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Tumor necrosis factor-alfa antagonists and paradoxical psoriasis: A case report
1869
1865
Treatment changes in patients with moderate to severe psoriasis Kathryn Anderson, Wake Forest Baptist Health, Winston Salem, NC, United States; Steven Feldman, MD, PhD, Wake Forest Baptist Health, Winston Salem, NC, United States Background: Psoriasis treatment involves topical medications, oral medications, phototherapy and/or biologics. The justification for which treatment to use depends on a myriad of factors and, due to the chronicity of the disease, may change. Reasons for treatment changes have been elucidated in other chronic diseases but have not been well characterized for psoriasis.
Tumor necrosis factor-alfa antagonists and paradoxical psoriasis: A case report Nikita Lakdawala, MD, University of Connecticut, Farmington, CT, United States; Arni Kristjansson, MD, University of Connecticut, Farmington, CT, United States
Objective: The purpose of our study is to analyze the reasons for treatment changes in 10 patients with moderate to severe psoriasis. Methods: Ten charts of patients with moderate to severe psoriasis were reviewed and the medication changes and the reasons for the change were extracted. Qualitative data analysis examined the frequency of different reasons for treatment changes. Results: The most common reason for a treatment change was inadequate disease control. Other justifications included side effects, problems with insurance covering the medication, patient preference, new to treatment, and maximum cumulative medication dose. Limitations: This study is limited by a small sample size and the single location of the chart review. Conclusions: The most common reason a physician changes the treatment for a patient with moderate to severe psoriasis is inadequate control by their current therapy. More efficacious drugs and drugs that maintain their initial efficacy need to be developed to improve psoriasis treatment. The Center for Dermatology Research is Supported by an unrestricted educational grant from Galderma Laboratories, L.P.
Background: Paradoxical cases of psoriasis induced by tumor necrosis factor (TNF)alfa antagonist for the treatment of inflammatory bowel disease have been more frequently cited in literature. Both exacerbations of psoriasis or new-onset psoriatic lesions can occur in patients on anti-TNF therapy. These eruptions have been more commonly identified in female patients and in those with Crohn’s disease. The time of presentation of psoriasis after initiation of anti-TNF therapy is variable but typically manifests within the first year. Management options include conventional therapy for psoriasis, discontinuation of the inciting biologic agent and potential replacement with an alternate biologic agent. Case report: We present a case of a 66-year-old female with a four-year history of Crohn’s disease treated with infliximab with good response. Approximately 1 year after initiation of biologic therapy, she developed a pustular eruption involving the scalp and psoriasiform plaques over the trunk and extremities. A diagnosis of psoriasis was made clinically and supported with histopathologic examination. The patient was treated with topical corticosteroids and cessation of infliximab therapy. However, the persistence of clinical lesions after discontinuation of infliximab necessitated a switch to an alternate biologic agent. The patient was trialed on but refractory to certolizumab. Subsequently, she was treated with adalimumab. Her psoriatic lesions improved significantly and the medication was well-tolerated. Discussion: While anti-TNF therapy has been used to treat moderate-severe psoriasis, paradoxical psoriasis with anti-TNF therapy has been reported, particularly in cases when used in treatment for inflammatory bowel disease. It is therefore important to consider psoriasis in the differential diagnosis of new eruptions in patients on anti-TNF therapy. The therapeutic approach to anti-TNF induced psoriasis, especially the decision to discontinue or trial alternative biologic agents, should be individualized. In this instance, the inciting agent, infliximab was discontinued and replaced with an alternative, adalimumab. Close monitoring of her psoriasis and clinical response to biologic therapy will continue. Commercial support: None identified.
1055
1469 Treatment patterns associated with biologics in psoriasis patients Shonda Foster, PharmD, MS, Eli Lilly and Company, Indianapolis, IN, United States; Baojin Zhu, PhD, Eli Lilly and Company, Indianapolis, Indiana, IN, United States; Jiaying Guo, MS, Eli Lilly and Company, Indianapolis, IN, United States; Clement Ojeh, DVM, PhD, Lilly USA, Indianapolis, IN, United States; Enkeleida Nikai, MS, Eli Lilly and Company, Indianapolis, IN, United States; Jashin Wu, MD, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, United States Background: Several medications are used for the treatment of psoriasis (Ps), including biologics. The objective of this study was to evaluate demographic and clinical characteristics of Ps patients on biologics and treatment patterns associated with biologic use. Methods: This study was a retrospective claims database analysis utilizing Marketscan commercial and Medicare data. Adult Ps patients who were newly initiated on a biologic (etanercept, adalimumab, ustekinumab, infliximab) with at least 1 prescription claim between January 1, 2010, and December 31, 2011, and continuous enrollment 12 months pre- and postindex date were selected. Demographic and clinical characteristics were evaluated in biologic na€ıve and biologic-experienced patients in the 12-month pre-index period and treatment patterns in the 12-month postperiod. Descriptive statistics were used to compare continuous and categorical variables. Results: Out of those who initiated a biologic (N ¼ 3367), 60% were biologic na€ıve and 40% were biologic-experienced. The mean age was 45.6 6 12.9 years and 56% were male. The most common comorbidities were hyperlipidemia (27%), hypertension (26%), psoriatic arthritis (15%), and diabetes (13%). The majority were on a topical in the pre-index period (79%) and the post-index period (61%). Biologicna€ıve patients were more likely to have been treated with topicals, methotrexate, acitretin, or phototherapy in the pre-index period compared to biologic-experienced patients; however, there were no differences in the use of nonbiologic Ps medications in the postperiod. Over half of biologic patients started after the induction phase on the recommended maintenance dose (RMD) and 87% of those remained on the RMD during the 12-month postindex period. Out of all biologic users, 7% switched biologics in the 12-month post-index period and 19% discontinued therapy. Biologic-na€ıve patients were less likely to switch to another biologic in the postperiod compared to those who were biologic-experienced (5% vs. 9%, P \.0001) but were more likely to discontinue therapy (22% vs. 13%, P \ .0001).
Two-year safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: Results from a phase 3, randomized, controlled trial (ESTEEM 1) Kim A. Papp, MD, Probity Medical Research Inc, Waterloo, Ontario, Canada; Kristian Reich, MD, SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany; Jeffrey M. Sobell, MD, Tufts University School of Medicine, Chestnut Hill, MA, United States; Alan Menter, MD, Baylor University Medical Center, Dallas, TX, United States; Jean-Philippe Lacour, MD, University Hospital of Nice, Nice, France; Sergio Chimenti, MD, University of Rome Tor Vergata, Rome, Italy; ChiaChi Hu, MS, Celgene Corporation, Warren, NJ, United States; Robert M. Day, MD, Celgene Corporation, Warren, NJ, United States; Kamal Shah, MD, Celgene Corporation, Warren, NJ, United States; Christopher E. M. Griffiths, MD, The Dermatology Center, The University of Manchester, Manchester, United Kingdom Background: ESTEEM 1, a phase 3, randomized trial with an open-label extension, evaluated the efficacy/safety of apremilast 30 mg BID (APR) in patients (pts) with moderate to severe plaque psoriasis. Methods: Safety findings are reported from the APR-exposure periods, Wks0- #52 and [52- #104.
Conclusions: Nonbiologic Ps medication use was common both before and after initiating biologic therapy. Switching and discontinuation patterns were observed within the first year after initiating a biologic; however, there were differences in treatment patterns between biologic-na€ıve and biologic-experienced patients.
Results: 804 pts (624.4 pt-yrs) were randomized; 444 (350.7 pt-yrs) continued in the second year. AEs occurring in $5% of pts were diarrhea (18.7%), nausea (15.2%), upper respiratory tract infection (18.2%), nasopharyngitis (13.7%), tension headache (9.6%), and headache (6.5%) during Wks0- #52; and upper respiratory tract infection (9.7%) and nasopharyngitis (6.8%) during Wks [ 52- #104. For either period, most AEs were mild or moderate in severity; severe AEs occurred in 6.2% and 3.2% of pts during Wks0- #52 and [ 52- #104, respectively. Diarrhea/nausea rates were lower during Wks [ 52- #104 (1.8% and 0.7%, respectively) than Wks0- #52 (18.7% and 15.2%). In APR-treated pts reporting diarrhea and nausea, more than half occurred within 2 wks following the first dose, were predominantly mild in severity, and generally resolved within 4 wks. Discontinuation rates due to AEs were low (7.8% and 2.9% in Wks0- #52 and [ 52- #104, respectively). Depression was reported in 2.0% and 0.5% of pts during Wks0- #52 and[52- #104, respectively. No APR-treated pt reported suicidal ideation, suicide attempt, or completed suicide up to 104 wks. Serious AEs occurred in 4.5% and 5.4% of pts during Wks0- #52 and [ 52- #104, respectively. No serious diarrhea was reported during Wks [ 52- #104. There was 1 case each of serious depression during Wks0- #52 and Wks [ 52#104. Only 6 (1.4%) serious infections were reported during Wks[52- #104; none were opportunistic infections. No cases of reactivation of tuberculosis were reported with APR. Of pts with evaluable data (n ¼ 473; mean baseline weight, 93.54 kg), mean/median percent change from baseline was -2.07%/-1.59% at Wk52. At Wk104 (n ¼ 202), mean/median percent change from baseline was -1.94%/1.56%. One death was reported (Wks [ 52- #104): 69 y/o male pt (history of DM, HTN, and hyperlipidemia) had a fatal CVA (Day 666 on APR). One death has been previously reported (Wks0- #52). There were no clinically meaningful changes on laboratory measurements. Conclusion: APR demonstrated an acceptable safety and tolerability profile for up to 104 wks, with no new safety signals identified.
100% funded by Eli Lilly.
100% is Sponsored by Celgene Corporation.
AB256
J AM ACAD DERMATOL
MAY 2015
1865
Treatment changes in patients with moderate to severe psoriasis Kathryn Anderson, Wake Forest Baptist Health, Winston Salem, NC, United States; Steven Feldman, MD, PhD, Wake Forest Baptist Health, Winston Salem, NC, United States Background: Psoriasis treatment involves topical medications, oral medications, phototherapy and/or biologics. The justification for which treatment to use depends on a myriad of factors and, due to the chronicity of the disease, may change. Reasons for treatment changes have been elucidated in other chronic diseases but have not been well characterized for psoriasis.
Tumor necrosis factor-alfa antagonists and paradoxical psoriasis: A case report Nikita Lakdawala, MD, University of Connecticut, Farmington, CT, United States; Arni Kristjansson, MD, University of Connecticut, Farmington, CT, United States
Objective: The purpose of our study is to analyze the reasons for treatment changes in 10 patients with moderate to severe psoriasis. Methods: Ten charts of patients with moderate to severe psoriasis were reviewed and the medication changes and the reasons for the change were extracted. Qualitative data analysis examined the frequency of different reasons for treatment changes. Results: The most common reason for a treatment change was inadequate disease control. Other justifications included side effects, problems with insurance covering the medication, patient preference, new to treatment, and maximum cumulative medication dose. Limitations: This study is limited by a small sample size and the single location of the chart review. Conclusions: The most common reason a physician changes the treatment for a patient with moderate to severe psoriasis is inadequate control by their current therapy. More efficacious drugs and drugs that maintain their initial efficacy need to be developed to improve psoriasis treatment. The Center for Dermatology Research is Supported by an unrestricted educational grant from Galderma Laboratories, L.P.
Background: Paradoxical cases of psoriasis induced by tumor necrosis factor (TNF)alfa antagonist for the treatment of inflammatory bowel disease have been more frequently cited in literature. Both exacerbations of psoriasis or new-onset psoriatic lesions can occur in patients on anti-TNF therapy. These eruptions have been more commonly identified in female patients and in those with Crohn’s disease. The time of presentation of psoriasis after initiation of anti-TNF therapy is variable but typically manifests within the first year. Management options include conventional therapy for psoriasis, discontinuation of the inciting biologic agent and potential replacement with an alternate biologic agent. Case report: We present a case of a 66-year-old female with a four-year history of Crohn’s disease treated with infliximab with good response. Approximately 1 year after initiation of biologic therapy, she developed a pustular eruption involving the scalp and psoriasiform plaques over the trunk and extremities. A diagnosis of psoriasis was made clinically and supported with histopathologic examination. The patient was treated with topical corticosteroids and cessation of infliximab therapy. However, the persistence of clinical lesions after discontinuation of infliximab necessitated a switch to an alternate biologic agent. The patient was trialed on but refractory to certolizumab. Subsequently, she was treated with adalimumab. Her psoriatic lesions improved significantly and the medication was well-tolerated. Discussion: While anti-TNF therapy has been used to treat moderate-severe psoriasis, paradoxical psoriasis with anti-TNF therapy has been reported, particularly in cases when used in treatment for inflammatory bowel disease. It is therefore important to consider psoriasis in the differential diagnosis of new eruptions in patients on anti-TNF therapy. The therapeutic approach to anti-TNF induced psoriasis, especially the decision to discontinue or trial alternative biologic agents, should be individualized. In this instance, the inciting agent, infliximab was discontinued and replaced with an alternative, adalimumab. Close monitoring of her psoriasis and clinical response to biologic therapy will continue. Commercial support: None identified.
1055
1469 Treatment patterns associated with biologics in psoriasis patients Shonda Foster, PharmD, MS, Eli Lilly and Company, Indianapolis, IN, United States; Baojin Zhu, PhD, Eli Lilly and Company, Indianapolis, Indiana, IN, United States; Jiaying Guo, MS, Eli Lilly and Company, Indianapolis, IN, United States; Clement Ojeh, DVM, PhD, Lilly USA, Indianapolis, IN, United States; Enkeleida Nikai, MS, Eli Lilly and Company, Indianapolis, IN, United States; Jashin Wu, MD, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, United States Background: Several medications are used for the treatment of psoriasis (Ps), including biologics. The objective of this study was to evaluate demographic and clinical characteristics of Ps patients on biologics and treatment patterns associated with biologic use. Methods: This study was a retrospective claims database analysis utilizing Marketscan commercial and Medicare data. Adult Ps patients who were newly initiated on a biologic (etanercept, adalimumab, ustekinumab, infliximab) with at least 1 prescription claim between January 1, 2010, and December 31, 2011, and continuous enrollment 12 months pre- and postindex date were selected. Demographic and clinical characteristics were evaluated in biologic na€ıve and biologic-experienced patients in the 12-month pre-index period and treatment patterns in the 12-month postperiod. Descriptive statistics were used to compare continuous and categorical variables. Results: Out of those who initiated a biologic (N ¼ 3367), 60% were biologic na€ıve and 40% were biologic-experienced. The mean age was 45.6 6 12.9 years and 56% were male. The most common comorbidities were hyperlipidemia (27%), hypertension (26%), psoriatic arthritis (15%), and diabetes (13%). The majority were on a topical in the pre-index period (79%) and the post-index period (61%). Biologicna€ıve patients were more likely to have been treated with topicals, methotrexate, acitretin, or phototherapy in the pre-index period compared to biologic-experienced patients; however, there were no differences in the use of nonbiologic Ps medications in the postperiod. Over half of biologic patients started after the induction phase on the recommended maintenance dose (RMD) and 87% of those remained on the RMD during the 12-month postindex period. Out of all biologic users, 7% switched biologics in the 12-month post-index period and 19% discontinued therapy. Biologic-na€ıve patients were less likely to switch to another biologic in the postperiod compared to those who were biologic-experienced (5% vs. 9%, P \.0001) but were more likely to discontinue therapy (22% vs. 13%, P \ .0001).
Two-year safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: Results from a phase 3, randomized, controlled trial (ESTEEM 1) Kim A. Papp, MD, Probity Medical Research Inc, Waterloo, Ontario, Canada; Kristian Reich, MD, SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany; Jeffrey M. Sobell, MD, Tufts University School of Medicine, Chestnut Hill, MA, United States; Alan Menter, MD, Baylor University Medical Center, Dallas, TX, United States; Jean-Philippe Lacour, MD, University Hospital of Nice, Nice, France; Sergio Chimenti, MD, University of Rome Tor Vergata, Rome, Italy; ChiaChi Hu, MS, Celgene Corporation, Warren, NJ, United States; Robert M. Day, MD, Celgene Corporation, Warren, NJ, United States; Kamal Shah, MD, Celgene Corporation, Warren, NJ, United States; Christopher E. M. Griffiths, MD, The Dermatology Center, The University of Manchester, Manchester, United Kingdom Background: ESTEEM 1, a phase 3, randomized trial with an open-label extension, evaluated the efficacy/safety of apremilast 30 mg BID (APR) in patients (pts) with moderate to severe plaque psoriasis. Methods: Safety findings are reported from the APR-exposure periods, Wks0- #52 and [52- #104.
Conclusions: Nonbiologic Ps medication use was common both before and after initiating biologic therapy. Switching and discontinuation patterns were observed within the first year after initiating a biologic; however, there were differences in treatment patterns between biologic-na€ıve and biologic-experienced patients.
Results: 804 pts (624.4 pt-yrs) were randomized; 444 (350.7 pt-yrs) continued in the second year. AEs occurring in $5% of pts were diarrhea (18.7%), nausea (15.2%), upper respiratory tract infection (18.2%), nasopharyngitis (13.7%), tension headache (9.6%), and headache (6.5%) during Wks0- #52; and upper respiratory tract infection (9.7%) and nasopharyngitis (6.8%) during Wks [ 52- #104. For either period, most AEs were mild or moderate in severity; severe AEs occurred in 6.2% and 3.2% of pts during Wks0- #52 and [ 52- #104, respectively. Diarrhea/nausea rates were lower during Wks [ 52- #104 (1.8% and 0.7%, respectively) than Wks0- #52 (18.7% and 15.2%). In APR-treated pts reporting diarrhea and nausea, more than half occurred within 2 wks following the first dose, were predominantly mild in severity, and generally resolved within 4 wks. Discontinuation rates due to AEs were low (7.8% and 2.9% in Wks0- #52 and [ 52- #104, respectively). Depression was reported in 2.0% and 0.5% of pts during Wks0- #52 and[52- #104, respectively. No APR-treated pt reported suicidal ideation, suicide attempt, or completed suicide up to 104 wks. Serious AEs occurred in 4.5% and 5.4% of pts during Wks0- #52 and [ 52- #104, respectively. No serious diarrhea was reported during Wks [ 52- #104. There was 1 case each of serious depression during Wks0- #52 and Wks [ 52#104. Only 6 (1.4%) serious infections were reported during Wks[52- #104; none were opportunistic infections. No cases of reactivation of tuberculosis were reported with APR. Of pts with evaluable data (n ¼ 473; mean baseline weight, 93.54 kg), mean/median percent change from baseline was -2.07%/-1.59% at Wk52. At Wk104 (n ¼ 202), mean/median percent change from baseline was -1.94%/1.56%. One death was reported (Wks [ 52- #104): 69 y/o male pt (history of DM, HTN, and hyperlipidemia) had a fatal CVA (Day 666 on APR). One death has been previously reported (Wks0- #52). There were no clinically meaningful changes on laboratory measurements. Conclusion: APR demonstrated an acceptable safety and tolerability profile for up to 104 wks, with no new safety signals identified.
100% funded by Eli Lilly.
100% is Sponsored by Celgene Corporation.
AB256
J AM ACAD DERMATOL
MAY 2015