Publications

Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis

N Engl J Med 2016;375:345–56. doi: 10.1056/NEJMoa1512711

Gordon KB,

Blauvelt A,

Papp KA,

Langley RG,

Luger T,

Ohtsuki M,

Reich K,

Amato D,

Ball SG,

Braun DK,

Cameron GS,

Erickson J,

Konrad RJ,

Muram TM,

Nickoloff BJ,

Osuntokun OO,

Secrest RJ,

Zhao F,

Mallbris L,

Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group

Gordon, et al. pool the results of UNCOVER-1, UNCOVER-2, and UNCOVER-3 to show that ixekizumab increases the proportion of patients achieving an sPGA score of 0/1 or PASI 75 versus placebo. Adverse events related to ixekizumab treatment included neutropenia, candidal infections, and inflammatory bowel disease.

Keywords:

• Efficacy,
• Ixekizumab,
• Phase 3,
• Skin

TNF İnhibitörlerine Yetersiz Yanıtlı veya İntolerans olan Aktif RA Hastalarında Sarilumab ve Biyolojik Olmayan Hastalık Modifıye Edici Antiromatizmal İlaçlar

Arthritis Rheumatol 2016. DOI:10.1002/art.39944.

Fleischmann R,

van Adelsberg J,

Lin Y,

da Rocha,

Castelar-Pinheiro G,

Brzezicki J,

Hrycaj P,

Graham NMH,

van Hoogstraten H,

Bauer D,

Burmester GR

In this Phase 3 study (TARGET) of TNF-IR patients, sarilumab plus csDMARD(s) demonstrated clinical efficacy and improvements in physical function versus placebo plus csDMARD(s).Patients (N=546) were randomised 1:1:1 to sarilumab 150 mg, 200 mg Q2W or placebo (all plus csDMARD[s]). Two co-primary endpoints versus placebo were investigated: ACR20 response rate at Week 24, and HAQ-DI change from baseline at Week 12.As well as improvements in ACR20 responses (33.7% vs 55.8 and 60.9%, for placebo, sa...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Aktif Romatoid Artrit Hastalarında Sarilumab Monoterapisinin Adalimumab Monoterapisine Göre Etkinlik ve Güvenliğinin Değerlendirilmesi (MONARCH): Randomize, Çift-Kör, Paralel-Grup Faz III Çalışma

Ann Rheum Dis 2016. DOI 10.1136/annrheumdis-2016-210310

Burmester GR,

Lin Y,

Patel R,

van Adelsberg J,

Mangan EK,

Graham NMH,

van Hoogstraten H,

Bauer D,

Vargas JI,

Lee E-B

In this Phase 3 superiority study (MONARCH) of patients with active RA who should not continue treatment with MTX because of intolerance or inadequate response, sarilumab monotherapy demonstrated superior efficacy to adalimumab (ADA) monotherapy. Patients receiving sarilumab versus ADA also reported greater improvement in health status, including a trend towards greater improvement in fatigue.In this randomised, multicentre study, patients received sarilumab 200 mg Q2W plus placebo (n=184) or AD...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Baricitinib, Methotrexate, or Combination in Patients with Rheumatoid Arthritis and no or Limited Prior Disease-Modifying Antirheumatic Drug Treatment

Arthritis Rheumatol 2016. DOI 10.1002/art.39953. Accepted article

Fleischmann F,

Schiff M,

van der Heijde D,

Ramos-Remus C,

Spindler A,

Stanislav M,

Zerbini CAF,

Gurbuz S,

Dickson C,

de Bono S,

Schlichting D,

Beattie S,

Kuo W-L,

Rooney T,

Macias W,

Takeuchi T

In this 52-week study of patients receiving initial therapy for RA, baricitinib alone or in combination with MTX demonstrated superior efficacy compared with MTX alone.Patients naïve to csDMARD (no or <3 doses of MTX) or bDMARD were randomised 4:3:4 (N=588) toMTX QW, baricitinib 4 mg QD or baricitinib 4 mg QD + MTX QW. The primary endpoint assessment was noninferiority of baricitinib monotherapy to MTX based on ACR20 response at Week 24.Not only was the primary endpoint met, baricitinib monother...

Keywords:

• JAK,
• Baricitinib,
• Phase 3

Sarilumab ve Metotreksat Kombinasyonu Metotreksata Yetersiz Yanıtlı Aktif Romatoid Artrit Hastalarında Hasta Tarafından Bildirilen Sonuçları (PRO) İyileştirir: Bir Faz III Çalışmanın Sonuçları

Arthritis Res Ther 2016; 18:198. DOI.10.1186/s13075-016-9

Strand V,

Kosinski M,

Chen C-I,

Joseph G,

Rendas-Baum R,

Graham NMH,

van Hoogstraten H,

Bayliss M,

Fan C,

Huizinga T,

Genovese MC

Evidence is presented that treatment with sarilumab improves patient-reported outcomes (PROs). These improvements complement the clinical efficacy previously reported for sarilumab.Data were analysed from the 52-week Phase 3 MOBILITY randomised controlled trial in adult patients with active RA and previous inadequate response to MTX. Patients received subcutaneous placebo or sarilumab 150 mg or 200 mg every 2 weeks in combination with MTX, for 52 weeks.PROs assessed were: Patient Global Assessme...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Aktif Romatoid Artrit Hastalarında Tofasitinib ve Konvansiyonel DMARD Kombinasyonu: Randomize Kontrollü Faz 3 Çalışma

Arthritis Care Res 2016; Accepted article. DOI 10.1002/acr.23004

Strand V,

Kremer JM,

Gruben D,

Krishnaswami S,

Zwillich SH,

Wallenstein GV

Further evidence is presented that treatment with tofacitinib improves patient-reported outcomes (PROs), in addition to improving underlying disease activity.Data were analysed from the Phase 3 ORAL Sync 12-month randomised controlled trial in adult patients with active RA and previous inadequate response to ≥1 conventional or biologic DMARD(s). Patients received (4:4:1:1) TOF 5mg or 10mg BID or Placebo advanced to 5 mg or10 mg BID plus conventional DMARD(s).PROs assessed at Month 3 were: Patien...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL

Romatoid Artritde Tocilizumabın Klinik Çalışmasında Radyografik Sonuçların Prediktörü olarak RAPID 3 ve ACR/EULAR Provizyonel Tanımlamaları

Arthritis Care Res 2016; Accepted article. DOI 10.1002/acr.23008.

Khawaja MN,

Bergman MJ,

Yourish J,

Pei J,

Reiss W,

Keystone E

The findings reported represent the first validation of RAPID3 (Routine Assessment of Patient Index Data 3) remission ± SJC ≤1 as an alternative to the established SDAI or Boolean remission definitions, which can be time consuming and costly to measure. RAPID3 is a pooled index of the patient-reported measures: function, pain and Patient Global estimate of status.Data were analysed from the TociLIzumab Safety and THE Prevention of Structural Joint Damage (LITHE) study, a 2-year double-blind Phas...

Metotreksata Yetersiz Yanıtlı Romatoid Artrit Hastalarında Seçici Bir JAK İnhibitörü olan ABT-494'ün Randomize Faz 2b Çalışması

Arthritis Rheumatol 2016; Accepted article DOI 10.1002/art-39808 [Epub 2016]

Genovese M,

Smolen J,

Weinblatt M,

Burmester G,

Meerwein S,

Camp H,

Wang L,

Othman A,

Khan N,

Pangan A,

Jungerwirth S

This dose-ranging study evaluated the efficacy of the novel, selective JAK1 inhibitor ABT-494 versus placebo in patients with moderate-to-severe RA and inadequate response (IR) to MTX.In this 12-week, randomised, double-blind study (BALANCE II), the efficacy and safety ofABT-494 dosed at 3mg, 6 mg, 12 mg, 18 mg (all twice daily) and 24 mg (once daily) was assessed. Patients included had not received prior biologic therapy.Of the 299 patients included in the analysis, the proportions of patients ...

Keywords:

• JAK,
• Updacitinib,
• Phase 2

Romatoid Artrit HastalarındaAdalimumab Tedavisinden Tofacitinib’e Geçiş

Arthritis Research & Therapy. 2016. DOI 10.1186/s13075-016-1049-3 [Epub ahead of print]

Genovese,

et al.

Results are reported from an analysis exploring the safety and efficacy of open-label tofacitinib (TOF) following blinded treatment with TOF or adalimumab (ADA) in patients with moderate to severe RA. The analysis included patients from ORAL Sequel, an open-label long-term extension study, which all patients entered following ORAL Standard (one of the studies in the TOF phase 3 program). Only those patients who had been randomized to ADA 40 mg Q2W + MTX or 10 mg TOF + MTX in ORAL Standard were i...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Switching

Klinik Uygulamada Tofasitinib’in İlk Deneyimi: ABD'de İki Sağlık Veritabanında Monoterapi veya Konvansiyonel Sentetik DMARD'larla Kombine Olarak Uygulanan Tofasitinibin Tedavi Şekilleri ve Maliyetleri

Clin Ther. 2016 Mar 28. doi: 10.1116/j.clinthera. 2016.03.038 [Epub ahead of print]

Harnett et al.

This study analyzes data from two US claims databases between November 2012 and June 2014. It was designed to build upon knowledge from tofacitinib Phase 3 clinical trials providing clinical insights from independent sources on treatment patterns and costs for tofacitinib. Data were collected from 337 patients in the Truven Marketscan (TM) and 118 patients in the Optum Clinformatics (OC) databases. In this early experience cohort for tofacitinib, approximately 75% of patients had previously rece...

Keywords:

• JAK,
• Tofacitinib,
• Cost / Cost Effectiveness