December 2017

Effetto dei Glucocorticoidi sull’Efficacia Clinica e Radiografica di Tofacitinib nei Pazienti con Artrite Reumatoide: Analisi Post-hoc di Dati da 6 Studi di Fase III

J Rheumatol 2018 Feb; 45(2):177-87

In this post hoc analysis, six Phase 3 studies were used to analyse the effect of glucocorticoids (GC) on the efficacy of tofacitinib (TOF) in patients with RA. Concomitant use of GC did not affect the clinical or radiographic outcomes of patients treated with TOF. Data from all six clinical trials were evaluated, with four studies (ORAL Scan, ORAL Standard, ORAL Sync and ORAL Step) being pooled for analysis. In these studies, MTX was used as a comparison and patients were required to maintain a...

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Terapia con Tofacitinib per l’Artrite Reumatoide: Uno Studio Comparativo Diretto tra Pazienti Naïve Per Biologici e Pazienti Già Trattati

Intern Med. 2018 Mar 1;57(5):663-670. doi: 10.2169/internalmedicine.9341-17

This 6-month prospective direct comparison study analysed the effectiveness of tofacitinib (TOF) therapy on bDMARD-naïve and bDMARD-experienced patients. bDMARD-naïve patients were more responsive to TOF therapy than bDMARD-experienced patients.The study analysed the data of 113 patients diagnosed with high or moderate disease activity, defined using CDAI scores. All patients had failed to achieve CDAI low disease activity or remission with MTX therapy for ≥3 months. Patients were given 5 mg TOF...

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August 2017

Evaluation of Newly Proposed Remission Cut-points for Disease Activity Score in 28 Joints (DAS28) in Rheumatoid Arthritis upon IL-6 Pathway Inhibition

Arthritis Res Ther. 2017 Jul 4;19(1):155. doi: 10.1186/s13075-017-1346-5

DAS28 is not currently included in the joint remission definitions of the ACR and the EULAR because its formula is disproportionately influenced by Acute Phase Response (APR).IL-6 pathway blockers or JAK inhibitors greatly reduce APR, causing patients to be classed as in DAS28 remission despite still having multiple swollen joints.To make DAS28 remission criteria more stringent, the alternative cut-points of <1.9 and <2.2 for CRP and ESR, respectively, have been proposed.This study questioned th...

Treatment Persistence and Clinical Outcomes of Tumor Necrosis Factor Inhibitor Cycling or Switching to a New Mechanism of Action Therapy: Real-world Observational Study of Rheumatoid Arthritis Patients in the United States with Prior Tumor Necrosis Factor Inhibitor Therapy

Adv Ther. 2017 Aug;34(8):1936-1952. doi: 10.1007/s12325-017-0578-8

This retrospective, observational study used a real-world US clinical database to demonstrate greater effectiveness of switching to a therapy with an alternative mechanism of action (MOA) vs cycling between TNF inhibitors (TNFis) in patients in which TNFi therapy has failed.Between 1 April 2010 and 31 March 2015, a total of 613 of the observed patients failed a TNFi therapy and then either cycled to another TNFi therapy (54.2%) or switched to a therapy with an alternative MOA (45.8%). The most c...

June 2017

Biologics or Tofacitinib for People with Rheumatoid Arthritis Naïve to Methotrexate: a Systematic Review and Network Meta-analysis

Cochrane Database Syst Rev. 2017 May 8;5:CD012657. doi: 10.1002/14651858.CD012657

This Cochrane systemic review and network meta-analysis looked at the benefits and harms of biologics or tofacitinib in patients with RA not previously treated with MTX.Using data from 19 RCTs including 6,485 participants, the review found that biologics (abatacept, adalimumab, etanercept, golimumab, infliximab, rituximab) in combination with MTX improved signs and symptoms of RA (ACR50) and increased the chances of remission (DAS <1.6 or DAS28 <2.6). There was also some evidence of an improveme...

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Outcomes of Tumor Necrosis Factor Inhibitor Cycling versus Switching to a Disease-modifying Anti-rheumatic Drug with a New Mechanism of Action Among Patients with Rheumatoid Arthritis

J Med Econ 2017;20:464–73

This retrospective study looked at claims-based datasets to establish whether it is preferable to switch to another TNF inhibitor (TNFi) or to a therapy with a different mechanism of action (MOA) when RA treatment failure occurs with an initial TNFi, due to inadequate response or lack of tolerability.Administrative claims data from a large US database were used to compare treatment patterns, treatment effectiveness (based on fulfillment of six criteria) and costs in in the 12 months after RA pat...

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May 2017

Discontinuation of Tofacitinib after achieving Low Disease Activity in Patients with Rheumatoid Arthritis: a Multicentere, Observational Study

Rheumatology. Doi 10.1093/rheumatology/kex068

This study showed that in patients who achieved low disease activity (LDA), it is possible to discontinue tofacitinib without flare in approximately one-third of patients. Patients from the tofacitinib Phase 3 programme and long-term extension study were enroled. Discontinuation was based on physician-patient decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib free at post-treatment Week 52. Of 64 patients treated with tofacitinib w...

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Tocilizumab Combination Therapy or Monotherapy or Methotrexate Monotherapy in Methotrexate-naïve Patients with Early Rheumatoid Arthritis: 2-year Clinical and Radiographic Results from the Randomized, Placebo-controlled FUNCTION Trial

Ann Rheum Dis Published Online First: 7 April 2017. Doi 10.1136/annrheumdis-20160210561

Burmester et al. present data showing that 52-week efficacy and safety of intravenous tocilizumab plus methotrexate, or tocilizumab monotherapy are maintained through to Week 104 in patients with early rheumatoid arthritis. Patients were assigned to four treatment groups: 4 mg/kg TCZ + MTX, 8 mg/kg TCZ + MTX, 8 mg/kg TCZ + placebo or placebo + MTX. Patients not achieving DAS28 ≤3.2 at Week 52 and who were not receiving 8 mg/kg TCZ were rescued to 8 mg/kg TCZ + MTX. Of the 1162 randomly assigned ...

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January 2017

Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis who were Methotrexate- and Biologic-naïve or Free of Methotrexate for 6 Months: the AMBITION Study

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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