Cytokine Signalling Forum

Publications





June 20

Eficiencia Comparada de los Agentes anti-factor de Necrosis Tumoral, Biológicos con un Modo de Acción Alternativo y Tofacitinib en una coorte observacional de pacientes con artritis reumatoide en Suiza

Finckh A, Tellenbach C, Herzog L, Scherer A, Moeller B, Ciurea A, von Muehlenen I, Gabay C, Kyburz D, Brulhart L, Müller R, Hasler P, Zufferey P.
RMD Open 2020;6:e001174 doi:10.1136/rmdopen-2020-001174

This nested cohort study found that, in Switzerland, there was a generally limited overall drug maintenance for b/tsDMARD options in RA. Using data from SCQM-RA – a prospective longitudinal registry, overall maintenance (drug survival) was calculated for TNFi, bDMARD-OMA or JAKi in patients with RA. After adjusting for potential confounding factors, there was a higher hazard of drug discontinuation with TNFi compared with tofacitinib; no significant difference was observed between non-TNF ...

Keywords: Cytokine Signalling, Real World, Efficacy

Translated by: Igor Kos

May 20

Análisis Integrado de Seguridad de Tofacitinib en Artritis Psoriásica en Estudios de Fase 3 y de Extensión a Largo Plazo y Comparación con Datos Observacionales de Mundo Real

Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R.
Drug Saf. 2020;43:379-392

Patients with psoriatic arthritis (PsA) had similar safety profile with TOF to that of other systemic therapies in real-world settings, except for the known risk of HZ. Treatment recommendations from EULAR and GRAPPA for patients with PsA vary according to adverse prognostic risk factors, disease manifestations and responsiveness to prior treatment. Safety concerns for most PsA therapies include gastrointestinal AEs, hepatotoxicity, opportunistic infections (OIs) including TB, and SIEs. This s...

Keywords: JAK, Tofacitinib, Real World, Safety

Translated by: Igor Koz

April 20

Vasculitis IgA como Efecto Adverso de Tofacitinib en Artritis Reumatoide

Itoh I, Kasuno K, Yamamoto C, Takahashi N, Shimizu H, Ojima T, Hayashi S, Kimura H, Iwano M.
Intern Med. 2020;59(6):817-821

Nephrotoxicity is a key side effect of NSAIDs and DMARDs used to treat RA, while biologics can reportedly cause proliferative glomerulonephritis or crescentic glomerulonephritis. This report reviews a patient on TOF presenting IgA vasculitis as an adverse effect that fully resolved following termination of TOF. Drug induced IgA vasculitis has been previously described for anti-TNFɑ therapies, but this is the first report with JAK inhibitor therapy. This is a case report of a 67-year old woman w...

Keywords: JAK, Tofacitinib, Real World, Safety

Translated by: Igor Koz

March 20

Exposición a Baricitinib Durante el Embarazo en Artritis Reumatoide

Costanzo G, Firinu D, Losa F, Deidda M, Barca MP, Del Giacco S.
Ther Adv Musculoskelet Dis. 2020;12:1759720X19899296

Broad and focused studies are required to have an insight of safety for small molecules, such as JAK inhibitors in the case of accidental exposure before or during pregnancy. This case study’s objective describes a case report of a 43-year-old woman affected by RA who became pregnant during BARI treatment. She has had two previous pregnancies at term without complications. After failure of bDMARDs due to loss of efficacy and adverse drug reactions, the patient was started on BARI when i...

Keywords: JAK, Baricitinib, Real World, Safety

Translated by: Igor Koz

October 19

Factores de Riesgo para Eventos Cardiovasculares Mayores en los Estudios de Extensión a Largo Plazo y de Fase III de Tofacitinib en Pacientes con Artritis Reumatoide

Christina Charles-Schoeman, Ryan DeMasi, Hernan Valdez, Koshika Soma, Lie-Ju Hwang, Mary G Boy, Pinaki Biswas, Iain B McInnes.
Ann Rheum Dis. 2019

Post hoc analyses of the six ORAL studies and two LTE’s suggested that after 24 weeks of TOF treatment, increases in HDL-c and decreases in the TC/HDL-c ratio appeared to be associated with reduced future MACE risk in RA patients. 52 MACE occurred in 4076 patients over 12873 patient-years of exposure. Separate Cox regression models were used to evaluate traditional CV risk factors’ association with time to first MACE at baseline and changes in lipid levels with time to future MACE ...

Keywords: JAK, Tofacitinib, Real World, Cardiovascular

Translated by: Igor Koz

September 18

Perfil de Lípidos y Efecto de Tratamiento con Estatinas en Agrupamiento de Estudios Fase II y Fase II de Baricitinib

Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB.
Ann Rheum Dis. 2018 Jul;77(7):988-995. DOI 10.1136/annrheumdis-2017-212461

Baricitinib (BARI) was associated with increased lipid levels; baseline statins did not alter these profiles. The introduction of statins during treatment reduced total cholesterol and LDL-C. The use of anti-inflammatory drugs in RA patients has been shown to alter lipid levels and is associated with reduced atherogenic risk. Increases in lipid levels, specifically HDL-C and LDL-C, have been observed in Phase 2 BARI studies1. This study analysed data from seven randomised RA Phase 2/3 studies o...

Keywords: JAK, Baricitinib, Real World, Cardiovascular

Translated by: Igor Kos

June 18

Características de los Pacientes influencian la elección de fármaco biológico en AR, y harán los biológicos no-TNFi aparentaren más nocivos que biológicos TNFi

Frisell T, Baecklund E, Bengtsson K, Giuseppe DD, Forsblad-d’Elia H, Askling J, on behalf of the ARTIS Study Group.
Ann Rheum Dis 2018; 77:650–57 DOI: 10.1136/annrheumdis-2017-212395

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...

Keywords: IL-6, Tocilizumab, Real World, Efficacy

Translated by: Igor Kos

April 18

Efectividad y Seguridad de Tofacitinib en Artritis Reumatoide: Un Estudio de Cohorte

Machado MAÁ, Moura CS, Guerra SF, Curtis JR, Abrahamowicz M, Bernatsky S.
Arthritis Res Ther 2018; 20(1):60 doi: 10.1186/s13075-018-1539-6

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, ...

Keywords: JAK, Tofacitinib, Real World, Safety

March 18

Experiencia Mundial de Vigilancia Después de la Comercialización de Tofacitinib en Artritis Reumatoide a lo largo de 3 Años

Cohen S, Curtis JE, DeMasi R, Chen Y, Fan H, Soonasra A, Fleischmann R.
Rheumatol Ther 2018 Jun; 5(1):283–91

This real-world analysis of tofacitinib (TOF) revealed that AEs reported by patients with RA from 2012 to 2015 were consistent with the known safety profile of TOF – no new safety risks were identified. As of August 2017, it is estimated that more than 102 000 patients worldwide have received TOF, but TOF safety has not been evaluated in patients with real-world experience. This analysis addressed this – by evaluating the safety of TOF from post-marketing surveillance (PMS) reports ...

Keywords: JAK, Tofacitinib, Real World, Safety

Translated by: Igor Kos

December 17

Efectividad a largo plazo de Tocilizumab en pacientes con Artritis Reumatoide, estratificados por número de Fracasos de Tratamiento con Agentes Biológicos: Resultados del estudio de cohorte Germánico RABBIT

Baganz L, Richter A, Kekow J, Bussmann A, Krause A, Stille C, Listing J, Zink A, Strangfeld A.
Rheumatol Int 2018 Apr; 38(4):579-87

In this observational study, the German RABBIT cohort was used to assess the long-term effectiveness and retention rates of tocilizumab (TCZ) in patients with prior bDMARD failures. Results of the study suggested that TCZ could be an effective treatment option for patients with difficult-to-treat RA. A total of 885 patients were involved in the study and these were categorised dependent on the number of bDMARD failures they had prior to TCZ treatment. Patient data recorded in the cohort include...

Keywords: IL-6, Tocilizumab, Real World, Efficacy

Translated by: Igor Kos

November 17

Persistencia en el tratamiento y Costos con Atención Médica entre Pacientes con Artritis Reumatoide Cambiando Biológicos en los Estados Unidos

Chastek B, Chieh-I Chen, Proudfoot C, Shinde S, Kuznik A, Wei W.
Adv Ther. 2017 Nov;34(11):2422-2435. doi: 10.1007/s12325-017-0617-5

Updated treatment guidelines recommend the use of different mechanism of action (MOA) therapies earlier in the treatment course. Clinical studies have revealed that this approach may be better than TNFi cycling, and may be more cost effective. This study of Commercial and Medicare Advantage claims data showed that patients who switched MOA had higher treatment persistence and lower healthcare costs than TNFi cyclers. After the first TNFi claim, patients either cycled to another TNFi (n=935) or...

Keywords: JAK, Tofacitinib, Real World, Value

Translated by: Igor Kos

July 17

Tratamiento de la Artritis Reumatoide con Antagonista del Factor de Necrosis Tumoral o Tocilizumab como el Primer Biológico en un Estudio Comparativo Observacional

Choy EH, Bernasconi C, Aassi M, Molina JF, Epis OM.
Arthritis Care Res (Hoboken). 2017 Oct;69(10):1484-1494. doi: 10.1002/acr.23303

To date, the comparative efficacy of tocilizumab and TNFi for patients with RA has only been investigated in a single head-to-head trial and network meta-analyses. This study, ACT-iON, is the first prospective, large-scale, global, multicentre, comparative effectiveness study comparing initiation of intravenous tocilizumab with initiation of a TNFi in patients with RA as the first-line biologic treatment after inadequate response to csDMARDs. Patients were observed in a real-world, clinical pra...

Keywords: IL-6, Tocilizumab, Real World, Efficacy

Translated by: Igor Kos

June 17

Resultados (outcomes) de La Inhibición cíclica del Factor de Necrosis Tumoral versus Cambiar para un fármaco modificador de enfermedad con un nuevo mecanismo de acción

Chastek B, Becker LK, Chen CI, Mahajan P and Curtis JR.
J Med Econ 2017;20:464–73

This retrospective study looked at claims-based datasets to establish whether it is preferable to switch to another TNF inhibitor (TNFi) or to a therapy with a different mechanism of action (MOA) when RA treatment failure occurs with an initial TNFi, due to inadequate response or lack of tolerability. Administrative claims data from a large US database were used to compare treatment patterns, treatment effectiveness (based on fulfillment of six criteria) and costs in in the 12 months after RA p...

Keywords: JAK, Tofacitinib, Real World, Value

Translated by: Igor Kos

May 15

Evaluation of the effect of tofacitinib on measured glomerular filtration rate in patients with active rheumatoid arthritis: results from a randomised controlled trial

Kremer JM, Kivitz AJ, Simon-Campos JA, Nasonov EL, Tony HP, Lee SK, Vlahos B, Hammond C, Bukowski J, Li H, Schulman SL, Raber S, Zuckerman A, Isaacs JD.
Arthritis Res Ther. 2015 Apr 6;17(1):95.

Mean increases from baseline in patient serum creatinine (SCr) levels have been observed in the clinical development programme for the JAK inhibitor tofacitinib. These increases predominantly occurred within the first three months, and reversed with tofacitinib withdrawal. This phase 1, randomised, placebo-controlled, parallel-group, 2-period study assessed changes in measured glomerular filtration rate (mGFR) with tofacitinib, relative to placebo, in 148 patients with active RA. Results sh...