Psoriasis Collection

Biologic agents have provided patients with moderate to severe psoriasis with treatment alternatives that have improved systemic safety profiles and disease control¹; however, case reports of associated neurologic complications have been emerging. Tumor necrosis factor α (TNF-α) inhibitors have been associated with central and peripheral demyelinating disorders. Notably, efalizumab was withdrawn from the market for its association with fatal cases of progressive multifocal leukoencephalopathy (PML).^2,3 It is imperative for dermatologists to be familiar with the clinical presentation, evaluation, and diagnostic criteria of neurologic complications of biologic agents used in the treatment of psoriasis.

Leukoencephalopathy

Progressive multifocal leukoencephalopathy is a fatal demyelinating neurodegenerative disease caused by reactivation of the ubiquitous John Cunningham virus. Primary asymptomatic infection is thought to occur during childhood, then the virus remains latent. Reactivation usually occurs during severe immunosuppression and is classically described in human immunodeficiency virus infection, lymphoproliferative disorders, and other forms of cancer.⁴ A summary of PML and its association with biologics is found in Table 1.^5-13 Few case reports of TNF-α inhibitor–associated PML exist, mostly in the presence of confounding factors such as immunosuppression or underlying autoimmune disease.^10-13 Presenting symptoms of PML often are subacute, rapidly progressive, and can be focal or multifocal and include motor, cognitive, and visual deficits. Of note, there are 2 reported cases of ustekinumab associated with reversible posterior leukoencephalopathy syndrome, which is a hypertensive encephalopathy characterized by headache, altered mental status, vision abnormalities, and seizures.^14,15 Fortunately, this disease is reversible with blood pressure control and removal of the immunosuppressive agent.¹⁶

Demyelinating Disorders

Clinical presentation of demyelinating events associated with biologic agents are varied but include optic neuritis, multiple sclerosis, transverse myelitis, and Guillain-Barré syndrome, among others.^17-28 These demyelinating disorders with their salient features and associated biologics are summarized in Table 2.^17-20,22-28 Patients on biologic agents, especially TNF-α inhibitors, with new-onset visual, motor, or sensory changes warrant closer inspection. Currently, there are no data on any neurologic side effects occurring with the new biologic secukinumab.²⁹

Conclusion

Biologic agents are effective in treating moderate to severe plaque psoriasis, but awareness of associated neurological adverse effects, though rare, is important to consider. Physicians need to be able to counsel patients concerning these risks and promote informed decision-making prior to initiating biologics. Patients with a personal or strong family history of demyelinating disease should be considered for alternative treatment options before initiating anti–TNF-α therapy. Since the withdrawal of efalizumab, no new cases of PML have been reported in patients who were previously on a long-term course. Dermatologists should be vigilant in detecting signs of neurological complications so that an expedited evaluation and neurology referral may prevent progression of disease.

Biologic agents have provided patients with moderate to severe psoriasis with treatment alternatives that have improved systemic safety profiles and disease control¹; however, case reports of associated neurologic complications have been emerging. Tumor necrosis factor α (TNF-α) inhibitors have been associated with central and peripheral demyelinating disorders. Notably, efalizumab was withdrawn from the market for its association with fatal cases of progressive multifocal leukoencephalopathy (PML).^2,3 It is imperative for dermatologists to be familiar with the clinical presentation, evaluation, and diagnostic criteria of neurologic complications of biologic agents used in the treatment of psoriasis.

Leukoencephalopathy

Progressive multifocal leukoencephalopathy is a fatal demyelinating neurodegenerative disease caused by reactivation of the ubiquitous John Cunningham virus. Primary asymptomatic infection is thought to occur during childhood, then the virus remains latent. Reactivation usually occurs during severe immunosuppression and is classically described in human immunodeficiency virus infection, lymphoproliferative disorders, and other forms of cancer.⁴ A summary of PML and its association with biologics is found in Table 1.^5-13 Few case reports of TNF-α inhibitor–associated PML exist, mostly in the presence of confounding factors such as immunosuppression or underlying autoimmune disease.^10-13 Presenting symptoms of PML often are subacute, rapidly progressive, and can be focal or multifocal and include motor, cognitive, and visual deficits. Of note, there are 2 reported cases of ustekinumab associated with reversible posterior leukoencephalopathy syndrome, which is a hypertensive encephalopathy characterized by headache, altered mental status, vision abnormalities, and seizures.^14,15 Fortunately, this disease is reversible with blood pressure control and removal of the immunosuppressive agent.¹⁶

Demyelinating Disorders

Clinical presentation of demyelinating events associated with biologic agents are varied but include optic neuritis, multiple sclerosis, transverse myelitis, and Guillain-Barré syndrome, among others.^17-28 These demyelinating disorders with their salient features and associated biologics are summarized in Table 2.^17-20,22-28 Patients on biologic agents, especially TNF-α inhibitors, with new-onset visual, motor, or sensory changes warrant closer inspection. Currently, there are no data on any neurologic side effects occurring with the new biologic secukinumab.²⁹

Conclusion

Biologic agents are effective in treating moderate to severe plaque psoriasis, but awareness of associated neurological adverse effects, though rare, is important to consider. Physicians need to be able to counsel patients concerning these risks and promote informed decision-making prior to initiating biologics. Patients with a personal or strong family history of demyelinating disease should be considered for alternative treatment options before initiating anti–TNF-α therapy. Since the withdrawal of efalizumab, no new cases of PML have been reported in patients who were previously on a long-term course. Dermatologists should be vigilant in detecting signs of neurological complications so that an expedited evaluation and neurology referral may prevent progression of disease.

Biologic agents have provided patients with moderate to severe psoriasis with treatment alternatives that have improved systemic safety profiles and disease control¹; however, case reports of associated neurologic complications have been emerging. Tumor necrosis factor α (TNF-α) inhibitors have been associated with central and peripheral demyelinating disorders. Notably, efalizumab was withdrawn from the market for its association with fatal cases of progressive multifocal leukoencephalopathy (PML).^2,3 It is imperative for dermatologists to be familiar with the clinical presentation, evaluation, and diagnostic criteria of neurologic complications of biologic agents used in the treatment of psoriasis.

Leukoencephalopathy

Progressive multifocal leukoencephalopathy is a fatal demyelinating neurodegenerative disease caused by reactivation of the ubiquitous John Cunningham virus. Primary asymptomatic infection is thought to occur during childhood, then the virus remains latent. Reactivation usually occurs during severe immunosuppression and is classically described in human immunodeficiency virus infection, lymphoproliferative disorders, and other forms of cancer.⁴ A summary of PML and its association with biologics is found in Table 1.^5-13 Few case reports of TNF-α inhibitor–associated PML exist, mostly in the presence of confounding factors such as immunosuppression or underlying autoimmune disease.^10-13 Presenting symptoms of PML often are subacute, rapidly progressive, and can be focal or multifocal and include motor, cognitive, and visual deficits. Of note, there are 2 reported cases of ustekinumab associated with reversible posterior leukoencephalopathy syndrome, which is a hypertensive encephalopathy characterized by headache, altered mental status, vision abnormalities, and seizures.^14,15 Fortunately, this disease is reversible with blood pressure control and removal of the immunosuppressive agent.¹⁶

Demyelinating Disorders

Clinical presentation of demyelinating events associated with biologic agents are varied but include optic neuritis, multiple sclerosis, transverse myelitis, and Guillain-Barré syndrome, among others.^17-28 These demyelinating disorders with their salient features and associated biologics are summarized in Table 2.^17-20,22-28 Patients on biologic agents, especially TNF-α inhibitors, with new-onset visual, motor, or sensory changes warrant closer inspection. Currently, there are no data on any neurologic side effects occurring with the new biologic secukinumab.²⁹

Conclusion

Biologic agents are effective in treating moderate to severe plaque psoriasis, but awareness of associated neurological adverse effects, though rare, is important to consider. Physicians need to be able to counsel patients concerning these risks and promote informed decision-making prior to initiating biologics. Patients with a personal or strong family history of demyelinating disease should be considered for alternative treatment options before initiating anti–TNF-α therapy. Since the withdrawal of efalizumab, no new cases of PML have been reported in patients who were previously on a long-term course. Dermatologists should be vigilant in detecting signs of neurological complications so that an expedited evaluation and neurology referral may prevent progression of disease.

Black, Asian, and other non-Hispanic Americans are less likely than are whites to seek treatment for psoriasis, according to data on 842 patients, reported Alexander H. Fischer, MD, of the University of Pennsylvania, Philadelphia, and his colleagues.

Data from previous studies have shown that racial and ethnic minorities have more severe psoriasis and a lower quality of life as a result of the disease, compared with white patients, the researchers noted in a study published as a research letter in the Journal of the American Academy of Dermatology.

Penn Medicine

SOURCE: Fischer AH et al. J Am Acad Dermatol. 2018 Jan;78[1]:200-3. doi: 10.1016/j.jaad.2017.07.052.

Black, Asian, and other non-Hispanic Americans are less likely than are whites to seek treatment for psoriasis, according to data on 842 patients, reported Alexander H. Fischer, MD, of the University of Pennsylvania, Philadelphia, and his colleagues.

Data from previous studies have shown that racial and ethnic minorities have more severe psoriasis and a lower quality of life as a result of the disease, compared with white patients, the researchers noted in a study published as a research letter in the Journal of the American Academy of Dermatology.

Penn Medicine

SOURCE: Fischer AH et al. J Am Acad Dermatol. 2018 Jan;78[1]:200-3. doi: 10.1016/j.jaad.2017.07.052.

Black, Asian, and other non-Hispanic Americans are less likely than are whites to seek treatment for psoriasis, according to data on 842 patients, reported Alexander H. Fischer, MD, of the University of Pennsylvania, Philadelphia, and his colleagues.

Data from previous studies have shown that racial and ethnic minorities have more severe psoriasis and a lower quality of life as a result of the disease, compared with white patients, the researchers noted in a study published as a research letter in the Journal of the American Academy of Dermatology.

Penn Medicine

SOURCE: Fischer AH et al. J Am Acad Dermatol. 2018 Jan;78[1]:200-3. doi: 10.1016/j.jaad.2017.07.052.

Myth: Patients Are Not Willing to Give Themselves Injections

Injectable biologics target specific parts of the immune system, making them popular treatment options for psoriasis patients, with ample research on their efficacy. Performing a self-injection can be daunting for patients trying a biologic for the first time, and clinicians should be aware of the dearth of patient education material. Although patients may be fearful of self-injections, especially the first few treatments, their worries can be assuaged with proper instruction and appropriate delivery method.

Abrouk et al sought to provide an online guide and video on biologic injections to increase the success of the therapy and compliance among patients. They created a printable guide that covers the supplies needed, procedure techniques, and plans for traveling with medications. Because pain is a common concern for patients, they suggest numbing the injection area with an ice pack first. They also offer tips on dealing with injection-site reactions such as redness or bruising.

Nurse practitioners and physician assistants can be used to give psoriasis patients more personalized attention regarding the fear of injections. They can explain the injection procedures and describe differences between administration techniques. Some patients may prefer using an autoinjector versus a prefilled syringe, which may impact the treatment administered. Taking photographs to show progress with therapy also may motivate patients to tolerate therapy.

The National Psoriasis Foundation provides the following tips to make it easier for patients to self-inject and reduce the chance of an injection-site reaction:

• Pick an easy injection site, such as the top of the rights, abdomen, or back of the arms.
• Rotate injection sites from right to left.
• Numb the area.
• Warm the pen up by taking it out of the refrigerator 1.5 hours before it is used.
• Be patient and avoid moving the injection pen before the needle is finished administering the drug.

By giving psoriasis patients educational materials, you can empower them to control their disease with injectable biologics.

Expert Commentary

Most of my patients who use a biologic for the first time are undaunted by learning to inject themselves. I can think of just 1 of my ~300 biologic patients who has to come in every few weeks for their medicine to be injected by one of our nurses. Surprisingly, some patients (I'd estimate 5% of my biologic patients) actually prefer the syringe compared to the autoinjector, with some comments saying that the syringe is less painful and less abrupt. Needle phobia should not be a reason to not prescribe a biologic for a patient with severe psoriasis who needs it.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Patients Are Not Willing to Give Themselves Injections

Injectable biologics target specific parts of the immune system, making them popular treatment options for psoriasis patients, with ample research on their efficacy. Performing a self-injection can be daunting for patients trying a biologic for the first time, and clinicians should be aware of the dearth of patient education material. Although patients may be fearful of self-injections, especially the first few treatments, their worries can be assuaged with proper instruction and appropriate delivery method.

Abrouk et al sought to provide an online guide and video on biologic injections to increase the success of the therapy and compliance among patients. They created a printable guide that covers the supplies needed, procedure techniques, and plans for traveling with medications. Because pain is a common concern for patients, they suggest numbing the injection area with an ice pack first. They also offer tips on dealing with injection-site reactions such as redness or bruising.

Nurse practitioners and physician assistants can be used to give psoriasis patients more personalized attention regarding the fear of injections. They can explain the injection procedures and describe differences between administration techniques. Some patients may prefer using an autoinjector versus a prefilled syringe, which may impact the treatment administered. Taking photographs to show progress with therapy also may motivate patients to tolerate therapy.

The National Psoriasis Foundation provides the following tips to make it easier for patients to self-inject and reduce the chance of an injection-site reaction:

• Pick an easy injection site, such as the top of the rights, abdomen, or back of the arms.
• Rotate injection sites from right to left.
• Numb the area.
• Warm the pen up by taking it out of the refrigerator 1.5 hours before it is used.
• Be patient and avoid moving the injection pen before the needle is finished administering the drug.

By giving psoriasis patients educational materials, you can empower them to control their disease with injectable biologics.

Expert Commentary

Most of my patients who use a biologic for the first time are undaunted by learning to inject themselves. I can think of just 1 of my ~300 biologic patients who has to come in every few weeks for their medicine to be injected by one of our nurses. Surprisingly, some patients (I'd estimate 5% of my biologic patients) actually prefer the syringe compared to the autoinjector, with some comments saying that the syringe is less painful and less abrupt. Needle phobia should not be a reason to not prescribe a biologic for a patient with severe psoriasis who needs it.

—Jashin J. Wu, MD (Los Angeles, California)

Myth: Patients Are Not Willing to Give Themselves Injections

Injectable biologics target specific parts of the immune system, making them popular treatment options for psoriasis patients, with ample research on their efficacy. Performing a self-injection can be daunting for patients trying a biologic for the first time, and clinicians should be aware of the dearth of patient education material. Although patients may be fearful of self-injections, especially the first few treatments, their worries can be assuaged with proper instruction and appropriate delivery method.

Abrouk et al sought to provide an online guide and video on biologic injections to increase the success of the therapy and compliance among patients. They created a printable guide that covers the supplies needed, procedure techniques, and plans for traveling with medications. Because pain is a common concern for patients, they suggest numbing the injection area with an ice pack first. They also offer tips on dealing with injection-site reactions such as redness or bruising.

Nurse practitioners and physician assistants can be used to give psoriasis patients more personalized attention regarding the fear of injections. They can explain the injection procedures and describe differences between administration techniques. Some patients may prefer using an autoinjector versus a prefilled syringe, which may impact the treatment administered. Taking photographs to show progress with therapy also may motivate patients to tolerate therapy.

The National Psoriasis Foundation provides the following tips to make it easier for patients to self-inject and reduce the chance of an injection-site reaction:

• Pick an easy injection site, such as the top of the rights, abdomen, or back of the arms.
• Rotate injection sites from right to left.
• Numb the area.
• Warm the pen up by taking it out of the refrigerator 1.5 hours before it is used.
• Be patient and avoid moving the injection pen before the needle is finished administering the drug.

By giving psoriasis patients educational materials, you can empower them to control their disease with injectable biologics.

Expert Commentary

Most of my patients who use a biologic for the first time are undaunted by learning to inject themselves. I can think of just 1 of my ~300 biologic patients who has to come in every few weeks for their medicine to be injected by one of our nurses. Surprisingly, some patients (I'd estimate 5% of my biologic patients) actually prefer the syringe compared to the autoinjector, with some comments saying that the syringe is less painful and less abrupt. Needle phobia should not be a reason to not prescribe a biologic for a patient with severe psoriasis who needs it.

—Jashin J. Wu, MD (Los Angeles, California)

GENEVA – The interleukin-23 inhibitor guselkumab generates the same impressive improvement in skin disease in psoriatic arthritis patients as has been seen in psoriasis without joint disease, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

However, psoriatic arthritis patients’ improvement in Dermatology Life Quality Index (DLQI) scores is less robust than in patients with psoriasis only, added Dr. Kimball, professor of dermatology at Harvard Medical School, Boston, and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center.

Bruce Jancin/Frontline Medical News

[email protected]

SOURCE: Kimball A et al. https://eadvgeneva2017.org/

GENEVA – The interleukin-23 inhibitor guselkumab generates the same impressive improvement in skin disease in psoriatic arthritis patients as has been seen in psoriasis without joint disease, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

However, psoriatic arthritis patients’ improvement in Dermatology Life Quality Index (DLQI) scores is less robust than in patients with psoriasis only, added Dr. Kimball, professor of dermatology at Harvard Medical School, Boston, and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center.

Bruce Jancin/Frontline Medical News

[email protected]

SOURCE: Kimball A et al. https://eadvgeneva2017.org/

GENEVA – The interleukin-23 inhibitor guselkumab generates the same impressive improvement in skin disease in psoriatic arthritis patients as has been seen in psoriasis without joint disease, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

However, psoriatic arthritis patients’ improvement in Dermatology Life Quality Index (DLQI) scores is less robust than in patients with psoriasis only, added Dr. Kimball, professor of dermatology at Harvard Medical School, Boston, and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center.

Bruce Jancin/Frontline Medical News

[email protected]

SOURCE: Kimball A et al. https://eadvgeneva2017.org/

The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.

Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

[email protected]

The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.

Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

[email protected]

The Food and Drug Administration has approved Ixifi (infliximab-qbtx), a biosimilar of Remicade, the original infliximab product. Ixifi is the third infliximab biosimilar to be approved by the FDA, and it is approved for all the same indications as Remicade, according to an announcement from its manufacturer, Pfizer.

Ixifi and Remicade are approved for the treatment of rheumatoid arthritis in combination with methotrexate, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

[email protected]

GENEVA – The merits of addressing interleukin-23 as a novel therapeutic target in moderate to severe plaque psoriasis were abundantly displayed in 2-year outcomes data for two anti–IL-23 monoclonal antibodies – guselkumab and tildrakizumab – in studies presented back to back at the annual congress of the European Academy of Dermatology and Venereology.

These long-term, open-label extensions of previously reported phase 3, randomized, double-blind clinical trials provided evidence of multiple advantages for IL-23 inhibition. The story was similar for both agents: After 2 years of use in the extension studies, the two biologics demonstrated stellar treatment response rates that would have been unimaginable only a few years ago, maintenance of efficacy without drop-off over time, exceedingly low dropout rates, and a safety picture that remains reassuring as experience accumulates. Also, the subcutaneously administered IL-23 inhibitors are attractive from a patient convenience standpoint in that maintenance guselkumab is dosed at 100 mg once every 8 weeks, and tildrakizumab is given once every 12 weeks.

Still, there are differences between the two drugs, most notably in apparent effectiveness. While more than half of guselkumab-treated patients had a Psoriasis Area Severity Index (PASI) 100 response – that is, totally clear skin – at 2 years, that was the case for only one-quarter to one-third of patients on tildrakizumab.

Guselkumab (Tremfya) was approved by the Food and Drug Administration in July 2017 for treatment of adults with moderate to severe plaque psoriasis. Tildrakizumab remains investigational.
 

Guselkumab

The 2-year, open-label extension of the phase 3 VOYAGE 1 trial included 735 patients who were either on guselkumab continuously, crossed from adalimumab (Humira) to guselkumab after 48 weeks, or switched from placebo after 16 weeks.

Bruce Jancin/Frontline Medical News

Tildrakizumab

Two-year results from the ongoing 5-year extension of the phase 3 reSURFACE 1 and reSURFACE 2 trials were presented by Kim A. Papp, MD, PhD, president of Probity Medical Research, Waterloo, Ont. This presentation of 2-year outcomes for 1,237 study participants was a feat, considering that the 12-week results of the trials had been published less than 3 months earlier (Lancet. 2017 Jul 15;390[10091]:276-88).

Bruce Jancin/Frontline Medical News

Controversy over how to report long-term outcomes

A hot topic among clinical trialists in dermatology concerns how to report study results. The traditional method in studies funded by pharmaceutical companies is known as the “last observation carried forward” analysis. It casts the study drug results in the most favorable possible light because, when a subject drops out of a trial for any reason, their last measured value for response to treatment is carried forward as though the patient completed the study. Thus, psoriasis patients who drop out because they couldn’t tolerate a therapy or developed a serious side effect dictating discontinuation will be scored on the basis of their last PASI response, creating a bias in favor of active treatment.

A more conservative analytic method is known as the “nonresponder imputation” analysis. By this method, a patient who drops out of a trial is automatically categorized as a treatment failure, even if the reason was that the patient moved and could no longer make visits to the study center.

The prespecified guselkumab analysis presented by Dr. Blauvelt involved nonresponder imputation through year 1 and imputation based on the reason for discontinuation in the second year. In contrast, the 2-year tildrakizumab analysis presented by Dr. Papp used the far more common last observation carried forward method.

To help the audience appreciate the importance of looking at the analytic methods used in a studies and help them understand the clinical significance of the results, Dr. Blauvelt provided a reanalysis of the 2-year guselkumab data using the last observation carried forward method. Across the board, the numbers became more favorable. For example, the PASI 75 rate of 95.7% using the prespecified nonresponder imputation analysis crept up to 96.8% under the last observation carried forward method; for comparison, the PASI 75 rates were 81%-84% in the tildrakizumab analysis.

“If you wanted to compare apples to apples with some other drugs, you would use these numbers – the as-observed analysis numbers used by most other companies with other drugs. If you wanted to determine what the true-life numbers are, they’d probably be something between the nonresponder imputation and as-observed numbers,” said to Dr. Blauvelt.

Dr. Papp was untroubled by the use of the last observation carried forward method in the particular case of the tildrakizumab long-term extension study.

“There is reason to believe the as-observed analysis doesn’t affect the integrity of the data because the dropout rate is extraordinarily low,” he said.

The guselkumab analysis was sponsored by Janssen Pharmaceutica; the tildrakizumab analysis was sponsored by Merck and by Sun Pharma. Dr. Blauvelt and Dr. Papp were paid investigators in both studies and serve as scientific advisers to virtually all companies invested in the psoriasis therapy developmental pipeline.

[email protected]

GENEVA – The merits of addressing interleukin-23 as a novel therapeutic target in moderate to severe plaque psoriasis were abundantly displayed in 2-year outcomes data for two anti–IL-23 monoclonal antibodies – guselkumab and tildrakizumab – in studies presented back to back at the annual congress of the European Academy of Dermatology and Venereology.

These long-term, open-label extensions of previously reported phase 3, randomized, double-blind clinical trials provided evidence of multiple advantages for IL-23 inhibition. The story was similar for both agents: After 2 years of use in the extension studies, the two biologics demonstrated stellar treatment response rates that would have been unimaginable only a few years ago, maintenance of efficacy without drop-off over time, exceedingly low dropout rates, and a safety picture that remains reassuring as experience accumulates. Also, the subcutaneously administered IL-23 inhibitors are attractive from a patient convenience standpoint in that maintenance guselkumab is dosed at 100 mg once every 8 weeks, and tildrakizumab is given once every 12 weeks.

Still, there are differences between the two drugs, most notably in apparent effectiveness. While more than half of guselkumab-treated patients had a Psoriasis Area Severity Index (PASI) 100 response – that is, totally clear skin – at 2 years, that was the case for only one-quarter to one-third of patients on tildrakizumab.

Guselkumab (Tremfya) was approved by the Food and Drug Administration in July 2017 for treatment of adults with moderate to severe plaque psoriasis. Tildrakizumab remains investigational.
 

Guselkumab

The 2-year, open-label extension of the phase 3 VOYAGE 1 trial included 735 patients who were either on guselkumab continuously, crossed from adalimumab (Humira) to guselkumab after 48 weeks, or switched from placebo after 16 weeks.

Bruce Jancin/Frontline Medical News

Tildrakizumab

Two-year results from the ongoing 5-year extension of the phase 3 reSURFACE 1 and reSURFACE 2 trials were presented by Kim A. Papp, MD, PhD, president of Probity Medical Research, Waterloo, Ont. This presentation of 2-year outcomes for 1,237 study participants was a feat, considering that the 12-week results of the trials had been published less than 3 months earlier (Lancet. 2017 Jul 15;390[10091]:276-88).

Bruce Jancin/Frontline Medical News

Controversy over how to report long-term outcomes

A hot topic among clinical trialists in dermatology concerns how to report study results. The traditional method in studies funded by pharmaceutical companies is known as the “last observation carried forward” analysis. It casts the study drug results in the most favorable possible light because, when a subject drops out of a trial for any reason, their last measured value for response to treatment is carried forward as though the patient completed the study. Thus, psoriasis patients who drop out because they couldn’t tolerate a therapy or developed a serious side effect dictating discontinuation will be scored on the basis of their last PASI response, creating a bias in favor of active treatment.

A more conservative analytic method is known as the “nonresponder imputation” analysis. By this method, a patient who drops out of a trial is automatically categorized as a treatment failure, even if the reason was that the patient moved and could no longer make visits to the study center.

The prespecified guselkumab analysis presented by Dr. Blauvelt involved nonresponder imputation through year 1 and imputation based on the reason for discontinuation in the second year. In contrast, the 2-year tildrakizumab analysis presented by Dr. Papp used the far more common last observation carried forward method.

To help the audience appreciate the importance of looking at the analytic methods used in a studies and help them understand the clinical significance of the results, Dr. Blauvelt provided a reanalysis of the 2-year guselkumab data using the last observation carried forward method. Across the board, the numbers became more favorable. For example, the PASI 75 rate of 95.7% using the prespecified nonresponder imputation analysis crept up to 96.8% under the last observation carried forward method; for comparison, the PASI 75 rates were 81%-84% in the tildrakizumab analysis.

“If you wanted to compare apples to apples with some other drugs, you would use these numbers – the as-observed analysis numbers used by most other companies with other drugs. If you wanted to determine what the true-life numbers are, they’d probably be something between the nonresponder imputation and as-observed numbers,” said to Dr. Blauvelt.

Dr. Papp was untroubled by the use of the last observation carried forward method in the particular case of the tildrakizumab long-term extension study.

“There is reason to believe the as-observed analysis doesn’t affect the integrity of the data because the dropout rate is extraordinarily low,” he said.

The guselkumab analysis was sponsored by Janssen Pharmaceutica; the tildrakizumab analysis was sponsored by Merck and by Sun Pharma. Dr. Blauvelt and Dr. Papp were paid investigators in both studies and serve as scientific advisers to virtually all companies invested in the psoriasis therapy developmental pipeline.

[email protected]

GENEVA – The merits of addressing interleukin-23 as a novel therapeutic target in moderate to severe plaque psoriasis were abundantly displayed in 2-year outcomes data for two anti–IL-23 monoclonal antibodies – guselkumab and tildrakizumab – in studies presented back to back at the annual congress of the European Academy of Dermatology and Venereology.

These long-term, open-label extensions of previously reported phase 3, randomized, double-blind clinical trials provided evidence of multiple advantages for IL-23 inhibition. The story was similar for both agents: After 2 years of use in the extension studies, the two biologics demonstrated stellar treatment response rates that would have been unimaginable only a few years ago, maintenance of efficacy without drop-off over time, exceedingly low dropout rates, and a safety picture that remains reassuring as experience accumulates. Also, the subcutaneously administered IL-23 inhibitors are attractive from a patient convenience standpoint in that maintenance guselkumab is dosed at 100 mg once every 8 weeks, and tildrakizumab is given once every 12 weeks.

Still, there are differences between the two drugs, most notably in apparent effectiveness. While more than half of guselkumab-treated patients had a Psoriasis Area Severity Index (PASI) 100 response – that is, totally clear skin – at 2 years, that was the case for only one-quarter to one-third of patients on tildrakizumab.

Guselkumab (Tremfya) was approved by the Food and Drug Administration in July 2017 for treatment of adults with moderate to severe plaque psoriasis. Tildrakizumab remains investigational.
 

Guselkumab

The 2-year, open-label extension of the phase 3 VOYAGE 1 trial included 735 patients who were either on guselkumab continuously, crossed from adalimumab (Humira) to guselkumab after 48 weeks, or switched from placebo after 16 weeks.

Bruce Jancin/Frontline Medical News

Tildrakizumab

Two-year results from the ongoing 5-year extension of the phase 3 reSURFACE 1 and reSURFACE 2 trials were presented by Kim A. Papp, MD, PhD, president of Probity Medical Research, Waterloo, Ont. This presentation of 2-year outcomes for 1,237 study participants was a feat, considering that the 12-week results of the trials had been published less than 3 months earlier (Lancet. 2017 Jul 15;390[10091]:276-88).

Bruce Jancin/Frontline Medical News

Controversy over how to report long-term outcomes

A hot topic among clinical trialists in dermatology concerns how to report study results. The traditional method in studies funded by pharmaceutical companies is known as the “last observation carried forward” analysis. It casts the study drug results in the most favorable possible light because, when a subject drops out of a trial for any reason, their last measured value for response to treatment is carried forward as though the patient completed the study. Thus, psoriasis patients who drop out because they couldn’t tolerate a therapy or developed a serious side effect dictating discontinuation will be scored on the basis of their last PASI response, creating a bias in favor of active treatment.

A more conservative analytic method is known as the “nonresponder imputation” analysis. By this method, a patient who drops out of a trial is automatically categorized as a treatment failure, even if the reason was that the patient moved and could no longer make visits to the study center.

The prespecified guselkumab analysis presented by Dr. Blauvelt involved nonresponder imputation through year 1 and imputation based on the reason for discontinuation in the second year. In contrast, the 2-year tildrakizumab analysis presented by Dr. Papp used the far more common last observation carried forward method.

To help the audience appreciate the importance of looking at the analytic methods used in a studies and help them understand the clinical significance of the results, Dr. Blauvelt provided a reanalysis of the 2-year guselkumab data using the last observation carried forward method. Across the board, the numbers became more favorable. For example, the PASI 75 rate of 95.7% using the prespecified nonresponder imputation analysis crept up to 96.8% under the last observation carried forward method; for comparison, the PASI 75 rates were 81%-84% in the tildrakizumab analysis.

“If you wanted to compare apples to apples with some other drugs, you would use these numbers – the as-observed analysis numbers used by most other companies with other drugs. If you wanted to determine what the true-life numbers are, they’d probably be something between the nonresponder imputation and as-observed numbers,” said to Dr. Blauvelt.

Dr. Papp was untroubled by the use of the last observation carried forward method in the particular case of the tildrakizumab long-term extension study.

“There is reason to believe the as-observed analysis doesn’t affect the integrity of the data because the dropout rate is extraordinarily low,” he said.

The guselkumab analysis was sponsored by Janssen Pharmaceutica; the tildrakizumab analysis was sponsored by Merck and by Sun Pharma. Dr. Blauvelt and Dr. Papp were paid investigators in both studies and serve as scientific advisers to virtually all companies invested in the psoriasis therapy developmental pipeline.

[email protected]

Myth: Psoriasis Treatments Should Not Be Used During Pregnancy

It is likely that dermatologists will encounter female patients with psoriasis who are pregnant or wish to become pregnant during the course of their psoriasis treatment. Earlier this year Porter et al evaluated several psoriasis therapies and discussed their safety for patients with psoriasis during pregnancy. Because psoriasis is a risk factor for adverse pregnancy outcomes, control of disease prior to and during pregnancy may optimize maternal and fetal health, according to the authors. As a result, they outlined the following treatment recommendations:

• Consider anti–tumor necrosis factor (TNF) α agents over IL-12/IL-23 and IL-17 inhibitors.
• Anti–TNF-α agents can be used during the first half of pregnancy.
• Longer-term use of anti–TNF-α agents during pregnancy can be considered depending on psoriasis disease severity.
• If biologic therapy is required during pregnancy, use certolizumab because it does not cross the placenta in significant amounts; etanercept also may be a reasonable alternative.
• Babies born to mothers who are continually treated with biologic agents should not be administered live vaccinations for at least 6 months after birth due to the increased risk of infection; inactive vaccinations can be administered according to Centers for Disease Control and Prevention guidelines.
• Breastfeeding by mothers currently treated with anti–TNF-α agents is generally considered safe.
• Cotreatment with methotrexate and a biologic agent should be avoided.

However, the National Psoriasis Foundation guidelines for treating psoriasis in pregnant or breastfeeding women advise that topical treatments are the first choice of treatment, particularly moisturizers and emollients. Limited use of low- to moderate-potency topical steroids appears to be safe, but women should avoid applying topical steroids to the breasts. Second-line treatment is narrowband UVB phototherapy; if narrowband UVB is not available, use broadband UVB. Breastfeeding women should avoid psoralen plus UVA. The foundation also advises that systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Childbearing women should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects. A useful table of US Food and Drug Administration–approved psoriasis treatments and their category for use by pregnant and breastfeeding women is available online. Specifically, drugs that should absolutely be avoided in this patient population include acitretin, methotrexate, and tazarotene.

For some patients, discontinuing therapy may not be practical. Dermatologists should be prepared to weigh the risks and benefits of treatment to advise patients appropriately. According to Dr. Jeffrey M. Weinberg’s pearls for treating psoriasis in pregnant women in Cutis, “Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry would be good options.”

RELATED ARTICLE: How to Manage Psoriasis Safely in Pregnant Women

More research is necessary; however, pregnant women often are excluded from clinical trials. Therefore, adverse outcomes should be reported to registries such as the Organization of Teratology Information Specialists or others sponsored by drug manufacturers, which will aid in understanding the effects of psoriasis treatments in pregnant and breastfeeding women.

Expert Commentary

The treatment of psoriasis in pregnancy should be approached in a thoughtful manner. While we always want to minimize therapeutic interventions in pregnant individuals, we also want to maintain control of a disease such as psoriasis. As outlined in this article, there is good amount of flexibility in terms of therapies available to us. It is important to discuss the situation carefully, including the benefits and risks, with the patient and the obstetric professionals, in order to design the optimal regimen for each individual.

—Jeffrey M. Weinberg (New York, New York)

Myth: Psoriasis Treatments Should Not Be Used During Pregnancy

It is likely that dermatologists will encounter female patients with psoriasis who are pregnant or wish to become pregnant during the course of their psoriasis treatment. Earlier this year Porter et al evaluated several psoriasis therapies and discussed their safety for patients with psoriasis during pregnancy. Because psoriasis is a risk factor for adverse pregnancy outcomes, control of disease prior to and during pregnancy may optimize maternal and fetal health, according to the authors. As a result, they outlined the following treatment recommendations:

• Consider anti–tumor necrosis factor (TNF) α agents over IL-12/IL-23 and IL-17 inhibitors.
• Anti–TNF-α agents can be used during the first half of pregnancy.
• Longer-term use of anti–TNF-α agents during pregnancy can be considered depending on psoriasis disease severity.
• If biologic therapy is required during pregnancy, use certolizumab because it does not cross the placenta in significant amounts; etanercept also may be a reasonable alternative.
• Babies born to mothers who are continually treated with biologic agents should not be administered live vaccinations for at least 6 months after birth due to the increased risk of infection; inactive vaccinations can be administered according to Centers for Disease Control and Prevention guidelines.
• Breastfeeding by mothers currently treated with anti–TNF-α agents is generally considered safe.
• Cotreatment with methotrexate and a biologic agent should be avoided.

However, the National Psoriasis Foundation guidelines for treating psoriasis in pregnant or breastfeeding women advise that topical treatments are the first choice of treatment, particularly moisturizers and emollients. Limited use of low- to moderate-potency topical steroids appears to be safe, but women should avoid applying topical steroids to the breasts. Second-line treatment is narrowband UVB phototherapy; if narrowband UVB is not available, use broadband UVB. Breastfeeding women should avoid psoralen plus UVA. The foundation also advises that systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Childbearing women should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects. A useful table of US Food and Drug Administration–approved psoriasis treatments and their category for use by pregnant and breastfeeding women is available online. Specifically, drugs that should absolutely be avoided in this patient population include acitretin, methotrexate, and tazarotene.

For some patients, discontinuing therapy may not be practical. Dermatologists should be prepared to weigh the risks and benefits of treatment to advise patients appropriately. According to Dr. Jeffrey M. Weinberg’s pearls for treating psoriasis in pregnant women in Cutis, “Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry would be good options.”

RELATED ARTICLE: How to Manage Psoriasis Safely in Pregnant Women

More research is necessary; however, pregnant women often are excluded from clinical trials. Therefore, adverse outcomes should be reported to registries such as the Organization of Teratology Information Specialists or others sponsored by drug manufacturers, which will aid in understanding the effects of psoriasis treatments in pregnant and breastfeeding women.

Expert Commentary

The treatment of psoriasis in pregnancy should be approached in a thoughtful manner. While we always want to minimize therapeutic interventions in pregnant individuals, we also want to maintain control of a disease such as psoriasis. As outlined in this article, there is good amount of flexibility in terms of therapies available to us. It is important to discuss the situation carefully, including the benefits and risks, with the patient and the obstetric professionals, in order to design the optimal regimen for each individual.

—Jeffrey M. Weinberg (New York, New York)

Myth: Psoriasis Treatments Should Not Be Used During Pregnancy

It is likely that dermatologists will encounter female patients with psoriasis who are pregnant or wish to become pregnant during the course of their psoriasis treatment. Earlier this year Porter et al evaluated several psoriasis therapies and discussed their safety for patients with psoriasis during pregnancy. Because psoriasis is a risk factor for adverse pregnancy outcomes, control of disease prior to and during pregnancy may optimize maternal and fetal health, according to the authors. As a result, they outlined the following treatment recommendations:

• Consider anti–tumor necrosis factor (TNF) α agents over IL-12/IL-23 and IL-17 inhibitors.
• Anti–TNF-α agents can be used during the first half of pregnancy.
• Longer-term use of anti–TNF-α agents during pregnancy can be considered depending on psoriasis disease severity.
• If biologic therapy is required during pregnancy, use certolizumab because it does not cross the placenta in significant amounts; etanercept also may be a reasonable alternative.
• Babies born to mothers who are continually treated with biologic agents should not be administered live vaccinations for at least 6 months after birth due to the increased risk of infection; inactive vaccinations can be administered according to Centers for Disease Control and Prevention guidelines.
• Breastfeeding by mothers currently treated with anti–TNF-α agents is generally considered safe.
• Cotreatment with methotrexate and a biologic agent should be avoided.

However, the National Psoriasis Foundation guidelines for treating psoriasis in pregnant or breastfeeding women advise that topical treatments are the first choice of treatment, particularly moisturizers and emollients. Limited use of low- to moderate-potency topical steroids appears to be safe, but women should avoid applying topical steroids to the breasts. Second-line treatment is narrowband UVB phototherapy; if narrowband UVB is not available, use broadband UVB. Breastfeeding women should avoid psoralen plus UVA. The foundation also advises that systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Childbearing women should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects. A useful table of US Food and Drug Administration–approved psoriasis treatments and their category for use by pregnant and breastfeeding women is available online. Specifically, drugs that should absolutely be avoided in this patient population include acitretin, methotrexate, and tazarotene.

For some patients, discontinuing therapy may not be practical. Dermatologists should be prepared to weigh the risks and benefits of treatment to advise patients appropriately. According to Dr. Jeffrey M. Weinberg’s pearls for treating psoriasis in pregnant women in Cutis, “Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry would be good options.”

RELATED ARTICLE: How to Manage Psoriasis Safely in Pregnant Women

More research is necessary; however, pregnant women often are excluded from clinical trials. Therefore, adverse outcomes should be reported to registries such as the Organization of Teratology Information Specialists or others sponsored by drug manufacturers, which will aid in understanding the effects of psoriasis treatments in pregnant and breastfeeding women.

Expert Commentary

The treatment of psoriasis in pregnancy should be approached in a thoughtful manner. While we always want to minimize therapeutic interventions in pregnant individuals, we also want to maintain control of a disease such as psoriasis. As outlined in this article, there is good amount of flexibility in terms of therapies available to us. It is important to discuss the situation carefully, including the benefits and risks, with the patient and the obstetric professionals, in order to design the optimal regimen for each individual.

—Jeffrey M. Weinberg (New York, New York)

Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.

“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.

In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).

Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.

Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).

For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity

The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.

The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.

The researchers had no financial conflicts to disclose.

Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.

“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.

In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).

Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.

Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).

For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity

The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.

The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.

The researchers had no financial conflicts to disclose.

Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.

“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.

In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).

Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.

Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).

For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity

The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.

The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.

The researchers had no financial conflicts to disclose.

The interleukin-17A antagonist ixekizumab has been approved by the Food and Drug Administration for treating adults with active psoriatic arthritis (PsA), based on two phase 3 studies, the manufacturer announced in a written statement Dec. 1.

The Eli Lilly statement noted that the approval is based on two randomized, double-blind, placebo-controlled studies; one compared ixekizumab to placebo in patients with active PsA never treated with a biologic (SPIRIT-P1) and another tested the drug in those who had been treated with a tumor necrosis factor inhibitor (TNFi) previously (SPIRIT-P2).

[email protected]

The interleukin-17A antagonist ixekizumab has been approved by the Food and Drug Administration for treating adults with active psoriatic arthritis (PsA), based on two phase 3 studies, the manufacturer announced in a written statement Dec. 1.

The Eli Lilly statement noted that the approval is based on two randomized, double-blind, placebo-controlled studies; one compared ixekizumab to placebo in patients with active PsA never treated with a biologic (SPIRIT-P1) and another tested the drug in those who had been treated with a tumor necrosis factor inhibitor (TNFi) previously (SPIRIT-P2).

[email protected]

The interleukin-17A antagonist ixekizumab has been approved by the Food and Drug Administration for treating adults with active psoriatic arthritis (PsA), based on two phase 3 studies, the manufacturer announced in a written statement Dec. 1.

The Eli Lilly statement noted that the approval is based on two randomized, double-blind, placebo-controlled studies; one compared ixekizumab to placebo in patients with active PsA never treated with a biologic (SPIRIT-P1) and another tested the drug in those who had been treated with a tumor necrosis factor inhibitor (TNFi) previously (SPIRIT-P2).

[email protected]

Approximately three-quarters of respondents indicated that they have used oral or injectable medications (eg, methotrexate, acitretin, cyclosporine, apremilast, biologics) to control their psoriasis, according to a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives on psoriasis. Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast.

Patients universally spoke about the benefits of their current treatments, especially the biologics, but variable experiences regarding the effectiveness of the therapies were reported, ranging from excellent improvement, to improvement that lasted only a few months, to a near-complete clearance. However, limitations to these therapies also were mentioned, which are areas where dermatologists can provide counseling and alternatives. For example, treatments were reported to be effective in clearing cutaneous psoriasis symptoms such as flaking and scaling, but pruritus, burning, and pain were still problematic and mostly limited to areas where the cutaneous symptoms had been located.

Other treatment downsides that dermatologists should discuss with patients are side effects, including fatigue, nausea, fluctuations in weight, increased facial hair growth, nosebleeds, increased blood pressure, headaches, and palpitations, according to the patients present at the meeting. Patients also expressed concern about immune compromise from the biologics. Others reported concerns that the treatments addressed specific psoriasis symptoms but led to worsening of other symptoms or development of new conditions such as uveitis and psoriatic arthritis. The burden of treatment infusions or required blood work also were discussed. These are areas in which dermatologists may be best suited to provide more patient education or support when prescribing these therapies. The National Psoriasis Foundation’s Patient Navigation Center is a tool for patients to access information and interact with members of the psoriasis patient community.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

Approximately three-quarters of respondents indicated that they have used oral or injectable medications (eg, methotrexate, acitretin, cyclosporine, apremilast, biologics) to control their psoriasis, according to a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives on psoriasis. Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast.

Patients universally spoke about the benefits of their current treatments, especially the biologics, but variable experiences regarding the effectiveness of the therapies were reported, ranging from excellent improvement, to improvement that lasted only a few months, to a near-complete clearance. However, limitations to these therapies also were mentioned, which are areas where dermatologists can provide counseling and alternatives. For example, treatments were reported to be effective in clearing cutaneous psoriasis symptoms such as flaking and scaling, but pruritus, burning, and pain were still problematic and mostly limited to areas where the cutaneous symptoms had been located.

Other treatment downsides that dermatologists should discuss with patients are side effects, including fatigue, nausea, fluctuations in weight, increased facial hair growth, nosebleeds, increased blood pressure, headaches, and palpitations, according to the patients present at the meeting. Patients also expressed concern about immune compromise from the biologics. Others reported concerns that the treatments addressed specific psoriasis symptoms but led to worsening of other symptoms or development of new conditions such as uveitis and psoriatic arthritis. The burden of treatment infusions or required blood work also were discussed. These are areas in which dermatologists may be best suited to provide more patient education or support when prescribing these therapies. The National Psoriasis Foundation’s Patient Navigation Center is a tool for patients to access information and interact with members of the psoriasis patient community.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

Approximately three-quarters of respondents indicated that they have used oral or injectable medications (eg, methotrexate, acitretin, cyclosporine, apremilast, biologics) to control their psoriasis, according to a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives on psoriasis. Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast.

Patients universally spoke about the benefits of their current treatments, especially the biologics, but variable experiences regarding the effectiveness of the therapies were reported, ranging from excellent improvement, to improvement that lasted only a few months, to a near-complete clearance. However, limitations to these therapies also were mentioned, which are areas where dermatologists can provide counseling and alternatives. For example, treatments were reported to be effective in clearing cutaneous psoriasis symptoms such as flaking and scaling, but pruritus, burning, and pain were still problematic and mostly limited to areas where the cutaneous symptoms had been located.

Other treatment downsides that dermatologists should discuss with patients are side effects, including fatigue, nausea, fluctuations in weight, increased facial hair growth, nosebleeds, increased blood pressure, headaches, and palpitations, according to the patients present at the meeting. Patients also expressed concern about immune compromise from the biologics. Others reported concerns that the treatments addressed specific psoriasis symptoms but led to worsening of other symptoms or development of new conditions such as uveitis and psoriatic arthritis. The burden of treatment infusions or required blood work also were discussed. These are areas in which dermatologists may be best suited to provide more patient education or support when prescribing these therapies. The National Psoriasis Foundation’s Patient Navigation Center is a tool for patients to access information and interact with members of the psoriasis patient community.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.