Publications

Long-term safety and efficacy of upadacitinib or adalimumab in patients with rheumatoid arthritis: results through 3 years from the SELECT-COMPARE study

RMD Open. 2022;8(1):e002012 doi: 10.1136/rmdopen-2021-002012

Fleischmann R,

Mysler E,

Bessette L,

Peterfy CG,

Durez P,

Tanaka Y,

Swierkot J,

Khan N,

Bu X,

Li Y,

Song IH

Upadacitinib continues to show consistently better clinical responses, compared with adalimumab, through 3 years, including rates of remission and low disease activity, physical function and pain severity.Following the favourable upadacitinib efficacy data seen in the SELECT-COMPARE study at 72 weeks, Fleischmann, et al. assessed the long-term safety and efficacy of upadacitinib versus adalimumab over 3 years in the long-term extension of this study, with promising results. ...

Keywords:

• JAK,
• Updacitinib,
• Safety,
• Efficacy,
• LTE

Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active crohn’s disease: Results from the VISIBLE 2 randomised trial

J Crohns Colitis. 2022 Jan 28;16(1):27-38 doi: 10.1093/ecco-jcc/jjab133

Vermeire S,

D'Haens G,

Baert F,

Danese S,

Kobayashi T,

Loftus EV,

Bhatia S,

Agboton C,

Rosario M,

Chen C,

Zhang W,

Kisfalvi K,

Sandborn WJ

The authors highlighted a significantly greater clinical remission rate at Week 52 for vedolizumab SC versus placebo in patients with moderately to severely active CD. This study aimed to report results from VISIBLE 2 which evaluated a new SC vedolizumab formulation as maintenance treatment in adults with moderately to severely active CD.

Keywords:

• Efficacy,
• Safety,
• PRO / QoL

Ozanimod as induction therapy and maintenance therapy for ulcerative colitis

N Engl J Med 2021;385:1280–91 doi: 10.1056/NEJMoa2033617

Sandborn WJ,

Feagan BG,

D’Haens G,

Wolf DC,

Jovanovic I,

Hanauer SB,

Ghosh S,

Petersen A,

Hua SY,

Lee JH,

Charles L,

Chitkara D,

Usiskin K,

Colombel JF,

Laine L,

Danese S,

True North Study Group

Patients receiving ozanimod displayed a significant improvement in clinical response and all secondary endpoints during both the 10-week induction and 52-week maintenance study periods. Percentage of patients achieving clinical remission at Weeks 10 and 52 was the primary endpoint.

Keywords:

• Efficacy,
• GI,
• Phase 3,
• Safety

Comparison of the effects of baricitinib and tocilizumab on disease activity in patients with rheumatoid arthritis: a propensity score matching analysis

Clin Rheumatol. 2021 Jun 16. DOI: 10.1007/s10067-021-05815-3

Asai S,

Takahashi N,

Kobayakawa T,

Kaneko A,

Watanabe T,

Kato T,

Nishiume T,

Ishikawa H,

Yoshioka Y,

Kanayama Y,

Watanabe T,

Hirano Y,

Hanabayashi M,

Yabe Y,

Yokota Y,

Suzuki M,

Terabe K,

Ishiguro N,

Imagama S,

Kojima T.

The influence of inflammation on patient global assessment (PGA) improvements differs between baricitinib and tocilizumab differs. Adequate PGA improvement remains one of the unmet needs in current RA treatment.Asai, et al. compared the effects of baricitinib and tocilizumab on disease activity in patients with RA while investigating the influence of inflammation on PGA improvement.Using data from a multicentre registry, 48 propensity-matched pairs of patients, who had been observed for longer t...

Keywords:

• JAK,
• IL-6,
• Baricitinib,
• Tocilizumab,
• Efficacy

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Rheumatology (Oxford). 2021;60(5):2256-2266.

Smolen JS,

Xie L,

Jia B,

Taylor PC,

Burmester G,

Tanaka Y,

Elias A,

Cardoso A,

Ortmann R,

Walls C,

Dougados M.

Baricitinib 4mg may be considered for long-term treatment of early and refractory rheumatoid arthritis following results demonstrating efficacy and tolerability for up to 3 years.Smolen JS, et al. analysed data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension study (RA-BEYOND) – providing data for 148 weeks in total. Results demonstrated that the long-term maintenance of clinically relevant treatment goals, including ...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy

Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study

Wells AF, et al. Rheumatol Ther. 2021. Epub ahead of print. DOI: 10.1007/s40744-021-00317-9.

Wells AF,

Jia B,

Xie L,

Valenzuela GJ,

Keystone EC,

Li Z,

Quebe AK,

Griffing K,

Otawa S,

Haraoui B.

Analysis by Wells, et al. demonstrates long-term efficacy and tolerability of baricitinib 2 mg daily for up to 120 weeks in patients with rheumatoid arthritis.Using data from two completed phase III studies, RA-BEAM (csDMARD-IR patients) and RA-BEACON (TNFi-IR patients), and one ongoing long-term extension study (RA-BEYOND), results demonstrated that the long-term maintenance of clinically relevant treatment goals, including LDA, remission and normative physical function, is achievable with bari...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• LTE,
• Phase 3

Upadacitinib Monotherapy Versus Methotrexate Monotherapy in Methotrexate-naïve Japanese Patients with Rheumatoid Arthritis: A Sub-analysis of The Phase 3 SELECT-EARLY study

Mod Rheumatol 2021;26:1–16.

Takeuchi T,

Rischmueller M,

Blanco R,

Xavier RM,

Ueki Y,

Atsumi T,

Chen S,

Friedman A,

Pangan AL,

Strand V,

van Vollenhoven RF

In this sub-analysis of the Phase 3 SELECT-EARLY study, UPA demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Along with a favourable efficacy observed with the Japan-specific 7.5 mg dose of UPA for all secondary endpoints. SELECT-EARLY was designed to study the safety and efficacy of UPA 15 and 30mg as monotherapy, but it also included a subset of 138 Japanese patients, 40% of whom were randomised to receive UPA 7.5mg. This was designed to meet the requirements o...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Comparative effectiveness of first-line tumour necrosis factor inhibitor versus non-tumour necrosis factor inhibitor biologics and targeted synthetic agents in patients with rheumatoid arthritis: results from a large US registry study

Ann Rheum Dis 2021;80:96–102.

Pappas DA,

St John G,

Etzel CJ,

Fiore S,

Blachley T,

Kimura T,

Punekar R,

Emeanuru K,

Choi J,

Boklage S,

Kremer JM

RA treatment guidelines recommend a treat-to-target approach guided by disease stage and treatment history, yet the optimal sequence of different treatment modalities has not been established. Data from Corrona – were used to evaluate the comparative effectiveness of TNFi versus non-TNFi bDMARDs and tsDMARDs as first-line treatment following csDMARD failure. Results support RA guidelines recommending individualised care based on clinical judgement and consideration of patient preference.The stud...

Keywords:

• Real-World

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Rheumatology 2020; doi:10.1093/rheumatology/keaa576

Smolen JS,

Xie L,

Jia B,

Taylor PC,

Burmester G,

Tanaka Y,

Elias A,

Cardoso A,

Ortmann R,

Walls C,

Dougados M

Three year follow up data for baricitinib demonstrated efficacy in populations that span the clinical disease continuum in RA, including DMARD-naïve, MTX-IR, csDMARD-IR, and bDMARD-IR and was well tolerated. This study evaluated achievement and maintenance of LDA, remission and physical functioning in patients treated with baricitinib for up to 3 years. Data were analysed from two 52-week, Phase 3 studies (RA-BEAM and RA-BEGIN), and one ongoing long-term extension (RA-BEYOND). Patients completin...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy

Trial of UPA or Abatacept in Rheumatoid Arthritis

N Engl J Med 2020;383:1511–21 DOI: 10.1056/NEJMoa2008250

Rubbert‑Roth A,

Enejosa J,

Pangan AL,

Haraoui B,

Rischmueller M,

Khan N,

Zhang Y,

Martin N,

Xavier RM

In patients with refractory RA to bDMARDs, upadacitinib was found to be superior to abatacept in DAS28-CRP change from baseline and the achievement of remission at week 12.612 bDMARD-IR patients were randomised 1:1 to UPA 15 mg QD or ABA, each in combination with stable synthetic DMARDs. At Week 12, patients with <20% decrease in TJC and Swollen joint count (SJC) had background medication adjusted or added. All patients completing Week 24 were eligible to remain in an open-label, long-term exten...

Keywords:

• JAK,
• Updacitinib