To describe the profile of patients with psoriasis who were treated with secukinumab, a newly approved biologic, in the U.S. and to examine secukinumab dosage use in real world practice. Retrospective data from the Symphony Health Solutions Lx commercial claims database between July 1, 2013 and July 31, 2015 (study period) were included in the study. Adult patients (≥18 years) with at least one secukinumab claim during the study period and with ≥1 pharmacy or medical claim in the 12 months before (baseline period) their first secukinumab claim (index date) were selected. Patient demographics, insurance type and secukinumab dosage (estimated based on the days of supply and quantity) were examined as of the index date. Comorbidities and prior systemic therapies were identified during the baseline period. A total of 1,947 secukinumab patients were included, with a mean age of 49.8 years (standard deviation (SD): 12.6). 47.9% of the patients were female, 40.8% from the south, and 89.3% had commercial insurance. The mean modified Charlson Comorbidity Index (excluding psoriasis-related comorbidities) was 0.14 (SD: 0.5); the most prevalent comorbidities included hypertension (19.1%), hyperlipidemia (16.7%), and psoriatic arthritis (15.0%). Most patients (72.9%) received systemic treatments in the baseline period: 58.6% of patients used a biologic, with the most common being ustekinumab (27.3%) and adalimumab (21.7%); 34.0% of patients used a non-biologic, mostly methotrexate (19.9%); and 2.7% used phototherapy. The majority of patients (99.8%) initiated secukinumab on the 300mg dose. The most prevalent comorbidities among secukinumab patients included hypertension, hyperlipidemia and psoriatic arthritis. Many patients received previous treatment, with more than half using a biologic prior to secukinumab. Almost all patients used the 300mg dose.
Over the past years, introduction of biologics for treatment of psoriatic arthritis (PsA) has improved the treatment responses in all clinical domains. However, little is known regarding the characteristics of patients who discontinue/switch biologics in non-clinical trial setting.
Objectives
To characterize PsA patients who discontinue/switch the index biologic and evaluate the reasons for discontinuation in the Corrona PsA/Spondyloarthritis (SpA) registry, a large US national cohort of patients with PsA/SpA.
Methods
PsA patients enrolled in the registry between 3/2013 and 7/2015, with a biologic at baseline (registry enrollment) and at least 2 follow-up visits were included. Two cohorts were identified: patients who discontinued/switched the index biologic (group 1) and those who stayed on the index biologic by the 2nd follow-up visit approximately 15 months after the enrollment (group 2). Descriptive analyses on patient demographics, clinical outcomes (eg. clinical disease activity index (CDAI), dactylitis, enthesitis), patient reported outcomes (eg. pain, fatigue, work productivity and activity impairment (WPAI)) and treatment at time of enrollment were examined. Chi-square tests and t-tests were used for continuous and categorical variables respectively to evaluate differences.
Results
Of the 251 PsA patients meeting the inclusion criteria, 26% (n=65) discontinued/switched the index biologic and 74% (n=186) stayed on the index biologic by the 2nd follow-up visit. A significantly greater percent of females discontinued/switched the index biologic (56% vs 41%, p<0.05). However both cohorts were similar in age (mean: 55 yrs vs 53 yrs), and disease duration (12 vs 12 yrs.). Group 1 patients reported significantly higher scores for pain (mean: 42 vs 27) and fatigue (mean: 48 vs 33) compared to Group 2 (p<.0001). Almost one-third of patients in Group 1 reported greater overall work impairment (mean: 30% vs 15%, p<0.01) compared to Group 2. Patients in Group 1 were most likely to have higher disease activity (mean CDAI: 13 vs 9, p<0.0001) and enthesitis (26% vs 15%, p<0.05) vs. group 2. Overall a majority of patients had a history of prior biologic use (97%), with about 55% on current monotherapy. The major reason for discontinuing the index biologic was lack of efficacy (60%), followed by other reasons (16%) and side effects (12%).
Conclusions
About a quarter of patients discontinued their index biologic over an average of 15 months follow up period. Those patients were more likely to have higher disease activity (CDAI) and poorer patient reported outcomes (pain, fatigue, WPAI) at enrollment. The most common reason for switching was lack of efficacy.
Acknowledgement
The design, study conduct, and financial support for this analysis was provided by Novartis. Corrona LLC: In the last two years, AbbVie, Amgen, BMS, Crescendo, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB have supported Corrona LLC through contracted subscriptions.
Disclosure of Interest
P. Mease Grant/research support from: Celgene, Novartis, Abbvie, Amgen, BMS, Janssen, Lilly, Pfizer, UCB, Consultant for: Celgene, Corrona, Merck, Novartis, Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Lilly, Merck, Pfizer, UCB;, Speakers bureau: Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, C. Karki Employee of: Corrona, LLC, M. Liu Employee of: Corrona, LLC, A. Kavanugh Grant/research support from: Amgen Abbvie Janssen Pfizer Novartis, C. Ritchlin Grant/research support from: Amgen, Janssen, and UCB, Consultant for: Abbvie, Amgen, Janssen, Regeneron, and UCB, D. Huynh Speakers bureau: AbbVie, BMS, R. Pandurengan Employee of: Corrona, LLC, V. Herrera Employee of: Novartis Pharmaceuticals Corporation, J. Palmer Employee of: Novartis Pharmaceuticals Corporation, J. Greenberg Shareholder of: Corrona, LLC, Consultant for: AstraZeneca, Celgene, Genentech, Janssen, Novartis and Pfizer, Employee of: Corrona, LLC
Psoriatic arthritis (PsA) is an inflammatory condition affecting joints and often occurs in combination with a skin disorder called psoriasis. In recent years biologic therapies have become widely used for this condition and have significantly improved outcomes for patients. Despite these innovations, little is known about what the most important clinical considerations in biologic treatment of PsA are, and how biologics perform against key clinical domains important in practice.
Objectives
This study seeks to understand the importance of biologic safety, efficacy, sustainability (duration of response), and speed (onset of action) in the treatment of PsA, and gauge how current biologics are perceived to perform against those key clinical domains.
Methods
Data were drawn from the Adelphi 2011 Rheumatology Disease Specific Programme – surveys of 100 rheumatologists in the USA. Rheumatologists rated the importance of 34 attributes describing considerations that may be of relevance when managing PsA on a 1 – 7 Likert scale (1 = no importance; 7 = extremely important). Biologic therapies indicated for PsA at the time of data collection (adalimumab, etanercept, golimumab, infliximab) were then rated against the same attributes on a Likert scale of 1 = no association to 7 = strong association. Attributes from the list of 34 were allocated to four clinical domains of safety, efficacy, sustainability and speed. Attributes not relevant to any of the four domains were removed from the analysis. The domains were assessed using Cronbach9s Alpha analysis and adjusted as appropriate to remove attributes weakening each domain9s internal consistency. The importance of each clinical domain was calculated using the mean “importance” scores across the individual attributes of each domain. Similarly, the extent of biologic therapies9 association with each domain was assessed as the mean of the scores for all four of the biologic therapies across each domain9s attributes.
Results
Cronbach9s Alpha analysis of the attribute allocation to domain groups resulted in 5 attributes in the “safety” domain (Alpha 0.87), 2 attributes in “speed” (Alpha 0.68), 1 attribute in “sustainability”, and 8 attributes in “efficacy” (Alpha 0.85). Based on clinician ratings of the importance of these domains scores ranged from 6.57 out of a maximum of 7 for “sustainability”, 6.38 for “safety”, 5.86 for “speed” to 5.77 for “efficacy”. Biologic association with the clinical domains ranged from 5.67 out of a maximum score of 7 for sustainability through speed 5.27, safety 5.17, and efficacy 5.14.
Conclusions
The scores indicate that the core domains of safety, efficacy, sustainability and speed are important themes in PsA treatment, with sustainability and safety seemingly most important. The biologic therapy “association” scores indicate that current biologics are providing a benefit in relation to these important clinical domains, however opportunity remains to more fully address each of these domains in the management of PsA.
Disclosure of Interest
S. Gabriel Employee of: Novartis Pharmaceutical Corporation, E. Sullivan Consultant for: Novartis Pharmaceutical Corporation, A. Roughley Consultant for: Novartis Pharmaceutical Corporation, J. Palmer Employee of: Novartis Pharmaceutical Corporation, V. Herrera Employee of: Novartis Pharmaceutical Corporation
This study examined mortality risk among patients with psoriasis in the United States. MarketScan databases were linked to the Social Security Administration death file to select adults with ≥1 inpatient or ≥2 outpatient diagnoses of psoriasis (ICD-9-CM 696.1x) during the study period (1/1/2006 to 6/30/2014). The first psoriasis diagnosis was the index date. Patients had 6 months of pre index continuous enrollment and were followed until the earliest of death or end of the study period. Comorbidities during the pre-index period were examined. Mortality incidence was calculated for psoriasis patients by comorbidities and age group. A Cox proportional hazards model was used to identify predictors of mortality. The sample comprised 102,573 psoriasis patients with mean age of 52.7 years (yrs). Patients were followed for an average of 4.9 yrs and 3.4% died during the study period. The mean age at death was 75.5 yrs. The mortality rate was 7.0 per 1,000 person-years (PY) and increased with age (0.8 per 1,000 PY in patients aged 18-24 yrs versus 45.5 per 1,000 PY in patients ≥ 75 yrs). The mortality rate was significantly higher for psoriasis patients with (versus without) diabetes (17.5 vs. 5.7), hypertension (12.6 vs. 4.8), coronary heart disease (24.9 vs. 5.4), cerebrovascular disease (31.9 vs. 6.2), and peripheral vascular disease (36.8 vs. 6.1) (all p<0.05). Multivariate analysis suggested that older age, female gender, higher Charlson Comorbidity Index (CCI) score, and presence of comorbidities (diabetes, coronary heart disease, cerebrovascular disease, peripheral vascular disease, and malignancy) were associated with increased risk of mortality amongst psoriasis patients (all p<0.001). Among patients with psoriasis, the rate of mortality was 7.0 per 1,000 person-years. Diabetes, cardiovascular diseases, malignancy, female gender, older age, and increased CCI scores were associated with an elevated risk of mortality in this cohort of psoriasis patients.
Little is known about how patient factors may effect the impact of biologics on various quality of life measures used in psoriatic arthritis (PsA).
Objectives
The objective of this study was to perform a systematic review and meta-regression analysis to explore the clinical factors that modify the effects of biologics on quality of life in PsA patients.
Methods
A systematic literature review was performed in Medline, EMBASE, and Cochrane Central and clinicaltrials.gov. Randomized controlled trials (RCTs) assessing biologics in adults with PsA were eligible. Outcomes of interest included the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS). Clinical factors evaluated for effect on biologic treatment response were age, gender, ethnicity, PsA duration, psoriasis duration, swollen and tender joint counts, steroid baseline use, methotrexate baseline use, prior anti-TNF use, Disease Activity Score (DAS) and study year. Clinical factors were considered potential effect modifiers (PEM) of quality of life in PsA if they graphically demonstrated associations via forest and l9Abbé plots. PEM were further investigated through meta-regression analyses where covariate effects were assumed to be similar for all treatments.
Results
Ten placebo-controlled RCTs were identified as eligible for analysis (10 reporting on SF-36 PCS, 9 reporting on SF-36 MCS, and 9 reporting on HAQ-DI). Treatments assessed in these trials included adalimumab, etanercept, infliximab, ustekinumab, abatacept, certolizumab pegol, golimumab and secukinumab. Age was found to be a PEM for HAQ-DI at 12 weeks. When this covariate was examined in meta-regression, trials with higher mean age at baseline tended to have higher HAQ-DI scores. Age and psoriasis duration were PEM for HAQ-DI at 24 weeks. In meta-regression, trials with higher mean age at baseline and shorter PsA duration tended to have higher HAQ-DI scores. Age was identified as a PEM for SF-36 PCS at 12 weeks, but this was not significant in the meta-regression. Psoriasis duration, PsA duration, baseline DAS, and study year were PEM for SF-36 PCS at 24 weeks. Meta-regression analysis of these covariates supported them as effect modifiers, showing trials with shorter psoriasis duration, shorter PsA duration, and more recent study year tended to have lower SF-36 PCS scores. DAS was not found to be related to SF-36 PCS scores. Age and white race were identified as PEM of SF-36 MCS at 12 weeks, but these were not significant in meta-regression. Age was identified as a PEM for SF-36 MCS at 24 weeks. When this was considered in meta-regression, trials with higher mean age at baseline tended to have lower SF-36 MCS scores.
Conclusions
These analyses identified key clinical factors such as age and disease duration, which modify the effects of biologics on quality of life. Accounting for these clinical factors in future real world clinical or pharmacoepidemiologic studies may be important to ensure the best evidence is used for biologic coverage and treatment decision-making.
Disclosure of Interest
J. Palmer Employee of: Novartis Pharmaceuticals Corporation, S. Kanter Consultant for: Novartis Pharmaceuticals Corporation, E. Druyts Consultant for: Novartis Pharmaceuticals Corporation, Y. Tsang Employee of: Novartis Pharmaceuticals Corporation, V. Herrera Employee of: Novartis Pharmaceuticals Corporation
Availability of oral disease-modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) may affect injectable DMT (iDMT) treatment patterns.The objective of this paper is to evaluate iDMT persistency, reasons for persistency lapses, and outcomes among newly diagnosed RRMS patients.Medical records of 300 RRMS patients initiated on iDMT between 2008 and 2013 were abstracted from 18 US-based neurology clinics. Eligible patients had ≥3 visits: pre-iDMT initiation, iDMT initiation (index), and ≥1 visit within 24 months post-index. MS-related symptoms, relapses, iDMT treatment patterns (i.e. persistency, discontinuation, switching, and restart), and reasons for non-persistency were tracked for 24 months.At 24 months, iDMT persistency was 61.0%; 28.0% of patients switched to another DMT, 8.0% discontinued, and 3.0% stopped and restarted the same iDMT. The most commonly identified reasons for non-persistency were perceived lack of efficacy (22.2%), adverse events (18.8%), and fear of needles/self-injecting (9.4%). At 24 months, 38.0% of patients had experienced a relapse and 11.0% had changes in MRI lesion counts. Patients without MS-related symptoms at index reported increases in the incidence of these symptoms at 24 months.Non-persistency with iDMT remains an issue in the oral DMT age. Many patients still experienced relapses and disease progression, and should consider switching to more effective therapies.
Psoriatic arthritis (PsA) is often presented with psoriasis (PsO). However, the severity of PsO among PsA patients varies, which may affect the comorbidity burden in this population.
Objectives
This study aimed to assess the comorbidity burden and medication use between PsA patients with moderate-to-severe PsO vs. those with minimal skin PsO.
Methods
Adults (18–64 years) with ≥2 claims for PsA (ICD-9-CM: 696.0) that were ≥30 days apart were selected from the Truven Health MarketScan claims database (data cut period 07/2009–06/2014). The index date was a randomly selected date after the first PsA claim. All patients were required to have ≥12-month continuous eligibility before (baseline period) and after (study period) the index date. Patients in the PsA+moderate-to-severe PsO group were required to have 1) ≥2 claims for PsO (ICD-9-CM: 696.1) that were ≥30 days apart, and 2) ≥1 PsO claim and ≥1 systemic therapy/phototherapy in the study period. PsA patients were classified into the PsA+minimal skin PsO group if they did not have any PsO claim or phototherapy in the data cut period, or had ≥1 PsO claim but no evidence of systemic therapy or phototherapy in the data cut period. Patient demographics as of the index date, comorbidities, and medication use during the study period were compared between these two groups. Wilcoxon rank sum tests were used to compare continuous variables and Chi-square tests were used to compare binary variables. Bonferroni correction was used to adjust for multiple comparisons.
Results
A total of 10,495 patients with PsA+moderate-to-severe PsO and 15,503 patients with PsA+minimal skin PsO were included in this study. Mean age and percent male were comparable (48.46±10.29 vs. 49.92±10.05 years; 48.2% vs. 46.7%). Compared to patients with PsA+minimal skin PsO, those with PsA+moderate-to-severe PsO had slightly higher rates of chronic pulmonary disease (23.6% vs. 21.4%) and liver disease (excluding fatty liver) (15.1% vs. 10.7%), but lower rates of co-prevalent rheumatic disease (5.1% vs. 7.0%) and rheumatoid arthritis (32.2% vs. 35.7%). Patients with PsA+moderate-to-severe PsO also had significant higher rates of several PsA-associated comorbidities, including anxiety (18.8% vs. 15.8%), depression (23.2% vs. 20.1%) and obesity (21.5% vs. 15.9%) (all p<0.0001). Patients with PsA+moderate-to-severe PsO had significantly higher rates of all-cause medication use (99.9% vs. 94.7%) and larger number of unique medications filled (13.38 vs. 11.28) than patients with PsA+minimal skin PsO (both p<0.0001). Significant differences were also observed in the mean number of unique medications filled between these two groups for PsA-related medications (2.78 vs. 2.14), non-PsA-related medications (10.60 vs. 9.14), antidepressants (0.60 vs. 0.55), and antidiabetics (0.30 vs. 0.25) (all p<0.0001).
Conclusions
PsA patients with moderate-to-severe PsO had a higher comorbidity burden compared to those with minimal skin PsO, and also incurred significantly more medication use overall and related to PsA and specific comorbid conditions.
Acknowledgement
This study is funded by Novartis Pharmaceuticals Corporation.
Disclosure of Interest
J. Merola Grant/research support from: Biogen IDEC, AbbVie, Amgen, Pfizer, Consultant for: Biogen IDEC, AbbVie, Eli Lilly, Novartis, Janssen, Momenta, Speakers bureau: AbbVie, V. Herrera Shareholder of: Novartis, Employee of: Novartis, J. Palmer Employee of: Novartis
