issue?
Many of the conditions that affect dermatology patients are chronic, serious, or both. For example, psoriasis is a chronic skin condition with the potential for serious associated rheumatologic or metabolic sequelae. In addition, skin malignancies (eg, basal cell carcinoma, squamous cell carcinoma, malignant melanoma) and cutaneous lymphoma (eg, mycosis fungoides) are conditions that require chronic surveillance and possibly may have serious consequences.
Expressive writing for dermatology patients might result in remarkable improvement in emotional and physical health. Perhaps dermatologists should recommend this intervention for their patients.