March 2017

Anti-TNF Tedavisine Refrakter Aktif Romatoid Artrit Hastalarında Sirukumab Etkinliği ve Güvenliliği (SIRROUND-T):Randomize, Çift Kör, Plasebo Kontrollu, Paralel Grup, Çok uluslu, Faz 3 Çalışma

Lancet 2017;pii:S0140-6736(17)30401-4

In this Phase 3 multicentre, randomised controlled trial in patients with active RA who were refractory or intolerant to previous biological treatment with at least one TNF inhibitor, sirukumab 50 mg every four weeks (Q4W) or 100 mg every two weeks (Q2W) was well tolerated and significantly improved signs and symptoms of disease.Patients were randomised 1:1:1 to placebo (n=294), sirukumab 50 mg Q4W (n=292) or sirukumab 100 mg Q2W (n=292), while continuing any concomitant DMARDs. Of the 878 rando...

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February 2017

Hamilelikte Tocilizumab Kullanımı: Klinik Çalışmalar ve Pazarlama Sonrası Verileri Içeren Global Güvenlik Veritabanı Analizi

Semin Arthritis Rheum 2016;46:238–45. DOI 10.1016/j.seminarthrit.2016.05.004.

This dataset is the largest series of tocilizumab (TCZ)-exposed pregnancies to date; considering the limitations of global safety databases, the data presented provide information to assist physicians and patients in making informed decisions.At present, published experience on TCZ use during pregnancy is very limited. In the current analysis, all pregnancy-related reports in the Roche Global Safety Database until December 31, 2014 were analysed. Outcomes assessed included: spontaneous abortion,...

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Orta ve Ciddi Romatoid Artrit Tedavisinde JAK Inhibitörü Peficitinib Tedavisinin Sınırlı Konvansiyonel Sentetik DMARD'lar ile Kombinasyonu

Arthritis Rheumatol DOI 10.1002/art.40054. Accepted article.

In this Phase 2b study in patients with moderate to severe RA, once-daily peficitinib in combination with limited csDMARDs reduced the symptoms of RA, demonstrated adose-dependent ACR20 response rate over 12 weeks, and showed acceptable tolerability. This 12-week study included patients who had an inadequate response or intolerance to csDMARDs (N=289). Patients were randomised 1:1:1:1:1 to peficitinib 25-, 50-, 100, 150 mg or matching placebo. Statistically significant differences in the ACR20 r...

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Konvansiyonel Sentetik DMARD'lara Yetersiz Yanıtlı veya İntoleransı Olan RA Hastalarında Baricitinib Tedavisi: RA-BUILD Çalışmasının Sonuçları

Ann Rheum Dis 2017;76:88–95.

Baricitinib improved symptoms of RA in the RA-BUILD trial, a Phase 3 study of baricitinib in patients with moderately to severely active RA, refractory to or intolerant to csDMARDs. As well as providing a short-term (24 weeks) benefit, there appeared to be joint damage benefit, considered a marker of long-term disability.RA-BUILD was a 24-week randomised, double-blind, placebo-controlled parallel-group study. Patients were randomised 1:1:1 to receive once-daily doses of placebo (n=228) or barici...

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January 2017

Aktif Romatoid Artrit Olguları Faz 2b Çalışmasında Baricitinibin Lipid, Apolipoprotein ve Lipoprotein Partikülleri Üzerine Etkileri

Arthritis Rheumatol 2017. DOI 10.1002/art.40036.

In this analysis of the effect of baricitinib on changes in lipid profile, lipoprotein particle size and apolipoprotein content, increases in serum lipids were observed with HDL-C increases correlating with improved clinical outcomes.Eligible patients (N=301) met the inclusion criteria for the Phase 2b randomised, double-blind, placebo-controlled study.1 Patients were assigned in a 2:1:1:1:1 ratio to once-daily doses of placebo or baricitinib 1, 2, 4, or 8 mg, respectively. Those receiving 2 mg,...

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Metotreksat ve Biyolojik Naif veya 6 ay Metotreksat Tedavisi Almayan Romatoid Artritli Hastalarında Tocilizumab Monoterapisinin 5 Yıllık Etkinliği ve Güvenliği: AMBITION Çalışması

J Rheumatol 2017;44:2. DOI 10.3899/jrheum.160287.

Results from the AMBITION study (Actemra versus Methotrexate double-Blind Investigate Trial In mONotherapy), showed the continuing efficacy and safety of tocilizumab up to 264 weeks.AMBITION was a 24-week randomised controlled trial in patients with active RA who were either MTX-naïve or MTX-free for 6 months prior to study entry. Patients received TCZ 8 mg/kg IV Q4W or oral MTX weekly (7.5 mg dose escalating to 20 mg). For those patients who then entered the long-term extension (LTE) study (N=1...

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December 2016

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.

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...

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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

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...

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RA Hastalarında VX-509 (Decernotinib) ve Hastalığı Modifiye Edici Bir Antiromatizmal İlaç Kombinasyonunun Etkinliği: Klinik ve MR Bulguları

Ann Rheum Dis 2016;75:1979–83

This Phase 2b study of VX-509 (decernotinib), a selective JAK3 inhibitor, showed that VX-509 in combination with stable DMARD therapy was effective for improving synovitis and osteitis as assessed by MRI in patients who had an inadequate response to DMARD therapy.Patients were randomised to treatment groups receiving either placebo, VX-509 100 mg, 200 mg or300 mg for 12 weeks. Minimum inclusion criteria included Grade ≥2 clinical synovitis in either the wrist or two metacarpophalangeal joints. A...

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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

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...

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