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Article: ANCA Associated Vasculitis Subtypes: Response [Letter].

Merkel, Peter A / Jayne, David R W / Bekker, Pirow

2022 Volume 15, Page(s) 5161–5162

Language	English
Publishing date	2022-09-09
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2494878-0
ISSN	1178-7031
ISSN	1178-7031
DOI	10.2147/JIR.S385293
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Article ; Online: Reply.

Chung, Sharon A / Seo, Philip / Merkel, Peter A / Langford, Carol A

Arthritis & rheumatology (Hoboken, N.J.)

2022 Volume 74, Issue 3, Page(s) 545–546

Language	English
Publishing date	2022-01-13
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.41991
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Article ; Online: Response to: 'Correspondence on 'Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis'' by Parikh

Smith, Rona M / Merkel, Peter A / Jayne, David

Annals of the rheumatic diseases

2021 Volume 82, Issue 1, Page(s) e24

MeSH term(s)	Humans ; Rituximab/therapeutic use ; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy ; Immunosuppressive Agents ; Recurrence ; Remission Induction ; Granulomatosis with Polyangiitis ; Antibodies, Antineutrophil Cytoplasmic ; Treatment Outcome
Chemical Substances	Rituximab (4F4X42SYQ6) ; Immunosuppressive Agents ; Antibodies, Antineutrophil Cytoplasmic
Language	English
Publishing date	2021-02-04
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/annrheumdis-2020-219329
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Article ; Online: Reduced-Dose vs High-Dose Glucocorticoids Added to Rituximab and Remission Induction in ANCA-Associated Vasculitis.

Jayne, David R W / Merkel, Peter A / Bekker, Pirow

JAMA

2021 Volume 326, Issue 15, Page(s) 1536

MeSH term(s)	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy ; Glucocorticoids ; Humans ; Remission Induction ; Rituximab
Chemical Substances	Glucocorticoids ; Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2021-10-19
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2021.13873
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Article ; Online: Avacopan for the Treatment of ANCA-Associated Vasculitis. Reply.

Jayne, David R W / Merkel, Peter A / Bekker, Pirow

The New England journal of medicine

2021 Volume 384, Issue 21, Page(s) e81

MeSH term(s)	Aniline Compounds ; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy ; Humans ; Nipecotic Acids
Chemical Substances	Aniline Compounds ; Nipecotic Acids ; avacopan (O880NM097T)
Language	English
Publishing date	2021-05-27
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2104672
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Article ; Online: Patient-Reported Sinonasal Symptoms and Risk of Relapse in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis.

Romich, Ellen / Banerjee, Shubhasree / Amudala, Naomi / Chou, Sherry / Li, Ruolan / Lee, Hongzhe / Cohen, Noam / Merkel, Peter A / Rhee, Rennie L

Arthritis care & research

2024

Abstract: Objective: Relapses are frequent and difficult to predict in antineutrophil cytoplasmic antibody-associated vasculitis (AAV), resulting in long-term use of immunosuppression. Although sinonasal disease is associated with relapse of AAV, detailed ... ...

Abstract	Objective: Relapses are frequent and difficult to predict in antineutrophil cytoplasmic antibody-associated vasculitis (AAV), resulting in long-term use of immunosuppression. Although sinonasal disease is associated with relapse of AAV, detailed characterization of sinonasal symptoms is lacking. Using a patient-reported outcome, the 22-item SinoNasal Outcome Test (SNOT-22), we investigated the relationship between sinonasal symptoms and disease activity in AAV. Methods: This was a prospective, longitudinal study of individual with AAV and healthy individuals. Relapse was defined as a Birmingham Vasculitis Activity Score for Wegner's Granulomatosis score >0. Higher SNOT-22 scores indicate worse symptoms. Generalized estimating equation and Cox proportional hazard models evaluated the association between SNOT-22 and relapse. Results: There were 773 visits (106 active disease visits) from 168 patients with AAV and 51 controls. Median SNOT-22 at remission was higher in AAV versus controls (20 vs 5; P < 0.001) and higher during active disease versus remission (P < 0.001). In all AAV, and particularly within granulomatosis with polyangiitis, higher SNOT-22 scores were observed months to years before relapse and were associated with increased risk of relapse (hazard ratio 2.7, 95% confidence interval 1.2-6.2; P = 0.02). Similar findings were seen when examining patients with versus without sinonasal disease and after removing relapses limited to the ear, nose, and throat. Conclusion: A patient-reported outcome measure of sinonasal disease, the SNOT-22, not only changes with disease activity in AAV, but also is associated with a higher risk of relapse within two years. These findings support the possibility that the SNOT-22 score may enhance prediction of relapse and that persistent sinonasal disease may be important in the pathophysiology of relapse.
Language	English
Publishing date	2024-03-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	645059-3
ISSN	2151-4658 ; 0893-7524 ; 2151-464X
ISSN (online)	2151-4658
ISSN	0893-7524 ; 2151-464X
DOI	10.1002/acr.25329
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Zs.A 2446: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Myocardial infarction in a population-based cohort of patients with biopsy-confirmed giant cell arteritis in southern Sweden.

Stamatis, Pavlos / Mohammad, Moman Aladdin / Gisslander, Karl / Merkel, Peter A / Englund, Martin / Turesson, Carl / Erlinge, David / Mohammad, Aladdin J

RMD open

2024 Volume 10, Issue 2

Abstract: Objectives: To determine the incidence rate (IR) of myocardial infarction (MI), relative risk of MI, and impact of incident MI on mortality in individuals with biopsy-confirmed giant cell arteritis (GCA).: Methods: MIs in individuals diagnosed with ... ...

Abstract	Objectives: To determine the incidence rate (IR) of myocardial infarction (MI), relative risk of MI, and impact of incident MI on mortality in individuals with biopsy-confirmed giant cell arteritis (GCA). Methods: MIs in individuals diagnosed with GCA 1998-2016 in Skåne, Sweden were identified by searching the SWEDEHEART register, a record of all patients receiving care for MI in a coronary care unit (CCU). The regional diagnosis database, with subsequent case review, identified GCA patients receiving care for MI outside of a CCU. A cohort of 10 reference subjects for each GCA case, matched for age, sex and area of residence, was used to calculate the incidence rate ratio (IRR) of MI in GCA to that in the general population. Results: The GCA cohort comprised 1134 individuals. During 7958 person-years of follow-up, 102 were diagnosed with incident MI, yielding an IR of 12.8 per 1000 person-years (95% CI 10.3 to 15.3). The IR was highest in the 30 days following GCA diagnosis and declined thereafter. The IRR of MI in GCA to that of the background population was 1.29 (95% CI 1.05 to 1.59). Mortality was higher in GCA patients who experienced incident MI than in those without MI (HR 2.8; 95% CI 2.2 to 3.6). Conclusions: The highest incidence of MI occurs within the 30 days following diagnosis of GCA. Individuals with GCA have a moderately increased risk of MI compared with a reference population. Incident MI has a major impact on mortality in GCA.
MeSH term(s)	Humans ; Giant Cell Arteritis/complications ; Giant Cell Arteritis/diagnosis ; Giant Cell Arteritis/epidemiology ; Sweden/epidemiology ; Myocardial Infarction/diagnosis ; Myocardial Infarction/epidemiology ; Myocardial Infarction/etiology ; Biopsy
Language	English
Publishing date	2024-04-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2812592-7
ISSN	2056-5933 ; 2056-5933
ISSN (online)	2056-5933
ISSN	2056-5933
DOI	10.1136/rmdopen-2023-003960
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Article ; Online: Risk of Relapse of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis in a Randomized Controlled Trial of Plasma Exchange and Glucocorticoids.

Junek, Mats L / Merkel, Peter A / Vilayur, Eswari / Wald, Ron / Khalidi, Nader / Jayne, David / Walsh, Michael

Arthritis & rheumatology (Hoboken, N.J.)

2024

Abstract: Objective: Relapses of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis are important events that can cause organ dysfunction and reduce quality of life. Understanding the effects of the initial treatments for ANCA-associated vasculitis ... ...

Abstract	Objective: Relapses of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis are important events that can cause organ dysfunction and reduce quality of life. Understanding the effects of the initial treatments for ANCA-associated vasculitis on the subsequent risk of relapse may help guide monitoring and treatment. Methods: We performed a post hoc analysis of participants with severe ANCA-associated vasculitis enrolled in an international two-by-two factorial randomized controlled trial comparing the effects of plasma exchange (PLEX) to no PLEX and a regimen of reduced glucocorticoid exposure to a standard regimen. We estimated the effects of treatments on relapses of any severity using three competing risk time-to-event models adjusted for patient and disease characteristics and other treatments. Each model was adjusted for disease manifestations in different ways. Results: Of 704 participants, 649 (92.2%) achieved remission and 147 (22.7%) experienced 204 relapses. The relapse rate was 10.3 (95% confidence interval [CI] 8.4-12.1) relapses per 100 patient-years. Neither the use of PLEX (subhazard ratio 0.91-0.94; 95% CIs range from 0.66 to 1.31) nor a glucocorticoid regimen (subhazard ratio 0.93-0.94; 95% CIs range from 0.67 to 1.35) appreciably changed the risk of relapse. Proteinase 3-ANCA and the presence of nonhemorrhagic respiratory manifestations of the disease at trial entry were associated with increased risks of relapse. Receiving dialysis at baseline and administration of oral cyclophosphamide as induction therapy were associated with lower risks of relapse. Conclusion: In patients with severe ANCA-associated vasculitis, relapses remain common; neither the use of PLEX nor an initial glucocorticoid tapering regimen impacted relapse risk.
Language	English
Publishing date	2024-03-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.42843
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Article ; Online: The impact of treatment with avacopan on health-related quality of life in antineutrophil cytoplasmic antibody-associated vasculitis: a post-hoc analysis of data from the ADVOCATE trial.

Strand, Vibeke / Jayne, David R W / Horomanski, Audra / Yue, Huibin / Bekker, Pirow / Merkel, Peter A

The Lancet. Rheumatology

2023 Volume 5, Issue 8, Page(s) e451–e460

Abstract: Background: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis is characterised by inflammation and destruction of small to medium sized blood vessels. In the previously reported ADVOCATE study, a phase 3 double-blind, double-dummy ... ...

Abstract	Background: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis is characterised by inflammation and destruction of small to medium sized blood vessels. In the previously reported ADVOCATE study, a phase 3 double-blind, double-dummy randomised controlled trial of patients with newly diagnosed or relapsing ANCA-associated vasculitis, the oral selective complement 5a receptor inhibitor avacopan was shown to be non-inferior with regard to remission induction at week 26 and superior with regard to sustained remission at week 52, compared with a prednisone taper in a standard of care regimen. In this Article, we report an in-depth analysis of prespecified and exploratory patient-reported outcomes from the ADVOCATE study, measuring health-related quality of life and health utilities. Methods: We did a post-hoc analysis of patient-reported outcome data from the ADVOCATE study (NCT02994927) of patients with newly diagnosed or relapsing ANCA-associated vasculitis. We analysed summary scores and individual domain scores for the prespecified health-related quality of life outcomes from ADVOCATE, which were evaluated at weeks 26 and 52 by use of the Medical Outcomes Survey 36-Item Short Form Health Survey (SF-36) version 2, the EuroQol 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L), and the EQ-5D health utility measure, assessed in the modified intention-to-treat population. We also calculated the Short Form 6 Dimension (SF-6D) score as an additional health utility measure. We evaluated the proportion of patients who reported scores that met or exceeded minimum clinically important differences in health-related quality of life, and we compared scores to normative values (age-specific and sex-specific scores from healthy populations from the USA matched to the protocol population). We also evaluated the proportion of patients who reported scores that met or exceeded minimum important difference in health utility scores. Findings: 331 patients were enrolled in the ADVOCATE trial, of whom 166 were in the avacopan group and 165 were in the prednisone standard of care group. In the avacopan group, the mean age was 61·2 years (SD 14·6), 98 (59%) of 166 patients were men, 68 (41%) were women, and 138 (83%) were White; in the prednisone group, the mean age was 60·5 years (14·5), 88 (54%) of 164 patients were men, 76 (46%) were women, and 140 (85%) were White. Patients treated with avacopan received approximately 2500 mg less median total prednisone up to week 52. Least squares means difference from baseline in physical component summary scores were significantly greater in patients in the avacopan group compared with those in the prednisone group at weeks 26 and 52, as well as in five of eight SF-36 domains at week 26 and two of eight SF-36 domains at week 52. The proportion of patients reporting scores equal to or greater than normative values was higher in the avacopan group than in the prednisone group across all SF-36 domains at both week 26 and 52, although the differences were not statistically significant with the exception of the role physical and vitality domains at week 26. Least squares means change from baseline in EQ-5D-5L visual analogue scale, EQ-5D health utility scores, and SF-6D health utility scores were significantly greater at week 52 in the avacopan group compared with the prednisone group. Interpretation: Patients with ANCA-associated vasculitis who received avacopan reported statistically significant and clinically meaningful improvements in health-related quality of life at 26 and 52 weeks and in health utility EQ-5D and SF-6D scores at 52 weeks. These patient-reported outcomes complement investigator assessments and support the efficacy of avacopan in patients with ANCA-associated vasculitis with use of lower prednisone doses. Funding: ChemoCentryx.
MeSH term(s)	Female ; Humans ; Male ; Middle Aged ; Aniline Compounds ; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy ; Antibodies, Antineutrophil Cytoplasmic ; Nipecotic Acids ; Prednisone/therapeutic use ; Quality of Life ; Double-Blind Method
Chemical Substances	Aniline Compounds ; Antibodies, Antineutrophil Cytoplasmic ; avacopan (O880NM097T) ; Nipecotic Acids ; Prednisone (VB0R961HZT)
Language	English
Publishing date	2023-07-24
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(23)00092-9
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Article ; Online: Reply.

Tian, Xinping / Li, Mengtao / Jiang, Nan / Merkel, Peter A / Zeng, Xiaofeng

Arthritis & rheumatology (Hoboken, N.J.)

2023 Volume 75, Issue 10, Page(s) 1871–1873

Language	English
Publishing date	2023-07-28
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.42532
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