July 2016

Orta ve ciddi Romatoid Artritte oral Janus Kinaz inhibitörü peficitinib'in (ASP015K) monoterapi olarak ekinlik ve güvenliği, Japonya verisi: 12 haftalık, randomize, çift-kör, plasebo-kontrollü faz llb çalışma

Ann Rheum Dis. 2016 Jun;75:1057-64. doi: 10.1136/annrheumdis-2015-208279. Epub 2015 Dec 15

Peficitinib (ASP015K) is a novel orally bioavailable JAK inhibitor in development for the treatment of RA. It inhibits JAK1, JAK2, JAK3 and Tyk2 enzyme activities and has moderate selectivity or JAK3 inhibition.Here the authors report the findings of a 12-week, randomized, double-blind, placebo-controlled phase IIb study evaluating efficacy, safety and dose response of peficitinib (25, 50, 100, or 150 mg) as once-daily oral monotherapy in Japanese patients with moderate to severe RA. The primar...

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March 2016

Metotreksata yetersiz yanıtlı romatoid artritli hastalarında metotreksata tosilizumab eklenmesi yada tosilizumab tedavisine geçiş tedavilerinin karşılaştırılması: 52 haftalık prospektif, randomize kontrollü çalışma (SURPRISE çalışması)

Ann Rheum Dis 2016 Jan 5 DOI: 10.1136/annrheumdis-2015-208426 [Epub ahead of print

MTX is the primary drug in RA management because of its long-term effectiveness and safety profile; however, in patients who have insufficient response (IR) to MTX, treatment adjustments are needed – either to combine a bDMARD with MTX or to switch to a bDMARD from MTX. In the SURPRISE study, the efficacy and safety of adding TCZ to MTX (ADD-ON) or switching MTX to TCZ (SWITCH) was evaluated in 233 patients with moderate to highly active RA who were randomised 1:1. Both treatment groups were adm...

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October 2015

Asya kökenli anti-TNF yanıtsız orta-ciddi RA hastalarında Olokizumab tedavisinin güvenlilik ve etkinliği: Randomize Faz II çalışmadan sonuçlar

Modern Rheumatology. 2015 Sep 10:1-9. [Epub ahead of print]

This Phase II study assessed the safety and efficacy of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy. After 12 weeks of treatment, olokizumab was found to rapidly improve disease activity in patients who had previously failed anti-TNF therapy. There was also a significant decrease in ACR20 and ACR50 responder rates at week 12. The safety findings were consistent with the safety profile expected for this drug class. These findin...

July 2015

Tocilizumabın uzun dönemdeki güvenliği: Pazarlama sonrası izlemde Japonya’daki 5573 romatoid artritli hastanın 3 yıllık takibinden elde edilen sonuçlar

The Journal of Rheumatology. 1 June 2015 DOI: 10.3899/jrheum.141210 [Epub ahead of print]

The humanised anti-interleukin 6 receptor monoclonal antibody tocilizumab (TCZ) has been available in clinical practice for several years. The purpose of this study was to evaluate the long-term safety of for the treatment of RA in a real-world clinical setting as a long-term extension of a single-arm, observational post marketing surveillance study. Data on selected adverse events (AEs) - fatal events, serious infection, malignancy, GI perforation, and serious cardiac dysfunction - were collect...

Romatoid Artrit hastalarında konvansiyonel DMARD ve intravenöz tocilizumab veya subkutan tocilizumab kombinasyonunun etkinlik ve güvenliğinin karşılaştırılması, 97.hafta (SUMMACTA )

Ann Rheum Dis. 10 May 2015 doi:10.1136/annrheumdis-2015-207281 [Epub ahead of print]

Tocilizumab (TCZ) has demonstrated efficacy and a well-established safety profile for intravenous (IV) administration. The Phase III SUMMACTA study evaluated the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) in combination with DMARDS in patients with moderate-to-severe RA and inadequate response to ≥1 DMARD. Patients were randomised to receive TCZ-SC 162 mg weekly or TCZ-IV 8 mg/kg q4w in combination with DMARDs. After a 24-week double-blind period, patients receiving TCZ-SC were re-...

May 2015

Aktif Romatoid Artrit hastalarında tofacitinibin ölçülmüş glomerüler filtrasyon oranına etkisinin değerlendirilmesi: Randomiza kontrollü çalışmalardan sonuçlar

Arthritis Res Ther. 2015 Apr 6;17(1):95.

Mean increases from baseline in patient serum creatinine (SCr) levels have been observed in the clinical development programme for the JAK inhibitor tofacitinib. These increases predominantly occurred within the first three months, and reversed with tofacitinib withdrawal.

This phase 1, randomised, placebo-controlled, parallel-group, 2-period study assessed changes in measured glomerular filtration rate (mGFR) with tofacitinib, relative to placebo, in 148 patients with active RA. Result...

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March 2015

Aktif Romatoid Artritli Hastalarda Monoterapi Olarak Oral Selektif Bir JAK-3 İnhibitörü Olan Decernotinib’in Randomize, Çift-Kör, Plasebo-Kontrollü, On İki-Haftalık Bir Doz-Aralığı Çalışması

Arthritis Rheumatol. 2015;67(2):334–343.

Decernotinib (VX-509; Vertex Pharmaceuticals Incorporated) is a JAK 3 inhibitor currently under investigation for its potential use in the treatment of RA. The potency and selectivity profiles of this oral compound have already been established in previous trials, so this study aimed to establish the efficacy and safety profiles of the drug, in RA patients who have had an inadequate response to at least one DMARD.

Four doses; 25 mg, 50 mg, 100 mg and 150 mg, were evaluated in this placebo...

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January 2015

Aktif Romatoid Artritli Japon Hastalarda Tofacitinib’in Monoterapi Olarak Etkinliği ve Güvenliği: Bir 12-Haftalık, Randomize, Faz 2 Çalışma

Mod Rheumatol. 2014 Dec 11:1–25. [Epub ahead of print]

In Japan, the biologic DMARDs infliximab, etanercept, adalimumab, golimumab and certolizumab pegol, as well as tocilizumab and abatacept are approved for use in patients with active RA and an inadequate response to existing therapies. However, not all patients respond to these therapies adequately, creating an unmet need for therapeutic options with alternative mechanisms of action.

The oral JAK inhibitor tofacitinib has demonstrated efficacy as monotherapy or in combination with DMARDs ...

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Bir Oral JAK 1/2 İnhibitörü Olan Baricitinib’in Sağlıklı Gönüllülerde Farmakokinetik, Farmakodinamik ve Güvenliği

Mod J Clin Pharmacol. 2014 Dec;54(12):1354-61. doi: 10.1002/jcph.354.

Current biologic therapies for RA, such as biologic cytokine inhibitors, which selectively target inflammatory molecules with an exquisite degree of specificity, are not clinically effective in all patients with rheumatoid arthritis. As such, there remains an unmet clinical need for more effective and better tolerated therapies. Baricitinib (LY3009104, also previously known as INCB028050) is a potent and selective small molecule inhibitor of JAK1/2, which play an important role in cytokine signa...

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July 2014

Romatoid Artritte Metotreksata Karşı Tofacitinib

N Engl J Med. 2014;370(25):2377–2386.

ORAL Start is the latest trial to be reported in the tofacitinib clinical development programme. It compares the use of tofacitinib monotherapy to MTX monotherapy, in RA patients who have had either no or a sub-therapeutic dose of MTX in the past. Nine hundred and fifty eight patients received either tofacitinib (5 mg or 10 mg) twice daily, or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks. The co primary efficacy endpoints were ACR 70 response, and mean c...

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