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[PMID]: 29520429
[Au] Autor:Lv W; Yuan Q; Wang Q; Ma J; Jiang J; Yang W; Feng Q; Chen W; Rahmim A; Lu L
[Ad] Address:School of Biomedical Engineering and Guangdong Provincal Key Laboratory of Medical Image Processing, Southern Medical University, 1023 Shatai Road, Baiyun District, Guangzhou, Guangdong, 510515, China.
[Ti] Title:Robustness versus disease differentiation when varying parameter settings in radiomics features: application to nasopharyngeal PET/CT.
[So] Source:Eur Radiol;, 2018 Mar 08.
[Is] ISSN:1432-1084
[Cp] Country of publication:Germany
[La] Language:eng
[Ab] Abstract:OBJECTIVES: To investigate the impact of parameter settings as used for the generation of radiomics features on their robustness and disease differentiation (nasopharyngeal carcinoma (NPC) versus chronic nasopharyngitis (CN) in FDG PET/CT imaging). METHODS: We studied 106 patients (69/37 NPC/CN, pathology confirmed), and extracted 57 radiomics features under different parameter settings. Robustness was assessed by the intra-class correlation coefficient (ICC). Logistic regression with leave-one-out cross validation was used to generate classification probabilities, and diagnostic performance was assessed by the area under the receiver operating characteristic curve (AUC). RESULTS: Varying averaging strategies and symmetry, 4/26 GLCM features showed poor range of pairwise ICCs of 0.02-0.98, while depicting good AUCs of 0.82-0.91. Varying distances, 5/26 GLCM features showed ICCs of 0.82-0.99 while corresponding AUCs were 0.52-0.91. 6/13 GLRLM features showed both high AUC (0.81-0.89) and high ICC (0.85-0.99) regarding to averaging strategies. 7/13 GLSZM features showed AUCs of 0.81-0.90 while having ICCs of 0.01-0.99 under different neighbourhoods. 2/5 NGTDM features showed AUCs of 0.81-0.85 while having ICCs of 0.19-0.89 for different window sizes. Differentiating a subset of NPC (stages I-II) form CN, both SumEntropy and SZLGE achieved significantly higher AUCs than metabolically active tumour volume (AUC: 0.91 vs. 0.72, p<0.01). CONCLUSIONS: Radiomics features depicting poor absolute-scale robustness regarding to parameter settings can still lead to good diagnostic performance. As such, robustness of radiomics features should not be overemphasized for removal of features towards assessment of clinical tasks. For differentiating NPC from CN, some radiomics features (e.g. SumEntropy, SZLGE, LGZE) outperformed conventional metrics. KEY POINTS: • Poor robustness did not necessarily translate into poor differentiation performance. • Absolute-scale robustness of radiomics features should not be overemphasized. • Radiomics features SumEntropy, SZLGE and LGZE outperformed conventional metrics.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:Publisher
[do] DOI:10.1007/s00330-018-5343-0

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[PMID]: 29310444
[Au] Autor:Oakes TMM; Skljarevski V; Zhang Q; Kielbasa W; Hodsdon ME; Detke HC; Camporeale A; Saper JR
[Ad] Address:1 Eli Lilly and Company, Indianapolis, IN, USA.
[Ti] Title:Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study.
[So] Source:Cephalalgia;:333102417747230, 2018 Jan 01.
[Is] ISSN:1468-2982
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Background Safety findings from a Phase 2b study of galcanezumab, a humanized monoclonal antibody against calcitonin gene-related peptide, for prevention of migraine (NCT02163993) are reported here. Methods Patients aged 18-65 years with episodic migraine were evaluated in this multicenter, double-blind, randomized study. After randomization, 410 patients were administered 5, 50, 120 or 300 mg of galcanezumab or placebo subcutaneously once every 4 weeks for 12 weeks, followed by a post-treatment off-drug period lasting 12 weeks. Results Treatment-emergent adverse events (TEAEs) were primarily rated as mild to moderate. Serious adverse events reported in galcanezumab dose groups were appendicitis, Crohn's disease, suicidal ideation, and congenital ankyloglossia in an infant of a paternal pregnancy; each of these were reported by one patient. Adverse events leading to discontinuation with galcanezumab treatment were abdominal pain, visual impairment, and upper limb fracture, each reported by one patient. Treatment-emergent injection-site reactions were reported significantly more frequently ( p = 0.013) with galcanezumab (13.9%) than with placebo (5.8%). Injection-site pain was the most common injection-site reaction (galcanezumab 11.4%; placebo 2.9%, p = 0.004). Upper respiratory tract infection (galcanezumab 10.0%; placebo 8.8%) and nasopharyngitis (galcanezumab 7.0%; placebo 2.2%) also occurred more frequently with galcanezumab treatment. Potential hypersensitivity events were reported at similar frequencies in galcanezumab (3.3%) and placebo (5.1%) groups. Incidence of treatment-emergent anti-drug antibodies in galcanezumab dose groups (4.6% of patients during treatment period) did not appear to have any meaningful effects on safety, the pharmacokinetics of galcanezumab, or its ability to bind to the target ligand. Conclusion The results from this 3-month Phase 2b study support the initiation of larger Phase 3 trials of longer duration.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1801
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:Publisher
[do] DOI:10.1177/0333102417747230

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[PMID]: 29516321
[Au] Autor:Wang Y; Wang J; Wang S
[Ad] Address:Department of Vascular Surgery, First Affiliated Hospital of Sun Yat-sen University, No. 58, Zhongshan Road 2, YueXiu District, Guangzhou, 510000, Guangdong, China. wangyang5@mail2.sysu.edu.cn.
[Ti] Title:Comparative Effectiveness of Inclisiran 100, 300, and 500mg in a Population with Hyperlipidemia: A Network Meta-Analysis of Randomized Controlled Trials.
[So] Source:Am J Cardiovasc Drugs;, 2018 Mar 07.
[Is] ISSN:1179-187X
[Cp] Country of publication:New Zealand
[La] Language:eng
[Ab] Abstract:BACKGROUND: To our knowledge, inclisiran was the first agent composed of small interfering RNAs (siRNAs) to be preliminarily used to reduce proatherogenic lipoprotein cholesterol levels. Inclisiran was evaluated in large clinical trials but did not receive government approval. The ability of inclisiran to reduce low-density lipoprotein cholesterol (LDL-C) greatly improved its chances of becoming a novel therapeutic option for patients with hyperlipidemia. OBJECTIVE: Our goal was to summarize the preliminary effectiveness and safety data for inclisiran. METHODS: We conducted a comprehensive search of PubMed, Scopus, Web of Science, the OVID EMB Reviews database, and Clinical Trials with the keyword "inclisiran" to find all related randomized controlled trials (RCTs). Five recently published RCTs involving 583 adults aged 18-65years with hyperlipidemia were included in the analysis. RESULTS: Subgroup analysis suggested that inclisiran 100mg (standard mean difference [SMD] - 2.09; 95% confidence interval [CI] - 2.51 to - 1.66; p<0.05), 300mg (SMD - 2.74; 95% CI - 3.61 to - 1.87; p<0.05), and 500mg (SMD - 2.21; 95% CI - 2.62 to - 1.80; p<0.05) significantly (p<0.05) reduced LDL-C and total cholesterol even though pooled analysis showed no LDL-C-lowering effect (SMD 0.15; 95% CI - 0.34 to 0.04; p=0.116). Compared with patients receiving placebo, pooled and subgroup analysis of patients receiving inclisiran showed no favorable changes in triglycerides or high-density lipoprotein cholesterol (p>0.05). The most commonly reported adverse events were musculoskeletal pain, nasopharyngitis, headache, and elevated C-reactive protein (CRP), none of which were significant (p>0.05). CONCLUSIONS: To date, inclisiran has been effective in treating hyperlipidemia. Major adverse events were not identified, although other possible adverse events may be discovered with more RCTs and extensive long-term follow-up.
[Pt] Publication type:JOURNAL ARTICLE; REVIEW
[Em] Entry month:1803
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[St] Status:Publisher
[do] DOI:10.1007/s40256-018-0270-7

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[PMID]: 29310899
[Au] Autor:Llibre JM; Hung CC; Brinson C; Castelli F; Girard PM; Kahl LP; Blair EA; Angelis K; Wynne B; Vandermeulen K; Underwood M; Smith K; Gartland M; Aboud M
[Ad] Address:Infectious Diseases, University Hospital Germans Trias, Barcelona, Spain; Fight AIDS Foundation, Barcelona, Spain.
[Ti] Title:Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies.
[So] Source:Lancet;391(10123):839-849, 2018 Mar 03.
[Is] ISSN:1474-547X
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:BACKGROUND: Lifelong HIV antiretroviral therapy (ART) has prompted an interest in two-drug regimens to minimise cumulative drug exposure and toxicities. The safety, tolerability, and efficacy of dolutegravir and rilpivirine suggest potential compatibility and effectiveness as a two-drug regimen. We aimed to investigate this two-drug regimen in a phase 3 study. METHODS: We identically designed SWORD-1 and SWORD-2, which were open-label, parallel-group, multicentre, phase 3, randomised, non-inferiority studies in 12 countries evaluating efficacy and safety of once-daily dolutegravir 50 mg plus rilpivirine 25 mg versus current ART regimen (CAR). We included participants aged 18 years or older who were on first or second ART with stable plasma HIV-1 RNA (viral load <50 copies per mL) for 6 months or longer at screening. We randomly assigned participants (1:1) with stratification by third-agent class, age, and planned participation in a bone mineral density substudy. The primary endpoint was proportion of participants with viral load lower than 50 copies per mL at week 48 among those individuals who received one or more doses of study medication. Investigators monitored adverse events to assess safety. These trials are registered with ClinicalTrials.gov, numbers NCT02429791 (SWORD-1) and NCT02422797 (SWORD-2). FINDINGS: We screened for participants from April 14, 2015, to Oct 15, 2015, for SWORD-1 and from April 21, 2015, to Sept 25, 2015, for SWORD-2. We randomly assigned 516 participants to dolutegravir-rilpivirine and 512 to continue with CAR. At week 48 (last patient visit was Nov 22, 2016), in the pooled analysis of the intention-to-treat population, 95% of participants had viral loads lower than 50 copies per mL in each group (486 of 513 in the dolutegravir-rilpivirine group vs 485 of 511 in the CAR group), with an adjusted treatment difference of -02% (95% CI -30 to 25) and showed non-inferiority with a predefined margin of -8%. 395 (77%) of 513 participants in the dolutegravir-rilpivirine group and 364 (71%) of 511 participants in the CAR group reported adverse events. The most common adverse events were nasopharyngitis (49 [10%] for dolutegravir-rilpivirine vs 50 [10%] for CAR) and headache (41 [8%] vs 23 [5%]). More participants taking dolutegravir-rilpivirine (17 [3%]) reported adverse events leading to withdrawal than did participants taking CAR (three [<1%]). INTERPRETATION: Dolutegravir-rilpivirine was non-inferior to CAR over 48 weeks in participants with HIV suppression and showed a safety profile consistent with its components. Results support the use of this two-drug regimen to maintain HIV suppression. FUNDING: ViiV Healthcare and Janssen Pharmaceutica NV.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1801
[Cu] Class update date: 180306
[Lr] Last revision date:180306
[Cl] Clinical Trial:ClinicalTrial
[St] Status:In-Data-Review

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[PMID]: 29500310
[Au] Autor:Johannsson G; Feldt-Rasmussen U; Holme Hkonsson I; Biering H; Rodien P; Tahara S; Toogood AA; Rasmussen MH
[Ad] Address:G Johannsson, ., University of Gteborg , Gteborg, Sweden.
[Ti] Title:Safety and Convenience of Once-Weekly Somapacitan in Adult GH Deficiency: A 26-Week Randomized, Controlled Trial.
[So] Source:Eur J Endocrinol;, 2018 Mar 02.
[Is] ISSN:1479-683X
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:OBJECTIVE: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin Local tolerability and treatment satisfaction were also assessed. DESIGN: 26-week randomized, controlled phase 3 safety and tolerability trial in six countries (NCT02382939). METHODS: Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies; and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). RESULTS: Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (p=0.0171). CONCLUSIONS: In this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin .
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180303
[Lr] Last revision date:180303
[Cl] Clinical Trial:ClinicalTrial
[St] Status:Publisher

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[PMID]: 29247148
[Au] Autor:van der Heijde D; Gladman DD; Kishimoto M; Okada M; Rathmann SS; Moriarty SR; Shuler CL; Carlier H; Benichou O; Mease PJ
[Ad] Address:From the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Immuno-Rheumatology Center, St. Luke's International Hospital, St. Luke's International University, Tokyo
[Ti] Title:Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1).
[So] Source:J Rheumatol;45(3):367-377, 2018 Mar.
[Is] ISSN:0315-162X
[Cp] Country of publication:Canada
[La] Language:eng
[Ab] Abstract:OBJECTIVE: To evaluate the efficacy and safety of ixekizumab (IXE), an interleukin 17A antagonist, in patients with psoriatic arthritis (PsA) after 52 weeks in a phase III study. METHODS: Patients were initially randomly assigned to IXE 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after a 160-mg starting dose, placebo (PBO), or adalimumab (ADA) 40 mg Q2W. At Week 24 (Week 16 for inadequate responders), ADA (8-week washout before starting IXE) and PBO patients were rerandomized to IXEQ2W or IXEQ4W. Six treatment groups were evaluated in the extension period (weeks 24-52): IXEQ2W/IXEQ2W, IXEQ4W/IXEQ4W, ADA/IXEQ2W, ADA/IXEQ4W, PBO/IXEQ2W, and PBO/IXEQ4W. The extension period population (EPP) included patients who received ≥ 1 dose of study medication during the extension period. RESULTS: There were 381/417 (91.4%) patients who entered the extension period. In the IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W groups (EPP), respectively, American College of Rheumatology (ACR)20 (69.1% and 68.8%), ACR50 (54.6% and 53.1%), and ACR70 (39.2% and 39.6%) response rates were sustained at Week 52. Patients rerandomized to IXE also demonstrated efficacy measured by ACR response rates at Week 52. A similar pattern was observed for Psoriasis Area and Severity Index outcomes. Radiographic progression in all 6 groups was minimal. The most frequently reported treatment-emergent adverse events (≥ 4%) were nasopharyngitis, injection site reaction, injection site erythema, upper respiratory tract infection, and back pain. No deaths were reported, and serious adverse event frequency was 0-4% with IXE. CONCLUSION: During the extension period, IXEQ4W or IXEQ2W treatment demonstrated sustained efficacy in key PsA domains with a safety profile consistent with other studies investigating IXE. Clinical trial number: NCT01695239; EudraCT 2011-002326-49.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1712
[Cu] Class update date: 180302
[Lr] Last revision date:180302
[Cl] Clinical Trial:ClinicalTrial
[St] Status:In-Data-Review
[do] DOI:10.3899/jrheum.170429

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[PMID]: 29471679
[Au] Autor:Dodick DW; Ashina M; Brandes JL; Kudrow D; Lanteri-Minet M; Osipova V; Palmer K; Picard H; Mikol DD; Lenz RA
[Ad] Address:1 Mayo Clinic, Scottsdale, AZ, USA.
[Ti] Title:ARISE: A Phase 3 randomized trial of erenumab for episodic migraine.
[So] Source:Cephalalgia;:333102418759786, 2018 Jan 01.
[Is] ISSN:1468-2982
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50% reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results Patients receiving erenumab experienced -2.9 days change in monthly migraine days, compared with -1.8 days for placebo, least-squares mean (95% CI) treatment difference of -1.0 (-1.6, -0.5) ( p < 0.001). A ≥ 50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) of patients (OR:1.59 (95% CI: 1.12, 2.27) ( p = 0.010). Migraine-specific medication treatment days were reduced by -1.2 (erenumab) and -0.6 (placebo) days, a treatment difference of -0.6 (-1.0, -0.2) ( p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary - Physical Impairment were 33.0% and 27.1% (OR:1.33 (0.92, 1.90) ( p = 0.13) and in Migraine Physical Function Impact Diary - Everyday Activities were 40.4% and 35.8% (OR:1.22 (0.87, 1.71) ( p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration ClinicalTrials.gov, NCT02483585.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180301
[Lr] Last revision date:180301
[Cl] Clinical Trial:ClinicalTrial
[St] Status:Publisher
[do] DOI:10.1177/0333102418759786

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[PMID]: 29462231
[Au] Autor:Stein Gold L; Bagel J; Lebwohl M; Jackson JM; Chen R; Goncalves J; Levi E; Duffin KC
[Ti] Title:Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL.
[So] Source:J Drugs Dermatol;17(2):221-228, 2018 Feb 01.
[Is] ISSN:1545-9616
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:

BACKGROUND: Many patients with moderate plaque psoriasis are undertreated despite broadening treatment options. In the phase IV UNVEIL study, oral apremilast demonstrated efficacy and safety in systemic-naive patients with chronic moderate plaque psoriasis with lower psoriasis-involved body surface area (BSA; 5%-10%) during the 16-week, double-blind, placebo-controlled phase. We describe efficacy and safety of apremilast in this population through week 52 in UNVEIL.

METHODS: Patients with moderate plaque psoriasis (BSA 5%-10%; static Physician's Global Assessment [sPGA] score of 3 [moderate]) and naive to systemic therapies for psoriasis were randomized (2:1) to receive apremilast 30 mg twice daily or placebo for 16 weeks. At week 16, patients continued on apremilast (apremilast/apremilast) or were switched from placebo to apremilast (placebo/apremilast) through week 52 (open-label apremilast treatment phase). Efficacy assessments included the product of sPGA and BSA (PGAxBSA) (mean percentage change from baseline; ≥75% reduction from baseline [PGAxBSA-75]), sPGA response (achievement of score of 0 [clear] or 1 [almost clear]), and the Dermatology Life Quality Index (DLQI; mean change from baseline).

RESULTS: A total of 136 patients completed the 52-week analysis period (placebo/apremilast, n=50/64; apremilast/apremilast, n=86/121). At week 52, improvements in all efficacy end points observed at week 16 were maintained in the apremilast/apremilast group (mean percentage change from baseline in PGAxBSA: -55.5%; PGAxBSA-75: 42.1%; sPGA response: 33.1%; mean change from baseline in DLQI score: -4.4); similar improvements emerged in the placebo/apremilast group after switching to apremilast. The most common adverse events (≥5% of patients) through week 52 were diarrhea (28.0%), nausea (19.0%), headache (15.2%), nasopharyngitis (10.4%), upper respiratory tract infection (7.1%), vomiting (5.7%), and decreased appetite (5.2%).

CONCLUSIONS: Apremilast was effective in systemic-naive patients with moderate plaque psoriasis with BSA 5%-10%; efficacy was sustained through week 52. No new safety signals emerged with continued apremilast exposure.

ClinicalTrials.gov: NCT02425826

J Drugs Dermatol. 2018;17(2):221-228.

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[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180301
[Lr] Last revision date:180301
[Cl] Clinical Trial:ClinicalTrial
[St] Status:In-Process

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[PMID]: 29255900
[Au] Autor:Skljarevski V; Oakes TM; Zhang Q; Ferguson MB; Martinez J; Camporeale A; Johnson KW; Shan Q; Carter J; Schacht A; Goadsby PJ; Dodick DW
[Ad] Address:Eli Lilly and Company, Indianapolis, Indiana.
[Ti] Title:Effect of Different Doses of Galcanezumab vs Placebo for Episodic Migraine Prevention: A Randomized Clinical Trial.
[So] Source:JAMA Neurol;75(2):187-193, 2018 Feb 01.
[Is] ISSN:2168-6157
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Importance: Galcanezumab (LY2951742), a monoclonal antibody against calcitonin gene-related peptide (CGRP), is one of a novel class of new medicines for migraine prevention. Objective: To assess whether at least 1 dose of galcanezumab was superior to placebo for episodic migraine prevention. Design, Setting, and Participants: A randomized clinical trial was conducted in the United States (July 7, 2014, to August 19, 2015) in clinics of 37 licensed physicians with a specialty including, but not limited to, psychiatry, neurology, internal medicine, and primary care. Subcutaneous injections of galcanezumab, 5, 50, 120, or 300 mg, or placebo were given monthly during the 3-month treatment period. A total of 936 patients were assessed; 526 did not meet study entry or baseline criteria and 410 patients were randomly assigned to receive placebo or galcanezumab. Analyses were conducted on an intent-to-treat population, which included all patients who were randomized and received at least 1 dose of study drug. Interventions: Short-term migraine treatments were allowed as needed except for opioids or barbiturates. Main Outcomes and Measures: To determine if at least 1 of the 4 doses of galcanezumab tested was superior to placebo for migraine prevention measured by the mean change from baseline in the number of migraine headache days 9 weeks to 12 weeks after randomization. Results: Of the 936 patients assessed, 410 met entry criteria (aged 18-65 years with 4-14 migraine headache days per month and migraine onset prior to age 50 years) and were randomized to receive placebo or galcanezumab. For the primary end point, galcanezumab, 120 mg, significantly reduced migraine headache days compared with placebo (99.6% posterior probability -4.8 days; 90% BCI, -5.4 to -4.2 days vs 95% superiority threshold [Bayesian analysis] -3.7 days; 90% BCI, -4.1 to -3.2 days). Adverse events reported by 5% or more of patients in at least 1 galcanezumab dose group and more frequently than placebo included injection-site pain, upper respiratory tract infection, nasopharyngitis, dysmenorrhea, and nausea. Conclusions and Relevance: Monthly subcutaneous injections of galcanezumab, both 120 mg and 300 mg, demonstrated efficacy (repeated-measures analysis) for the preventive treatment of migraine and support further development in larger phase 3 studies. All dosages were safe and well tolerated for the preventive treatment of episodic migraine. Trial Registration: clinicaltrials.gov Identifier: NCT02163993.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1712
[Cu] Class update date: 180228
[Lr] Last revision date:180228
[Cl] Clinical Trial:ClinicalTrial
[St] Status:In-Data-Review
[do] DOI:10.1001/jamaneurol.2017.3859

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[PMID]: 29247068
[Au] Autor:Danese S; Vermeire S; Hellstern P; Panaccione R; Rogler G; Fraser G; Kohn A; Desreumaux P; Leong RW; Comer GM; Cataldi F; Banerjee A; Maguire MK; Li C; Rath N; Beebe J; Schreiber S
[Ad] Address:Gastrointestinal Immunopathology Lab and IBD Unit, Humanitas Clinical and Research Center and Humanitas University, Milan, Italy.
[Ti] Title:Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).
[So] Source:Gut;, 2017 Dec 15.
[Is] ISSN:1468-3288
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:OBJECTIVE: Neutralising pro-inflammatory interleukin-6 (IL-6) may effectively treat Crohn's disease (CD). Effects of PF-04236921, an anti-IL-6 antibody, in adults with CD are reported. DESIGN: Parallel-group, dose-ranging, double-blind trial with 4-week screening and 12-week treatment periods. After induction, patients entered 28-week follow-up or 48-week open-label extension (OLE) with 28-week follow-up. Adults with confirmed CD and inadequate response to anti-tumour necrosis factor (TNF) therapy were included. : 249 patients randomised 1:1:1:1 to placebo, PF-04236921 10, 50 or 200 mg by subcutaneous injection on days 1 and 28. : PF-04236921 50 mg every 8 weeks up to six doses followed by 28-week follow-up. RESULTS: 247 patients were randomised and received treatment in the induction study. The 200 mg dose was discontinued due to safety findings in another study (NCT01405196) and was not included in the primary efficacy analysis. Crohn's Disease Activity Index (CDAI)-70 response rates with PF-04236921 50 mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. Week 12 CDAI remission rates with PF-04236921 50 mg and placebo were 27.4% and 10.9%, respectively (16.5% difference; P<0.05). 191 subjects received treatment in the OLE. Common treatment-emergent and serious adverse events in both studies included worsening CD, abdominal pain and nasopharyngitis. CONCLUSIONS: PF-04236921 50 mg induced clinical response and remission in refractory patients with moderate-to-severe CD following failure of anti-TNF therapy. GI abscess and perforation were observed, a specific focus of attention during future clinical development. TRIAL REGISTRATION NUMBER: NCT01287897 and NCT01345318.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1712
[Cu] Class update date: 180228
[Lr] Last revision date:180228
[St] Status:Publisher


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