March 2017

A Phase IIb Study of ABT-494, a Selective JAK-1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti–Tumor Necrosis Factor Therapy

Arthritis Rheumatol 2016;68:2867–77

The summary and accompanying slide deck have been developed in conjunction with the Genovese et al. study (Study 1) which examined ABT-494 in MTX-IR patients in order to compare and contrast the data. In these two Phase 2b studies, ABT-494 (a novel selective JAK-1 inhibitor) was shown to be effective in patients with active RA who were non-responders to MTX or at least one TNF inhibitor.Patients with active RA who had an inadequate response to MTX (study 1) or were refractory to or intolerant of...

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Efficacy and Safety of ABT-494, a Selective JAK-1 Inhibitor, in a Phase IIb Study in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Arthritis Rheumatol 2016;68:2857–66

The summary and accompanying slide deck have been developed in conjunction with the Kremer et al. study (Study 2) which examined ABT-494 in TNF-IR patients in order to compare and contrast the data. In these two Phase 2b studies, ABT-494 (a novel selective JAK-1 inhibitor) was shown to be effective in patients with active RA who were non-responders to MTX or at least one TNF inhibitor.Patients with active RA who had an inadequate response to MTX (study 1) or were refractory to or intolerant of p...

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Efficacy and Safety of Tofacitinib in Older and Younger Patients with Rheumatoid Arthritis

Clin Exp Rheumatol 2017 Jan 4

In this analysis of patients with moderate to severe RA treated with tofacitinib (TOF) in Phase 3 and long-term extension (LTE) studies, patients aged 65 years had similar efficacy and a numerically higher risk of SAEs and discontinuations due to AEs compared with younger patients.The Phase 3 population included patients from five trials (n=3111) of TOF 5 mg or 10 mg BID or placebo. The LTE population (n=4102) included patients from two studies who had participated in Phase 1, 2 or 3 TOF studie...

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Efficacy and Safety of Sirukumab in Patients with Active Rheumatoid Arthritis Refractory to Anti-TNF Therapy (SIRROUND-T): A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multinational, Phase 3 Study

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

Tocilizumab Use in Pregnancy: Analysis of a Global Safety Database Including Data from Clinical Trials and Post-marketing Data

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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Peficitinib, a JAK Inhibitor, in Combination with Limited Conventional Synthetic DMARDs in the Treatment of Moderate-to-severe Rheumatoid Arthritis

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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Baricitinib in Patients with Inadequate Response or Intolerance to Conventional Synthetic DMARDs: Results from the RA-BUILD Study

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

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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Evaluation of Real-World Experience with Tofacitinib Compared with Adalimumab, Etanercept, and Abatacept in RA Patients with 1 Previous Biologic DMARD: Data from a U.S. Administrative Claims Database

J Manag Care Spec Pharm. 2016 Dec;22(12):1457-1471.

Data were examined to compare patient characteristics, treatment patterns and costs in patients with RA receiving tofacitinib (TOF) or common bDMARDs (adalimumab [ADA], etanercept (ETN) or abatacept [ABA]) who had previously received a single bDMARD.This study analyses real-world data from two US claims databases between November 2012 and October 2014. Data were collected from a total of 1252 patients in the Truven Marketscan Commercial and Medicare Supplemental databases. Pre-index (12-months b...

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fficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the Phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial

J Am Acad Dermatol 2017;76:405–17. doi: 10.1016/j.jaad.2016.11.041

Guselkumab demonstrated superiority to adalimumab and placebo in treating PsO in this Phase 3 study. Improvements in IGA and PASI scores were observed as early as Week 16 and were maintained up to Week 48. Incidence of adverse events was similar across both treatment groups.

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