December 2015

Aktif romatoid artritli ve DMARDlara yetersiz yanıtlı hastaların dahil edildiği bir randomize, faz 3 çalışmada tofacitinib monoterapisinin hastalar tarafından bildirilen sonuçlar üzerindeki etkileri

Arthritis Research & Therapy (2015) 17:307 DOI: 10.1186/s13075-015-0825-9 [Epub ahead of print]

RA presents a significant health and socioeconomic burden particularly in physical functioning, fatigue, and emotional roles. A phase III 6-month study of tofacitinib in patients with active RA, who had prior inadequate responses to cDMARDs or bDMARDs, uses patient-reported outcomes (PROs) to assess the impact on quality of life. Patients were randomized 4:4:1:1 to receive tofacitinib 5 or 10 mg BID, or placebo for 3 months followed by tofacitinib 5 or 10 mg BID. At month 3, tofacitinib 5 and 10...

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October 2015

Sentetik hastalık modifiye edici anti romatizmal ilaçlarla birlikte ve birlikte olmaksızın tocilizumabın romatoid artritte etkinliği: Bir Avrupa ortak çalışmasından sonuçlar

Ann Rheum Dis. 2015 Sep 15. doi:10.1136/ annrheumdis-2015-207760

Biological DMARDs have markedly changed the management and outcome of rheumatoid arthritis. Most international guidelines recommend the use of biological DMARDs in combination with MTX or other synthetic DMARDs (sDMARDs) (where MTX is not tolerated or contraindicated), based primarily on the observation that MTX enhances the efficacy of TNF antagonists in both clinical trials and observational studies.This study examined the effectiveness of tocilizumab (TCZ), an anti-IL-6 monoclonal antibody, ...

Güney Kore’de orta ve ciddi Romatoit Artrit tedavisinde kullanılan Tofasitinib tedavisinin maliyet-etkinliği

Clinical Therapeutics. 2015:37(8). [Epub ahead of print]

This study evaluated the cost-effectiveness of introducing tofacitinib, an oral Janus kinase inhibitor, to the treatment of Korean patients with RA and an inadequate response to conventional DMARDs. The model showed that the inclusion of tofacitinib as a treatment strategy for moderate to severe RA is cost-effective; this conclusion was considered robust based on multiple sensitivity analyses.First-line tofacitinib used before the standard of care (base-case analysis) increased both treatment c...

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Geleneksel sentetik veya biyolojik hastalık modifiye edici antiromatizmal ilaçlara yetersiz cevabı takiben tofacitinibin etkinliği ve güvenliği

Annals of the Rheumatic Diseases. 2015 Aug 14. doi:pii: annrheumdis-2014-207178.

This study evaluated the efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in patients with inadequate response to sDMARDs or bDMARDs. Findings from this study show both doses of tofacitinib were associated with improvements in efficacy parameters at month 3 versus placebo, and clinical response was numerically greater with bDMARD-naïve versus bDMARD-IR patients (95% CI overlapping). Safety parameters were generally similar; however, patients receiving glucocorticoids had more ...

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September 2015

Aktif Romatoid Artrit Hastalarında Tofacitinib Monoterapisinin Etkinlik ve Güvenliliği: 12 haftalık, Randomize, Faz 2 çalışma

Modern Rheumatology. 2015 Jul;25(4):514-21. doi: 10.3109/14397595.2014.995875.

The oral Janus kinase (JAK) inhibitor, Tofacitinib, preferentially inhibits signalling by heterodimeric receptors associated with JAK3 and/or JAK1, blocking signalling for several cytokines. The purpose of this study was to evaluate the efficacy of tofacitinib monotherapy versus placebo in Japanese patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARDs). Data on response rates – ACR20/50/70, DAS28-4(ESR), and HAQ-DI – laboratory parameters and adverse events were col...

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July 2015

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-...

April 2015

Aktif Romatoid Artritli ve Metoktreksata Yetersiz Yanıtlı Hastalarda Sarilumab artı Metotreksat: Bir Faz III Çalışmanın Sonuçları

Arthritis Rheumatol. Vol. 67, No. 6, June 2015, pp 1424–1437

Biologic DMARDs targeting TNF-alpha, IL-1, T-cell co-stimulatory blockade, B-cell depletion, and IL-6R, as well as the newer JAK inhibitors have greatly improved clinical outcomes in RA. However, not all patients respond to current biologic or small molecule DMARDs.

Sarilumab is a fully human anti-IL-6Rα mAb that binds membrane-bound and soluble human IL-6R with high affinity, blocking cis and trans IL-6-mediated signalling. This study (MOBILITY) is the first randomised, double-blin...

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Tofacitinib’in romatoid artritte pnömokok ve influenza aşısı yanıtlarına etkisi

Ann Rheum Dis. 2015 Mar 20. pii: annrheumdis-2014-207191. doi: 10.1136/annrheumdis-2014-207191. [Epub ahead of print]

The increased risk of serious infection among RA patients means vaccinations against pneumococcus and influenza are recommended in this group of patients. Studies evaluating immune response to these vaccines in conjunction with DMARD therapy can provide clinicians with important information relating to things such as timing of vaccination.

This study aimed to assess the effect of tofacitinib on vaccine responses to PPSV-23 and the trivalent seasonal influenza vaccine in those whom tofacit...

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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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