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Myth: Psoriasis Therapies Can Cause Suicidal Ideation in Psoriasis Patients
Psoriasis takes a toll on patients, both physically and emotionally. Depression is one of the comorbidities of psoriasis due to biological changes that cause psoriasis as well as the stigma of visible psoriasis. Severe depression and suicidal ideation have been perceived to be features of life-threatening medical disorders, but dermatologists need to be aware of the relationship between depressive symptoms, suicidal ideation, and psoriasis severity.
A 2010 United Kingdom study of 916,948 patients with mild psoriasis, severe psoriasis, or controls without psoriasis indicated that patients with psoriasis have an increased risk for depression, anxiety, and suicidality. The relative risk of these outcomes is elevated in younger patients with psoriasis, with the greatest relative risk being for depression in patients with severe psoriasis.
Kimball et al conducted a study in the United States of 7404 patients with psoriasis and 37,020 controls without psoriasis (age, <18 years). They reported that pediatric patients with psoriasis were significantly more at risk of developing psychiatric disorders versus controls (P=.0001), especially depression (P=.0036) and anxiety (P=.0048).
In February 2017, the US Food and Drug Administration (FDA) announced approval of brodalumab for use in adults with moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy or phototherapy but have failed to respond or have stopped responding to other systemic therapies. Lebwohl et al published the results of the phase 3 clinical trials, which showed that brodalumab was highly effective in reducing plaque psoriasis, even compared to ustekinumab. In fact, psoriasis area and severity index scores of 100 were significantly higher in the brodalumab 210-mg group versus ustekinumab group by week 12 (P<.001).
However, the approval is accompanied with a strict warning from the FDA and tightly regulated access to the drug, as suicidal ideation and behavior, including 4 suicides, occurred in patients treated with brodalumab during clinical trials, particularly patients with a history of depression or suicidality. According to the FDA, "[a] causal association between treatment with [brodalumab] and increased risk of suicidal ideation and behavior has not been established." The label includes a black box warning and the drug will only be available through a restricted Risk Evaluation and Mitigation Strategy program, which has the following requirements from the FDA:
- Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
- Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety, or other mood changes.
- Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive the drug.
A medication guide is available for patients to inform them of the risk for suicidal ideation and behavior. The benefit of treatment must be weighed carefully against the seriousness of the risks associated with use.
Regardless of the therapy prescribed, dermatologists should be aware of the symptoms of depression. The National Psoriasis Foundation suggests you ask patients how they dress: Do they always wear long-sleeved shirts when they leave the house? Do they wear black? These questions can help determine if patients feel socially isolated or stigmatized by the disease. The National Psoriasis Foundation offers a Patient Navigation Center to help patients find a psychologist who specializes in issues related to psoriatic disease. Antidepressants and seeing a mental health professional can help, but ultimately taking control of the disease is the best way to improve depression.
Expert Commentary
According to the prescribing information for brodalumab, "Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior." Thus, 80% of these cases were at risk even before receiving 1 injection of brodalumab. Long-term registries will determine if there is truly an increased risk for suicidal ideation or behavior when taking brodalumab.
Brodalumab will be commercially available around the fall 2017. Before prescribing brodalumab, I will counsel patients about this potential increased risk of suicidal ideation or behavior as noted in the prescribing information, but I will tell them that a true risk has not yet been determined in long-term registries. I will mention to patients that if they really do feel depressed or experience suicidal ideation or behavior after starting brodalumab, they should stop taking brodalumab and contact me or a mental health professional.
—Jashin J. Wu, MD (Los Angeles, California)
FDA approves new psoriasis drug [news release]. Silver Spring, MD: US Food and Drug Administration; February 15, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm. Accessed April 5, 2017.
Gupta MA, Schork NJ, Gupta AK, et al. Suicidal ideation in psoriasis. Int J Dermatol. 1993;32:188-190.
Kimball AB, Wu EQ, Guérin A, et al. Risks of developing psychiatric disorders in pediatric patients with psoriasis. J Am Acad Dermatol. 2012;67:651-7.e1-651-7.e2.
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.
Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373:1318-1328.
Life with psoriasis: depression. National Psoriasis Foundation website. https://www.psoriasis.org/life-with-psoriasis/depression. Accessed April 5, 2017.
Özkaya Ö. Biologic psoriasis treatment, Siliq, approved by FDA with strong warning of possible suicide risk. https://psoriasisnewstoday.com/2017/02/16/psoriasis-drug-siliq-approved-by-fda-with-warning-of-possible-suicide-risk/. Published February 16, 2017. Accessed April 5, 2017.
Myth: Psoriasis Therapies Can Cause Suicidal Ideation in Psoriasis Patients
Psoriasis takes a toll on patients, both physically and emotionally. Depression is one of the comorbidities of psoriasis due to biological changes that cause psoriasis as well as the stigma of visible psoriasis. Severe depression and suicidal ideation have been perceived to be features of life-threatening medical disorders, but dermatologists need to be aware of the relationship between depressive symptoms, suicidal ideation, and psoriasis severity.
A 2010 United Kingdom study of 916,948 patients with mild psoriasis, severe psoriasis, or controls without psoriasis indicated that patients with psoriasis have an increased risk for depression, anxiety, and suicidality. The relative risk of these outcomes is elevated in younger patients with psoriasis, with the greatest relative risk being for depression in patients with severe psoriasis.
Kimball et al conducted a study in the United States of 7404 patients with psoriasis and 37,020 controls without psoriasis (age, <18 years). They reported that pediatric patients with psoriasis were significantly more at risk of developing psychiatric disorders versus controls (P=.0001), especially depression (P=.0036) and anxiety (P=.0048).
In February 2017, the US Food and Drug Administration (FDA) announced approval of brodalumab for use in adults with moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy or phototherapy but have failed to respond or have stopped responding to other systemic therapies. Lebwohl et al published the results of the phase 3 clinical trials, which showed that brodalumab was highly effective in reducing plaque psoriasis, even compared to ustekinumab. In fact, psoriasis area and severity index scores of 100 were significantly higher in the brodalumab 210-mg group versus ustekinumab group by week 12 (P<.001).
However, the approval is accompanied with a strict warning from the FDA and tightly regulated access to the drug, as suicidal ideation and behavior, including 4 suicides, occurred in patients treated with brodalumab during clinical trials, particularly patients with a history of depression or suicidality. According to the FDA, "[a] causal association between treatment with [brodalumab] and increased risk of suicidal ideation and behavior has not been established." The label includes a black box warning and the drug will only be available through a restricted Risk Evaluation and Mitigation Strategy program, which has the following requirements from the FDA:
- Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
- Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety, or other mood changes.
- Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive the drug.
A medication guide is available for patients to inform them of the risk for suicidal ideation and behavior. The benefit of treatment must be weighed carefully against the seriousness of the risks associated with use.
Regardless of the therapy prescribed, dermatologists should be aware of the symptoms of depression. The National Psoriasis Foundation suggests you ask patients how they dress: Do they always wear long-sleeved shirts when they leave the house? Do they wear black? These questions can help determine if patients feel socially isolated or stigmatized by the disease. The National Psoriasis Foundation offers a Patient Navigation Center to help patients find a psychologist who specializes in issues related to psoriatic disease. Antidepressants and seeing a mental health professional can help, but ultimately taking control of the disease is the best way to improve depression.
Expert Commentary
According to the prescribing information for brodalumab, "Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior." Thus, 80% of these cases were at risk even before receiving 1 injection of brodalumab. Long-term registries will determine if there is truly an increased risk for suicidal ideation or behavior when taking brodalumab.
Brodalumab will be commercially available around the fall 2017. Before prescribing brodalumab, I will counsel patients about this potential increased risk of suicidal ideation or behavior as noted in the prescribing information, but I will tell them that a true risk has not yet been determined in long-term registries. I will mention to patients that if they really do feel depressed or experience suicidal ideation or behavior after starting brodalumab, they should stop taking brodalumab and contact me or a mental health professional.
—Jashin J. Wu, MD (Los Angeles, California)
Myth: Psoriasis Therapies Can Cause Suicidal Ideation in Psoriasis Patients
Psoriasis takes a toll on patients, both physically and emotionally. Depression is one of the comorbidities of psoriasis due to biological changes that cause psoriasis as well as the stigma of visible psoriasis. Severe depression and suicidal ideation have been perceived to be features of life-threatening medical disorders, but dermatologists need to be aware of the relationship between depressive symptoms, suicidal ideation, and psoriasis severity.
A 2010 United Kingdom study of 916,948 patients with mild psoriasis, severe psoriasis, or controls without psoriasis indicated that patients with psoriasis have an increased risk for depression, anxiety, and suicidality. The relative risk of these outcomes is elevated in younger patients with psoriasis, with the greatest relative risk being for depression in patients with severe psoriasis.
Kimball et al conducted a study in the United States of 7404 patients with psoriasis and 37,020 controls without psoriasis (age, <18 years). They reported that pediatric patients with psoriasis were significantly more at risk of developing psychiatric disorders versus controls (P=.0001), especially depression (P=.0036) and anxiety (P=.0048).
In February 2017, the US Food and Drug Administration (FDA) announced approval of brodalumab for use in adults with moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy or phototherapy but have failed to respond or have stopped responding to other systemic therapies. Lebwohl et al published the results of the phase 3 clinical trials, which showed that brodalumab was highly effective in reducing plaque psoriasis, even compared to ustekinumab. In fact, psoriasis area and severity index scores of 100 were significantly higher in the brodalumab 210-mg group versus ustekinumab group by week 12 (P<.001).
However, the approval is accompanied with a strict warning from the FDA and tightly regulated access to the drug, as suicidal ideation and behavior, including 4 suicides, occurred in patients treated with brodalumab during clinical trials, particularly patients with a history of depression or suicidality. According to the FDA, "[a] causal association between treatment with [brodalumab] and increased risk of suicidal ideation and behavior has not been established." The label includes a black box warning and the drug will only be available through a restricted Risk Evaluation and Mitigation Strategy program, which has the following requirements from the FDA:
- Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
- Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety, or other mood changes.
- Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive the drug.
A medication guide is available for patients to inform them of the risk for suicidal ideation and behavior. The benefit of treatment must be weighed carefully against the seriousness of the risks associated with use.
Regardless of the therapy prescribed, dermatologists should be aware of the symptoms of depression. The National Psoriasis Foundation suggests you ask patients how they dress: Do they always wear long-sleeved shirts when they leave the house? Do they wear black? These questions can help determine if patients feel socially isolated or stigmatized by the disease. The National Psoriasis Foundation offers a Patient Navigation Center to help patients find a psychologist who specializes in issues related to psoriatic disease. Antidepressants and seeing a mental health professional can help, but ultimately taking control of the disease is the best way to improve depression.
Expert Commentary
According to the prescribing information for brodalumab, "Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior." Thus, 80% of these cases were at risk even before receiving 1 injection of brodalumab. Long-term registries will determine if there is truly an increased risk for suicidal ideation or behavior when taking brodalumab.
Brodalumab will be commercially available around the fall 2017. Before prescribing brodalumab, I will counsel patients about this potential increased risk of suicidal ideation or behavior as noted in the prescribing information, but I will tell them that a true risk has not yet been determined in long-term registries. I will mention to patients that if they really do feel depressed or experience suicidal ideation or behavior after starting brodalumab, they should stop taking brodalumab and contact me or a mental health professional.
—Jashin J. Wu, MD (Los Angeles, California)
FDA approves new psoriasis drug [news release]. Silver Spring, MD: US Food and Drug Administration; February 15, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm. Accessed April 5, 2017.
Gupta MA, Schork NJ, Gupta AK, et al. Suicidal ideation in psoriasis. Int J Dermatol. 1993;32:188-190.
Kimball AB, Wu EQ, Guérin A, et al. Risks of developing psychiatric disorders in pediatric patients with psoriasis. J Am Acad Dermatol. 2012;67:651-7.e1-651-7.e2.
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.
Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373:1318-1328.
Life with psoriasis: depression. National Psoriasis Foundation website. https://www.psoriasis.org/life-with-psoriasis/depression. Accessed April 5, 2017.
Özkaya Ö. Biologic psoriasis treatment, Siliq, approved by FDA with strong warning of possible suicide risk. https://psoriasisnewstoday.com/2017/02/16/psoriasis-drug-siliq-approved-by-fda-with-warning-of-possible-suicide-risk/. Published February 16, 2017. Accessed April 5, 2017.
FDA approves new psoriasis drug [news release]. Silver Spring, MD: US Food and Drug Administration; February 15, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm. Accessed April 5, 2017.
Gupta MA, Schork NJ, Gupta AK, et al. Suicidal ideation in psoriasis. Int J Dermatol. 1993;32:188-190.
Kimball AB, Wu EQ, Guérin A, et al. Risks of developing psychiatric disorders in pediatric patients with psoriasis. J Am Acad Dermatol. 2012;67:651-7.e1-651-7.e2.
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.
Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373:1318-1328.
Life with psoriasis: depression. National Psoriasis Foundation website. https://www.psoriasis.org/life-with-psoriasis/depression. Accessed April 5, 2017.
Özkaya Ö. Biologic psoriasis treatment, Siliq, approved by FDA with strong warning of possible suicide risk. https://psoriasisnewstoday.com/2017/02/16/psoriasis-drug-siliq-approved-by-fda-with-warning-of-possible-suicide-risk/. Published February 16, 2017. Accessed April 5, 2017.
