Use of Thalidomide In Erythematosus Lupus Treatment

A890

VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 8 5 3 – A 9 4 3

I2: 0.9%; p= 0.388). However, metabolic outcomes were poorly described, preventing a meta-analysis. A mixed treatment comparison corroborated the direct metaanalysis.  Conclusions: Considering the high level of risk of bias and the absence of important published outcomes for anti-obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status. PSY3 Medical Treatments for Acromegaly: Systematic Review and Network Meta-Analysis Leonart LP, Ferreira VL, Tonin FS, Pontarolo R Universidade Federal do Paraná, Curitiba, Brazil

Objectives: To evaluate the safety and efficacy of medical treatments used in acromegaly.  Methods: A systematic search was conducted in the electronic databases PubMed, Scopus, Web of Science, and Scielo. Head-to-head or against placebo randomized controlled trials (RCT) in acromegaly patients were included. Data regarding baseline characteristics, the outcomes insulin-like growth factor 1 (IGF-1) and/or growth hormone (GH) control and adverse events were extracted. The meta-analyses were performed using the software Addis 1.16.8.  Results: 10 studies were included in this review. The records involved the drugs Pegvisomant, Lanreotide Autogel, Lanreotide SR, Octreotide, Octreotide LAR, Pasireotide, Bromocriptine, and placebo. A network meta-analysis was performed for the outcome patients with IGF-1 control. Pegvisomant and Lanrotide Autogel showed statistically significant superiority compared to placebo (Odds Ratio with 95% credible interval of 0.06 [0.00-0.55] and 0.09 [0.01-0.88], respectively). No other statistical differences were observed. The probability rank suggested that Pegvisomant and Pasireotide have similar probabilities of being the best drug to control IGF-1 circulating levels (33% and 34%, respectively). It was not possible to build a network for GH outcome because the definition of GH control was not standardized among the studies. Considering adverse events, most of trials reported complaints related to the gastrointestinal tract (e.g., diarrhea and nausea).  Conclusions: This was the first meta-analysis to compare high quality evidence (RCT) of medical treatments used in acromegaly. Despite the low number of trials, it was possible to compare the interventions though an indirect analysis. Considering that acromegaly is a rare disease, the publication of interventional studies is not frequent. Thus, we recommend the addition of a control group using a different drug when trials are performed, making the comparison of efficacy between drugs feasible. Pasireotide, newer and cheaper than Pegvisomant, seems to be a promising drug that should be more investigated. PSY4 ASSOCIATION Between Second-Line Therapy (2LT) Regimen Type, Duration of Therapy (DOT), and Time To Next Treatment (TTNT) In A United States (US) Relapsed/Refractory Multiple Myeloma (RRMM) Cohort: An Electronic Medical Records (EMR)-Based Study Romanus D1, Raju A2, Yong C1, Farrelly E2, Luptakova K1, Labotka R1, Noga SJ1, Blazer M2, Hari P3 1Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA, 2Xcenda, LLC, Palm Harbor, FL, USA, 3Medical College of Wisconsin, Division of Hematology Oncology, Milwaukee, WI, USA

Objectives: Extended DOT in MM trials may improve outcomes, but data in RRMM patients treated in routine care are limited. We evaluated DOT and TTNT (a surrogate for progression-free survival) by 2LT regimen type in a US cohort of RRMM patients.  Methods: In this retrospective EMR-database study, adult RRMM patients diagnosed between 1/1/2007—6/30/2015 initiating bortezomib-, carfilzomib-, or lenalidomide-based (Bort-, Carf-, or Len-based) 2LT were grouped into mutually exclusive categories: Bort- (+/-Len); Carf- (+/-Len); Len-based (-Carf/Bort). DOT was defined as the time from first to last administration of all 2LT drugs or death and TTNT as the time from 2LT initiation to 3LT initiation or death. KaplanMeier method was used for 2LT DOT and TTNT descriptive analyses and  Cox proportional-hazards regression for multivariate analyses.  Results: Among 492 RRMM patients, median age in the Len-based [n= 227]; Bort-based [n= 213], and Carf-based [n= 52]) groups was 69, 72, and 67 years. Overall, unadjusted median 2LT DOT: 7.7 months (95% CI: 6.6, 9.2) and TTNT: 14.7 months (95% CI: 12.9, 17.7). Len-based patients had the longest unadjusted median (months) DOT and TTNT vs other groups; 2LT DOT: Len- (10.1 [95% CI: 7.9, 11.9]); Bort- (6.6 [95% CI: 5.1, 8.2]); Carfbased (4.6 [95%CI: 3.0, 7.5]), and 2LT TTNT: Len- (20.1 [95% CI: 17.7, 29.2]); Bort- (11.9 [95%CI: 9.5, 13.7]); Carf-based (5.7 [95%CI: 3.7, 8.2]), (P< 0.01 for both). In adjusted analysis, 2LT regimen type was significantly associated with DOT (adjusted HRBort for treatment discontinuation: 1.41 [95% CI: 1.11, 1.79] and HRCarf: 1.93 [95% CI: 1.25, 2.96] vs Len-based), and with. TTNT (adjusted HRBort: 1.91 [95% CI: 1.45, 2.52] and HRCarf: 3.21 [95% CI: 2.00, 5.17] vs Len-based).  Conclusions: In this RRMM cohort, 2LT TTNT was ~2-fold longer than DOT, Lenalidomide-based regimens were associated with the longest unadjusted and adjusted 2LT DOT and TTNT. Future research is needed for confirmation. PSY5 Use of Thalidomide In Erythematosus Lupus Treatment Teixeira DR1, Galdino-Pitta MR1, Nunes TR2, Viana DC3, Araujo BC2, Zanghelini F4, Pereira MC2, Rego MJ4, Oliveira MD5, PittaId 4, Pitta MG2, Andrade CA2 1Federal University of Pernambuco, Recife, Brazil, 2Universidade Federal de Pernambuco, Recife, Brazil, 3Avenida Professor Moraes Rego, Recife, Brazil, 4UFPE, Recife, Brazil, 5University Federal de Pernambuco, Recife, Brazil

Objectives: Thalidomide is listed in the National List of Essential Medicines in Brazil (RENAME 2014) for the treatment of Hansen’s disease, multiple myeloma and systemic erythematosus lupus (LES). This study aimed to evaluate the therapeutic indication of thalidomide in the treatment of systemic erythematosus lupus patients. Methods: The research was carried out on March 16, 2015

on the literature on Best Practice (BMJ), Dynamed and UpToDate, being used the DeCS and MeSH indexed terms: “Lupus Erythematosus, Cutaneous” and “Thalidomide”.  Results: According to the evidence on the BMJ, Thalidomide is indicated as a third-line treatment in systemic erythematosus lupus (LES) patients in the following situations: all patients for cutaneous erythematosus lupus (LEC) who do not respond to other treatments; including discoid erythematosus lupus (LED) lesions indicated in once a day doses of oral 50-200mg. On Dynamed, a update (2013) indicates the use of thalidomide in improving the recurrent (refractory) LEC but it was found high neurotoxicity. The UpToDate evidence synthesis reports that when one or more of first line agents is not successful, more aggressive therapy to reduce remission of the disease should be considered. Still, thalidomide is highly efficacious for LEC, but has potential for serious adverse effects, including teratogenicity and a relatively high risk of peripheral neuropathy. Thalidomide has a rapid onset of action, usually with response within the first month of treatment. This should be initiated at 50mg to 100mg daily doses, and reduced to the minimal effective dose after clinical improvement.  Conclusions: Thalidomide can be used for the treatment of patients with LES, especially refractory and who did not respond to first-line treatments. Potential adverse effects of thalidomide make it more useful as short-term remission inducing agent and as maintenance treatment, concurrently with conventional medications or other systemic medicinal products for the refractory LEC. PSY6 Treatment Patterns and Impact of Not Achieving Skin Clearance for Psoriasis Patients In Latin America Papadimitropoulos M1, Romiti R2, Garcia EG3, Lobosco S4, Leonardi Reyes F5, Wang X6, Haynes G7 1Eli Lilly and Company, Canada, Toronto, ON, Canada, 2Hospital das Clínicas University of São Paulo (USP), São Paulo, Brazil, 3Elil Lilly and Co, Mexico City, Mexico, 4Adelphi Real World, Macclesfield, UK, 5Eli Lilly, Bogota, Colombia, 6University of Toronto, Toronto, ON, Canada, 7Eli Lilly and Company, Indianapolis, IN, USA

Objectives: To describe psoriasis treatments in Latin America and the impact of failing to achieve high psoriasis skin clearance.  Methods: One hundred and forty-four dermatologists and 941 of their psoriasis patients from Brazil, Colombia, Argentina and Mexico participated in the Adelphi Latin America Disease Specific Programme, answering questions about current disease severity, treatment, satisfaction and treatment history. The Physician’s Global Assessment (PGA) identified patients with clear skin or substantial coverage remaining; EQ-5D (5L) questionnaire captured quality of life (QoL); Work Productivity and Activity Impairment (WPAI) questionnaire assessed work productivity.  Results: Current psoriasis treatments for the 941 patients were biologic agents (38.4%), conventional systemic treatment (45.4%) or combination of both (13.9%); 38% patients were receiving a steroid and 11% phototherapy. Of those treated with biologics, conventional systemic treatment or combination of both, 42.7%, 63.2% and 45.8% respectively were not considered by the dermatologist to be in remission. Among patients with clear to nearly clear skin (PGA 0-1; n=  343) 86.3% patients currently treated with a biologic were in remission compared with 79.1% treated with a conventional systemic treatment. Compared to patients with substantial skin coverage (PGA 2-5; n=  597), patients in the clear or nearly clear skin group had fewer areas of the body affected in difficult to treat areas such as scalp (19.2% vs 51.9%), groin/genitals (0.6% vs 17.7%) and palmar-plantar regions (11.4% vs 26.6%); had lower incidence of flares (5.2% vs 37%), greater satisfaction (96.5% vs 53.7%); better mean (SD) EQ-5D (5L) (0.87 [0.2] vs 0.77 [0.2]) and mean total WPAI (6.5 [13.7] vs 18.0 [26.5]).  Conclusions: Many Latin American patients had substantial skin coverage, even when treated with biologics. More biologictreated patients were in remission than conventional systemic-treated patients. Better skin clearance was associated with improved QoL and work productivity, reflecting the need of treatments providing higher skin clearance. PSY7 Characteristics of Latin American Patients With Rheumatoid Arthritis Receiving Advanced Therapy Brnabic A1, Xavier R2, Goncalves L3, Lucas J4, Hernandez P5, Gaich CL6, Papadimitropoulos M7 1Eli Lilly and Company, Sydney, Australia, 2Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, 3Eli Lilly and Company, São Paulo, Brazil, 4Adelphi Real World, Bollington, UK, 5Compañía Farmacéutica Eli Lilly de Centroamérica, S.A, Este San José, Costa Rica, 6Eli Lilly and Company, Indianapolis, IN, USA, 7Eli Lilly and Company, Canada, Toronto, ON, Canada

Objectives: To present demographics and characteristics of Latin American patients with rheumatoid arthritis (RA).  Methods: Data was collected in 2015 for the Adelphi RA Latin America Disease Specific Programme, a cross-sectional survey of rheumatologists and their RA patients. Rheumatologists (N= 188) from Brazil (n= 47), Argentina (n= 42), Colombia (n= 33), Mexico (n= 41) and Venezuela (n= 25) provided demographics and clinical characteristics for patients > 18 years currently prescribed a biologic DMARD (bDMARD) or JAK inhibitor with/without a conventional DMARD.  Results: Approximately 54.8% rheumatologists were female and on average, saw 107 patients/5-day week. The analysis included 801 patients from Brazil (n=  246), Argentina (n= 239), Colombia (n= 137), Mexico (n= 82) and Venezuela (n= 97). Majority of patients (82.8%) were female, aged mean (SD) 51.9 (13.3) years with mean (SD) disease duration 11.1 (9.4) years. At the time of survey 31.8% patients were classified as moderate-severe based on rheumatologist’s judgement despite 98.5% currently receiving a bDMARD or JAK inhibitor. Mean (SD) DAS-28 disease activity was 3.8 (1.4). Many patients (38.4%) reported via a VAS scale moderate-high levels of pain and were currently experiencing mean (SD) of 3.2 (3.0) symptoms, including joint tenderness (47.3%), swollen joints (46.3%) and morning stiffness (42.2%). The mean (SD) number of joints affected was 4.5 (2.2); wrists (89.1%), MCP joints (85.4%) and knees (62.7%) were most prevalent. According to the rheumatologist, 14.1% patients were flaring at time of survey (defined as temporary worsening of symptoms), and 79.4% were not in remission (defined as DAS-28 < 2.6) irrespective of treatment.  The mean (n, SD) EQ-5D 5L utility and EQ-5D VAS scores were 0.7 (509, 0.2) and 70.7