Publications

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

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...

Aktif Romatoid Artrit Hastalarında Klinik Pratikte Tocilizumab'ın İki Yıllık Etkinliği

Reumatol Clin. 2016; May 10 doi: 10.1016/j.reuma.2016.03.014 [Epub ahead of print]

Notario Ferreira,

Ferrer González MA,

Morales Garrido P,

et al.

The efficacy and safety of tocilizumab has been studied in several randomized clinical trials (RCTs) but due to the strict inclusion and exclusion criteria of RCTs, real-life observational studies are needed to supplement the findings from these trials. This small longitudinal, open-label study from an outpatient clinic in Spain evaluated the effectiveness, survival rate and reasons for treatment discontinuations in 85 patients treated with tocilizumab over a 24-month period. The study also ass...

Tofasitinib ve Biyolojik Tedavi Alan Romatoid Artrit Hastalarında Herpes Virüs Enfeksiyonlarının Gerçek-Dünya Karşılaştırmalı Riskleri

Ann Rheum Dis. 2016 Apr 25;0:1–5 doi: 10.1136/annrheumdis-2016-209131

Curtis et al.

Herpes Zoster (HZ) complications can cause considerable morbidity including debilitating pain syndromes. Clinical trials of tofacitinib have suggested it may increase the risk of HZ. Although unclear, the mechanism may involve reduced CD4 T-cell function and interference of interferon signalling. Following approval of tofacitinib in the US in 2012, real-world data from Medicare (2006–2013) and from the US longitudinal database, Marketscan, (2010–2014) were analysed. A total of 2526 patients who...

Keywords:

• JAK,
• Tofacitinib,
• Real-World,
• Infections

Tofasitinib veya adalimumab tedavilerinin plasebo ile kaşılaştırılması: aktif romatoid artrit hastalarının faz 3 çalışmasından hasta bildirimli sonlanım (PRO)

Strand et al. Rheumatology (Oxford). 2016 Feb 29. doi:pii: kev442. [Epub ahead of print]

Strand V,

van Vollenhoven R,

Bong Lee E et al.

RA not only affects the physical aspects of a patient’s health but also has an impact on the psychological well-being causing a significant disease burden. This paper reports on the patient-reported outcomes (PROs) from the ORAL Standard study. This study investigated tofacitinib 5mg BID, 10mg BID, adalimumab vs. placebo over 12 months with a primary endpoint at month 3. All treatment groups showed significant improvements over placebo in HAQ-DI, PtGA and Pain with LSM changes in baseline sustai...

Keywords:

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