Publications

Sicurezza ed Efficacia di Baricitinib nei Pazienti Trattati con Farmaci Antireumatici Modificanti la Malattia Sintetici Convenzionali o Corticosteroidi

Arthritis Rheumatol 2018 DOI: 10. 1002/art.40780

van Vollenhoven R,

Lee EB,

Strengholt S,

Mojcik C,

Valdez H,

Krishnaswami S,

Biswas P,

Lazariciu I,

Hazra A,

Clark JD,

Hodge J,

Wang L,

Choy E

Tofacitinib (TOF) treatment is associated with short-term transient increases in absolute lymphocyte counts (ALC), followed by a gradual decline to reach steady state by ~48 months. Changes in both ALC and lymphocyte subset counts (LSC) were reversible upon TOF discontinuation. Low ALC but not LSC were associated with an increased risk of serious infective episodes (SIEs) and herpes zoster (HZ). This data supported the treatment recommendations on ALC counts for starting and continuing therapy w...

Keywords:

• JAK,
• Tofacitinib,
• MOA

L’incidenza di Herpes Zoster nel trattamento con Tofacitinib Aumenta Ulteriormente con i Glucocorticoidi ma non con il Methotrexate

Arthritis Care Res 2018 DOI 10.1002/acr.23769

Curtis JR,

Xie F,

Yang S,

Bernatsky S,

Chen L,

Yun H,

Winthrop K

The rate of Herpes Zoster (HZ) in tofacitinib (TOF) users with concomitant glucocorticoids (GC) was approximately double that of other TOF combination therapies.TOF is an effective treatment for RA. Increased HZ risk has been observed with the use of JAK inhibitors, whereas the HZ risk with biologics and targeted RA therapies are comparable. This study evaluated the HZ risk in TOF users according to concomitant GC, MTX, both, or neither. MarketScan and Medicare data were used to identify 8030 rh...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Infections

Riduzione del Dosaggio di Baricitinib Nei Pazienti con Artrite Reumatoide che Hanno Raggiunto il Controllo della Malattia Prolungato: Risultati di uno StudioProspettico

Ann Rheum Dis. 2019 Feb;78(2):171-178. DOI 10.1136/annrheumdis-2018-213271

Takeuchi T,

Genovese MC,

Haraoui B,

Li Z,

Xie L,

Klar R,

Pinto Correia A,

Otawa S,

Lopez-Romero P,

de la Torre I,

Rooney TP,

Smolen JS

In active RA patients, with an inadequate response (IR) to DMARDs who achieve low disease activity (LDA) following baricitinib (BARI) 4 mg treatment, disease control is better maintained with continued BARI 4 mg compared to tapering to 2 mg.The objective of this study was to investigate the effect of BARI tapering in patients achieving sustained disease control with BARI 4 mg.In the long-term extension study RA-BEYOND, patients receiving BARI 4 mg who achieved sustained LDA or remission at two c...

Keywords:

• JAK,
• Baricitinib

Profilo di Sicurezza di Baricitinib in Pazienti con Artrite Reumatoide Attiva con un Periodo di Trattamento in Media di Oltre 2 Anni

J Rheumatol. 2019 Jan;46(1):7-18. DOI: 10.3899/jrheum.171361

Smolen J,

Genovese M,

Takeuchi T,

Hyslop D,

Macias W,

Rooney T,

Chen L,

Dickson C,

Riddle Camp J,

Cardillo T,

Ishii T and Winthrop K

Baricitinib (BARI) showed an acceptable 5.5-year safety profile in this integrated analysis of patients with moderate-to-severe, active RA.This study evaluated the safety profile of the oral, once daily Janus kinase inhibitor, BARI, in adults with moderately to severely active RA. Data from eight randomised clinical trials and one long-term extension study were pooled and analysed for placebo comparison and dose response.There were 3492 patients who received BARI for a total of 6637 patient-yea...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Review

Eventi Avversi, Considerazioni Cliniche e Raccomandazioni per la gestione dei Pazienti con Artrite Reumatoide Trattati con Inibitori di JAK

Exp Rev Clin Immunol 2018 Nov;14(11):945-956. DOI: 10.1080/1744666X.2018.1504678

Atzeni F,

Talotta R,

Nucera V,

Marino F,

Gerratana E,

Sangari D,

Masala IF,

Sarzi-Puttini P

Janus kinase (JAK) inhibitors are efficacious in patients with moderate-to-severe RA and have a favourable safety profile. However adverse events (AE), in particular infections, are associated with the use of JAK inhibitors. This paper reviews the mechanism behind JAK inhibitors, the AEs associated with them, and provides consideration in the management of AEs in clinical practice. Data on two RA approved JAK inhibitors – tofacitinib (TOF) and baricitinib (BARI) – was obtained using PubMed, Medl...

Keywords:

• JAK,
• Safety,
• Review

Sicurezza ed Efficacia di Upadacitinib nei Pazienti con Artrite Reumatoide Attiva Refrattaria a Farmaci Biologici Antireumatici Modificanti l’Attività di Malattia (SELECT-BEYOND): un Trial di Fase 3, in Doppio Cieco, Randomizzato, Controllato

Lancet 2018;391:2513–24

Genovese MC,

Fleischmann R,

Combe B,

Hall S,

Rubbert-Roth A,

Zhang Y,

Zhou Y,

Mohamed M-EF,

Meerwein S,

Pangan AL

Upadacitinib (UPA) extended release formulation was effective in treating patients with moderate-to-severe RA with an inadequate response to bDMARDs.Phase 2 study data has shown that UPA is an efficacious and safe treatment for active RA.1,2 SELECT-BEYOND was a double-blind, long-term extension, Phase 3 study to assess the efficacy of UPA in patients with RA who were bDMARD-IR. The first 12-weeks of SELECT-BEYOND were placebo-controlled, with a double-blind period followed by an ongoing double-b...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Sicurezza ed Efficacia di Upadacitinib nei Pazienti con Artrite Reumatoide e Risposta Inadeguata a Farmaci Antireumatici Convenzionali Sintetici Modificanti l’attività di Malattia (SELECT-NEXT): un Trial di Fase 3 Randomizzato, in Doppio Cieco, Controllato con Placebo

Lancet 2018;391:2503–12

Burmester GR,

Kremer JM,

Van den Bosch F,

Kivitz A,

Bessette L,

Li Y,

Zhou Y,

Othman AA,

Pangan AL,

Camp HS

Patients with moderate-to-severe active RA had significant improvements in clinical signs and symptoms with upadacitinib (UPA) compared with placebo.In Phase 2 studies, UPA showed favourable efficacy when administered twice daily as an immediate-release formulation at doses of 6–12 mg in patients with active RA who had TNFi-IR.1,2 An extended-release formulation allowing once-daily (QD) administration was developed for Phase 3 studies. SELECT-NEXT was a double-blind, multicentre, Phase 3 study t...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Le caratteristiche dei Pazienti Influenzano la Scelta dei Farmaci Biologici nella AR, e Faranno Apparire gli Agenti Biologici non-iTNF più Dannosi di Quelli iTNF

Ann Rheum Dis 2018; 77:650–57 DOI: 10.1136/annrheumdis-2017-212395

Frisell T,

Baecklund E,

Bengtsson K,

Giuseppe DD,

Forsblad-d’Elia H,

Askling J,

on behalf of the ARTIS Study Group

Analysis of patient characteristics revealed that older and less healthy patients with RA were more likely to receive non-TNFi bDMARDs as a first bDMARD compared to other treatments.This study aimed to describe patient characteristics at initiation of bDMARD treatment at two-time points: first bDMARD initiation and switch to second bDMARD after TNFi treatment. The second aim of the study was to estimate the potential of treatment channelling to confound results in comparative treatment studies i...

Keywords:

• Safety,
• Review

Efficacia e Sicurezza di Tofacitinib nell’Artrite Reumatoide: uno Studio di Coorte

Arthritis Res Ther 2018; 20(1):60 doi: 10.1186/s13075-018-1539-6

Machado MAÁ,

Moura CS,

Guerra SF,

Curtis JR,

Abrahamowicz M,

Bernatsky S

A retrospective cohort study of tofacitinib (TOF) revealed that patients previously treated with methotrexate who initiated TOF, presented no differences in hospitalised infections or effectiveness, compared with non-TNF biologics. Currently, TOF is recommended in ACR and EULAR guidelines as an alternative to biologics after first-line cDMARD therapy. Previous indirect comparisons have shown that patients with RA who experience cDMARD failure show similar efficacy when given TNFis, abatacept, to...

Keywords:

• JAK,
• Tofacitinib,
• Real-World