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Observational secukinumab data reflect clinical trial results in patients with moderate to severe psoriasis
A in a report published in the Journal of the European Academy of Dermatology and Venereology.
“The safety profile of secukinumab was similar to that reported in previous clinical trials, and no new or unexpected safety signals were observed,” according to Diamant Thaci, MD, of the Comprehensive Centre of Inflammation Medicine, University of Lübeck (Germany) and coauthors. Moreover, effectiveness in those who started treatment with secukinumab at baseline, they added, “was comparable to that observed in Phase 3 trials. High levels of effectiveness were observed also in subjects who had received previous biologic therapies, although the response rates were numerically lower, as might be expected in a difficult to treat population. In addition, lower baseline PASI [Psoriasis Area and Severity Index] in patients with prior biologic treatment could also reduce the relative decrease in PASI observed over the course of the study.”
They reported on an interim analysis of the first 1,988 patients enrolled in the PROSPECT study, an observational 24-week study conducted in Germany; 1,323 patients completed the 24 week study; total cumulative exposure to secukinumab was 746.3 patient-years. Their mean baseline PASI was 17.7, slightly lower than those in typical clinical trials, and most (91%) had received systemic therapies before.
Almost half the patients (46%) experienced an adverse event during treatment, and about 4% experienced a serious adverse event; only 1% of serious adverse events were considered related to the study drug. About 7% discontinued treatment with secukinumab because of an adverse event. The most common reasons for discontinuation were lack of benefit in 2.4%, psoriasis in 2.3%, and upper respiratory tract viral infection in 0.5%.
The most common adverse events were nasopharyngitis (8.7%), pruritus (2.9%), and headache (2.4%). Rates of neoplastic disorders and major cerebrovascular events were similar to published data, with 5 patients (0.3%) experiencing a major adverse cardiovascular event and 10 (0.5%) experiencing a malignancy. Four patients (0.2%) developed inflammatory bowel disease, 42 (2.1%) developed Candida infection, 2 (0.1%) developed hepatotoxicity, and 11 (0.6%) an injection-site reaction. There were three deaths, determined not to be related to secukinumab, the authors wrote.
Efficacy was also similar to that observed in earlier studies, they noted, with positive results regardless of concomitant medication. Overall, 44% of the cohort used concomitant medications.
Of the 829 patients using concomitant topical treatments, 73% had started before baseline. In all, 110 patients were also using conventional systemic medications and phototherapy; 77 started treatment before baseline. The most commonly employed concomitant therapies were topical steroids and phototherapy.
Overall, most patients (86%) achieved a PASI 75 by week 24, with 68.5% achieving a PASI 90, and 40% achieving a PASI 100 at that time point.
Secukinumab was most effective among the 83 patients who were naive to systemic therapies; in these patients, results at week 24 were as follows: PASI 75, 93%; PASI 90, 84%; and PASI 100, 66%. Among patients who had previously received a biologic, scores were slightly lower: PASI 75, 78%; PASI 90, 55%; and PASI 100, 29%.
“These interim data from PROSPECT confirm the effectiveness and safety of secukinumab in the routine clinical setting, in a large cohort of psoriasis patients with high disease severity,” the investigators concluded.
Initially approved in the United States in 2015, secukinumab, an interleukin-17A antagonist, is indicated for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, adults with psoriatic arthritis, and adults with active ankylosing spondylitis.
The study was funded by Novartis, Germany; four authors are employees of the company. Dr. Thaci has served as an investigator and/or consultant for multiple pharmaceutical companies, including Novartis, AbbVie, Amgen, Arena, Biogen Idec, Boehringer Ingelheim, and Celgene. Other authors also disclosed serving as investigators, consultants, and/or speakers for Novartis and other companies.
SOURCE: J Eur Acad Dermatol Venereol. 2019 Sep 21. doi: 10.1111/jdv.15962.
A in a report published in the Journal of the European Academy of Dermatology and Venereology.
“The safety profile of secukinumab was similar to that reported in previous clinical trials, and no new or unexpected safety signals were observed,” according to Diamant Thaci, MD, of the Comprehensive Centre of Inflammation Medicine, University of Lübeck (Germany) and coauthors. Moreover, effectiveness in those who started treatment with secukinumab at baseline, they added, “was comparable to that observed in Phase 3 trials. High levels of effectiveness were observed also in subjects who had received previous biologic therapies, although the response rates were numerically lower, as might be expected in a difficult to treat population. In addition, lower baseline PASI [Psoriasis Area and Severity Index] in patients with prior biologic treatment could also reduce the relative decrease in PASI observed over the course of the study.”
They reported on an interim analysis of the first 1,988 patients enrolled in the PROSPECT study, an observational 24-week study conducted in Germany; 1,323 patients completed the 24 week study; total cumulative exposure to secukinumab was 746.3 patient-years. Their mean baseline PASI was 17.7, slightly lower than those in typical clinical trials, and most (91%) had received systemic therapies before.
Almost half the patients (46%) experienced an adverse event during treatment, and about 4% experienced a serious adverse event; only 1% of serious adverse events were considered related to the study drug. About 7% discontinued treatment with secukinumab because of an adverse event. The most common reasons for discontinuation were lack of benefit in 2.4%, psoriasis in 2.3%, and upper respiratory tract viral infection in 0.5%.
The most common adverse events were nasopharyngitis (8.7%), pruritus (2.9%), and headache (2.4%). Rates of neoplastic disorders and major cerebrovascular events were similar to published data, with 5 patients (0.3%) experiencing a major adverse cardiovascular event and 10 (0.5%) experiencing a malignancy. Four patients (0.2%) developed inflammatory bowel disease, 42 (2.1%) developed Candida infection, 2 (0.1%) developed hepatotoxicity, and 11 (0.6%) an injection-site reaction. There were three deaths, determined not to be related to secukinumab, the authors wrote.
Efficacy was also similar to that observed in earlier studies, they noted, with positive results regardless of concomitant medication. Overall, 44% of the cohort used concomitant medications.
Of the 829 patients using concomitant topical treatments, 73% had started before baseline. In all, 110 patients were also using conventional systemic medications and phototherapy; 77 started treatment before baseline. The most commonly employed concomitant therapies were topical steroids and phototherapy.
Overall, most patients (86%) achieved a PASI 75 by week 24, with 68.5% achieving a PASI 90, and 40% achieving a PASI 100 at that time point.
Secukinumab was most effective among the 83 patients who were naive to systemic therapies; in these patients, results at week 24 were as follows: PASI 75, 93%; PASI 90, 84%; and PASI 100, 66%. Among patients who had previously received a biologic, scores were slightly lower: PASI 75, 78%; PASI 90, 55%; and PASI 100, 29%.
“These interim data from PROSPECT confirm the effectiveness and safety of secukinumab in the routine clinical setting, in a large cohort of psoriasis patients with high disease severity,” the investigators concluded.
Initially approved in the United States in 2015, secukinumab, an interleukin-17A antagonist, is indicated for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, adults with psoriatic arthritis, and adults with active ankylosing spondylitis.
The study was funded by Novartis, Germany; four authors are employees of the company. Dr. Thaci has served as an investigator and/or consultant for multiple pharmaceutical companies, including Novartis, AbbVie, Amgen, Arena, Biogen Idec, Boehringer Ingelheim, and Celgene. Other authors also disclosed serving as investigators, consultants, and/or speakers for Novartis and other companies.
SOURCE: J Eur Acad Dermatol Venereol. 2019 Sep 21. doi: 10.1111/jdv.15962.
A in a report published in the Journal of the European Academy of Dermatology and Venereology.
“The safety profile of secukinumab was similar to that reported in previous clinical trials, and no new or unexpected safety signals were observed,” according to Diamant Thaci, MD, of the Comprehensive Centre of Inflammation Medicine, University of Lübeck (Germany) and coauthors. Moreover, effectiveness in those who started treatment with secukinumab at baseline, they added, “was comparable to that observed in Phase 3 trials. High levels of effectiveness were observed also in subjects who had received previous biologic therapies, although the response rates were numerically lower, as might be expected in a difficult to treat population. In addition, lower baseline PASI [Psoriasis Area and Severity Index] in patients with prior biologic treatment could also reduce the relative decrease in PASI observed over the course of the study.”
They reported on an interim analysis of the first 1,988 patients enrolled in the PROSPECT study, an observational 24-week study conducted in Germany; 1,323 patients completed the 24 week study; total cumulative exposure to secukinumab was 746.3 patient-years. Their mean baseline PASI was 17.7, slightly lower than those in typical clinical trials, and most (91%) had received systemic therapies before.
Almost half the patients (46%) experienced an adverse event during treatment, and about 4% experienced a serious adverse event; only 1% of serious adverse events were considered related to the study drug. About 7% discontinued treatment with secukinumab because of an adverse event. The most common reasons for discontinuation were lack of benefit in 2.4%, psoriasis in 2.3%, and upper respiratory tract viral infection in 0.5%.
The most common adverse events were nasopharyngitis (8.7%), pruritus (2.9%), and headache (2.4%). Rates of neoplastic disorders and major cerebrovascular events were similar to published data, with 5 patients (0.3%) experiencing a major adverse cardiovascular event and 10 (0.5%) experiencing a malignancy. Four patients (0.2%) developed inflammatory bowel disease, 42 (2.1%) developed Candida infection, 2 (0.1%) developed hepatotoxicity, and 11 (0.6%) an injection-site reaction. There were three deaths, determined not to be related to secukinumab, the authors wrote.
Efficacy was also similar to that observed in earlier studies, they noted, with positive results regardless of concomitant medication. Overall, 44% of the cohort used concomitant medications.
Of the 829 patients using concomitant topical treatments, 73% had started before baseline. In all, 110 patients were also using conventional systemic medications and phototherapy; 77 started treatment before baseline. The most commonly employed concomitant therapies were topical steroids and phototherapy.
Overall, most patients (86%) achieved a PASI 75 by week 24, with 68.5% achieving a PASI 90, and 40% achieving a PASI 100 at that time point.
Secukinumab was most effective among the 83 patients who were naive to systemic therapies; in these patients, results at week 24 were as follows: PASI 75, 93%; PASI 90, 84%; and PASI 100, 66%. Among patients who had previously received a biologic, scores were slightly lower: PASI 75, 78%; PASI 90, 55%; and PASI 100, 29%.
“These interim data from PROSPECT confirm the effectiveness and safety of secukinumab in the routine clinical setting, in a large cohort of psoriasis patients with high disease severity,” the investigators concluded.
Initially approved in the United States in 2015, secukinumab, an interleukin-17A antagonist, is indicated for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, adults with psoriatic arthritis, and adults with active ankylosing spondylitis.
The study was funded by Novartis, Germany; four authors are employees of the company. Dr. Thaci has served as an investigator and/or consultant for multiple pharmaceutical companies, including Novartis, AbbVie, Amgen, Arena, Biogen Idec, Boehringer Ingelheim, and Celgene. Other authors also disclosed serving as investigators, consultants, and/or speakers for Novartis and other companies.
SOURCE: J Eur Acad Dermatol Venereol. 2019 Sep 21. doi: 10.1111/jdv.15962.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
New psoriatic patients may have lower serious infection risk with IL-12/23 inhibition
, according to data from a retrospective study of nearly 10,000 adults.
Biologics, though effective, can increase the risk for serious infection in psoriatic arthritis and psoriasis patients, and comparison data on the safety of various biologics are limited, wrote Xintong Li of Johns Hopkins University, Baltimore, and colleagues.
In a study published in Annals of the Rheumatic Diseases, the researchers identified 11,560 treatment episodes for 9,305 adults during January 1, 2015, through May 1, 2018, which included 6,043 episodes of psoriasis only, 1,869 episodes of psoriatic arthritis only, and 3,648 episodes of both conditions. The average age of the patients was 46 years, and 53% were men. The investigators studied the IL-12/23 inhibitor ustekinumab (Stelara), the IL-17A inhibitors secukinumab (Cosentyx) and ixekizumab (Taltz), and TNF inhibitors adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade). They did not study the interleukin-17 (IL-17) inhibitor brodalumab (Siliq) or IL-23 inhibitors guselkumab (Tremfya), risankizumab (Skyrizi), or tildrakizumab (Ilumya) since they were FDA approved after or toward the end of the study period.
The primary outcome of serious infection, defined as hospitalization with infection as part of the diagnostic codes, occurred in 190 cases (2% of all treatment episodes); the most common serious infections were sepsis and pneumonia.
Overall, new biologics users had similar infection risks with IL-17 and TNF inhibitors, with incidence rates per 100 person-years of 3.4 and 2.2, respectively. By contrast, the incidence rate per 100 person-years was 0.9 with IL-12/23 inhibitors. Incidence rates were similar across all three biologic types for experienced biologics users.
The researchers also grouped patients by condition, including both treatment-naive and -experienced patients. Of the 156 serious infections in psoriasis patients, 26 occurred with IL-17 inhibitors, 29 with IL-12/23 inhibitors, and 101 with TNF inhibitors. Of 105 serious infections in the psoriatic arthritis group, 14 occurred with IL-17, 13 with IL-12/23, and 78 with TNF.
After adjusting for propensity scores, researchers found no evidence of increased serious infection risk for treatment with IL-17 inhibitors, compared with IL-12/23 (hazard ratio, 1.12; 95% confidence interval, 0.62-2.03) or TNF inhibitors (HR, 0.89; 95% CI, 0.48-1.66).
The study findings were limited by several factors, including the use of ICD diagnostic codes that were not fully validated in the patient population, a short follow-up period, and inclusion of only insured patients in the United States, the researchers noted.
However, the results suggest that serious infection risk may vary between patients with psoriasis and psoriatic arthritis, and between biologic-naive and -experienced patients, and that, despite the relatively small difference in absolute effect, “this potentially clinically relevant signal for reduced infections among the IL-12/23 inhibitors warrants further investigation and surveillance efforts,” they concluded. In addition, they said, the findings might guide clinicians and patients in choosing appropriate biologics for a particular condition.
The study was supported by the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health. The researchers had no financial conflicts to disclose. Ms. Li conducted the research while she was at Johns Hopkins, but is now with the University of North Carolina, Chapel Hill.
SOURCE: Li X et al. Ann Rheum Dis. 2019 Oct 31. doi: 10.1136/annrheumdis-2019-216102.
, according to data from a retrospective study of nearly 10,000 adults.
Biologics, though effective, can increase the risk for serious infection in psoriatic arthritis and psoriasis patients, and comparison data on the safety of various biologics are limited, wrote Xintong Li of Johns Hopkins University, Baltimore, and colleagues.
In a study published in Annals of the Rheumatic Diseases, the researchers identified 11,560 treatment episodes for 9,305 adults during January 1, 2015, through May 1, 2018, which included 6,043 episodes of psoriasis only, 1,869 episodes of psoriatic arthritis only, and 3,648 episodes of both conditions. The average age of the patients was 46 years, and 53% were men. The investigators studied the IL-12/23 inhibitor ustekinumab (Stelara), the IL-17A inhibitors secukinumab (Cosentyx) and ixekizumab (Taltz), and TNF inhibitors adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade). They did not study the interleukin-17 (IL-17) inhibitor brodalumab (Siliq) or IL-23 inhibitors guselkumab (Tremfya), risankizumab (Skyrizi), or tildrakizumab (Ilumya) since they were FDA approved after or toward the end of the study period.
The primary outcome of serious infection, defined as hospitalization with infection as part of the diagnostic codes, occurred in 190 cases (2% of all treatment episodes); the most common serious infections were sepsis and pneumonia.
Overall, new biologics users had similar infection risks with IL-17 and TNF inhibitors, with incidence rates per 100 person-years of 3.4 and 2.2, respectively. By contrast, the incidence rate per 100 person-years was 0.9 with IL-12/23 inhibitors. Incidence rates were similar across all three biologic types for experienced biologics users.
The researchers also grouped patients by condition, including both treatment-naive and -experienced patients. Of the 156 serious infections in psoriasis patients, 26 occurred with IL-17 inhibitors, 29 with IL-12/23 inhibitors, and 101 with TNF inhibitors. Of 105 serious infections in the psoriatic arthritis group, 14 occurred with IL-17, 13 with IL-12/23, and 78 with TNF.
After adjusting for propensity scores, researchers found no evidence of increased serious infection risk for treatment with IL-17 inhibitors, compared with IL-12/23 (hazard ratio, 1.12; 95% confidence interval, 0.62-2.03) or TNF inhibitors (HR, 0.89; 95% CI, 0.48-1.66).
The study findings were limited by several factors, including the use of ICD diagnostic codes that were not fully validated in the patient population, a short follow-up period, and inclusion of only insured patients in the United States, the researchers noted.
However, the results suggest that serious infection risk may vary between patients with psoriasis and psoriatic arthritis, and between biologic-naive and -experienced patients, and that, despite the relatively small difference in absolute effect, “this potentially clinically relevant signal for reduced infections among the IL-12/23 inhibitors warrants further investigation and surveillance efforts,” they concluded. In addition, they said, the findings might guide clinicians and patients in choosing appropriate biologics for a particular condition.
The study was supported by the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health. The researchers had no financial conflicts to disclose. Ms. Li conducted the research while she was at Johns Hopkins, but is now with the University of North Carolina, Chapel Hill.
SOURCE: Li X et al. Ann Rheum Dis. 2019 Oct 31. doi: 10.1136/annrheumdis-2019-216102.
, according to data from a retrospective study of nearly 10,000 adults.
Biologics, though effective, can increase the risk for serious infection in psoriatic arthritis and psoriasis patients, and comparison data on the safety of various biologics are limited, wrote Xintong Li of Johns Hopkins University, Baltimore, and colleagues.
In a study published in Annals of the Rheumatic Diseases, the researchers identified 11,560 treatment episodes for 9,305 adults during January 1, 2015, through May 1, 2018, which included 6,043 episodes of psoriasis only, 1,869 episodes of psoriatic arthritis only, and 3,648 episodes of both conditions. The average age of the patients was 46 years, and 53% were men. The investigators studied the IL-12/23 inhibitor ustekinumab (Stelara), the IL-17A inhibitors secukinumab (Cosentyx) and ixekizumab (Taltz), and TNF inhibitors adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade). They did not study the interleukin-17 (IL-17) inhibitor brodalumab (Siliq) or IL-23 inhibitors guselkumab (Tremfya), risankizumab (Skyrizi), or tildrakizumab (Ilumya) since they were FDA approved after or toward the end of the study period.
The primary outcome of serious infection, defined as hospitalization with infection as part of the diagnostic codes, occurred in 190 cases (2% of all treatment episodes); the most common serious infections were sepsis and pneumonia.
Overall, new biologics users had similar infection risks with IL-17 and TNF inhibitors, with incidence rates per 100 person-years of 3.4 and 2.2, respectively. By contrast, the incidence rate per 100 person-years was 0.9 with IL-12/23 inhibitors. Incidence rates were similar across all three biologic types for experienced biologics users.
The researchers also grouped patients by condition, including both treatment-naive and -experienced patients. Of the 156 serious infections in psoriasis patients, 26 occurred with IL-17 inhibitors, 29 with IL-12/23 inhibitors, and 101 with TNF inhibitors. Of 105 serious infections in the psoriatic arthritis group, 14 occurred with IL-17, 13 with IL-12/23, and 78 with TNF.
After adjusting for propensity scores, researchers found no evidence of increased serious infection risk for treatment with IL-17 inhibitors, compared with IL-12/23 (hazard ratio, 1.12; 95% confidence interval, 0.62-2.03) or TNF inhibitors (HR, 0.89; 95% CI, 0.48-1.66).
The study findings were limited by several factors, including the use of ICD diagnostic codes that were not fully validated in the patient population, a short follow-up period, and inclusion of only insured patients in the United States, the researchers noted.
However, the results suggest that serious infection risk may vary between patients with psoriasis and psoriatic arthritis, and between biologic-naive and -experienced patients, and that, despite the relatively small difference in absolute effect, “this potentially clinically relevant signal for reduced infections among the IL-12/23 inhibitors warrants further investigation and surveillance efforts,” they concluded. In addition, they said, the findings might guide clinicians and patients in choosing appropriate biologics for a particular condition.
The study was supported by the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health. The researchers had no financial conflicts to disclose. Ms. Li conducted the research while she was at Johns Hopkins, but is now with the University of North Carolina, Chapel Hill.
SOURCE: Li X et al. Ann Rheum Dis. 2019 Oct 31. doi: 10.1136/annrheumdis-2019-216102.
FROM ANNALS OF THE RHEUMATIC DISEASES
Severe psoriasis associated with increased cancer risk, mortality
according to a meta-analysis of cohort and case-control studies.
Compared with a psoriasis-free population, having a diagnosis of severe psoriasis was associated with a 22% increase in cancer risk, Alex Trafford of the University of Manchester (England) and colleagues reported in JAMA Dermatology. The risk of cancer mortality was also increased by 22% among those with severe psoriasis.
The site-specific risks ranged from a low of 18% for colon cancer to more than a twofold increased risk for oral and esophageal cancer, according to the investigators.
Since these were associations only, any underlying mechanism is still unclear, they wrote. The chronic inflammation that drives psoriasis can also drive the development of cancer, but immunomodulatory therapies may also play a part, they suggested.
“Of particular relevance in this regard are biological therapies, which are being increasingly used for the management of psoriasis,” they added. “Although preliminary studies have suggested little to no increased risk of cancer incidence in patients with psoriasis receiving these therapies, further study allowing greater follow-up and increased power is required to properly examine the potential cancer risk, particularly for site-specific cancers.”
The analysis included 58 studies, published between 1983 and 2017. Nine of these reported risks for cancer incidence among patients with severe psoriasis, and seven reported the risk of cancer mortality among patients with all severities of psoriasis.
Overall, severe psoriasis was associated with an increased cancer risk of 22%; for all severities of psoriasis combined, the risk increase was 18%. Relative risks for specific cancer types were as follows: colon, 1.18; colorectal, 1.34; kidney, 1.58; laryngeal, 1.79; liver, 1.83; lymphoma, 1.40; non-Hodgkin lymphoma, 1.28; keratinocyte cancers, 1.71; esophageal 2.05; oral cavity, 2.80; and pancreatic, 1.41.
Overall cancer mortality risk was 22% higher in patients with severe psoriasis than the general population. Site-specific relative mortality risks included liver, 1.43; esophageal 2.53; and pancreatic, 1.31.
In light of these findings, clinicians should stress lifestyle modifications known to decrease cancer risk, the investigators said. “Although it has been noted that lifestyle behavior change is challenging for healthcare professionals to implement, the importance of a more holistic approach to psoriasis care involving lifestyle behavior change is reinforced through the results of this meta-analysis.”
Among the coauthors were Darren M. Ashcroft, PhD, the senior author, and Christopher Griffiths, MD, both of the University of Manchester. Dr. Ashcroft reported receiving research grants from AbbVie, Almirall, Celgene, Eli Lilly, Novartis, UCB, and the Leo Foundation. Dr. Griffiths reported receiving honoraria and/or research grants from AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Sandoz, and UCB. The lead author and the other authors had no disclosures. The Global Psoriasis Atlas (GPA) Collaborating Organizations (the International Federation of Psoriasis Associations, the International League of Dermatological Societies, and the International Psoriasis Council) were involved with funding of the study.
SOURCE: Trafford A et al. JAMA Dermatol. 2019 Oct 16. doi:10.1001/jamadermatol.2019.3056.
according to a meta-analysis of cohort and case-control studies.
Compared with a psoriasis-free population, having a diagnosis of severe psoriasis was associated with a 22% increase in cancer risk, Alex Trafford of the University of Manchester (England) and colleagues reported in JAMA Dermatology. The risk of cancer mortality was also increased by 22% among those with severe psoriasis.
The site-specific risks ranged from a low of 18% for colon cancer to more than a twofold increased risk for oral and esophageal cancer, according to the investigators.
Since these were associations only, any underlying mechanism is still unclear, they wrote. The chronic inflammation that drives psoriasis can also drive the development of cancer, but immunomodulatory therapies may also play a part, they suggested.
“Of particular relevance in this regard are biological therapies, which are being increasingly used for the management of psoriasis,” they added. “Although preliminary studies have suggested little to no increased risk of cancer incidence in patients with psoriasis receiving these therapies, further study allowing greater follow-up and increased power is required to properly examine the potential cancer risk, particularly for site-specific cancers.”
The analysis included 58 studies, published between 1983 and 2017. Nine of these reported risks for cancer incidence among patients with severe psoriasis, and seven reported the risk of cancer mortality among patients with all severities of psoriasis.
Overall, severe psoriasis was associated with an increased cancer risk of 22%; for all severities of psoriasis combined, the risk increase was 18%. Relative risks for specific cancer types were as follows: colon, 1.18; colorectal, 1.34; kidney, 1.58; laryngeal, 1.79; liver, 1.83; lymphoma, 1.40; non-Hodgkin lymphoma, 1.28; keratinocyte cancers, 1.71; esophageal 2.05; oral cavity, 2.80; and pancreatic, 1.41.
Overall cancer mortality risk was 22% higher in patients with severe psoriasis than the general population. Site-specific relative mortality risks included liver, 1.43; esophageal 2.53; and pancreatic, 1.31.
In light of these findings, clinicians should stress lifestyle modifications known to decrease cancer risk, the investigators said. “Although it has been noted that lifestyle behavior change is challenging for healthcare professionals to implement, the importance of a more holistic approach to psoriasis care involving lifestyle behavior change is reinforced through the results of this meta-analysis.”
Among the coauthors were Darren M. Ashcroft, PhD, the senior author, and Christopher Griffiths, MD, both of the University of Manchester. Dr. Ashcroft reported receiving research grants from AbbVie, Almirall, Celgene, Eli Lilly, Novartis, UCB, and the Leo Foundation. Dr. Griffiths reported receiving honoraria and/or research grants from AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Sandoz, and UCB. The lead author and the other authors had no disclosures. The Global Psoriasis Atlas (GPA) Collaborating Organizations (the International Federation of Psoriasis Associations, the International League of Dermatological Societies, and the International Psoriasis Council) were involved with funding of the study.
SOURCE: Trafford A et al. JAMA Dermatol. 2019 Oct 16. doi:10.1001/jamadermatol.2019.3056.
according to a meta-analysis of cohort and case-control studies.
Compared with a psoriasis-free population, having a diagnosis of severe psoriasis was associated with a 22% increase in cancer risk, Alex Trafford of the University of Manchester (England) and colleagues reported in JAMA Dermatology. The risk of cancer mortality was also increased by 22% among those with severe psoriasis.
The site-specific risks ranged from a low of 18% for colon cancer to more than a twofold increased risk for oral and esophageal cancer, according to the investigators.
Since these were associations only, any underlying mechanism is still unclear, they wrote. The chronic inflammation that drives psoriasis can also drive the development of cancer, but immunomodulatory therapies may also play a part, they suggested.
“Of particular relevance in this regard are biological therapies, which are being increasingly used for the management of psoriasis,” they added. “Although preliminary studies have suggested little to no increased risk of cancer incidence in patients with psoriasis receiving these therapies, further study allowing greater follow-up and increased power is required to properly examine the potential cancer risk, particularly for site-specific cancers.”
The analysis included 58 studies, published between 1983 and 2017. Nine of these reported risks for cancer incidence among patients with severe psoriasis, and seven reported the risk of cancer mortality among patients with all severities of psoriasis.
Overall, severe psoriasis was associated with an increased cancer risk of 22%; for all severities of psoriasis combined, the risk increase was 18%. Relative risks for specific cancer types were as follows: colon, 1.18; colorectal, 1.34; kidney, 1.58; laryngeal, 1.79; liver, 1.83; lymphoma, 1.40; non-Hodgkin lymphoma, 1.28; keratinocyte cancers, 1.71; esophageal 2.05; oral cavity, 2.80; and pancreatic, 1.41.
Overall cancer mortality risk was 22% higher in patients with severe psoriasis than the general population. Site-specific relative mortality risks included liver, 1.43; esophageal 2.53; and pancreatic, 1.31.
In light of these findings, clinicians should stress lifestyle modifications known to decrease cancer risk, the investigators said. “Although it has been noted that lifestyle behavior change is challenging for healthcare professionals to implement, the importance of a more holistic approach to psoriasis care involving lifestyle behavior change is reinforced through the results of this meta-analysis.”
Among the coauthors were Darren M. Ashcroft, PhD, the senior author, and Christopher Griffiths, MD, both of the University of Manchester. Dr. Ashcroft reported receiving research grants from AbbVie, Almirall, Celgene, Eli Lilly, Novartis, UCB, and the Leo Foundation. Dr. Griffiths reported receiving honoraria and/or research grants from AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Sandoz, and UCB. The lead author and the other authors had no disclosures. The Global Psoriasis Atlas (GPA) Collaborating Organizations (the International Federation of Psoriasis Associations, the International League of Dermatological Societies, and the International Psoriasis Council) were involved with funding of the study.
SOURCE: Trafford A et al. JAMA Dermatol. 2019 Oct 16. doi:10.1001/jamadermatol.2019.3056.
FROM JAMA DERMATOLOGY
Did You Know? Psoriasis and psoriatic arthritis
Psoriasis Journal Scan: October 2019
Psoriasis Associated with Tumor Necrosis Factor-Alpha Inhibitors in Children with Inflammatory Diseases.
Buckley, L. H., Xiao, R. , Perman, M. et al. Arthritis Care Res. 2019 Oct 23.
The study aimed to estimate the incidence rate (IR) of psoriasis in children with inflammatory bowel disease (IBD), juvenile idiopathic arthritis (JIA), and chronic noninfectious osteomyelitis (CNO) with tumor necrosis factor‐alpha inhibitor (TNFi) exposure as compared to those without TNFi exposure and to the general pediatric population. Researchers found that children with IBD, JIA, and CNO had an increased rate of psoriasis compared to the general pediatric population, with the highest rate in those with TNFi exposure.
Skin Patterning in Psoriasis by Spatial Interactions between Pathogenic Cytokines.
Ringham, L, Prusinkiewicz, P, Gniadeck R. iScience. 2019 Oct 25;20:546-553.
This study shows that all known patterns of psoriasis, a common inflammatory skin disease, can be explained in terms of reaction-diffusion. Researchers constructed a computational model based on the known interactions between the main pathogenic cytokines: interleukins IL-17 and IL-23, and tumor necrosis factor TNF-α. Simulations revealed that the parameter space of the model contained all classes of psoriatic lesion patterns. They also faithfully reproduced the growth and evolution of the plaques and the response to treatment by cytokine targeting. Thus the pathogenesis of inflammatory diseases, such as psoriasis, may be readily understood in the framework of the stimulatory and inhibitory interactions between a few diffusing mediators.
SEfficacy of Secukinumab for Plaque Psoriasis in a Patient on Hemodialysis.
Ikuma D, Oguro M, Hoshino J, et al. CEN Case Rep. 2019 Oct 25.
The case report discusses the safety and efficiency of secukinumab on a 60-year-old patient on hemodialysis. The psoriasis area and severity index (PASI) score decreased from 49.8 to 14.8 after 2 weeks and to 0 after 6 weeks, with remission being maintained after 28 months. No adverse reactions were seen. This case indicates that secukinumab may be effective for severe psoriasis in patients on hemodialysis for end-stage renal disease.
Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients.
Bruin, G, Hockey, H‐UP, La Stella, P, et al. Br J Clin Pharmacol. 2019.
The aim of the study was to compare the pharmacokinetics, safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL. Collective evidence from both studies demonstrated that 2 mL injections of secukinumab into the abdomen or thigh using different devices resulted in comparable PK characteristics and were all well tolerated without noticable local reactions.
Dual biologic therapy for recalcitrant psoriasis and psoriatic arthritis
Thibodeaux, Quinn et al. JAAD Case Reports, Volume 5, Issue 10, 928 – 930.
This study presents a patient with severe psoriatic skin and joint disease who has been treated with multiple combinations of dual biologic therapy, including ustekinumab plus etanercept for 12 months, secukinumab plus etanercept for 6 months, and guselkumab plus etanercept for 15 months. Throughout the patient's treatment, adverse events only occurred with the ustekinumab plus etanercept combination and consisted of an increased incidence of urinary tract and upper respiratory infections, including a hospitalization for H2N1 flu.
Psoriasis Associated with Tumor Necrosis Factor-Alpha Inhibitors in Children with Inflammatory Diseases.
Buckley, L. H., Xiao, R. , Perman, M. et al. Arthritis Care Res. 2019 Oct 23.
The study aimed to estimate the incidence rate (IR) of psoriasis in children with inflammatory bowel disease (IBD), juvenile idiopathic arthritis (JIA), and chronic noninfectious osteomyelitis (CNO) with tumor necrosis factor‐alpha inhibitor (TNFi) exposure as compared to those without TNFi exposure and to the general pediatric population. Researchers found that children with IBD, JIA, and CNO had an increased rate of psoriasis compared to the general pediatric population, with the highest rate in those with TNFi exposure.
Skin Patterning in Psoriasis by Spatial Interactions between Pathogenic Cytokines.
Ringham, L, Prusinkiewicz, P, Gniadeck R. iScience. 2019 Oct 25;20:546-553.
This study shows that all known patterns of psoriasis, a common inflammatory skin disease, can be explained in terms of reaction-diffusion. Researchers constructed a computational model based on the known interactions between the main pathogenic cytokines: interleukins IL-17 and IL-23, and tumor necrosis factor TNF-α. Simulations revealed that the parameter space of the model contained all classes of psoriatic lesion patterns. They also faithfully reproduced the growth and evolution of the plaques and the response to treatment by cytokine targeting. Thus the pathogenesis of inflammatory diseases, such as psoriasis, may be readily understood in the framework of the stimulatory and inhibitory interactions between a few diffusing mediators.
SEfficacy of Secukinumab for Plaque Psoriasis in a Patient on Hemodialysis.
Ikuma D, Oguro M, Hoshino J, et al. CEN Case Rep. 2019 Oct 25.
The case report discusses the safety and efficiency of secukinumab on a 60-year-old patient on hemodialysis. The psoriasis area and severity index (PASI) score decreased from 49.8 to 14.8 after 2 weeks and to 0 after 6 weeks, with remission being maintained after 28 months. No adverse reactions were seen. This case indicates that secukinumab may be effective for severe psoriasis in patients on hemodialysis for end-stage renal disease.
Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients.
Bruin, G, Hockey, H‐UP, La Stella, P, et al. Br J Clin Pharmacol. 2019.
The aim of the study was to compare the pharmacokinetics, safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL. Collective evidence from both studies demonstrated that 2 mL injections of secukinumab into the abdomen or thigh using different devices resulted in comparable PK characteristics and were all well tolerated without noticable local reactions.
Dual biologic therapy for recalcitrant psoriasis and psoriatic arthritis
Thibodeaux, Quinn et al. JAAD Case Reports, Volume 5, Issue 10, 928 – 930.
This study presents a patient with severe psoriatic skin and joint disease who has been treated with multiple combinations of dual biologic therapy, including ustekinumab plus etanercept for 12 months, secukinumab plus etanercept for 6 months, and guselkumab plus etanercept for 15 months. Throughout the patient's treatment, adverse events only occurred with the ustekinumab plus etanercept combination and consisted of an increased incidence of urinary tract and upper respiratory infections, including a hospitalization for H2N1 flu.
Psoriasis Associated with Tumor Necrosis Factor-Alpha Inhibitors in Children with Inflammatory Diseases.
Buckley, L. H., Xiao, R. , Perman, M. et al. Arthritis Care Res. 2019 Oct 23.
The study aimed to estimate the incidence rate (IR) of psoriasis in children with inflammatory bowel disease (IBD), juvenile idiopathic arthritis (JIA), and chronic noninfectious osteomyelitis (CNO) with tumor necrosis factor‐alpha inhibitor (TNFi) exposure as compared to those without TNFi exposure and to the general pediatric population. Researchers found that children with IBD, JIA, and CNO had an increased rate of psoriasis compared to the general pediatric population, with the highest rate in those with TNFi exposure.
Skin Patterning in Psoriasis by Spatial Interactions between Pathogenic Cytokines.
Ringham, L, Prusinkiewicz, P, Gniadeck R. iScience. 2019 Oct 25;20:546-553.
This study shows that all known patterns of psoriasis, a common inflammatory skin disease, can be explained in terms of reaction-diffusion. Researchers constructed a computational model based on the known interactions between the main pathogenic cytokines: interleukins IL-17 and IL-23, and tumor necrosis factor TNF-α. Simulations revealed that the parameter space of the model contained all classes of psoriatic lesion patterns. They also faithfully reproduced the growth and evolution of the plaques and the response to treatment by cytokine targeting. Thus the pathogenesis of inflammatory diseases, such as psoriasis, may be readily understood in the framework of the stimulatory and inhibitory interactions between a few diffusing mediators.
SEfficacy of Secukinumab for Plaque Psoriasis in a Patient on Hemodialysis.
Ikuma D, Oguro M, Hoshino J, et al. CEN Case Rep. 2019 Oct 25.
The case report discusses the safety and efficiency of secukinumab on a 60-year-old patient on hemodialysis. The psoriasis area and severity index (PASI) score decreased from 49.8 to 14.8 after 2 weeks and to 0 after 6 weeks, with remission being maintained after 28 months. No adverse reactions were seen. This case indicates that secukinumab may be effective for severe psoriasis in patients on hemodialysis for end-stage renal disease.
Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients.
Bruin, G, Hockey, H‐UP, La Stella, P, et al. Br J Clin Pharmacol. 2019.
The aim of the study was to compare the pharmacokinetics, safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL. Collective evidence from both studies demonstrated that 2 mL injections of secukinumab into the abdomen or thigh using different devices resulted in comparable PK characteristics and were all well tolerated without noticable local reactions.
Dual biologic therapy for recalcitrant psoriasis and psoriatic arthritis
Thibodeaux, Quinn et al. JAAD Case Reports, Volume 5, Issue 10, 928 – 930.
This study presents a patient with severe psoriatic skin and joint disease who has been treated with multiple combinations of dual biologic therapy, including ustekinumab plus etanercept for 12 months, secukinumab plus etanercept for 6 months, and guselkumab plus etanercept for 15 months. Throughout the patient's treatment, adverse events only occurred with the ustekinumab plus etanercept combination and consisted of an increased incidence of urinary tract and upper respiratory infections, including a hospitalization for H2N1 flu.
Psoriasis risk rises with TNF inhibitor use in children with inflammatory disorders
, a retrospective cohort study has determined.
“The incidence rate and risk factors of psoriasis in children with IBD [inflammatory bowel disease], JIA [juvenile idiopathic arthritis], or CNO [chronic nonbacterial osteomyelitis] who are exposed to TNFi [tumor necrosis factor inhibitors] are unknown. Additionally, there is a well-established association between these inflammatory conditions and psoriasis development. Yet, as TNFi can both treat and trigger psoriasis, it is not clear how TNFi exposure affects this relationship,” wrote Lisa H. Buckley, MD, of Children’s Hospital at Vanderbilt, Nashville, Tenn., and colleagues. Their report is in Arthritis Care & Research.
The team examined the relationship in children who were treated for an inflammatory disorder at Children’s Hospital of Philadelphia during 2008-2018. IBD was most common at 74%, followed by JIA at 24% and CNO at 2%.
Among 4,111 children with those inflammatory disorders, the psoriasis incidence was 12.3 per 1,000 person-years in exposed children and 3.8 per 1,000 person-years in unexposed. This significant difference equated to a hazard ratio of 3.84 for developing psoriasis after TNFi exposure.
“These data reflect the established association between inflammatory conditions and psoriasis development and suggest that TNFi exposure further increases the risk of psoriasis,” Dr. Buckley and coauthors wrote.
The median duration of follow-up in this study was about 2.5 years for patients exposed to TNFi and 2 years for those unexposed. Among the entire cohort, 39% had been exposed to a TNFi, with 4,705 person-years of follow-up. Among the unexposed children (61%), there were 6,604 person-years of follow-up.
In all, 83 cases of psoriasis developed: 58 in the exposed group and 25 in the unexposed group. Psoriasis incidence varied by disorder. Exposed children with IBD had a higher incidence than did unexposed children (10.9 vs. 2.6 per 1,000 person-years; HR = 4.52). Exposed children with JIA also had a higher incidence than did unexposed children (14.7 vs. 5.5 per 1,000 person-years; HR = 2.90). Among those with CNO, incidences were similar for exposed and unexposed children (33.5 and 38.9 per 1,000 person-years).
A family history of psoriasis significantly increased the risk of psoriasis with a hazard ratio of 3.11, the authors noted. But none of the other covariates (age, sex, race, obesity, methotrexate exposure, and underlying diagnosis) exerted a significant additional risk.
The study had no outside funding source. The authors had no financial disclosures. Dr. Buckley conducted the research when she was a pediatric rheumatology fellow at Children’s Hospital of Philadelphia.
SOURCE: Buckley LH et al. Arthritis Care Res. 2019 Oct 23. doi: 10.1002/ACR.24100
, a retrospective cohort study has determined.
“The incidence rate and risk factors of psoriasis in children with IBD [inflammatory bowel disease], JIA [juvenile idiopathic arthritis], or CNO [chronic nonbacterial osteomyelitis] who are exposed to TNFi [tumor necrosis factor inhibitors] are unknown. Additionally, there is a well-established association between these inflammatory conditions and psoriasis development. Yet, as TNFi can both treat and trigger psoriasis, it is not clear how TNFi exposure affects this relationship,” wrote Lisa H. Buckley, MD, of Children’s Hospital at Vanderbilt, Nashville, Tenn., and colleagues. Their report is in Arthritis Care & Research.
The team examined the relationship in children who were treated for an inflammatory disorder at Children’s Hospital of Philadelphia during 2008-2018. IBD was most common at 74%, followed by JIA at 24% and CNO at 2%.
Among 4,111 children with those inflammatory disorders, the psoriasis incidence was 12.3 per 1,000 person-years in exposed children and 3.8 per 1,000 person-years in unexposed. This significant difference equated to a hazard ratio of 3.84 for developing psoriasis after TNFi exposure.
“These data reflect the established association between inflammatory conditions and psoriasis development and suggest that TNFi exposure further increases the risk of psoriasis,” Dr. Buckley and coauthors wrote.
The median duration of follow-up in this study was about 2.5 years for patients exposed to TNFi and 2 years for those unexposed. Among the entire cohort, 39% had been exposed to a TNFi, with 4,705 person-years of follow-up. Among the unexposed children (61%), there were 6,604 person-years of follow-up.
In all, 83 cases of psoriasis developed: 58 in the exposed group and 25 in the unexposed group. Psoriasis incidence varied by disorder. Exposed children with IBD had a higher incidence than did unexposed children (10.9 vs. 2.6 per 1,000 person-years; HR = 4.52). Exposed children with JIA also had a higher incidence than did unexposed children (14.7 vs. 5.5 per 1,000 person-years; HR = 2.90). Among those with CNO, incidences were similar for exposed and unexposed children (33.5 and 38.9 per 1,000 person-years).
A family history of psoriasis significantly increased the risk of psoriasis with a hazard ratio of 3.11, the authors noted. But none of the other covariates (age, sex, race, obesity, methotrexate exposure, and underlying diagnosis) exerted a significant additional risk.
The study had no outside funding source. The authors had no financial disclosures. Dr. Buckley conducted the research when she was a pediatric rheumatology fellow at Children’s Hospital of Philadelphia.
SOURCE: Buckley LH et al. Arthritis Care Res. 2019 Oct 23. doi: 10.1002/ACR.24100
, a retrospective cohort study has determined.
“The incidence rate and risk factors of psoriasis in children with IBD [inflammatory bowel disease], JIA [juvenile idiopathic arthritis], or CNO [chronic nonbacterial osteomyelitis] who are exposed to TNFi [tumor necrosis factor inhibitors] are unknown. Additionally, there is a well-established association between these inflammatory conditions and psoriasis development. Yet, as TNFi can both treat and trigger psoriasis, it is not clear how TNFi exposure affects this relationship,” wrote Lisa H. Buckley, MD, of Children’s Hospital at Vanderbilt, Nashville, Tenn., and colleagues. Their report is in Arthritis Care & Research.
The team examined the relationship in children who were treated for an inflammatory disorder at Children’s Hospital of Philadelphia during 2008-2018. IBD was most common at 74%, followed by JIA at 24% and CNO at 2%.
Among 4,111 children with those inflammatory disorders, the psoriasis incidence was 12.3 per 1,000 person-years in exposed children and 3.8 per 1,000 person-years in unexposed. This significant difference equated to a hazard ratio of 3.84 for developing psoriasis after TNFi exposure.
“These data reflect the established association between inflammatory conditions and psoriasis development and suggest that TNFi exposure further increases the risk of psoriasis,” Dr. Buckley and coauthors wrote.
The median duration of follow-up in this study was about 2.5 years for patients exposed to TNFi and 2 years for those unexposed. Among the entire cohort, 39% had been exposed to a TNFi, with 4,705 person-years of follow-up. Among the unexposed children (61%), there were 6,604 person-years of follow-up.
In all, 83 cases of psoriasis developed: 58 in the exposed group and 25 in the unexposed group. Psoriasis incidence varied by disorder. Exposed children with IBD had a higher incidence than did unexposed children (10.9 vs. 2.6 per 1,000 person-years; HR = 4.52). Exposed children with JIA also had a higher incidence than did unexposed children (14.7 vs. 5.5 per 1,000 person-years; HR = 2.90). Among those with CNO, incidences were similar for exposed and unexposed children (33.5 and 38.9 per 1,000 person-years).
A family history of psoriasis significantly increased the risk of psoriasis with a hazard ratio of 3.11, the authors noted. But none of the other covariates (age, sex, race, obesity, methotrexate exposure, and underlying diagnosis) exerted a significant additional risk.
The study had no outside funding source. The authors had no financial disclosures. Dr. Buckley conducted the research when she was a pediatric rheumatology fellow at Children’s Hospital of Philadelphia.
SOURCE: Buckley LH et al. Arthritis Care Res. 2019 Oct 23. doi: 10.1002/ACR.24100
FROM ARTHRITIS RESEARCH & CARE
No infection increase seen with biologics in older psoriasis patients
MADRID – Psoriasis patients aged 65 years and older are at more than twice the risk of serious bacterial and opportunistic infections, compared with younger patients, but that risk is not further elevated by being on biologic agents, Joseph F. Merola, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
He presented a large, The study implications, he said, are clear: When moderate to severe psoriasis warrants consideration of highly effective biologic therapies, that therapeutic option shouldn’t be taken off the table on the basis of a mistaken belief that biologics pose a greater infection risk just because the affected patient is over age 65 years.
“We really think that older patients should be offered treatments at the same level of disease control as all the rest of our psoriasis patients, in the context of shared decision making,” said Dr. Merola, a dermatologist and rheumatologist who is the director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston.
The study utilized longitudinal claims data from a very large U.S. database covering the years 2003-2017. Among the 185 million covered lives were 1.1 million individuals with psoriasis, including 150,000 aged 65 years or older. After excluding older psoriasis patients with comorbid cancer or autoimmune disease, the investigators were left with 11,218 older psoriasis patients initiating systemic therapy for the first time and therefore eligible for propensity score matching using a highly accurate proprietary platform. The final study population consisted of 2,795 older psoriasis patients newly initiating biologic therapy, 2,795 others newly initiating nonbiologic systemic agents, and 2,529 seniors starting phototherapy. The matching was based upon factors including age, sex, prior infections, comorbid psoriatic arthritis, diabetes, and obesity.
The primary study endpoint was the rate of serious bacterial or opportunistic infections requiring hospitalization during the first 6 months of treatment. The bottom line: The rates were closely similar across all three groups, with the most common serious infections being pneumonia and cellulitis.
In contrast, among a population of 115,047 senior psoriasis patients who never used systemic therapy, the risk of serious infection was 12.2 events per 1,000 patients over 6 months, compared with 5.3 events in 120,174 matched controls without psoriasis. That translates to a 2.24-fold increased risk.
One audience member commented that a limitation of the study was that all biologics were lumped together. He would expect that the tumor necrosis factor inhibitors, for example, would be associated with a significantly higher serious infection risk than biologics with other targets.
Dr. Merola conceded the point, adding that the investigators are trying to reanalyze the data in a more granular way to address that shortcoming. Other study limitations included an inability to access the specific doses of systemic treatments used or to stratify patients by disease severity.
Another audience member noted that dermatologists often reassure surgeons that there’s no increased risk of infection associated with psoriasis when in fact there is increased risk in older psoriasis patients, according to these new data.
“We’re not trying to send a message to surgeons to withhold a knee transplant because of a psoriasis plaque over the knee,” Dr. Merola replied. “I think we’ve all been there; we’ve all fought that battle.” Based on the data, he said, he would advise that “our patients who need to be on systemics should remain appropriately on systemics as we see fit.”
The study was entirely funded by Brigham and Women’s Hospital. Dr. Merola reported serving as a consultant to and/or recipient of research grants from nearly two dozen pharmaceutical companies.
MADRID – Psoriasis patients aged 65 years and older are at more than twice the risk of serious bacterial and opportunistic infections, compared with younger patients, but that risk is not further elevated by being on biologic agents, Joseph F. Merola, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
He presented a large, The study implications, he said, are clear: When moderate to severe psoriasis warrants consideration of highly effective biologic therapies, that therapeutic option shouldn’t be taken off the table on the basis of a mistaken belief that biologics pose a greater infection risk just because the affected patient is over age 65 years.
“We really think that older patients should be offered treatments at the same level of disease control as all the rest of our psoriasis patients, in the context of shared decision making,” said Dr. Merola, a dermatologist and rheumatologist who is the director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston.
The study utilized longitudinal claims data from a very large U.S. database covering the years 2003-2017. Among the 185 million covered lives were 1.1 million individuals with psoriasis, including 150,000 aged 65 years or older. After excluding older psoriasis patients with comorbid cancer or autoimmune disease, the investigators were left with 11,218 older psoriasis patients initiating systemic therapy for the first time and therefore eligible for propensity score matching using a highly accurate proprietary platform. The final study population consisted of 2,795 older psoriasis patients newly initiating biologic therapy, 2,795 others newly initiating nonbiologic systemic agents, and 2,529 seniors starting phototherapy. The matching was based upon factors including age, sex, prior infections, comorbid psoriatic arthritis, diabetes, and obesity.
The primary study endpoint was the rate of serious bacterial or opportunistic infections requiring hospitalization during the first 6 months of treatment. The bottom line: The rates were closely similar across all three groups, with the most common serious infections being pneumonia and cellulitis.
In contrast, among a population of 115,047 senior psoriasis patients who never used systemic therapy, the risk of serious infection was 12.2 events per 1,000 patients over 6 months, compared with 5.3 events in 120,174 matched controls without psoriasis. That translates to a 2.24-fold increased risk.
One audience member commented that a limitation of the study was that all biologics were lumped together. He would expect that the tumor necrosis factor inhibitors, for example, would be associated with a significantly higher serious infection risk than biologics with other targets.
Dr. Merola conceded the point, adding that the investigators are trying to reanalyze the data in a more granular way to address that shortcoming. Other study limitations included an inability to access the specific doses of systemic treatments used or to stratify patients by disease severity.
Another audience member noted that dermatologists often reassure surgeons that there’s no increased risk of infection associated with psoriasis when in fact there is increased risk in older psoriasis patients, according to these new data.
“We’re not trying to send a message to surgeons to withhold a knee transplant because of a psoriasis plaque over the knee,” Dr. Merola replied. “I think we’ve all been there; we’ve all fought that battle.” Based on the data, he said, he would advise that “our patients who need to be on systemics should remain appropriately on systemics as we see fit.”
The study was entirely funded by Brigham and Women’s Hospital. Dr. Merola reported serving as a consultant to and/or recipient of research grants from nearly two dozen pharmaceutical companies.
MADRID – Psoriasis patients aged 65 years and older are at more than twice the risk of serious bacterial and opportunistic infections, compared with younger patients, but that risk is not further elevated by being on biologic agents, Joseph F. Merola, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
He presented a large, The study implications, he said, are clear: When moderate to severe psoriasis warrants consideration of highly effective biologic therapies, that therapeutic option shouldn’t be taken off the table on the basis of a mistaken belief that biologics pose a greater infection risk just because the affected patient is over age 65 years.
“We really think that older patients should be offered treatments at the same level of disease control as all the rest of our psoriasis patients, in the context of shared decision making,” said Dr. Merola, a dermatologist and rheumatologist who is the director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston.
The study utilized longitudinal claims data from a very large U.S. database covering the years 2003-2017. Among the 185 million covered lives were 1.1 million individuals with psoriasis, including 150,000 aged 65 years or older. After excluding older psoriasis patients with comorbid cancer or autoimmune disease, the investigators were left with 11,218 older psoriasis patients initiating systemic therapy for the first time and therefore eligible for propensity score matching using a highly accurate proprietary platform. The final study population consisted of 2,795 older psoriasis patients newly initiating biologic therapy, 2,795 others newly initiating nonbiologic systemic agents, and 2,529 seniors starting phototherapy. The matching was based upon factors including age, sex, prior infections, comorbid psoriatic arthritis, diabetes, and obesity.
The primary study endpoint was the rate of serious bacterial or opportunistic infections requiring hospitalization during the first 6 months of treatment. The bottom line: The rates were closely similar across all three groups, with the most common serious infections being pneumonia and cellulitis.
In contrast, among a population of 115,047 senior psoriasis patients who never used systemic therapy, the risk of serious infection was 12.2 events per 1,000 patients over 6 months, compared with 5.3 events in 120,174 matched controls without psoriasis. That translates to a 2.24-fold increased risk.
One audience member commented that a limitation of the study was that all biologics were lumped together. He would expect that the tumor necrosis factor inhibitors, for example, would be associated with a significantly higher serious infection risk than biologics with other targets.
Dr. Merola conceded the point, adding that the investigators are trying to reanalyze the data in a more granular way to address that shortcoming. Other study limitations included an inability to access the specific doses of systemic treatments used or to stratify patients by disease severity.
Another audience member noted that dermatologists often reassure surgeons that there’s no increased risk of infection associated with psoriasis when in fact there is increased risk in older psoriasis patients, according to these new data.
“We’re not trying to send a message to surgeons to withhold a knee transplant because of a psoriasis plaque over the knee,” Dr. Merola replied. “I think we’ve all been there; we’ve all fought that battle.” Based on the data, he said, he would advise that “our patients who need to be on systemics should remain appropriately on systemics as we see fit.”
The study was entirely funded by Brigham and Women’s Hospital. Dr. Merola reported serving as a consultant to and/or recipient of research grants from nearly two dozen pharmaceutical companies.
REPORTING FROM EADV 2019
PASI-75 with ixekizumab approaches 90% in pediatric psoriasis study
MADRID – The interleukin-17A inhibitor , Kim A. Papp, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The results bode well for an underserved population.
“I think all of us know that there is still a vulnerable population that remains a high-risk population because of the limited number of therapies available for them, and that is children,” said Dr. Papp, a dermatologist and president of Probity Medical Research, Inc., of Waterloo, Ont.
At present, etanercept, one of the earliest biologics to become available, and a relatively less effective one, is the only biologic approved for treatment of pediatric psoriasis. However, Lilly, which sponsored the phase 3 ixekizumab study, has announced that based upon the highly positive findings the company plans to seek Food and Drug Administration approval for an expanded indication for the medication in pediatric psoriasis. The company now markets ixekizumab for the approved indications of treatment of adults with moderate to severe plaque psoriasis, active psoriatic arthritis, or active ankylosing spondylitis.
The 12-week, double-blind, multicenter phase 3 trial known as IXORA-PEDS included 115 pediatric psoriasis patients randomized to weight-based ixekizumab, 30 on weight-based etanercept, and 58 on placebo. At the 12-week mark, everyone was switched to open-label ixekizumab in a long-term extension study. Children weighing less than 25 kg received a 40-mg loading dose of ixekizumab, followed by a maintenance dose of 20 mg by subcutaneous injection every 4 weeks. Patients weighing 25-50 kg got a starting dose of 80 mg, then 40 mg for maintenance therapy. Those who weighed more than 50 kg got the usual adult dosing: a 160-mg loading dose followed by 80 mg every 4 weeks. Etanercept was dosed at 0.8 mg/kg once weekly.
The coprimary endpoints were the proportion of subjects achieving a static Physician’s Global Assessment (sPGA) of 0 or 1 – that is, clear or almost clear skin – at week 12, and the PASI 75 response rate.
An sPGA of 0 or 1 at week 12 was documented in 81% of the ixekizumab group, 11% on placebo, and 40% of etanercept-treated patients, who on average had more severe baseline disease than did the other two groups.
The PASI 75 rate was 89% with ixekizumab, 25% for placebo, and 63% on etanercept. But Dr. Papp indicated that’s too low a bar. “I don’t think PASI 75s are the standard any longer,” he said.
More revealing was the PASI 90 rate: 78% with the IL-17A inhibitor, 5% in placebo-treated controls, and 40% with etanercept.
And then there’s the PASI 100 response rate: 50% with ixekizumab, 2% for placebo, and 17% for etanercept.
“I think this is very telling. I’ll leave it as a tantalizing comment that if one looks at the slope of the curve, it doesn’t yet seem to have reached its plateau at week 12 – and this is very similar to the pattern that we see in the adult population. I don’t have the long-term extension efficacy data, but I am, like you, very interested in seeing where this PASI 100 response rate finally plateaus,” Dr. Papp said.
He did, however, have the combined safety data for the 12-week double-blind phase plus the open-label extension, which he described as essentially the same as the adult experience. Injection-site reactions occurred in 19% of pediatric patients on ixekizumab, but they were generally mild and there were few if any treatment discontinuations for that reason. There was a 2% incidence of Crohn’s disease. Candidiasis and other infections were rare.
Seventy-one percent of the ixekizumab group had at least a 4-point improvement in itch on a 10-point self-rated scale by week 12, as did 20% of placebo-treated controls. A Dermatologic Life Quality Index score of 0 or 1 at week 12, indicative of no or minimal impact of psoriasis on quality of life, was documented in 64% of the ixekizumab group and 23% of controls.
Dr. Papp reported serving as a consultant, investigator, and/or speaker for Lilly and more than three dozen other pharmaceutical companies.
SOURCE: Papp KA. EADV Late breaker.
MADRID – The interleukin-17A inhibitor , Kim A. Papp, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The results bode well for an underserved population.
“I think all of us know that there is still a vulnerable population that remains a high-risk population because of the limited number of therapies available for them, and that is children,” said Dr. Papp, a dermatologist and president of Probity Medical Research, Inc., of Waterloo, Ont.
At present, etanercept, one of the earliest biologics to become available, and a relatively less effective one, is the only biologic approved for treatment of pediatric psoriasis. However, Lilly, which sponsored the phase 3 ixekizumab study, has announced that based upon the highly positive findings the company plans to seek Food and Drug Administration approval for an expanded indication for the medication in pediatric psoriasis. The company now markets ixekizumab for the approved indications of treatment of adults with moderate to severe plaque psoriasis, active psoriatic arthritis, or active ankylosing spondylitis.
The 12-week, double-blind, multicenter phase 3 trial known as IXORA-PEDS included 115 pediatric psoriasis patients randomized to weight-based ixekizumab, 30 on weight-based etanercept, and 58 on placebo. At the 12-week mark, everyone was switched to open-label ixekizumab in a long-term extension study. Children weighing less than 25 kg received a 40-mg loading dose of ixekizumab, followed by a maintenance dose of 20 mg by subcutaneous injection every 4 weeks. Patients weighing 25-50 kg got a starting dose of 80 mg, then 40 mg for maintenance therapy. Those who weighed more than 50 kg got the usual adult dosing: a 160-mg loading dose followed by 80 mg every 4 weeks. Etanercept was dosed at 0.8 mg/kg once weekly.
The coprimary endpoints were the proportion of subjects achieving a static Physician’s Global Assessment (sPGA) of 0 or 1 – that is, clear or almost clear skin – at week 12, and the PASI 75 response rate.
An sPGA of 0 or 1 at week 12 was documented in 81% of the ixekizumab group, 11% on placebo, and 40% of etanercept-treated patients, who on average had more severe baseline disease than did the other two groups.
The PASI 75 rate was 89% with ixekizumab, 25% for placebo, and 63% on etanercept. But Dr. Papp indicated that’s too low a bar. “I don’t think PASI 75s are the standard any longer,” he said.
More revealing was the PASI 90 rate: 78% with the IL-17A inhibitor, 5% in placebo-treated controls, and 40% with etanercept.
And then there’s the PASI 100 response rate: 50% with ixekizumab, 2% for placebo, and 17% for etanercept.
“I think this is very telling. I’ll leave it as a tantalizing comment that if one looks at the slope of the curve, it doesn’t yet seem to have reached its plateau at week 12 – and this is very similar to the pattern that we see in the adult population. I don’t have the long-term extension efficacy data, but I am, like you, very interested in seeing where this PASI 100 response rate finally plateaus,” Dr. Papp said.
He did, however, have the combined safety data for the 12-week double-blind phase plus the open-label extension, which he described as essentially the same as the adult experience. Injection-site reactions occurred in 19% of pediatric patients on ixekizumab, but they were generally mild and there were few if any treatment discontinuations for that reason. There was a 2% incidence of Crohn’s disease. Candidiasis and other infections were rare.
Seventy-one percent of the ixekizumab group had at least a 4-point improvement in itch on a 10-point self-rated scale by week 12, as did 20% of placebo-treated controls. A Dermatologic Life Quality Index score of 0 or 1 at week 12, indicative of no or minimal impact of psoriasis on quality of life, was documented in 64% of the ixekizumab group and 23% of controls.
Dr. Papp reported serving as a consultant, investigator, and/or speaker for Lilly and more than three dozen other pharmaceutical companies.
SOURCE: Papp KA. EADV Late breaker.
MADRID – The interleukin-17A inhibitor , Kim A. Papp, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The results bode well for an underserved population.
“I think all of us know that there is still a vulnerable population that remains a high-risk population because of the limited number of therapies available for them, and that is children,” said Dr. Papp, a dermatologist and president of Probity Medical Research, Inc., of Waterloo, Ont.
At present, etanercept, one of the earliest biologics to become available, and a relatively less effective one, is the only biologic approved for treatment of pediatric psoriasis. However, Lilly, which sponsored the phase 3 ixekizumab study, has announced that based upon the highly positive findings the company plans to seek Food and Drug Administration approval for an expanded indication for the medication in pediatric psoriasis. The company now markets ixekizumab for the approved indications of treatment of adults with moderate to severe plaque psoriasis, active psoriatic arthritis, or active ankylosing spondylitis.
The 12-week, double-blind, multicenter phase 3 trial known as IXORA-PEDS included 115 pediatric psoriasis patients randomized to weight-based ixekizumab, 30 on weight-based etanercept, and 58 on placebo. At the 12-week mark, everyone was switched to open-label ixekizumab in a long-term extension study. Children weighing less than 25 kg received a 40-mg loading dose of ixekizumab, followed by a maintenance dose of 20 mg by subcutaneous injection every 4 weeks. Patients weighing 25-50 kg got a starting dose of 80 mg, then 40 mg for maintenance therapy. Those who weighed more than 50 kg got the usual adult dosing: a 160-mg loading dose followed by 80 mg every 4 weeks. Etanercept was dosed at 0.8 mg/kg once weekly.
The coprimary endpoints were the proportion of subjects achieving a static Physician’s Global Assessment (sPGA) of 0 or 1 – that is, clear or almost clear skin – at week 12, and the PASI 75 response rate.
An sPGA of 0 or 1 at week 12 was documented in 81% of the ixekizumab group, 11% on placebo, and 40% of etanercept-treated patients, who on average had more severe baseline disease than did the other two groups.
The PASI 75 rate was 89% with ixekizumab, 25% for placebo, and 63% on etanercept. But Dr. Papp indicated that’s too low a bar. “I don’t think PASI 75s are the standard any longer,” he said.
More revealing was the PASI 90 rate: 78% with the IL-17A inhibitor, 5% in placebo-treated controls, and 40% with etanercept.
And then there’s the PASI 100 response rate: 50% with ixekizumab, 2% for placebo, and 17% for etanercept.
“I think this is very telling. I’ll leave it as a tantalizing comment that if one looks at the slope of the curve, it doesn’t yet seem to have reached its plateau at week 12 – and this is very similar to the pattern that we see in the adult population. I don’t have the long-term extension efficacy data, but I am, like you, very interested in seeing where this PASI 100 response rate finally plateaus,” Dr. Papp said.
He did, however, have the combined safety data for the 12-week double-blind phase plus the open-label extension, which he described as essentially the same as the adult experience. Injection-site reactions occurred in 19% of pediatric patients on ixekizumab, but they were generally mild and there were few if any treatment discontinuations for that reason. There was a 2% incidence of Crohn’s disease. Candidiasis and other infections were rare.
Seventy-one percent of the ixekizumab group had at least a 4-point improvement in itch on a 10-point self-rated scale by week 12, as did 20% of placebo-treated controls. A Dermatologic Life Quality Index score of 0 or 1 at week 12, indicative of no or minimal impact of psoriasis on quality of life, was documented in 64% of the ixekizumab group and 23% of controls.
Dr. Papp reported serving as a consultant, investigator, and/or speaker for Lilly and more than three dozen other pharmaceutical companies.
SOURCE: Papp KA. EADV Late breaker.
REPORTING FROM THE EADV CONGRESS
Serlopitant improves psoriatic itch in phase 2 study
MADRID – Serlopitant, an investigational once-daily oral neurokinin-1 receptor antagonist, resulted in clinically meaningful improvement in psoriatic itch in a phase 2, double-blind, placebo-controlled randomized trial, David M. Pariser, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The drug is not an effective stand alone treatment for psoriasis, though.
“The psoriasis itself did not improve during the trial. It’s the itch that improved. This drug is not designed for psoriasis; it’s going to be used for itching. If this does materialize as a treatment for psoriasis, it would be as an adjunct,” according to Dr. Pariser, a dermatologist at the Eastern Virginia School of Medicine, Norfolk.
Still, serlopitant addresses an unmet need for better treatment options for psoriatic itch. Up to 90% of psoriasis patients report experiencing pruritus, regardless of their disease severity.
“Although patients consider pruritus one of the most important, severe, and troublesome symptoms of psoriasis, clinicians have not historically recognized itch as a significant symptom, and treatments for psoriasis often don’t alleviate the associated pruritus,” he said.
Serlopitant has already shown efficacy and good tolerability in phase 2 studies in patients with prurigo nodularis and chronic pruritus.
The 8-week psoriatic itch trial included 204 adults with plaque psoriasis randomized to 5 mg of serlopitant once daily or placebo. Patients averaged 4.3% involved body surface area, and nearly two-thirds of them had moderate psoriasis by physician global assessment. The majority of patients rated their itch as severe; The average baseline score on the 0-10 Worst Itch Numeric Rating Scale was 8.2.
The primary study endpoint was achievement of at least a 4-point improvement on the Worst Itch Numeric Rating Scale. This was achieved in 33.9% of the serlopitant group and 21.1% of placebo-treated controls. The therapeutic benefit was consistent regardless of baseline body weight, gender, age, or extent of psoriasis-involved body surface area.
The safety data were consistent with what was seen in prior phase 2 studies for other dermatologic disorders. There were no serious adverse events, and the type and frequency of adverse events deemed related to treatment was similar in the two study arms.
“These results support the ongoing development of serlopitant across the spectrum of psoriatic disease,” Dr. Pariser declared.
The study was funded by Menlo Therapeutics. Dr. Pariser reported receiving research funding from and/or serving as a consultant to or advisory board member for roughly two dozen pharmaceutical companies.
MADRID – Serlopitant, an investigational once-daily oral neurokinin-1 receptor antagonist, resulted in clinically meaningful improvement in psoriatic itch in a phase 2, double-blind, placebo-controlled randomized trial, David M. Pariser, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The drug is not an effective stand alone treatment for psoriasis, though.
“The psoriasis itself did not improve during the trial. It’s the itch that improved. This drug is not designed for psoriasis; it’s going to be used for itching. If this does materialize as a treatment for psoriasis, it would be as an adjunct,” according to Dr. Pariser, a dermatologist at the Eastern Virginia School of Medicine, Norfolk.
Still, serlopitant addresses an unmet need for better treatment options for psoriatic itch. Up to 90% of psoriasis patients report experiencing pruritus, regardless of their disease severity.
“Although patients consider pruritus one of the most important, severe, and troublesome symptoms of psoriasis, clinicians have not historically recognized itch as a significant symptom, and treatments for psoriasis often don’t alleviate the associated pruritus,” he said.
Serlopitant has already shown efficacy and good tolerability in phase 2 studies in patients with prurigo nodularis and chronic pruritus.
The 8-week psoriatic itch trial included 204 adults with plaque psoriasis randomized to 5 mg of serlopitant once daily or placebo. Patients averaged 4.3% involved body surface area, and nearly two-thirds of them had moderate psoriasis by physician global assessment. The majority of patients rated their itch as severe; The average baseline score on the 0-10 Worst Itch Numeric Rating Scale was 8.2.
The primary study endpoint was achievement of at least a 4-point improvement on the Worst Itch Numeric Rating Scale. This was achieved in 33.9% of the serlopitant group and 21.1% of placebo-treated controls. The therapeutic benefit was consistent regardless of baseline body weight, gender, age, or extent of psoriasis-involved body surface area.
The safety data were consistent with what was seen in prior phase 2 studies for other dermatologic disorders. There were no serious adverse events, and the type and frequency of adverse events deemed related to treatment was similar in the two study arms.
“These results support the ongoing development of serlopitant across the spectrum of psoriatic disease,” Dr. Pariser declared.
The study was funded by Menlo Therapeutics. Dr. Pariser reported receiving research funding from and/or serving as a consultant to or advisory board member for roughly two dozen pharmaceutical companies.
MADRID – Serlopitant, an investigational once-daily oral neurokinin-1 receptor antagonist, resulted in clinically meaningful improvement in psoriatic itch in a phase 2, double-blind, placebo-controlled randomized trial, David M. Pariser, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The drug is not an effective stand alone treatment for psoriasis, though.
“The psoriasis itself did not improve during the trial. It’s the itch that improved. This drug is not designed for psoriasis; it’s going to be used for itching. If this does materialize as a treatment for psoriasis, it would be as an adjunct,” according to Dr. Pariser, a dermatologist at the Eastern Virginia School of Medicine, Norfolk.
Still, serlopitant addresses an unmet need for better treatment options for psoriatic itch. Up to 90% of psoriasis patients report experiencing pruritus, regardless of their disease severity.
“Although patients consider pruritus one of the most important, severe, and troublesome symptoms of psoriasis, clinicians have not historically recognized itch as a significant symptom, and treatments for psoriasis often don’t alleviate the associated pruritus,” he said.
Serlopitant has already shown efficacy and good tolerability in phase 2 studies in patients with prurigo nodularis and chronic pruritus.
The 8-week psoriatic itch trial included 204 adults with plaque psoriasis randomized to 5 mg of serlopitant once daily or placebo. Patients averaged 4.3% involved body surface area, and nearly two-thirds of them had moderate psoriasis by physician global assessment. The majority of patients rated their itch as severe; The average baseline score on the 0-10 Worst Itch Numeric Rating Scale was 8.2.
The primary study endpoint was achievement of at least a 4-point improvement on the Worst Itch Numeric Rating Scale. This was achieved in 33.9% of the serlopitant group and 21.1% of placebo-treated controls. The therapeutic benefit was consistent regardless of baseline body weight, gender, age, or extent of psoriasis-involved body surface area.
The safety data were consistent with what was seen in prior phase 2 studies for other dermatologic disorders. There were no serious adverse events, and the type and frequency of adverse events deemed related to treatment was similar in the two study arms.
“These results support the ongoing development of serlopitant across the spectrum of psoriatic disease,” Dr. Pariser declared.
The study was funded by Menlo Therapeutics. Dr. Pariser reported receiving research funding from and/or serving as a consultant to or advisory board member for roughly two dozen pharmaceutical companies.
REPORTING FROM EADV 2019
Role of Psoriasis in the Development of Merkel Cell Carcinoma
1. O’Brien T, Power DG. Metastatic Merkel-cell carcinoma: the dawn of a new era. BMJ Case Rep. 2018;11:2018. doi:10.1136/bcr-2018-224924.
2. Del Marmol V, Lebbé C. New perspectives in Merkel cell carcinoma. Curr Opin Oncol. 2019;31:72-83.
3. Garcia-Carbonero R, Marquez-Rodas I, de la Cruz-Merino L, et al. Recent therapeutic advances and change in treatment paradigm of patients with Merkel cell carcinoma [published online April 8, 2019]. Oncologist. doi:10.1634/theoncologist.2018-0718.
4. Samimi M, Gardair C, Nicol JT, et al. Merkel cell polyomavirus in Merkel cell carcinoma: clinical and therapeutic perspectives. Semin Oncol. 2015;42:347-358.
5. Kitamura N, Tomita R, Yamamoto M, et al. Complete remission of Merkel cell carcinoma on the upper lip treated with radiation monotherapy and a literature review of Japanese cases. World J Surg Oncol. 2015;13:152.
6. Timmer FC, Klop WM, Relyveld GN, et al. Merkel cell carcinoma of the head and neck: emphasizing the risk of undertreatment. Eur Arch Otorhinolaryngol. 2016;273:1243-1252.
7. Açıkalın A, Paydas¸ S, Güleç ÜK, et al. A unique case of Merkel cell carcinoma with ovarian metastasis. Balkan Med J. 2014;31:356-359.
8. Yousif J, Yousif B, Kuriata MA. Complete remission of metastatic Merkel cell carcinoma in a patient with severe psoriasis. Cutis. 2018;101:E24-E27.
9. Grandhaye M, Teixeira PG, Henrot P, et al. Focus on Merkel cell carcinoma: diagnosis and staging. Skeletal Radiol. 2015;44:777-786.
10. Chatzinasiou F, Papadavid E, Korkolopoulou P, et al. An unusual case of diffuse Merkel cell carcinoma successfully treated with low dose radiotherapy. Dermatol Ther. 2015;28:282-286.
11. Pang C, Sharma D, Sankar T. Spontaneous regression of Merkel cell carcinoma: a case report and review of the literature. Int J Surg Case Rep. 2015;7C:104-108.
12. National Comprehensive Cancer Network. Merkel cell carcinoma. Published October 3, 2016. http://merkelcell.org/wp-content/uploads/2015/10/MccNccn.pdf. Accessed September 10, 2019.
13. Coggshall K, Tello TL, North JP, Yu SS. Merkel cell carcinoma: an update and review: pathogenesis, diagnosis, and staging. J Am Acad Dermatol. 2018;78:433-442.
14. Lanoy E, Engels EA. Skin cancers associated with autoimmune conditions among elderly adults. Br J Cancer. 2010;103:112-114.
15. Mertz KD, Junt T, Schmid M, et al. Inflammatory monocytes are a reservoir for Merkel cell polyomavirus. J Invest Dermatol. 2009;130:1146-1151.
1. O’Brien T, Power DG. Metastatic Merkel-cell carcinoma: the dawn of a new era. BMJ Case Rep. 2018;11:2018. doi:10.1136/bcr-2018-224924.
2. Del Marmol V, Lebbé C. New perspectives in Merkel cell carcinoma. Curr Opin Oncol. 2019;31:72-83.
3. Garcia-Carbonero R, Marquez-Rodas I, de la Cruz-Merino L, et al. Recent therapeutic advances and change in treatment paradigm of patients with Merkel cell carcinoma [published online April 8, 2019]. Oncologist. doi:10.1634/theoncologist.2018-0718.
4. Samimi M, Gardair C, Nicol JT, et al. Merkel cell polyomavirus in Merkel cell carcinoma: clinical and therapeutic perspectives. Semin Oncol. 2015;42:347-358.
5. Kitamura N, Tomita R, Yamamoto M, et al. Complete remission of Merkel cell carcinoma on the upper lip treated with radiation monotherapy and a literature review of Japanese cases. World J Surg Oncol. 2015;13:152.
6. Timmer FC, Klop WM, Relyveld GN, et al. Merkel cell carcinoma of the head and neck: emphasizing the risk of undertreatment. Eur Arch Otorhinolaryngol. 2016;273:1243-1252.
7. Açıkalın A, Paydas¸ S, Güleç ÜK, et al. A unique case of Merkel cell carcinoma with ovarian metastasis. Balkan Med J. 2014;31:356-359.
8. Yousif J, Yousif B, Kuriata MA. Complete remission of metastatic Merkel cell carcinoma in a patient with severe psoriasis. Cutis. 2018;101:E24-E27.
9. Grandhaye M, Teixeira PG, Henrot P, et al. Focus on Merkel cell carcinoma: diagnosis and staging. Skeletal Radiol. 2015;44:777-786.
10. Chatzinasiou F, Papadavid E, Korkolopoulou P, et al. An unusual case of diffuse Merkel cell carcinoma successfully treated with low dose radiotherapy. Dermatol Ther. 2015;28:282-286.
11. Pang C, Sharma D, Sankar T. Spontaneous regression of Merkel cell carcinoma: a case report and review of the literature. Int J Surg Case Rep. 2015;7C:104-108.
12. National Comprehensive Cancer Network. Merkel cell carcinoma. Published October 3, 2016. http://merkelcell.org/wp-content/uploads/2015/10/MccNccn.pdf. Accessed September 10, 2019.
13. Coggshall K, Tello TL, North JP, Yu SS. Merkel cell carcinoma: an update and review: pathogenesis, diagnosis, and staging. J Am Acad Dermatol. 2018;78:433-442.
14. Lanoy E, Engels EA. Skin cancers associated with autoimmune conditions among elderly adults. Br J Cancer. 2010;103:112-114.
15. Mertz KD, Junt T, Schmid M, et al. Inflammatory monocytes are a reservoir for Merkel cell polyomavirus. J Invest Dermatol. 2009;130:1146-1151.
1. O’Brien T, Power DG. Metastatic Merkel-cell carcinoma: the dawn of a new era. BMJ Case Rep. 2018;11:2018. doi:10.1136/bcr-2018-224924.
2. Del Marmol V, Lebbé C. New perspectives in Merkel cell carcinoma. Curr Opin Oncol. 2019;31:72-83.
3. Garcia-Carbonero R, Marquez-Rodas I, de la Cruz-Merino L, et al. Recent therapeutic advances and change in treatment paradigm of patients with Merkel cell carcinoma [published online April 8, 2019]. Oncologist. doi:10.1634/theoncologist.2018-0718.
4. Samimi M, Gardair C, Nicol JT, et al. Merkel cell polyomavirus in Merkel cell carcinoma: clinical and therapeutic perspectives. Semin Oncol. 2015;42:347-358.
5. Kitamura N, Tomita R, Yamamoto M, et al. Complete remission of Merkel cell carcinoma on the upper lip treated with radiation monotherapy and a literature review of Japanese cases. World J Surg Oncol. 2015;13:152.
6. Timmer FC, Klop WM, Relyveld GN, et al. Merkel cell carcinoma of the head and neck: emphasizing the risk of undertreatment. Eur Arch Otorhinolaryngol. 2016;273:1243-1252.
7. Açıkalın A, Paydas¸ S, Güleç ÜK, et al. A unique case of Merkel cell carcinoma with ovarian metastasis. Balkan Med J. 2014;31:356-359.
8. Yousif J, Yousif B, Kuriata MA. Complete remission of metastatic Merkel cell carcinoma in a patient with severe psoriasis. Cutis. 2018;101:E24-E27.
9. Grandhaye M, Teixeira PG, Henrot P, et al. Focus on Merkel cell carcinoma: diagnosis and staging. Skeletal Radiol. 2015;44:777-786.
10. Chatzinasiou F, Papadavid E, Korkolopoulou P, et al. An unusual case of diffuse Merkel cell carcinoma successfully treated with low dose radiotherapy. Dermatol Ther. 2015;28:282-286.
11. Pang C, Sharma D, Sankar T. Spontaneous regression of Merkel cell carcinoma: a case report and review of the literature. Int J Surg Case Rep. 2015;7C:104-108.
12. National Comprehensive Cancer Network. Merkel cell carcinoma. Published October 3, 2016. http://merkelcell.org/wp-content/uploads/2015/10/MccNccn.pdf. Accessed September 10, 2019.
13. Coggshall K, Tello TL, North JP, Yu SS. Merkel cell carcinoma: an update and review: pathogenesis, diagnosis, and staging. J Am Acad Dermatol. 2018;78:433-442.
14. Lanoy E, Engels EA. Skin cancers associated with autoimmune conditions among elderly adults. Br J Cancer. 2010;103:112-114.
15. Mertz KD, Junt T, Schmid M, et al. Inflammatory monocytes are a reservoir for Merkel cell polyomavirus. J Invest Dermatol. 2009;130:1146-1151.
