Publications

Sarilumab plus Methotrexate Improves Patient-reported Outcomes in Patients with Active Rheumatoid Arthritis and Inadequate Responses to Methotrexate: Results of a Phase III Trial

Arthritis Res Ther 2016; 18:198. DOI.10.1186/s13075-016-9

Strand V,

Kosinski M,

Chen C-I,

Joseph G,

Rendas-Baum R,

Graham NMH,

van Hoogstraten H,

Bayliss M,

Fan C,

Huizinga T,

Genovese MC

Evidence is presented that treatment with sarilumab improves patient-reported outcomes (PROs). These improvements complement the clinical efficacy previously reported for sarilumab.Data were analysed from the 52-week Phase 3 MOBILITY randomised controlled trial in adult patients with active RA and previous inadequate response to MTX. Patients received subcutaneous placebo or sarilumab 150 mg or 200 mg every 2 weeks in combination with MTX, for 52 weeks.PROs assessed were: Patient Global Assessme...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

A Randomized Phase 2b Study of ABT-494, a Selective JAK Inhibitor in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Arthritis Rheumatol 2016; Accepted article DOI 10.1002/art-39808 [Epub 2016]

Genovese M,

Smolen J,

Weinblatt M,

Burmester G,

Meerwein S,

Camp H,

Wang L,

Othman A,

Khan N,

Pangan A,

Jungerwirth S

This dose-ranging study evaluated the efficacy of the novel, selective JAK1 inhibitor ABT-494 versus placebo in patients with moderate-to-severe RA and inadequate response (IR) to MTX.In this 12-week, randomised, double-blind study (BALANCE II), the efficacy and safety ofABT-494 dosed at 3mg, 6 mg, 12 mg, 18 mg (all twice daily) and 24 mg (once daily) was assessed. Patients included had not received prior biologic therapy.Of the 299 patients included in the analysis, the proportions of patients ...

Keywords:

• JAK,
• Updacitinib,
• Phase 2

Switching from Adalimumab to Tofacitinib in the Treatment of Patients with Rheumatoid Arthritis

Arthritis Research & Therapy. 2016. DOI 10.1186/s13075-016-1049-3 [Epub ahead of print]

Genovese,

et al.

Results are reported from an analysis exploring the safety and efficacy of open-label tofacitinib (TOF) following blinded treatment with TOF or adalimumab (ADA) in patients with moderate to severe RA. The analysis included patients from ORAL Sequel, an open-label long-term extension study, which all patients entered following ORAL Standard (one of the studies in the TOF phase 3 program). Only those patients who had been randomized to ADA 40 mg Q2W + MTX or 10 mg TOF + MTX in ORAL Standard were i...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Switching

Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan:a 12-week, randomised, double-blind, placebo-controlled phase IIb study

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

Takeuchi et al.

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...

Keywords:

• JAK,
• Peficitinib,
• Phase 2

Two-year Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis in Clinical Practice

Reumatol Clin. 2016; May 10 doi: 10.1016/j.reuma.2016.03.014 [Epub ahead of print]

Notario Ferreira,

Ferrer González MA,

Morales Garrido P,

et al.

The efficacy and safety of tocilizumab has been studied in several randomized clinical trials (RCTs) but due to the strict inclusion and exclusion criteria of RCTs, real-life observational studies are needed to supplement the findings from these trials. This small longitudinal, open-label study from an outpatient clinic in Spain evaluated the effectiveness, survival rate and reasons for treatment discontinuations in 85 patients treated with tocilizumab over a 24-month period. The study also ass...

Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study

J Rheumatol. 2016;43(3):504–511.

Tanaka Y,

Emoto K,

Cai Z,

et al.

Clinical trials have shown baricitinib once daily to be effective in patients with RA. However, this Janus kinase (JAK) 1/JAK2 inhibitor has not been evaluated in a Japanese population. In this 12-week, placebo-controlled study, 145 Japanese patients were enrolled and received placebo, 1 mg, 2 mg, 4 mg or 8 mg oral baricitinib daily. Efficacy results were encouraging and consistent with earlier trials. Significantly more baricitinib patients achieved ACR20 response at Week 12 of treatment compar...

Keywords:

• JAK,
• Baricitinib,
• Phase 2

Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis

N Engl J Med 2016;375:345–56. doi: 10.1056/NEJMoa1512711

Gordon KB,

Blauvelt A,

Papp KA,

Langley RG,

Luger T,

Ohtsuki M,

Reich K,

Amato D,

Ball SG,

Braun DK,

Cameron GS,

Erickson J,

Konrad RJ,

Muram TM,

Nickoloff BJ,

Osuntokun OO,

Secrest RJ,

Zhao F,

Mallbris L,

Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group

Gordon, et al. pool the results of UNCOVER-1, UNCOVER-2, and UNCOVER-3 to show that ixekizumab increases the proportion of patients achieving an sPGA score of 0/1 or PASI 75 versus placebo. Adverse events related to ixekizumab treatment included neutropenia, candidal infections, and inflammatory bowel disease.

Keywords:

• Efficacy,
• Ixekizumab,
• Phase 3,
• Skin

The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase 2b Study of Adults with Active Psoriatic Arthritis

Arthritis Rheumatol. 2016 Mar 24. DOI 10.1002/art.39700 [Epub ahead of print]

Mease et al.

Encouraging results have been seen with clazakizumab in RA, but the results of anti-IL6 therapy in patients with psoriatic arthritis (PsA) have so far been unclear. This Phase 2b dose-ranging study examined the efficacy and safety of clazakizumab given subcutaneously q4w, with or without MTX, in 165 patients with PsA who had inadequate response to NSAIDs.ACR20 response at Week 16, the primary endpoint, was significantly higher in patients receiving clazakizumab 100 mg compared with placebo (52.4...

Keywords:

• IL-6,
• Clazakizumab,
• Phase 2

Baricitinib in Patients with Refractory Rheumatoid Arthritis

N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247

Genovese et al.

For patients who have an inadequate response or unacceptable side effects associated with biologic DMARDs, the options for treatment beyond conventional DMARDs are limited. This phase 3 trial of the JAK 1/2 inhibitor, baricitinib, studied its efficacy in bDMARD-IR patients. 527 patients were randomized to either baricitinib 2mg, 4mg or placebo for up to 24 weeks. At week 12 the primary endpoints were tested hierarchically to control type 1 error; these endpoints were ACR20, HAQ-DI score, DAS28-C...

Keywords:

• JAK,
• Baricitinib,
• Review

Pregnancy outcome after tocilizumab therapy in early pregnancy – a case series from the German Embryotox Pharmacovigilance Center

Reproductive Toxicology doi:10.1016/j.reprotox.2016.01.002

Weber-Schoendorfer et al.

MTX users have an increased incidence of spontaneous abortions (SABs) compared to baseline risk (42.5%1 vs. 13-17%2). Tocilizumab (TCZ) has been shown to have similar efficacy with or without MTX. There is currently limited data on the effect of TCZ on pregnancy, but with more safety data, TCZ could be an alternative for RA patients of reproductive age. The patients were enrolled at Embryotox Berlin, a pharmacovigilance center providing risk assessment during pregnancy, between 2011 and 2014 dur...

Keywords:

• IL-6,
• Tocilizumab,
• Safety,
• Real-World,
• Pregnancy / Fertility