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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ.
Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ.
Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.
On November 19, 2025, the institutional Ethics Committee approved an amendment to extend the project's timeframe to evaluate the following hypothesis:
- Immunosuppression may hamper 5-year long-term sustainability of humoral and cellular immune responses to RZV in ARD patients.
No new patients will be recruited, nor will any new intervations be performed. ARD patients previously included in the study and non-immunosuppressed control subjects who received both vaccine doses and collected samples for immunogenicity 6 weeks and one year after the second dose will be part of the proposed extension. A total of 1,025 ARD patients enrolled and 365 healthy controls will be included in the long-term follow-up phase. Considering a conservative 10% dropout, the final patient sample will be approximately 1,000.
Ethical statement: The extension protocol was approved by the institutional Ethics Committee (report 7.988.896), and written consent will be obtained from all participants prior to inclusion. Humoral immunogenicity will be evaluated by analyzing the serum concentrations of anti-gE antibodies (ELISA) of blood samples collected from participants at 5-year after complete VZR vaccination, as previously described (Cunningham et al., 2018). Cellular immunogenicity will be evaluated in a convenience sample (20% of the total research participants) of patients with ARDs and healthy controls at 5-year after complete VZR vaccination. Vaccine efficacy will be evaluated by incident cases of HZ in the period of 5 years after RZV vaccination. Participants will be followed for 5 years after the second RZV dose through monthly contacts and routine clinical visits every 3-6 months.
Methods:
Subproject A: This is a phase 4 randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart. A control group of non-immunosuppressed individuals (CG) aged ≥ 50 years will also be included, in the proportion of 3 patients:1 control. Patients with ARDs will be randomly allocated into two groups: P1 and P2. CG and P1 will receive the vaccine soon after randomization, on D0 and D42. P2 will be vaccinated 12 weeks after randomization, on D84 and D126. All groups will collect blood samples immediately before vaccination, at baseline, and then receive the 1st dose of vaccine on the same day (D0 for CG and P1, and D84 for P2). The second dose will be applied 6 weeks after the first dose (D42 for P1 and CG, and D126 for P2). Blood samples for disease activity and immunogenicity will be collected 6 weeks after the 2nd dose (D84 for CG and P1 and D168 for P2). The influence of vaccination on disease activity will be evaluated in the first three months of follow-up through disease-specific activity indices. Safety analysis regarding adverse effects (AEs) of the vaccine will be performed using standardized questionnaires on D42 and D84 for CG and P1 and on D126 and D168 for P2. Severe AEs and incident cases of HZ will be evaluated throughout the study period. The persistence of immunogenicity will be evaluated one year after the 2nd dose (D407 for CG and P1, and D491 for P2).
Subproject B: Specific studies will also be carried out to evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance), with assessments of immunogenicity and disease activity. The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose). Based on a recently published study (Petri et al., 2023), discontinuation time of the MMF after each vaccine dose was reduced from two weeks to one week. In fact, these authors observed in a cohort of 334 patients with systemic lupus erythematosus that discontinuing MMF for one week after vaccination against COVID-19 (mRNA vaccine) improved vaccine efficacy without leading to exacerbations of the underlying disease (Petri et al., 2023). Thus, we considered it appropriate to reduce the MMF discontinuation time to one week after each dose of the recombinant vaccine for herpes zoster in our population of patients with autoimmune rheumatic diseases.
Total population: The total population will consist of 2005 participants comprising 1180 patients with ARDs (590 in P1 and 590 in P2), 393 healthy controls. 202 patients on the MTX maintenance/discontinuation RA protocol for two weeks after each vaccine dose, and 230 patients with ARDs on the MMF maintenance/discontinuation protocol for one week after each vaccine dose.
Immunogenicity analysis: Humoral immunogenicity will be evaluated through serum concentrations of anti-gE antibodies [enzyme-linked immunosorbent assay (ELISA)] of blood samples collected from participants pre-vaccination, 2 months and one year after the second dose of RZV. The frequencies of gE-specific CD4[2+] T cells will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of the total number of participants) from patients with ARDs and healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subproject A: Patients with ARDs who received the vaccine at study entry (P1) | Active Comparator | Patients with ARDs who received the vaccine at study entry (P1) (n = 590). ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126. |
|
| Subproject A: Patients with ARDs who received the placebo at study entry (P2) | Placebo Comparator | Subproject A: Patients with ARDs who received the placebo at study entry (P2) (n = 590). ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126. |
|
| Subproject A: Control group of non-immunosuppressed individuals (CG) | Active Comparator | Subproject A: Control group of non-immunosuppressed individuals (CG) (n = 393). The control group of non-immunosuppressed individuals (CG) (≥50 years old) will be invited to receive the vaccine at study entry (3 patients:1 control). |
|
| Subproject B: MTX-withhold |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Herpes Zoster Vaccine (RZV) | Biological | RZV comprise 50 μg of recombinant VZV glycoprotein E and the liposome-based AS01B adjuvant system (which contains 50 μg of 3-O-desacyl-4'-monophosphoryl lipid A [MPL] and 50 μg of Quillaja saponaria Molina, fraction 21 (QS21, licensed by GSK from Antigenics, a subsidiary of Agenus)). Vaccine will be administered (0.5 ml) into the deltoid muscle at inclusion and 6 weeks (two doses). |
| Measure | Description | Time Frame |
|---|---|---|
| Subproject A: Disease safety (flare) in ARD patients immunized with RZV in comparison to non-vaccinated ARD patients (placebo group) | Flare will be defined as a new flare or worsening of previous disease activity according to established scores for each ARD or the change of therapy. Disease activity will be evaluated in ARD patients according to specific standardized disease activity indexes: RA (DAS28 - Disease Activity Score 28, RA-CDAI - Rheumatoid Arthritis Clinical Disease Activity Index), SLE (SLEDAI2K - Systemic Lupus Erythematosus Disease Activity Index 2000), pSS (ESSDAI- EULAR Sjögren's Syndrome Disease Activity Index), IIM (MMT - Manual Muscle Test), AxS (ASDAS - Ankylosing Spondylitis Disease Activity Score), and vasculitis (Birmingham Vasculitis Activity Score). | Six months |
| Subproject B: Effect of MTX discontinuation on immunogenicity in comparison to MTX maintenance | Humoral immunogenicity will be assessed through serum anti-gE antibody concentrations analysis (ELISA) of blood samples collected from participants at pre-vaccination, 6 weeks, and one-year after the second dose of RZV. The frequencies of gE-specific CD4[2+] T cells (CD4+ T-cells expressing at least 2 activation markers of the 4 markers assessed: interferon-γ, interleukin 2, tumor necrosis factor-α, and CD40 ligand) will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of total research participants). | One year |
| Subproject B: Effect of MMF discontinuation on immunogenicity in comparison to MMF maintenance | Humoral immunogenicity will be assessed through serum anti-gE antibody concentrations analysis (ELISA) of blood samples collected from participants at pre-vaccination, 6 weeks, and one-year after the second dose of RZV. The frequencies of gE-specific CD4[2+] T cells (CD4+ T-cells expressing at least 2 activation markers of the 4 markers assessed: interferon-γ, interleukin 2, tumor necrosis factor-α, and CD40 ligand) will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of total research participants). |
| Measure | Description | Time Frame |
|---|---|---|
| Subproject A: Incidence of vaccine adverse events [safety and tolerability] in ARD patients immunized with RZV in comparison to non-vaccinated ARD patients (placebo group) and non-immunosupressed controls (control group) | A standardized diary card of AEs for recording of solicited local and systemic manifestations will be systematically provided to all patients and healthy controls collected for 7 days post each vaccination. Unsolicited AEs will be recorded within 6 weeks post each vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) [potential immune mediated disorder (pIMDs)] will be evaluated throughout the entire study duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Subproject A: Incident cases of HZ after RZV vaccination in ARD patients and in the non-immunosupressed control group | A suspected case of HZ will be defined as (1) a new unilateral, dermatomal, rash with pain (broadly defined to include allodynia, pruritus, or other abnormal sensations) without any alternative diagnosis or (2A) or a vesicular rash suggestive of varicella zoster virus infection regardless of the distribution, and no alternative diagnosis; without any alternative diagnosis. For each suspected case, the rash will be photographed and samples will be collected from three lesions to confirm the diagnosis of HZ by real-time polymerase-chain reaction (PCR) assay. If the PCR results were indeterminate or if samples were not available, the final diagnosis will be determined by unanimous agreement among the five members of an ascertainment committee, which includes a dermatologist. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Division of Hospital das ClÃnicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35772416 | Background | Abhishek A, Boyton RJ, Peckham N, McKnight A, Coates LC, Bluett J, Barber V, Cureton L, Francis A, Appelbe D, Eldridge L, Julier P, Valdes AM, Brooks T, Rombach I, Altmann DM, Nguyen-Van-Tam JS, Williams HC, Cook JA; VROOM study investigators. Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial. Lancet Respir Med. 2022 Sep;10(9):840-850. doi: 10.1016/S2213-2600(22)00186-2. Epub 2022 Jun 27. | |
| 20872595 |
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Subproject A: Randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart or placebo.
Subproject B: Specific studies will evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance), with assessments of immunogenicity and disease activity. The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose).
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Subproject A: Randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart or placebo.
Subproject B: Specific studies will to evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance).
The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose).
| Active Comparator |
Subproject B: MTX-withhold (n = 101). Patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab, to be randomized into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain). |
|
| Subproject B: MTX-maintain | Active Comparator | Subproject B: MTX-maintain (n = 101). Patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab, to be randomized into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain). |
|
| Subproject B: MMF-withhold | Active Comparator | Subproject B: MMF-withhold (n = 115). Patients with ARDs using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for one week after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain). |
|
| Subproject B: MMF-maintain | Active Comparator | Subproject B: MMF-maintain (n = 115). Patients with ARDs using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for one week after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain). |
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|
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| MTX Discontinuation | Other | Evaluation of discontinuation of the use of methotrexate (MTX) for 2 weeks after each vaccine dose in ARD patients: patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain). |
|
| MMF Discontinuation | Other | Evaluation of discontinuation of the use of mycophenolate mofetil (MMF) for one week after each vaccine dose in ARD patients: patients using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for 2 weeks after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain). |
|
| Placebo | Other | Patients with ARDs who received the placebo at study entry (P2). ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126. |
|
| MTX maintain | Other | MTX dose will be held stable after the two vaccine doses for comparison of vaccine immunogenicity and disease activity with the MTX-withhold group. |
|
| MMF maintain | Other | MMF dose will be held stable after the two vaccine doses for comparison of vaccine immunogenicity and disease activity with the MMF-withhold group. |
|
| One year |
| Eighteen months |
| Subproject A: Humoral immunogenicity of the RZV in ARD patients in comparison to non-immunosupressed control group | Humoral immunogenicity will be assessed through serum anti-gE antibody concentrations analysis (ELISA) of blood samples collected from participants at pre-vaccination, 6 weeks, and one-year after the second dose of RZV. The frequencies of gE-specific CD4[2+] T cells (CD4+ T-cells expressing at least 2 activation markers of the 4 markers assessed: interferon-γ, interleukin 2, tumor necrosis factor-α, and CD40 ligand) will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of total research participants). | One year |
| Eighteen months |
| Background |
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| 22588741 | Background | Anderson JK, Zimmerman L, Caplan L, Michaud K. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S14-36. doi: 10.1002/acr.20621. No abstract available. |
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| 31399377 | Background | Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6. |
| 34127481 | Background | Furer V, Eviatar T, Zisman D, Peleg H, Paran D, Levartovsky D, Zisapel M, Elalouf O, Kaufman I, Meidan R, Broyde A, Polachek A, Wollman J, Litinsky I, Meridor K, Nochomovitz H, Silberman A, Rosenberg D, Feld J, Haddad A, Gazzit T, Elias M, Higazi N, Kharouf F, Shefer G, Sharon O, Pel S, Nevo S, Elkayam O. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis. 2021 Oct;80(10):1330-1338. doi: 10.1136/annrheumdis-2021-220647. Epub 2021 Jun 14. |
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| 18625618 | Background | Lukas C, Landewe R, Sieper J, Dougados M, Davis J, Braun J, van der Linden S, van der Heijde D; Assessment of SpondyloArthritis international Society. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Jan;68(1):18-24. doi: 10.1136/ard.2008.094870. Epub 2008 Jul 14. |
| 29079590 | Background | Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Torre IG, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project consortium, The Euromyositis register and The Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. Ann Rheum Dis. 2017 Dec;76(12):1955-1964. doi: 10.1136/annrheumdis-2017-211468. Epub 2017 Oct 27. |
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| 19054820 | Background | Mukhtyar C, Lee R, Brown D, Carruthers D, Dasgupta B, Dubey S, Flossmann O, Hall C, Hollywood J, Jayne D, Jones R, Lanyon P, Muir A, Scott D, Young L, Luqmani RA. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis. 2009 Dec;68(12):1827-32. doi: 10.1136/ard.2008.101279. Epub 2008 Dec 3. |
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| 20391500 | Background | Rider LG, Koziol D, Giannini EH, Jain MS, Smith MR, Whitney-Mahoney K, Feldman BM, Wright SJ, Lindsley CB, Pachman LM, Villalba ML, Lovell DJ, Bowyer SL, Plotz PH, Miller FW, Hicks JE. Validation of manual muscle testing and a subset of eight muscles for adult and juvenile idiopathic inflammatory myopathies. Arthritis Care Res (Hoboken). 2010 Apr;62(4):465-72. doi: 10.1002/acr.20035. |
| 19297344 | Background | Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. |
| 19561361 | Background | Seror R, Ravaud P, Bowman SJ, Baron G, Tzioufas A, Theander E, Gottenberg JE, Bootsma H, Mariette X, Vitali C; EULAR Sjogren's Task Force. EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis. 2010 Jun;69(6):1103-9. doi: 10.1136/ard.2009.110619. Epub 2009 Jun 28. |
| 32412669 | Background | Stevens E, Weinblatt ME, Massarotti E, Griffin F, Emani S, Desai S. Safety of the Zoster Vaccine Recombinant Adjuvanted in Rheumatoid Arthritis and Other Systemic Rheumatic Disease Patients: A Single Center's Experience With 400 Patients. ACR Open Rheumatol. 2020 Jun;2(6):357-361. doi: 10.1002/acr2.11150. Epub 2020 May 15. |
| 22089469 | Background | Tillett W, Costa L, Jadon D, Wallis D, Cavill C, McHugh J, Korendowych E, McHugh N. The ClASsification for Psoriatic ARthritis (CASPAR) criteria--a retrospective feasibility, sensitivity, and specificity study. J Rheumatol. 2012 Jan;39(1):154-6. doi: 10.3899/jrheum.110845. Epub 2011 Nov 15. |
| 24092682 | Background | van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424. |
| 30707761 | Background | Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1. |
| 30843046 | Background | Vink P, Ramon Torrell JM, Sanchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, Ortiz F, Campistol Plana JM, Fernandez Rodriguez AM, Rebollo Rodrigo H, Campins Marti M, Perez R, Gonzalez Roncero FM, Kumar D, Chiang YJ, Doucette K, Pipeleers L, Aguera Morales ML, Rodriguez-Ferrero ML, Secchi A, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Z-041 Study Group. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 2020 Jan 2;70(2):181-190. doi: 10.1093/cid/ciz177. |
| 12006334 | Background | Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjogren's Syndrome. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. doi: 10.1136/ard.61.6.554. |
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| 26990731 | Background | Yun H, Yang S, Chen L, Xie F, Winthrop K, Baddley JW, Saag KG, Singh J, Curtis JR. Risk of Herpes Zoster in Autoimmune and Inflammatory Diseases: Implications for Vaccination. Arthritis Rheumatol. 2016 Sep;68(9):2328-37. doi: 10.1002/art.39670. |
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| 36714913 | Background | Petri M, Joyce D, Haag K, Fava A, Goldman DW, Zhong D, Xiao S, Milstone A, Magder LS. Effect of Systemic Lupus Erythematosus and Immunosuppressive Agents on COVID-19 Vaccination Antibody Response. Arthritis Care Res (Hoboken). 2023 Sep;75(9):1878-1885. doi: 10.1002/acr.25094. Epub 2023 Mar 1. |
| 42294825 | Derived | Pasoto SG, Gorayeb THB, Luppino-Assad AP, Aikawa NE, Medeiros-Ribeiro AC, Kupa LVK, Borges BS, Shinjo SK, de Souza FHC, Miossi R, Bonfa E, Silva CA. Immunogenicity, Safety, and Determinants of Recombinant Zoster Vaccine Response in Idiopathic Inflammatory Myopathies: A Phase 4 Randomized Trial. Arthritis Care Res (Hoboken). 2026 Jun 15. doi: 10.1002/acr.80103. Online ahead of print. |
| 42261247 | Derived | Luppino-Assad AP, Mello RP, Medeiros-Ribeiro AC, Aikawa NE, Pasoto SG, Praxedes AC, Kupa LV, Miossi R, Sampaio-Barros PD, Borba EF, Bonfa E, Silva CA. Prospective evaluation of recombinant Herpes zoster vaccine in SSc: immunogenicity, safety and disease outcomes. Rheumatology (Oxford). 2026 Jun 3;65(6):keag294. doi: 10.1093/rheumatology/keag294. |
| 41932224 | Derived | Pasoto SG, Ribeiro TO, Aikawa NE, Medeiros-Ribeiro AC, Borges BDS, Franco AS, Silveira CGT, da Silva HC, Bonfa E, da Silva CAA. Lower magnitude of humoral response to recombinant herpes zoster vaccine in immunocompromised Sjogren's disease patients: evidence from a randomized double-blinded placebo-controlled trial. Semin Arthritis Rheum. 2026 Jun;78:152974. doi: 10.1016/j.semarthrit.2026.152974. Epub 2026 Mar 24. |
| 41679320 | Derived | Aikawa NE, Medeiros-Ribeiro AC, Pasoto SG, Kupa LVK, Seguro LPC, Luppino-Assad AP, Borba EF, Saad CGS, Yuki EFN, Andrade DCO, Shimabuco AY, Bonfiglioli KR, Domiciano DS, Moares JCB, Shinjo SK, Sampaio-Barros PD, Giardini HAM, de Oliveira JCS, Antonelli IPB, Mello RLP, Gorayeb TB, Farias LGN, Negrini AA, Chaer FGG, Praxedes ACSL, Lopes MH, Silva CA, Bonfa E. Recombinant herpes zoster vaccine in patients with autoimmune rheumatic diseases in Brazil: a double-blind, randomised, placebo-controlled, phase 4, non-inferiority study. Lancet Rheumatol. 2026 May;8(5):e363-e376. doi: 10.1016/S2665-9913(25)00313-3. Epub 2026 Feb 9. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D025241 | Spondylarthritis |
| D008180 | Lupus Erythematosus, Systemic |
| D012859 | Sjogren's Syndrome |
| D012595 | Scleroderma, Systemic |
| D009220 | Myositis |
| D056647 | Systemic Vasculitis |
| D001171 | Arthritis, Juvenile |
| D003882 | Dermatomyositis |
| D001528 | Behcet Syndrome |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012871 | Skin Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017285 | Polymyositis |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D017445 | Skin Diseases, Vascular |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided