Effect of Disease Activity at Three and Six Months After Diagnosis on Long-Term Outcomes in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis.

Abstract

OBJECTIVE:

The treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) aims to suppress disease activity and prevent subsequent disease flare. This study sought to explore the association of early disease control with long-term outcomes to validate early disease control as an end point for future clinical trials in AAV.

METHODS:

Data from 4 European Vasculitis Society inception clinical trials in AAV (1995-2002) and subsequent data on long-term outcomes from the trial data registry were studied. Clinical parameters in patients with AAV at baseline and at 3 and 6 months after diagnosis were assessed to study the long-term risk of death and end-stage renal failure (ESRF). At 6 months, outcomes were defined based on a disease status of either sustained remission (remission by 3 months, sustained to 6 months), late remission (remission after 3 months and by 6 months), relapsing disease (remission by 3 months but relapse by 6 months), or refractory disease (no remission by 6 months).

RESULTS:

Of the 354 patients with AAV who were followed up for a median of 5.7 years, 46 (13%) developed ESRF, 66 (18.6%) died, and 89 (25.1%) had either died or developed ESRF. At 6 months, predictors of the composite end point of death or ESRF were as follows: age (hazard ratio [HR] 1.02, 95% confidence interval [95% CI] 1-1.05; P = 0.012), estimated glomerular filtration rate (HR 0.94, 95% CI 0.92-0.95; P < 0.001), and disease status at 6 months (late remission, HR 2.94, 95% CI 1.1-7.85 [P = 0.031]; relapsing disease, HR 8.21, 95% CI 2.73-24.65 [P < 0.001]; refractory disease, HR 4.89, 95% CI 1.96-12.18 [P = 0.001]). Similar results were observed when these analyses were performed separately for death and for ESRF.

CONCLUSION:

The results of this study suggest that disease status at 3 and 6 months following the diagnosis of AAV may be predictive of the long-term risk of mortality and ESRF, and therefore these may be valid end points for induction trials in AAV. The current findings need to be validated in a larger data set.

• Authors: Seerapani Gopaluni, Oliver Flossmann, Mark A Little, Paul O'Hara, Pirow Bekker, David Jayne, European Vasculitis Society
• Journal: Arthritis & rheumatology (Hoboken, N.J.) (Arthritis Rheumatol) Vol. 71 Issue 5 Pg. 784-791 (05 2019) ISSN: 2326-5205 [Electronic] United States
• PMID: 30418705 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2018, American College of Rheumatology.

Chemical References

• Immunosuppressive Agents

Topics

• Adult
• Age Factors
• Aged
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (mortality, physiopathology, therapy)
• Female
• Glomerular Filtration Rate
• Humans
• Immunosuppressive Agents (therapeutic use)
• Kidney Failure, Chronic (epidemiology)
• Male
• Middle Aged
• Mortality
• Plasma Exchange
• Prognosis
• Proportional Hazards Models
• Recurrence
• Remission Induction
• Severity of Illness Index