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Comparative effectiveness of adalimumab versus ustekinumab treatment for psoriasis: Clinical efficacy, safety, and cost per responder
P3307
P3309
Comparison of response rates and drug costs during maintenance therapy with adalimumab versus ustekinumab in patients with moderate to severe psoriasis James Signorovitch, Analysis Group, Boston, MA, United States; Evan Kantor, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objective: In the absence of a head-to-head randomized trial directly comparing adalimumab versus ustekinumab for the treatment of moderate to severe psoriasis, this study provided an adjusted indirect comparison by matching baseline characteristics between clinical trial populations. The objective was to compare sustained response rates and drugs costs per responder up to week 52.
Statin therapy and psoriasis severity Adam Perry, Emory University, Atlanta, GA, United States; Julia Kamalpour, MD, Emory University, Atlanta, GA, United States; Nikki Hill, Boston University School of Medicine, Boston, MA, United States; Suephy Chen, MD, Emory University, Atlanta, GA, United States
Methods: Patient-level data from a placebo-controlled adalimumab trial and its openlabel extension (REVEAL/OLE) were reweighted to match baseline characteristics and week-12 placebo arm outcomes reported for a placebo-controlled ustekinumab trial (PHOENIX I) in the treatment of moderate to severe psoriasis. All average baseline characteristics reported for PHOENIX I were matched, including the Psoriasis Area and Severity Index (PASI), psoriasis duration, and treatment history (except for previous use of anti-TNF therapies, which was an exclusion criterion for REVEAL/OLE). After matching, PASI responses at week 52 were compared for the adalimumab 40mg every other week (eow) arm versus the ustekinumab 45-mg and 90-mg every 12 weeks arms for patients who remained in study following a sustained PASI 75 response (ie, a $ 75% PASI reduction from baseline at weeks 28 and 40). Incremental drug costs from weeks 40 to 52 were determined per week-52 PASI 75 responder (using German pricing). Statistical significance was assessed using the bootstrap. Results: After matching, patients with previous sustained PASI 75 responses had similar week-52 PASI 75 response rates for adalimumab 40mg eow versus ustekinumab 45mg or 90mg every 12 weeks (94% vs 87% or 91%; P ¼ .09 or P ¼ .39). Incremental drug costs per maintained PASI 75 responder were less for adalimumab than for ustekinumab 45mg or 90mg (V5,548 vs V5,717 or V10,931). Conclusions: Maintenance therapy with adalimumab 40mg eow versus ustekinumab 45mg or 90mg was associated with similar rates of sustained response and decreased drug costs per maintained responder. Commercial support: This study is sponsored by Abbott Laboratories.
Introduction: Inflammation is known to play a key role in the pathogenesis of psoriasis. Statins have been shown to reduce inflammatory markers. Statin use is associated with significant improvement in patients with rheumatoid arthritis, another inflammatory disease. In addition, a small pilot study of seven psoriasis patients by Shirinsky et al showed a 47.3% mean reduction in the Psoriasis Area and Severity Index (PASI) score after 8 weeks of statin therapy. With the exception of this small study, there are very little data in the literature regarding the effect of statins in psoriasis patients. Methods: We performed a retrospective chart review of 233 psoriasis patients. Demographic information was obtained. Psoriasis severity was measured by the percentage of body surface area (BSA) covered by psoriatic lesions. BSA was recorded at the last visit a new psoriasis medication was started (initial psoriasis severity) and the most recent visit (current psoriasis severity). T tests were used to evaluate differences between the two time points and between the statin and nonstatin group. Results: Before initiating a new psoriasis medication there was a small trend toward more severe disease severity among statin users. The initial BSA among the 66 statin users was 13.26% and among the 166 nonestatin users was 12.25% (P ¼ .6600). However following the initiation of a new psoriasis medication, the trend reversed. At the most recent visit, statin users had less severe disease compared to nonestatin users. The BSA at the most recent visit was 5.21% among statin users and 7.43% among nonestatin users (P ¼ .1214). The statin group showed a 64% reduction in psoriasis severity while the non-statin group showed a 45% reduction in severity following the initiation of a new psoriasis medication (P ¼ .2561). Despite the fact that the difference did not reach statistical significance, there was an interesting trend toward greater improvement in statin users compared to nonestatin users following the initiation of a new psoriasis medication. Conclusions: The exact role of statin therapy in psoriasis patients remains unclear. However, statin therapy when used in conjunction with standard psoriasis therapy showed a trend towards greater improvement in psoriasis severity. Therefore, statins may be a useful adjunct medication for psoriasis patients. Commercial support: None identified.
P3310
P3308 Pregnancy outcomes in psoriasis: A retrospective analysis Xinaida T. Lima, MD, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; Alexandra B. Kimball, MD, MPH, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; Katrina Abuabara, MD, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States Background: Psoriasis affects approximately 2.5% of American women and a high proportion are of child-bearing potential (Qureshi, 2009). Pregnancy has an impact in psoriasis in most patients (Murase, 2005), and a previous study suggests an association between psoriasis and some pregnancy complications, such as recurrent abortions and hypertension (Ben-David, 2008). Objective: The goal of this retrospective study is to define impact of psoriasis in pregnancy outcomes with the aim of verifying whether psoriasis adversely affects pregnancy. Methods: Using a research registry that contains medical and demographic information on more than three million patients within the Partners healthcare system in Boston, Massachusetts, we wanted to measure rates of pregnancy complications among patients with psoriasis compared to pregnant patients without psoriasis. We compared rates of specific pregnancy outcomes in patients with more than two diagnoses of psoriasis and patients without a diagnosis of psoriasis. Results: The psoriasis group presented a significant increase in certain pregnancy complications such as, but not limited to, spontaneous abortion, molar pregnancy, and ectopic pregnancy.
Comparative effectiveness of adalimumab versus ustekinumab treatment for psoriasis: Clinical efficacy, safety, and cost per responder Eric Wu, Analysis Group, Boston, MA, United States; James Signorovitch, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objective: No randomized trial has directly compared adalimumab versus ustekinumab treatment for moderate to severe psoriasis. This study provides an indirect comparison of their efficacy, safety, and cost per responder, adjusting for baseline differences across trials. Methods: Patient-level data from a placebo-controlled trial of adalimumab (REVEAL) were reweighted to match average baseline characteristics and placebo-arm responses with those pooled from published ustekinumab trials (PHOENIX I and II). All average baseline characteristics reported in PHOENIX I and II were matched, including Psoriasis Area and Severity Index (PASI) scores, psoriasis duration, and treatment history. After matching, the adalimumab 40-mg every other week (eow) treatment group was compared with the ustekinumab 45-mg and 90-mg every 12 weeks groups at week 12 in terms of PASI 75 response rates, rates of adverse events (AEs), and drug costs per PASI 75 responder (using German pricing). Statistical significance was assessed using the bootstrap method. Results: After matching, treatment with adalimumab 40mg eow versus ustekinumab 45mg or 90mg every 12 weeks was associated with similar week 12 PASI 75 response rates (68.0% vs 66.9% or 72.1%; P ¼ .67 or P ¼ .13). There were no statistically significant differences in rates of serious AEs (1.8% vs 1.5% or 1.3%; P ¼.69 or P ¼ .55), AEs leading to withdrawal (1.6% vs 0.3% or 1.5%; P ¼.06 or P ¼.90), infectious AEs (23.2% vs 25.3% or 23.7%; P ¼.42 or P ¼.85), or serious infectious AEs (0.6% vs 0.0% or 0.4%; P ¼.09 or P ¼.73). Drug costs per PASI 75 responder at week 12 were substantially lower for adalimumab than for ustekinumab 45mg or 90mg (V9,791 vs V14,854 or V27,423).
Limitations: This is a retrospective study. Given that the data were collected from a research database, there is a chance of including patients with an inaccurate diagnosis of psoriasis. In order to minimize this, we only included in the psoriasis group patients with more than two diagnoses of psoriasis.
Conclusions: Compared with ustekinumab 45mg or 90mg, adalimumab 40-mg eow treatment for moderate to severe psoriasis was associated with no significant differences in efficacy and safety profiles and with 34% to 64% lower costs per week 12 responder.
Commercial support: None identified.
Commercial support: This study is sponsored by Abbott Laboratories.
MARCH 2010
J AM ACAD DERMATOL
AB125
P3309
Comparison of response rates and drug costs during maintenance therapy with adalimumab versus ustekinumab in patients with moderate to severe psoriasis James Signorovitch, Analysis Group, Boston, MA, United States; Evan Kantor, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objective: In the absence of a head-to-head randomized trial directly comparing adalimumab versus ustekinumab for the treatment of moderate to severe psoriasis, this study provided an adjusted indirect comparison by matching baseline characteristics between clinical trial populations. The objective was to compare sustained response rates and drugs costs per responder up to week 52.
Statin therapy and psoriasis severity Adam Perry, Emory University, Atlanta, GA, United States; Julia Kamalpour, MD, Emory University, Atlanta, GA, United States; Nikki Hill, Boston University School of Medicine, Boston, MA, United States; Suephy Chen, MD, Emory University, Atlanta, GA, United States
Methods: Patient-level data from a placebo-controlled adalimumab trial and its openlabel extension (REVEAL/OLE) were reweighted to match baseline characteristics and week-12 placebo arm outcomes reported for a placebo-controlled ustekinumab trial (PHOENIX I) in the treatment of moderate to severe psoriasis. All average baseline characteristics reported for PHOENIX I were matched, including the Psoriasis Area and Severity Index (PASI), psoriasis duration, and treatment history (except for previous use of anti-TNF therapies, which was an exclusion criterion for REVEAL/OLE). After matching, PASI responses at week 52 were compared for the adalimumab 40mg every other week (eow) arm versus the ustekinumab 45-mg and 90-mg every 12 weeks arms for patients who remained in study following a sustained PASI 75 response (ie, a $ 75% PASI reduction from baseline at weeks 28 and 40). Incremental drug costs from weeks 40 to 52 were determined per week-52 PASI 75 responder (using German pricing). Statistical significance was assessed using the bootstrap. Results: After matching, patients with previous sustained PASI 75 responses had similar week-52 PASI 75 response rates for adalimumab 40mg eow versus ustekinumab 45mg or 90mg every 12 weeks (94% vs 87% or 91%; P ¼ .09 or P ¼ .39). Incremental drug costs per maintained PASI 75 responder were less for adalimumab than for ustekinumab 45mg or 90mg (V5,548 vs V5,717 or V10,931). Conclusions: Maintenance therapy with adalimumab 40mg eow versus ustekinumab 45mg or 90mg was associated with similar rates of sustained response and decreased drug costs per maintained responder. Commercial support: This study is sponsored by Abbott Laboratories.
Introduction: Inflammation is known to play a key role in the pathogenesis of psoriasis. Statins have been shown to reduce inflammatory markers. Statin use is associated with significant improvement in patients with rheumatoid arthritis, another inflammatory disease. In addition, a small pilot study of seven psoriasis patients by Shirinsky et al showed a 47.3% mean reduction in the Psoriasis Area and Severity Index (PASI) score after 8 weeks of statin therapy. With the exception of this small study, there are very little data in the literature regarding the effect of statins in psoriasis patients. Methods: We performed a retrospective chart review of 233 psoriasis patients. Demographic information was obtained. Psoriasis severity was measured by the percentage of body surface area (BSA) covered by psoriatic lesions. BSA was recorded at the last visit a new psoriasis medication was started (initial psoriasis severity) and the most recent visit (current psoriasis severity). T tests were used to evaluate differences between the two time points and between the statin and nonstatin group. Results: Before initiating a new psoriasis medication there was a small trend toward more severe disease severity among statin users. The initial BSA among the 66 statin users was 13.26% and among the 166 nonestatin users was 12.25% (P ¼ .6600). However following the initiation of a new psoriasis medication, the trend reversed. At the most recent visit, statin users had less severe disease compared to nonestatin users. The BSA at the most recent visit was 5.21% among statin users and 7.43% among nonestatin users (P ¼ .1214). The statin group showed a 64% reduction in psoriasis severity while the non-statin group showed a 45% reduction in severity following the initiation of a new psoriasis medication (P ¼ .2561). Despite the fact that the difference did not reach statistical significance, there was an interesting trend toward greater improvement in statin users compared to nonestatin users following the initiation of a new psoriasis medication. Conclusions: The exact role of statin therapy in psoriasis patients remains unclear. However, statin therapy when used in conjunction with standard psoriasis therapy showed a trend towards greater improvement in psoriasis severity. Therefore, statins may be a useful adjunct medication for psoriasis patients. Commercial support: None identified.
P3310
P3308 Pregnancy outcomes in psoriasis: A retrospective analysis Xinaida T. Lima, MD, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; Alexandra B. Kimball, MD, MPH, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; Katrina Abuabara, MD, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States Background: Psoriasis affects approximately 2.5% of American women and a high proportion are of child-bearing potential (Qureshi, 2009). Pregnancy has an impact in psoriasis in most patients (Murase, 2005), and a previous study suggests an association between psoriasis and some pregnancy complications, such as recurrent abortions and hypertension (Ben-David, 2008). Objective: The goal of this retrospective study is to define impact of psoriasis in pregnancy outcomes with the aim of verifying whether psoriasis adversely affects pregnancy. Methods: Using a research registry that contains medical and demographic information on more than three million patients within the Partners healthcare system in Boston, Massachusetts, we wanted to measure rates of pregnancy complications among patients with psoriasis compared to pregnant patients without psoriasis. We compared rates of specific pregnancy outcomes in patients with more than two diagnoses of psoriasis and patients without a diagnosis of psoriasis. Results: The psoriasis group presented a significant increase in certain pregnancy complications such as, but not limited to, spontaneous abortion, molar pregnancy, and ectopic pregnancy.
Comparative effectiveness of adalimumab versus ustekinumab treatment for psoriasis: Clinical efficacy, safety, and cost per responder Eric Wu, Analysis Group, Boston, MA, United States; James Signorovitch, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objective: No randomized trial has directly compared adalimumab versus ustekinumab treatment for moderate to severe psoriasis. This study provides an indirect comparison of their efficacy, safety, and cost per responder, adjusting for baseline differences across trials. Methods: Patient-level data from a placebo-controlled trial of adalimumab (REVEAL) were reweighted to match average baseline characteristics and placebo-arm responses with those pooled from published ustekinumab trials (PHOENIX I and II). All average baseline characteristics reported in PHOENIX I and II were matched, including Psoriasis Area and Severity Index (PASI) scores, psoriasis duration, and treatment history. After matching, the adalimumab 40-mg every other week (eow) treatment group was compared with the ustekinumab 45-mg and 90-mg every 12 weeks groups at week 12 in terms of PASI 75 response rates, rates of adverse events (AEs), and drug costs per PASI 75 responder (using German pricing). Statistical significance was assessed using the bootstrap method. Results: After matching, treatment with adalimumab 40mg eow versus ustekinumab 45mg or 90mg every 12 weeks was associated with similar week 12 PASI 75 response rates (68.0% vs 66.9% or 72.1%; P ¼ .67 or P ¼ .13). There were no statistically significant differences in rates of serious AEs (1.8% vs 1.5% or 1.3%; P ¼.69 or P ¼ .55), AEs leading to withdrawal (1.6% vs 0.3% or 1.5%; P ¼.06 or P ¼.90), infectious AEs (23.2% vs 25.3% or 23.7%; P ¼.42 or P ¼.85), or serious infectious AEs (0.6% vs 0.0% or 0.4%; P ¼.09 or P ¼.73). Drug costs per PASI 75 responder at week 12 were substantially lower for adalimumab than for ustekinumab 45mg or 90mg (V9,791 vs V14,854 or V27,423).
Limitations: This is a retrospective study. Given that the data were collected from a research database, there is a chance of including patients with an inaccurate diagnosis of psoriasis. In order to minimize this, we only included in the psoriasis group patients with more than two diagnoses of psoriasis.
Conclusions: Compared with ustekinumab 45mg or 90mg, adalimumab 40-mg eow treatment for moderate to severe psoriasis was associated with no significant differences in efficacy and safety profiles and with 34% to 64% lower costs per week 12 responder.
Commercial support: None identified.
Commercial support: This study is sponsored by Abbott Laboratories.
MARCH 2010
J AM ACAD DERMATOL
AB125