Cytokine Signalling Forum

Publications





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

Efectividad a Largo Plazo de la Vacuna Viva Herpes Zoster en Pacientes con Artritis Reumatoide Tratados Posteriormente con Tofacitinib

Winthrop KL, Wouters A, Choy EH, Chen C, Biswas P, Wang L, Soma K, Needle E, Valdez H, Rigby WFC.
Ann Rheum Dis. 2020 DOI: 10.1136/annrheumdis-2019-216566

The results of ORAL Sequel suggest that the live zoster vaccine (LZV) may not provide adequate long-term protection in patients with RA receiving TOF. This LTE study enrolled 100 patients with RA, 14 weeks post LZV vaccination. Patients received either TOF 5 mg BID, or TOF 10 mg BID in addition to any background csDMARDs. Incidence rates and 95% CIs for HZ post-vaccination were calculated based on time to first event. Short-term varicella zoster vaccine (VZV) specific immunity was evaluated a...

Keywords: JAK, Tofacitinib, Clinical, Safety

Translated by: Igor Koz

December 18

Evaluación de Efectos a Corto, Medio y Largo-plazo de Tofacitinib en Linfocitos de Pacientes con Artritis Reumatoide

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

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, Clinical, Safety

Translated by: Igor

October 17

Linfoma en el Programa Clínico de Desarrollo de Tofacitinib en Artritis Reumatoide

Mariette X, Chen C, Biswas P, Kwok K, Boy MG.
Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421

Analysis of 19 studies involving the use of tofacitinib to treat RA showed that lymphoma incidence rate and type were consistent with expectations in the RA population as a whole, and did not increase with tofacitinib exposure time. Previous research has suggested that there is a link between the likelihood of developing malignant tumours and RA. Previously, it has been unclear whether the increased rates seen are due to the use of immunomodulatory therapies, such as tofacitinib, which are used...

Keywords: JAK, Tofacitinib, Clinical, Safety

Translated by: Igor Kos

September 17

Seguridad E Inmunogenicidad de la Vacunación Para Herpes Zoster en Pacientes con Artritis Reumatoide Antes de Empezar Tofacitinib: Un Ensayo Aleatorizado Fase II

Winthrop KL, Wouters A, Choy E, Soma K, Hodge J, Nduaka C, Biswas P, Needle E, Passador MS, Mojcik C, Rigby W.
Arthritis Rheumatol. 2017 Oct;69(10):1969-1977. doi: 10.1002/art.40187

Patients with RA who started treatment with tofacitinib 2–3 weeks after being vaccinated against herpes zoster had similar varicella zoster virus (VZV)-specific humoral and cell-mediated responses to the live vaccine compared to patients who received placebo. In this Phase 2 study, humoral and cell-mediated immune responses were evaluated before receipt of live zoster vaccine (LZV) and at 2, 6 and 14 weeks after vaccination, having been randomised to tofacitinib 5 mg BID or placebo, 2&nda...

Keywords: JAK, Tofacitinib, Clinical, Safety

Translated by: Igor Kos

March 17

Efficacy and Safety of Tofacitinib in Older and Younger Patients with Rheumatoid Arthritis

Curtis JR, Schulze-Koops H, Takiya L, Mebus CA, Terry KK, Biswas P and Jones TV.
Clin Exp Rheumatol 2017 Jan 4

In this analysis of patients with moderate to severe RA treated with tofacitinib (TOF) in Phase 3 and long-term extension (LTE) studies, patients aged 65 years had similar efficacy and a numerically higher risk of SAEs and discontinuations due to AEs compared with younger patients. The Phase 3 population included patients from five trials (n=3111) of TOF 5 mg or 10 mg BID or placebo. The LTE population (n=4102) included patients from two studies who had participated in Phase 1, 2 or 3 TOF stud...