Publications

Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221276.

Taylor PC,

Takeuchi T,

Burmester GR,

Durez P,

Smolen JS,

Deberdt W,

Issa M,

Terres JR,

Bello N,

Winthrop KL

Analysis of data from the highest level of patient exposure to baricitinib across the spectrum of the RA population demonstrates that baricitinib maintained a similar safety profile to earlier analyses, with no new safety signals identified.Using integrated data from nine randomised controlled trials, Taylor, et al. assessed the safety of baricitinib 2 mg and 4 mg once-daily. Analysis of data from 3770 patients (median 4.6 years, up to 9.3 years) with active RA showed that baricitinib maintained...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• LTE

Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND

J Rheumatol. 2021 Sep 15:jrheum.210346.

van der Heijde D,

Kartman CE,

Xie L,

Beattie S,

Schlichting D,

Mo D,

Durez P,

Tanaka Y,

Fleischmann R.

Oral baricitinib maintained lower levels of radiographic progression than initial csDMARD or placebo through 5 years in patients with active RA.It is well known that persistent joint inflammation in RA can lead to irreversible structural damage that impacts on patient physical function and quality-of-life. To this end, van der Heijde, et al. evaluated the effect of baricitinib on inhibiting radiographic progression of structural joint damage over 5 years in patients with active RA. Results from ...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy,
• Radiographic

Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3

RMD Open. 2021;7(2):e001621.

Aletaha D,

Westhovens R,

Gaujoux-Viala C,

Adami G,

Matsumoto A,

Bird P,

Messina OD,

Buch MH,

Bartok B,

Yin Z,

Guo Y,

Hendrikx T,

Burmester GR.

Post hoc analysis of the phase III FINCH study shows that filgotinib may be an alternative treatment option for patients with RA who have poor prognostic factors (PPFs), especially those not responding to standard treatment such as methotrexate (MTX).PPFs are associated with severe disease and risk for disease progression in patients with RA. Consequently, the 2019 EULAR management guidelines for RA recommend early treatment escalation for patients with PPFs who have inadequate response to first...

Keywords:

• JAK,
• Fenebrutinib,
• Efficacy,
• Safety,
• Phase 3

La monoterapia con upadacitinib migliora i risultati riportati dai pazienti nell'artrite reumatoide: risultati di SELECT-EARLY e SELECT-MONOTHERAPY

Rheumatology (Oxford). 2021;60(7):3209–21

Strand V,

Tundia N,

Wells A,

Buch MH,

Radominski SC,

Camp HS,

Friedman A,

Suboticki JL,

Dunlap K,

Goldschmidt D,

Bergman M.

Upadacitinib treatment results in statistically significant and clinically meaningful improvements in health-related quality of life.Strand, et al. evaluated the effect of upadacitinib monotherapy versus methotrexate (MTX) on patient-reported outcomes (PRO) in MTX-naïve and MTX-inadequate responder patients with moderately-to-severely active RA. Their research from the SELECT-EARLY and SELECT-MONOTHERAPY randomised controlled trials found that upadacitinib monotherapy resulted in clinically mean...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• PRO / QoL

Efficacia di baricitinib in pazienti con artrite reumatoide da moderata a grave dopo 3 anni di trattamento: risultati di uno studio a lungo termine

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

Efficacia Del Trattamento a Lungo Termine con Baricitinib 2 mg die in Pazienti Con Artrite Reumatoide Attiva: Analisi Post Hoc di Due Studi Di Fase III, Randomizzati e Controllati di 24 Settimane e Uno Studio di Estensione a Lungo Termine

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

Comparative efficacy and safety of secukinumab, ixekizumab, and tofacitinib in patients with active psoriatic arthritis showing insufficient response to tumor necrosis factor inhibitors

Int J Clin Pharmacol Ther. 2021. Epub ahead of print.

Song GG,

Lee YH.

Bayesian network meta-analysis of randomised controlled trials (RCTs) highlights the effectiveness of secukinumab, ixekizumab, and tofacitinib in patients with psoriatic arthritis (PsA) and an inadequate response to tumour necrosis factor inhibitors (TNFi).There is a current need for therapies with alternative mechanisms of actions to DMARDs and TNFi, for the significant proportion of patients with PsA who insufficiently respond to these therapies. While RCTs for therapies such as secukinumab a...

Keywords:

• JAK,
• IL-17,
• Secukinumab,
• Tofacitinib,
• Efficacy,
• Safety

Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies

Rheumatology (Oxford). 2021;60(4):1708-1716.

van der Heijde D,

Landewé RBM,

Wollenhaupt J,

Strengholt S,

Terry K,

Kwok K,

Wang L,

Cohen S.

Long-term evaluation of tofacitinib has found limited progression of structural damage in patients with RA treated with tofacitinib for up to 5 years. Similar results were also observed for patients receiving tofacitinib monotherapy or combination therapy for up to 3 years.It is well known that inflammation in RA leads to structural damage over time, and therapies such as DMARDS have the ability to reduce inflammation whilst inhibiting the progression of structural damage. In this study, van der...

Keywords:

• JAK,
• Tofacitinib,
• LTE,
• Radiographic

Safety and Efficacy of Filgotinib: Up to 4-Year Results From an Open-Label Extension Study of Phase 2 Rheumatoid Arthritis Programs

J Rheumatol. 2021 Feb 1:jrheum.201183. DOI: 10.3899/jrheum.201183.

Kavanaugh A,

Westhovens RR,

Winthrop KL,

Lee SJ,

Tan Y,

An D,

Ye L,

Sundy JS,

Besuyen R,

Meuleners L,

Stanislavchuk M,

Spindler AJ,

Greenwald M,

Alten R,

Genovese MC

A long-term extension study of filgotinib showed consistent safety profile and sustained efficacy with the drug for up to four years. The DARWIN 3 study, for patients who previously completed either the 24-week DARWIN 1 study (filgotinib + MTX) or the DARWIN 2 study (filgotinib monotherapy), enrolled 739 patients with RA. At the time of analysis, 440 patients had received four years or more of filgotinib. Exposure-adjusted incidence rate per 100 patient-years-of-exposure for TEAEs was 24.6 in th...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 2,
• LTE