Publications

Immunogenicity and Safety of Adjuvanted Recombinant Zoster Vaccine in Rheumatoid Arthritis Patients on Anti-Cellular Biologic Agents or JAK Inhibitors: A Prospective Observational Study

Int JMol Sci 2023;24(8):6967 doi 10.3390/ijms24086967

Venerito V,

Stefanizzi P,

Cantarini L,

Lavista M,

Galeone MG,

Lorenzo AD,

Iannone F,

Tafuri F,

Lopalco G

A prospective observational study showed that recombinant zoster vaccine (RZV) immunogenicity is not impaired in RA patients on JAK inhibitors or anti-cellular bDMARDs.

Keywords:

• Efficacy,
• Vaccination

Herpes Zoster en Pacientes con Artritis Inflamatorias o Colitis Ulcerosa Tratados con Tofacitinib, Baricitinib o Upadacitinib: Una Revisión Sistemática de Estudios Clínicos y Estudios de Mundo Real

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

Gialouri CG,

Moustafa S,

Thomas K,

Hadziyannis E,

Vassilopoulos D

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

Keywords:

• JAK,
• Safety,
• Infections,
• Review

Evaluación de la respuesta a la vacuna 13-valente neumocócica conjugada en pacientes con artritis reumatoide recibiendo upadacitinib: resultados de un estudio abierto de extensión de fase 2

RMD Open. 2022;8(1):e002110 doi: 10.1136/rmdopen-2021-002110

Winthrop K,

Vargas JI,

Drescher E,

Garcia C,

Friedman A,

Hendrickson B,

Li Y,

Klaff J,

Kivitz A

Vaccine sub-study of the BALANCE-EXTEND upadacitinib trial finds that approximately two-thirds of patients receiving upadacitinib 15 mg once-daily achieve a satisfactory humoral response to pneumococcal 13-valent conjugate (PCV-13) vaccine, despite receiving concomitant methotrexate (MTX).It is well known that a weakened immune response, comorbidities and immunosuppressant drug therapy all contribute to an increased susceptibility to infections in patients with RA. Likewise, the morbidity and mo...

Keywords:

• JAK,
• Updacitinib,
• Vaccination

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

Ann Rheum Dis. 2020 10.1136/annrheumdis-2019-216566

Winthrop KL,

Wouters A,

Choy EH,

Chen C,

Biswas P,

Wang L,

Soma K,

Needle E,

Valdez H,

Rigby WFC

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 at ...

Keywords:

• JAK,
• Tofacitinib,
• Vaccination

Vacuna Viva Zoster en Pacientes con Artritis Reumatoide Tratados con Tofacitinib con o sin Metotrexato, o Adalimumab con Metotrexato

Arthritis Care and Research 2019 DOI: 10.1002/acr.24010

Calabrese LH,

Abud-Mendoza C,

Lindsey SM,

Lee SH,

Tatulych S,

Takiya L,

Iikuni N,

Soma K,

Luo Z,

Fleischmann R

Live zoster vaccine (LZV) was well tolerated, and herpes zoster (HZ) incidence rates were generally similar between treatment groups in vaccinated versus non-vaccinated patients in a subset of RA who received LZV before TOF ± MTX, or ADA + MTX, in ORAL Strategy. It is known that patient with RA are at increased risk of developing HZ though the mechanisms behind this are currently not well understood though therapies, such as TOF, are thought to increase the risk. ACR and EULAR recommend using LZ...

Keywords:

• JAK,
• Tofacitinib,
• Vaccination

Evaluación de las Respuestas Vacunales Neumocócica y Antitetánica en Pacientes con Artritis Reumatoide recibiendo Baricitinib: Resultados de un Subestudiode Extensión

Arthritis Res Ther. 2019 Apr 18;21(1):102

Winthrop KL,

Bingham CO III,

Komocsar WJ,

Bradley J,

Issa M,

Klar R,

Kartman CE

Approximately two thirds of long-term BARI treated patients achieved satisfactory humoral and functional responses to 13-serotype pneumococcal conjugate vaccine (PCV-13), whereas tetanus toxoid vaccine (TTV) responses were less robust. Both RA management guidelines and recommendations suggest vaccinating patients with RA against pneumococcal disease with PCV-13 and PPSV-23. The inhibition of the JAK mediated signal transduction pathways in RA treatment could diminish vaccine responses. Given the...

Keywords:

• JAK,
• Baricitinib,
• Vaccination

Herpes Zoster con Tofacitinib está aún más Aumentado con Glucocorticoides pero no con Metotrexate

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

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

Arthritis Rheumatol. 2017 Oct;69(10):1969-1977. doi: 10.1002/art.40187

Winthrop KL,

Wouters A,

Choy E,

Soma K,

Hodge J,

Nduaka C,

Biswas P,

Needle E,

Passador MS,

Mojcik C,

Rigby W

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, 2–3 weeks aft...

Keywords:

• JAK,
• Tofacitinib,
• Vaccination,
• Infections

Herpes Zoster y Tofacitinib en Pacientes con Artritis Reumatoide

Arthritis Rheumatol 2014;66:2675–84

Winthrop KL,

Yamanaka H,

Valdez H,

Mortensen E,

Chew R,

Krishnaswami S,

Kawabata T,

Riese R

Patients who were treated with tofacitinib in the RA clinical development programme were more likely to develop herpes zoster than were those who received placebo.Cases of herpes zoster reported by investigators in the Phase 2, Phase 3 and long-term extension studies of tofacitinib were evaluated. Herpes zoster was noted in 5% of tofacitinib-treated patients; only 7% of these cases were serious, no patients with herpes zoster died and only 10% permanently discontinued tofacitinib treatment.The o...

Keywords:

• JAK,
• Tofacitinib,
• Infections

The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis

Ann Rheum Dis. 2015 Mar 20. pii: annrheumdis-2014-207191. doi: 10.1136/annrheumdis-2014-207191. [Epub ahead of print]

Winthrop KL,

Silverfield J,

Racewicz A,

Neal J,

Lee EB,

Hrycaj P,

Gomez-Reino J,

Soma K,

Mebus C,

Wilkinson B,

Hodge J,

Fan H,

Wang T,

Bingham CO 3rd.

The increased risk of serious infection among RA patients means vaccinations against pneumococcus and influenza are recommended in this group of patients. Studies evaluating immune response to these vaccines in conjunction with DMARD therapy can provide clinicians with important information relating to things such as timing of vaccination.

This study aimed to assess the effect of tofacitinib on vaccine responses to PPSV-23 and the trivalent seasonal influenza vaccine in those whom tofacit...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Vaccination