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Infliximab biosimilar posts mostly reassuring data in Norway’s NOR-SWITCH study
WASHINGTON – Data from the first randomized trial of switching from an originator biologic to a biosimilar of the originator indicate that the infliximab biosimilar Remsima is no different from the infliximab originator Remicade in the rate of disease worsening over 1 year across a combination of all its approved indications.
The outcomes of the Norwegian, double-blind, noninferiority trial, called NOR-SWITCH, indicate similar rates of disease worsening across patients switched to Remsima and those who stayed on Remicade. However, exploratory group analyses conducted on the different disease subgroups in the trial (Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriasis, and psoriatic arthritis) showed a potentially concerning level of disease worsening among Crohn’s disease patients on Remsima with a confidence interval that nearly fell entirely within the range favoring Remicade.
In the United States, Remsima, also known as CT-P13, is marketed by Pfizer as Inflectra.
The trial randomized 482 patients who were on stable treatment with Remicade for at least 6 months for any of the six indications for which Remicade and Remsima are approved to either stay on Remicade or switch to Remsima with the same dosing regimen for 52 weeks. Overall, patients had a mean age of about 48 years and 36%-41% were female. They had a mean disease duration of about 17 years and had been taking Remicade for a mean of nearly 7 years.
The primary endpoint was disease worsening during follow-up, according to worsening in disease-specific composite measures and/or a consensus between an investigator and a patient that led to a major change in treatment. The investigators made an assumption of 30% disease worsening across all the indications for the trial’s power calculation, based on available literature and observational data.
Disease worsening occurred in 26.2% of patients who stayed on Remicade and 29.6% of patients who switched to Remsima, based on a per-protocol analysis of 202 Remicade and 206 Remsima patients. The 95% confidence interval of the adjusted treatment difference of –4.4% was –12.7% to 3.9%, which was within the pre-specified noninferiority margin of 15%.
Exploratory subgroup analyses of the different disease subgroups showed no statistically significant differences between the two treatments in disease worsening. However, in Crohn’s disease patients, who formed the largest subgroup in the study at 155 patients, the adjusted treatment difference was –14.3% (21.2% with disease worsening for Remicade and 36.5% for Remsima) with a 95% CI of –29.3% to 0.7%.
It’s difficult to discern whether the 95% confidence interval seen in the Crohn’s disease subgroup is a part of the natural variation one would expect to see in a subgroup analysis of different diseases or if there might be a true signal for disease worsening in the Crohn’s disease patients who took Remsima. “The problem is that it’s in the largest subgroup that has no other data. If this had been in rheumatoid arthritis, that would be different,” coauthor Inge C. Olsen, PhD, a biostatistician at Diakonhjemmet Hospital, said in an interview. “All the registry trials were done in RA and spondyloarthritis patients. ... That’s an issue, but with regards to the [NOR-SWITCH] study, it’s very clear that you have no power to show anything in the subgroup analysis, and they are exploratory analyses and are not answering any hypothesis.” Currently, there are no plans to follow up on these results in another study, he said.
Other issues that the NOR-SWITCH study does not answer are the outcomes of switching back and forth between Remicade and Remsima, switching from one infliximab biosimilar to another infliximab biosimilar, and switching from other originator biologics to their biosimilars.
“Is that feasible? Is that safe? Will it retain efficacy? We don’t know. There’s a real need for those studies to be done,” Dr. Goll said.
In Norway, the remaining patients who had not switched yet from Remicade to Remsima are now doing so based on the trial’s results, Dr. Goll said. The cost of Remsima in Norway was about 75% less than Remicade in 2015 and about 60% less in 2016, she noted.
It’s still an open question what the results of the NOR-SWITCH trial might indicate for how clinicians in the United States will use Inflectra and other biosimilars, according to John J. Cush, MD, professor of medicine and rheumatology at Baylor University, Dallas.
“I think the real problem here is that it’s nice to know that [CT-P13] wasn’t inferior, but when you get into the weeds and you look at the details, those of us who may not have a lot of certainty about this might worry about this, especially when there are three new biosimilars approved in the United States: Amjevita, which is an adalimumab biosimilar; Erelzi, which is an etanercept biosimilar; and Inflectra’s about to be launched as an infliximab biosimilar,” Dr. Cush said during a session reviewing selected abstracts from the meeting. “When this NOR-SWITCH study was done in Norway, it’s a 70% savings over the original product. The new ones being introduced over here [in the United States] start at about 15%. I’m less motivated with that degree of savings to want to take some chances on my patients. So we need a little bit more certainty; we need to feel better about the cost savings to patients and health care overall. Confidence in biosimilars is what’s going to sell biosimilars. We’re a long way from confidence still.”
NOR-SWITCH was funded by the Norwegian government. Some of the investigators disclosed relationships with Pfizer and/or Celltrion, which separately market CT-P13 in different parts of the world.
jevans@frontlinemedcom.com
WASHINGTON – Data from the first randomized trial of switching from an originator biologic to a biosimilar of the originator indicate that the infliximab biosimilar Remsima is no different from the infliximab originator Remicade in the rate of disease worsening over 1 year across a combination of all its approved indications.
The outcomes of the Norwegian, double-blind, noninferiority trial, called NOR-SWITCH, indicate similar rates of disease worsening across patients switched to Remsima and those who stayed on Remicade. However, exploratory group analyses conducted on the different disease subgroups in the trial (Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriasis, and psoriatic arthritis) showed a potentially concerning level of disease worsening among Crohn’s disease patients on Remsima with a confidence interval that nearly fell entirely within the range favoring Remicade.
In the United States, Remsima, also known as CT-P13, is marketed by Pfizer as Inflectra.
The trial randomized 482 patients who were on stable treatment with Remicade for at least 6 months for any of the six indications for which Remicade and Remsima are approved to either stay on Remicade or switch to Remsima with the same dosing regimen for 52 weeks. Overall, patients had a mean age of about 48 years and 36%-41% were female. They had a mean disease duration of about 17 years and had been taking Remicade for a mean of nearly 7 years.
The primary endpoint was disease worsening during follow-up, according to worsening in disease-specific composite measures and/or a consensus between an investigator and a patient that led to a major change in treatment. The investigators made an assumption of 30% disease worsening across all the indications for the trial’s power calculation, based on available literature and observational data.
Disease worsening occurred in 26.2% of patients who stayed on Remicade and 29.6% of patients who switched to Remsima, based on a per-protocol analysis of 202 Remicade and 206 Remsima patients. The 95% confidence interval of the adjusted treatment difference of –4.4% was –12.7% to 3.9%, which was within the pre-specified noninferiority margin of 15%.
Exploratory subgroup analyses of the different disease subgroups showed no statistically significant differences between the two treatments in disease worsening. However, in Crohn’s disease patients, who formed the largest subgroup in the study at 155 patients, the adjusted treatment difference was –14.3% (21.2% with disease worsening for Remicade and 36.5% for Remsima) with a 95% CI of –29.3% to 0.7%.
It’s difficult to discern whether the 95% confidence interval seen in the Crohn’s disease subgroup is a part of the natural variation one would expect to see in a subgroup analysis of different diseases or if there might be a true signal for disease worsening in the Crohn’s disease patients who took Remsima. “The problem is that it’s in the largest subgroup that has no other data. If this had been in rheumatoid arthritis, that would be different,” coauthor Inge C. Olsen, PhD, a biostatistician at Diakonhjemmet Hospital, said in an interview. “All the registry trials were done in RA and spondyloarthritis patients. ... That’s an issue, but with regards to the [NOR-SWITCH] study, it’s very clear that you have no power to show anything in the subgroup analysis, and they are exploratory analyses and are not answering any hypothesis.” Currently, there are no plans to follow up on these results in another study, he said.
Other issues that the NOR-SWITCH study does not answer are the outcomes of switching back and forth between Remicade and Remsima, switching from one infliximab biosimilar to another infliximab biosimilar, and switching from other originator biologics to their biosimilars.
“Is that feasible? Is that safe? Will it retain efficacy? We don’t know. There’s a real need for those studies to be done,” Dr. Goll said.
In Norway, the remaining patients who had not switched yet from Remicade to Remsima are now doing so based on the trial’s results, Dr. Goll said. The cost of Remsima in Norway was about 75% less than Remicade in 2015 and about 60% less in 2016, she noted.
It’s still an open question what the results of the NOR-SWITCH trial might indicate for how clinicians in the United States will use Inflectra and other biosimilars, according to John J. Cush, MD, professor of medicine and rheumatology at Baylor University, Dallas.
“I think the real problem here is that it’s nice to know that [CT-P13] wasn’t inferior, but when you get into the weeds and you look at the details, those of us who may not have a lot of certainty about this might worry about this, especially when there are three new biosimilars approved in the United States: Amjevita, which is an adalimumab biosimilar; Erelzi, which is an etanercept biosimilar; and Inflectra’s about to be launched as an infliximab biosimilar,” Dr. Cush said during a session reviewing selected abstracts from the meeting. “When this NOR-SWITCH study was done in Norway, it’s a 70% savings over the original product. The new ones being introduced over here [in the United States] start at about 15%. I’m less motivated with that degree of savings to want to take some chances on my patients. So we need a little bit more certainty; we need to feel better about the cost savings to patients and health care overall. Confidence in biosimilars is what’s going to sell biosimilars. We’re a long way from confidence still.”
NOR-SWITCH was funded by the Norwegian government. Some of the investigators disclosed relationships with Pfizer and/or Celltrion, which separately market CT-P13 in different parts of the world.
jevans@frontlinemedcom.com
WASHINGTON – Data from the first randomized trial of switching from an originator biologic to a biosimilar of the originator indicate that the infliximab biosimilar Remsima is no different from the infliximab originator Remicade in the rate of disease worsening over 1 year across a combination of all its approved indications.
The outcomes of the Norwegian, double-blind, noninferiority trial, called NOR-SWITCH, indicate similar rates of disease worsening across patients switched to Remsima and those who stayed on Remicade. However, exploratory group analyses conducted on the different disease subgroups in the trial (Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriasis, and psoriatic arthritis) showed a potentially concerning level of disease worsening among Crohn’s disease patients on Remsima with a confidence interval that nearly fell entirely within the range favoring Remicade.
In the United States, Remsima, also known as CT-P13, is marketed by Pfizer as Inflectra.
The trial randomized 482 patients who were on stable treatment with Remicade for at least 6 months for any of the six indications for which Remicade and Remsima are approved to either stay on Remicade or switch to Remsima with the same dosing regimen for 52 weeks. Overall, patients had a mean age of about 48 years and 36%-41% were female. They had a mean disease duration of about 17 years and had been taking Remicade for a mean of nearly 7 years.
The primary endpoint was disease worsening during follow-up, according to worsening in disease-specific composite measures and/or a consensus between an investigator and a patient that led to a major change in treatment. The investigators made an assumption of 30% disease worsening across all the indications for the trial’s power calculation, based on available literature and observational data.
Disease worsening occurred in 26.2% of patients who stayed on Remicade and 29.6% of patients who switched to Remsima, based on a per-protocol analysis of 202 Remicade and 206 Remsima patients. The 95% confidence interval of the adjusted treatment difference of –4.4% was –12.7% to 3.9%, which was within the pre-specified noninferiority margin of 15%.
Exploratory subgroup analyses of the different disease subgroups showed no statistically significant differences between the two treatments in disease worsening. However, in Crohn’s disease patients, who formed the largest subgroup in the study at 155 patients, the adjusted treatment difference was –14.3% (21.2% with disease worsening for Remicade and 36.5% for Remsima) with a 95% CI of –29.3% to 0.7%.
It’s difficult to discern whether the 95% confidence interval seen in the Crohn’s disease subgroup is a part of the natural variation one would expect to see in a subgroup analysis of different diseases or if there might be a true signal for disease worsening in the Crohn’s disease patients who took Remsima. “The problem is that it’s in the largest subgroup that has no other data. If this had been in rheumatoid arthritis, that would be different,” coauthor Inge C. Olsen, PhD, a biostatistician at Diakonhjemmet Hospital, said in an interview. “All the registry trials were done in RA and spondyloarthritis patients. ... That’s an issue, but with regards to the [NOR-SWITCH] study, it’s very clear that you have no power to show anything in the subgroup analysis, and they are exploratory analyses and are not answering any hypothesis.” Currently, there are no plans to follow up on these results in another study, he said.
Other issues that the NOR-SWITCH study does not answer are the outcomes of switching back and forth between Remicade and Remsima, switching from one infliximab biosimilar to another infliximab biosimilar, and switching from other originator biologics to their biosimilars.
“Is that feasible? Is that safe? Will it retain efficacy? We don’t know. There’s a real need for those studies to be done,” Dr. Goll said.
In Norway, the remaining patients who had not switched yet from Remicade to Remsima are now doing so based on the trial’s results, Dr. Goll said. The cost of Remsima in Norway was about 75% less than Remicade in 2015 and about 60% less in 2016, she noted.
It’s still an open question what the results of the NOR-SWITCH trial might indicate for how clinicians in the United States will use Inflectra and other biosimilars, according to John J. Cush, MD, professor of medicine and rheumatology at Baylor University, Dallas.
“I think the real problem here is that it’s nice to know that [CT-P13] wasn’t inferior, but when you get into the weeds and you look at the details, those of us who may not have a lot of certainty about this might worry about this, especially when there are three new biosimilars approved in the United States: Amjevita, which is an adalimumab biosimilar; Erelzi, which is an etanercept biosimilar; and Inflectra’s about to be launched as an infliximab biosimilar,” Dr. Cush said during a session reviewing selected abstracts from the meeting. “When this NOR-SWITCH study was done in Norway, it’s a 70% savings over the original product. The new ones being introduced over here [in the United States] start at about 15%. I’m less motivated with that degree of savings to want to take some chances on my patients. So we need a little bit more certainty; we need to feel better about the cost savings to patients and health care overall. Confidence in biosimilars is what’s going to sell biosimilars. We’re a long way from confidence still.”
NOR-SWITCH was funded by the Norwegian government. Some of the investigators disclosed relationships with Pfizer and/or Celltrion, which separately market CT-P13 in different parts of the world.
jevans@frontlinemedcom.com
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: Disease worsening occurred in 26.2% of patients who stayed on Remicade and 29.6% of patients who switched to Remsima, based on a per-protocol analysis.
Data source: The multicenter, double-blind, randomized NOR-SWITCH trial of 482 patients.
Disclosures: The trial was funded by the Norwegian government. Some of the investigators disclosed relationships with Pfizer and/or Celltrion, which separately market CT-P13 in different parts of the world.
Debunking Psoriasis Myths: Do Psoriasis Therapies Cause Depression?
Myth: Psoriasis treatments may cause depression
It has been well documented that patients with inflammatory diseases such as psoriasis have an increased risk for depression. One population-based cohort study in the United Kingdom reported the risk of depression was greater in patients with severe psoriasis versus mild psoriasis. Younger psoriasis patients also had a higher risk compared to older patients. A US population-based study also reported that psoriasis was associated with major depression, but the severity of psoriasis and patient's age were unrelated. Therefore, all psoriasis patients may be at risk.
But are some therapies associated with an increased risk of depression? Increased concentrations of proinflammatory cytokines such as tumor necrosis factor α have been associated with depression apart from psoriasis. Administering immunomodulating agents has been shown to increase the risk of depression.
Depression has been cited as an adverse effect of apremilast in the drug's package insert, which states, "Before using [apremilast] in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment." In clinical trials, 1.3% (12/920) of participants treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. Dermatologists should remain vigilant about monitoring for symptoms of depression in patients treated with apremilast.
However, depression in the context of autoimmune disorders or any disorder with increased inflammation has responded to treatment with tumor necrosis factor α antagonists. The relationship between depression and inflammation suggests that there is an inflammatory subtype of depression and use of anti-inflammatory agents may treat both inflammation and depression.
Disease control has been shown to improve symptoms of depression in psoriasis patients. A study of 618 patients with moderate to severe psoriasis who were treated with etanercept or placebo for 12 weeks revealed that more patients receiving etanercept experienced 50% improvement in 2 rating scales of depression compared to placebo.
Excessive worrying, a form of psychological distress, can impact treatment outcomes in patients with psoriasis. A 2003 study found that patients with psoriasis who are classified as high-level worriers may benefit from adjunctive psychological intervention before and during treatment. In this cohort of psoriasis patients receiving psoralen plus UVA (PUVA) therapy, high-level worry was the only significant predictor of time taken for PUVA to clear psoriasis (P=.01). Patients in the high-level worry group cleared with PUVA treatment at a rate of 1.8 times slower than the low-level worry group.
In conclusion, psoriasis patients should follow the treatment plan outlined by dermatologists, as improving psoriasis symptoms may help alleviate depression or prevent it from occurring. Patients with a history of depression should be monitored carefully by dermatologists or referred to another health care professional, and patients as well as family and friends should be encouraged to report any depression symptoms.
Expert Commentary
The prescribing information for apremilast lists a warning (but not a black-box warning) for depression. Long-term registries will determine if there is truly an increased risk of depression when taking apremilast. When I counsel patients before prescribing apremilast, I mention this potential increased risk of depression as noted in the prescribing information, but I tell them that the risk is very low and that a true risk has not yet been determined in long-term registries. I mention to patients that if they really do feel depressed after starting apremilast, they should stop taking apremilast and contact me.
Long-term registries for etanercept, adalimumab, infliximab, and ustekinumab do not indicate an increased risk for depression. Intuitively, if a patient with severe psoriasis has depression worsened by their psoriasis, it stands to reason that improving their skin will likely improve their mood, which clinical trials have shown using patient-related outcomes.
—Jashin J. Wu, MD (Los Angeles, California)
Almond M. Depression and inflammation: examining the link. Current Psychiatry. 2013;12:24-32.
Cohen BE, Martires KJ, Ho RS. Psoriasis and the risk of depression in the US population: National Health and Nutrition Examination Survey 2009-2012. JAMA Dermatol. 2016;152:73-79.
Fortune DG, Richards HL, Kirby B, et al. Psychological distress impairs clearance of psoriasis in patients treated with photochemotherapy. Arch Dermatol. 2003;139:752-756.
Kurd SK, Troxel AB, Crits-Christoph P, et al. The risk of depression, anxiety and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol. 2010;146:891-895.
Otezla [package insert]. Summit, NJ: Celgene Corporation; 2015.Research links psoriasis, depression [press release]. New York, NY: American Academy of Dermatology; August 20, 2015. https://www.aad.org/media/news-releases/research-links-psoriasis-depression. Accessed November 16, 2016.
Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367:29-35
Myth: Psoriasis treatments may cause depression
It has been well documented that patients with inflammatory diseases such as psoriasis have an increased risk for depression. One population-based cohort study in the United Kingdom reported the risk of depression was greater in patients with severe psoriasis versus mild psoriasis. Younger psoriasis patients also had a higher risk compared to older patients. A US population-based study also reported that psoriasis was associated with major depression, but the severity of psoriasis and patient's age were unrelated. Therefore, all psoriasis patients may be at risk.
But are some therapies associated with an increased risk of depression? Increased concentrations of proinflammatory cytokines such as tumor necrosis factor α have been associated with depression apart from psoriasis. Administering immunomodulating agents has been shown to increase the risk of depression.
Depression has been cited as an adverse effect of apremilast in the drug's package insert, which states, "Before using [apremilast] in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment." In clinical trials, 1.3% (12/920) of participants treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. Dermatologists should remain vigilant about monitoring for symptoms of depression in patients treated with apremilast.
However, depression in the context of autoimmune disorders or any disorder with increased inflammation has responded to treatment with tumor necrosis factor α antagonists. The relationship between depression and inflammation suggests that there is an inflammatory subtype of depression and use of anti-inflammatory agents may treat both inflammation and depression.
Disease control has been shown to improve symptoms of depression in psoriasis patients. A study of 618 patients with moderate to severe psoriasis who were treated with etanercept or placebo for 12 weeks revealed that more patients receiving etanercept experienced 50% improvement in 2 rating scales of depression compared to placebo.
Excessive worrying, a form of psychological distress, can impact treatment outcomes in patients with psoriasis. A 2003 study found that patients with psoriasis who are classified as high-level worriers may benefit from adjunctive psychological intervention before and during treatment. In this cohort of psoriasis patients receiving psoralen plus UVA (PUVA) therapy, high-level worry was the only significant predictor of time taken for PUVA to clear psoriasis (P=.01). Patients in the high-level worry group cleared with PUVA treatment at a rate of 1.8 times slower than the low-level worry group.
In conclusion, psoriasis patients should follow the treatment plan outlined by dermatologists, as improving psoriasis symptoms may help alleviate depression or prevent it from occurring. Patients with a history of depression should be monitored carefully by dermatologists or referred to another health care professional, and patients as well as family and friends should be encouraged to report any depression symptoms.
Expert Commentary
The prescribing information for apremilast lists a warning (but not a black-box warning) for depression. Long-term registries will determine if there is truly an increased risk of depression when taking apremilast. When I counsel patients before prescribing apremilast, I mention this potential increased risk of depression as noted in the prescribing information, but I tell them that the risk is very low and that a true risk has not yet been determined in long-term registries. I mention to patients that if they really do feel depressed after starting apremilast, they should stop taking apremilast and contact me.
Long-term registries for etanercept, adalimumab, infliximab, and ustekinumab do not indicate an increased risk for depression. Intuitively, if a patient with severe psoriasis has depression worsened by their psoriasis, it stands to reason that improving their skin will likely improve their mood, which clinical trials have shown using patient-related outcomes.
—Jashin J. Wu, MD (Los Angeles, California)
Myth: Psoriasis treatments may cause depression
It has been well documented that patients with inflammatory diseases such as psoriasis have an increased risk for depression. One population-based cohort study in the United Kingdom reported the risk of depression was greater in patients with severe psoriasis versus mild psoriasis. Younger psoriasis patients also had a higher risk compared to older patients. A US population-based study also reported that psoriasis was associated with major depression, but the severity of psoriasis and patient's age were unrelated. Therefore, all psoriasis patients may be at risk.
But are some therapies associated with an increased risk of depression? Increased concentrations of proinflammatory cytokines such as tumor necrosis factor α have been associated with depression apart from psoriasis. Administering immunomodulating agents has been shown to increase the risk of depression.
Depression has been cited as an adverse effect of apremilast in the drug's package insert, which states, "Before using [apremilast] in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment." In clinical trials, 1.3% (12/920) of participants treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. Dermatologists should remain vigilant about monitoring for symptoms of depression in patients treated with apremilast.
However, depression in the context of autoimmune disorders or any disorder with increased inflammation has responded to treatment with tumor necrosis factor α antagonists. The relationship between depression and inflammation suggests that there is an inflammatory subtype of depression and use of anti-inflammatory agents may treat both inflammation and depression.
Disease control has been shown to improve symptoms of depression in psoriasis patients. A study of 618 patients with moderate to severe psoriasis who were treated with etanercept or placebo for 12 weeks revealed that more patients receiving etanercept experienced 50% improvement in 2 rating scales of depression compared to placebo.
Excessive worrying, a form of psychological distress, can impact treatment outcomes in patients with psoriasis. A 2003 study found that patients with psoriasis who are classified as high-level worriers may benefit from adjunctive psychological intervention before and during treatment. In this cohort of psoriasis patients receiving psoralen plus UVA (PUVA) therapy, high-level worry was the only significant predictor of time taken for PUVA to clear psoriasis (P=.01). Patients in the high-level worry group cleared with PUVA treatment at a rate of 1.8 times slower than the low-level worry group.
In conclusion, psoriasis patients should follow the treatment plan outlined by dermatologists, as improving psoriasis symptoms may help alleviate depression or prevent it from occurring. Patients with a history of depression should be monitored carefully by dermatologists or referred to another health care professional, and patients as well as family and friends should be encouraged to report any depression symptoms.
Expert Commentary
The prescribing information for apremilast lists a warning (but not a black-box warning) for depression. Long-term registries will determine if there is truly an increased risk of depression when taking apremilast. When I counsel patients before prescribing apremilast, I mention this potential increased risk of depression as noted in the prescribing information, but I tell them that the risk is very low and that a true risk has not yet been determined in long-term registries. I mention to patients that if they really do feel depressed after starting apremilast, they should stop taking apremilast and contact me.
Long-term registries for etanercept, adalimumab, infliximab, and ustekinumab do not indicate an increased risk for depression. Intuitively, if a patient with severe psoriasis has depression worsened by their psoriasis, it stands to reason that improving their skin will likely improve their mood, which clinical trials have shown using patient-related outcomes.
—Jashin J. Wu, MD (Los Angeles, California)
Almond M. Depression and inflammation: examining the link. Current Psychiatry. 2013;12:24-32.
Cohen BE, Martires KJ, Ho RS. Psoriasis and the risk of depression in the US population: National Health and Nutrition Examination Survey 2009-2012. JAMA Dermatol. 2016;152:73-79.
Fortune DG, Richards HL, Kirby B, et al. Psychological distress impairs clearance of psoriasis in patients treated with photochemotherapy. Arch Dermatol. 2003;139:752-756.
Kurd SK, Troxel AB, Crits-Christoph P, et al. The risk of depression, anxiety and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol. 2010;146:891-895.
Otezla [package insert]. Summit, NJ: Celgene Corporation; 2015.Research links psoriasis, depression [press release]. New York, NY: American Academy of Dermatology; August 20, 2015. https://www.aad.org/media/news-releases/research-links-psoriasis-depression. Accessed November 16, 2016.
Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367:29-35
Almond M. Depression and inflammation: examining the link. Current Psychiatry. 2013;12:24-32.
Cohen BE, Martires KJ, Ho RS. Psoriasis and the risk of depression in the US population: National Health and Nutrition Examination Survey 2009-2012. JAMA Dermatol. 2016;152:73-79.
Fortune DG, Richards HL, Kirby B, et al. Psychological distress impairs clearance of psoriasis in patients treated with photochemotherapy. Arch Dermatol. 2003;139:752-756.
Kurd SK, Troxel AB, Crits-Christoph P, et al. The risk of depression, anxiety and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol. 2010;146:891-895.
Otezla [package insert]. Summit, NJ: Celgene Corporation; 2015.Research links psoriasis, depression [press release]. New York, NY: American Academy of Dermatology; August 20, 2015. https://www.aad.org/media/news-releases/research-links-psoriasis-depression. Accessed November 16, 2016.
Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367:29-35
VIDEO: Consider comorbidities when preparing patients for systemic psoriasis therapy
LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.
In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.
Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.
In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.
Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.
In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.
Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
VIDEO: Biosimilars show promise and progress
LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.
“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.
The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.
However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.
“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.
The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.
However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.
“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.
The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.
However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Optimize anti–TNF-alpha therapy for psoriasis
While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.
Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
However, “no evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis,” Dr. Kerdel noted.
Patient factors that impact the choice and potential response of anti–TNF-alpha therapy include not only physical issues such as weight, disease activity, and comorbidities, but also patient preferences for simpler dosing regimens or a desire to avoid injections, he said.
Despite these issues, there is currently no consensus on and no guidelines for switching treatments after failure with an anti–TNF-alpha agent, he noted.
Other questions associated with anti–TNF-alpha agents in psoriasis include whether the loading dose recommended by most drug labels is necessary, according to Dr. Kerdel. “In practice, many clinicians omit the loading dosage and initiate therapy with maintenance doses,” he said. In addition, “physicians should use clinical judgment when screening and monitoring patients taking biologic agents.”
From a dermatologist perspective, the top unmet therapeutic needs in the treatment of psoriasis were improved efficacy, improved tolerability, improved long-term safety, another oral treatment option, and a new mechanism of action, based on a survey that included 391 dermatologists (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:2002-10).
As psoriasis treatments evolve, other issues include compiling real-world, postmarketing data on biosimilars; monitoring patients for the emergence of significant adverse events; and searching for biomarkers to help target biologics to specific patients and psoriasis subtypes, Dr. Kerdel added.
SDEF and this news organization are owned by the same parent company.
Dr. Kerdel disclosed being a speaker for AbbVie, Amgen, Celgene, Galderma, and Janssen; conducting research for those 5 companies and for Novartis, Pfizer, and Valeant; he is also on the board of Celgene.
While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.
Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
However, “no evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis,” Dr. Kerdel noted.
Patient factors that impact the choice and potential response of anti–TNF-alpha therapy include not only physical issues such as weight, disease activity, and comorbidities, but also patient preferences for simpler dosing regimens or a desire to avoid injections, he said.
Despite these issues, there is currently no consensus on and no guidelines for switching treatments after failure with an anti–TNF-alpha agent, he noted.
Other questions associated with anti–TNF-alpha agents in psoriasis include whether the loading dose recommended by most drug labels is necessary, according to Dr. Kerdel. “In practice, many clinicians omit the loading dosage and initiate therapy with maintenance doses,” he said. In addition, “physicians should use clinical judgment when screening and monitoring patients taking biologic agents.”
From a dermatologist perspective, the top unmet therapeutic needs in the treatment of psoriasis were improved efficacy, improved tolerability, improved long-term safety, another oral treatment option, and a new mechanism of action, based on a survey that included 391 dermatologists (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:2002-10).
As psoriasis treatments evolve, other issues include compiling real-world, postmarketing data on biosimilars; monitoring patients for the emergence of significant adverse events; and searching for biomarkers to help target biologics to specific patients and psoriasis subtypes, Dr. Kerdel added.
SDEF and this news organization are owned by the same parent company.
Dr. Kerdel disclosed being a speaker for AbbVie, Amgen, Celgene, Galderma, and Janssen; conducting research for those 5 companies and for Novartis, Pfizer, and Valeant; he is also on the board of Celgene.
While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.
Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
However, “no evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis,” Dr. Kerdel noted.
Patient factors that impact the choice and potential response of anti–TNF-alpha therapy include not only physical issues such as weight, disease activity, and comorbidities, but also patient preferences for simpler dosing regimens or a desire to avoid injections, he said.
Despite these issues, there is currently no consensus on and no guidelines for switching treatments after failure with an anti–TNF-alpha agent, he noted.
Other questions associated with anti–TNF-alpha agents in psoriasis include whether the loading dose recommended by most drug labels is necessary, according to Dr. Kerdel. “In practice, many clinicians omit the loading dosage and initiate therapy with maintenance doses,” he said. In addition, “physicians should use clinical judgment when screening and monitoring patients taking biologic agents.”
From a dermatologist perspective, the top unmet therapeutic needs in the treatment of psoriasis were improved efficacy, improved tolerability, improved long-term safety, another oral treatment option, and a new mechanism of action, based on a survey that included 391 dermatologists (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:2002-10).
As psoriasis treatments evolve, other issues include compiling real-world, postmarketing data on biosimilars; monitoring patients for the emergence of significant adverse events; and searching for biomarkers to help target biologics to specific patients and psoriasis subtypes, Dr. Kerdel added.
SDEF and this news organization are owned by the same parent company.
Dr. Kerdel disclosed being a speaker for AbbVie, Amgen, Celgene, Galderma, and Janssen; conducting research for those 5 companies and for Novartis, Pfizer, and Valeant; he is also on the board of Celgene.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
VIDEO: IL-23 inhibitors on the upswing
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.
“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.
Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Include quality of life measures in evaluating treatment success of psoriasis
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Biologic-naive psoriasis patients get biggest boost with treatment
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
LAS VEGAS – Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another, according to a systematic review of 15 studies in adults with psoriasis.
In a real-world setting, patients who fail treatment with a tumor necrosis factor–alfa (TNF-alfa) inhibitor or ustekinumab may be switched from one treatment to another, Steven R. Feldman, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said in a poster presented at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “However, there is conflicting evidence of reduced effectiveness in later lines of treatment,” he added.
In four of the studies, biologic-naive patients showed significantly better responses when given anti-TNF agents than patients who had been treated with a biologic. Another study showed that the reduced effectiveness of adalimumab treatment was associated with the number of previous treatments with anti-TNFs (hazard ratio, 1.63). Another study found an association between previous treatment with etanercept and loss of response and serious adverse effects (HR, 4.32).
The other nine studies suggested some evidence of effectiveness for treatment with anti-TNFs or ustekinumab as later lines of treatment for psoriasis patients, but most of the studies (six of nine) did not include information on whether the results were statistically significant.
“More real-world evidence and future research in studies with large sample sizes are needed to further understand the role of anti-TNF and ustekinumab as later-line treatment in psoriasis management,” Dr. Feldman said.
He disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis. SDEF and this organization are owned by the same parent company.
AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
Key clinical point:
Major finding: Biologic-naive psoriasis patients had stronger responses to treatment than those who were previously treated and switched from one biologic to another.
Data source: A systematic review of 15 observational studies of adults with psoriasis evaluating anti-TNF agents or ustekinumab as second-line or later-line treatments.
Disclosures: Dr. Feldman disclosed relationships with multiple companies, including study sponsor Novartis; one of the study coauthors is affiliated with Novartis.
Study offers reassuring data on certolizumab use in pregnancy
VIENNA – Data from a large prospective registry of pregnancy outcomes in women on certolizumab are reassuring to date, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“This unique dataset of pregnancies exposed to a single agent suggests that exposure is really not a problem, although we’ll continue to collect prospective data and anticipate doing so in women with psoriasis going forward,” said Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
Certolizumab is a tumor necrosis factor–alpha inhibitor currently approved in the United States for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is now in clinical trials for psoriasis, and Dr. Kimball said she expects that it will eventually receive an indication for that disease as well. In the interim, she switches her psoriasis patients who are pregnant or plan to become so to either off-label certolizumab or etanercept (Enbrel). She does the same for her psoriatic arthritis patients, although in that situation certolizumab is on-label therapy.
The reason she turns to etanercept or certolizumab in pregnancy or anticipated pregnancy is that these two biologics, unlike others, don’t cross the placenta in the third trimester.
“I’m concerned about the selective uptake of other monoclonal antibodies in the third trimester. We do see in babies born to moms exposed to these other drugs – like ustekinumab, infliximab, and adalimumab – that the baby’s drug blood levels at birth are higher than the mom’s, so you have potentially put them at some risk for infections unnecessarily and maybe have affected how their immune system develops. So if a woman comes to me who is pregnant and on a biologic agent I would either stop treatment in the second trimester or switch to etanercept or certolizumab,” the dermatologist said.
Of the 256 pregnancies prospectively followed in the UCB certolizumab registry, 80.9% resulted in live births, and 10.2% ended in spontaneous abortion or miscarriage. In addition, the induced abortion rate was 8.6%, and there was a single stillbirth.
Of note, the mean age at pregnancy was 31 years, and 29% of the women became pregnant at age 35 or older. In contrast, the mean age at first pregnancy in the general population is 26, and only about 10% are 35 or older. These data are consistent with Dr. Kimball’s own clinical experience, which is that women with moderate to severe psoriasis or psoriatic arthritis often have trouble conceiving, and if they eventually succeed it’s often at a more advanced age.
The rate of maternal complications in this series was unremarkable: preeclampsia in 3.5%, infection in 3.9%, disease flare in 5.1%, and gestational diabetes in 3.1%. The median gestational age at birth was 39 weeks. The rate of early preterm birth before 32 weeks was 3.5%, with 12.6% of babies arriving at 32-36 weeks. Considering these are older moms being treated for serious underlying systemic inflammatory diseases, these numbers look good, according to Dr. Kimball.
Most women were exposed to certolizumab during the first trimester at least, and many were on the drug throughout pregnancy.
She said about one-third of psoriasis patients experience improvement in their skin diseases during pregnancy.
“If they’re doing really well, I see no reason to keep them on systemic therapy during pregnancy. But I will say that I see a lot of very bad postpartum flares, and I’m quite cautious about that. For the women with psoriatic arthritis there may not be a choice; you may need to continue to treat them all the way through their pregnancy to keep from getting permanent joint destruction,” the dermatologist said.
Dr. Kimball reported receiving research grants from and serving as a consultant to UCB and numerous other pharmaceutical companies.
VIENNA – Data from a large prospective registry of pregnancy outcomes in women on certolizumab are reassuring to date, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“This unique dataset of pregnancies exposed to a single agent suggests that exposure is really not a problem, although we’ll continue to collect prospective data and anticipate doing so in women with psoriasis going forward,” said Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
Certolizumab is a tumor necrosis factor–alpha inhibitor currently approved in the United States for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is now in clinical trials for psoriasis, and Dr. Kimball said she expects that it will eventually receive an indication for that disease as well. In the interim, she switches her psoriasis patients who are pregnant or plan to become so to either off-label certolizumab or etanercept (Enbrel). She does the same for her psoriatic arthritis patients, although in that situation certolizumab is on-label therapy.
The reason she turns to etanercept or certolizumab in pregnancy or anticipated pregnancy is that these two biologics, unlike others, don’t cross the placenta in the third trimester.
“I’m concerned about the selective uptake of other monoclonal antibodies in the third trimester. We do see in babies born to moms exposed to these other drugs – like ustekinumab, infliximab, and adalimumab – that the baby’s drug blood levels at birth are higher than the mom’s, so you have potentially put them at some risk for infections unnecessarily and maybe have affected how their immune system develops. So if a woman comes to me who is pregnant and on a biologic agent I would either stop treatment in the second trimester or switch to etanercept or certolizumab,” the dermatologist said.
Of the 256 pregnancies prospectively followed in the UCB certolizumab registry, 80.9% resulted in live births, and 10.2% ended in spontaneous abortion or miscarriage. In addition, the induced abortion rate was 8.6%, and there was a single stillbirth.
Of note, the mean age at pregnancy was 31 years, and 29% of the women became pregnant at age 35 or older. In contrast, the mean age at first pregnancy in the general population is 26, and only about 10% are 35 or older. These data are consistent with Dr. Kimball’s own clinical experience, which is that women with moderate to severe psoriasis or psoriatic arthritis often have trouble conceiving, and if they eventually succeed it’s often at a more advanced age.
The rate of maternal complications in this series was unremarkable: preeclampsia in 3.5%, infection in 3.9%, disease flare in 5.1%, and gestational diabetes in 3.1%. The median gestational age at birth was 39 weeks. The rate of early preterm birth before 32 weeks was 3.5%, with 12.6% of babies arriving at 32-36 weeks. Considering these are older moms being treated for serious underlying systemic inflammatory diseases, these numbers look good, according to Dr. Kimball.
Most women were exposed to certolizumab during the first trimester at least, and many were on the drug throughout pregnancy.
She said about one-third of psoriasis patients experience improvement in their skin diseases during pregnancy.
“If they’re doing really well, I see no reason to keep them on systemic therapy during pregnancy. But I will say that I see a lot of very bad postpartum flares, and I’m quite cautious about that. For the women with psoriatic arthritis there may not be a choice; you may need to continue to treat them all the way through their pregnancy to keep from getting permanent joint destruction,” the dermatologist said.
Dr. Kimball reported receiving research grants from and serving as a consultant to UCB and numerous other pharmaceutical companies.
VIENNA – Data from a large prospective registry of pregnancy outcomes in women on certolizumab are reassuring to date, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“This unique dataset of pregnancies exposed to a single agent suggests that exposure is really not a problem, although we’ll continue to collect prospective data and anticipate doing so in women with psoriasis going forward,” said Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.
Certolizumab is a tumor necrosis factor–alpha inhibitor currently approved in the United States for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is now in clinical trials for psoriasis, and Dr. Kimball said she expects that it will eventually receive an indication for that disease as well. In the interim, she switches her psoriasis patients who are pregnant or plan to become so to either off-label certolizumab or etanercept (Enbrel). She does the same for her psoriatic arthritis patients, although in that situation certolizumab is on-label therapy.
The reason she turns to etanercept or certolizumab in pregnancy or anticipated pregnancy is that these two biologics, unlike others, don’t cross the placenta in the third trimester.
“I’m concerned about the selective uptake of other monoclonal antibodies in the third trimester. We do see in babies born to moms exposed to these other drugs – like ustekinumab, infliximab, and adalimumab – that the baby’s drug blood levels at birth are higher than the mom’s, so you have potentially put them at some risk for infections unnecessarily and maybe have affected how their immune system develops. So if a woman comes to me who is pregnant and on a biologic agent I would either stop treatment in the second trimester or switch to etanercept or certolizumab,” the dermatologist said.
Of the 256 pregnancies prospectively followed in the UCB certolizumab registry, 80.9% resulted in live births, and 10.2% ended in spontaneous abortion or miscarriage. In addition, the induced abortion rate was 8.6%, and there was a single stillbirth.
Of note, the mean age at pregnancy was 31 years, and 29% of the women became pregnant at age 35 or older. In contrast, the mean age at first pregnancy in the general population is 26, and only about 10% are 35 or older. These data are consistent with Dr. Kimball’s own clinical experience, which is that women with moderate to severe psoriasis or psoriatic arthritis often have trouble conceiving, and if they eventually succeed it’s often at a more advanced age.
The rate of maternal complications in this series was unremarkable: preeclampsia in 3.5%, infection in 3.9%, disease flare in 5.1%, and gestational diabetes in 3.1%. The median gestational age at birth was 39 weeks. The rate of early preterm birth before 32 weeks was 3.5%, with 12.6% of babies arriving at 32-36 weeks. Considering these are older moms being treated for serious underlying systemic inflammatory diseases, these numbers look good, according to Dr. Kimball.
Most women were exposed to certolizumab during the first trimester at least, and many were on the drug throughout pregnancy.
She said about one-third of psoriasis patients experience improvement in their skin diseases during pregnancy.
“If they’re doing really well, I see no reason to keep them on systemic therapy during pregnancy. But I will say that I see a lot of very bad postpartum flares, and I’m quite cautious about that. For the women with psoriatic arthritis there may not be a choice; you may need to continue to treat them all the way through their pregnancy to keep from getting permanent joint destruction,” the dermatologist said.
Dr. Kimball reported receiving research grants from and serving as a consultant to UCB and numerous other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point:
Major finding: The rate of major congenital malformations in a large prospective series of pregnancies in women on certolizumab was reassuringly low at 4.2%, with no pattern of malformations being seen.
Data source: This was a report on maternal and fetal outcomes of 256 prospectively followed pregnancies in women on certolizumab.
Disclosures: The presenter reported receiving research funds from and serving as a consultant to UCB, which markets certolizumab and maintains the pregnancy registry.
What good are biosimilars if patients won’t use them?
BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.
BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.
BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.
EXPERT ANALYSIS FROM A BIOSIMILARS IN RHEUMATOLOGY SYMPOSIUM
