Association Between Severe Nonadherence to Hydroxychloroquine and Systemic Lupus Erythematosus Flares, Damage, and Mortality in 660 Patients From the SLICC Inception Cohort
(2023) In Arthritis and Rheumatology 75(12). p.2195-2206- Abstract
Objective: The goals of this study were to assess the associations of severe nonadherence to hydroxychloroquine (HCQ), objectively assessed by HCQ serum levels, and risks of systemic lupus erythematosus (SLE) flares, damage, and mortality rates over five years of follow-up. Methods: The Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort is an international multicenter initiative (33 centers throughout 11 countries). The serum of patients prescribed HCQ for at least three months at enrollment were analyzed. Severe nonadherence was defined by a serum HCQ level <106 ng/mL or <53 ng/mL for HCQ doses of 400 or 200 mg/day, respectively. Associations with the risk of a flare (defined as a Systemic Lupus... (More)
Objective: The goals of this study were to assess the associations of severe nonadherence to hydroxychloroquine (HCQ), objectively assessed by HCQ serum levels, and risks of systemic lupus erythematosus (SLE) flares, damage, and mortality rates over five years of follow-up. Methods: The Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort is an international multicenter initiative (33 centers throughout 11 countries). The serum of patients prescribed HCQ for at least three months at enrollment were analyzed. Severe nonadherence was defined by a serum HCQ level <106 ng/mL or <53 ng/mL for HCQ doses of 400 or 200 mg/day, respectively. Associations with the risk of a flare (defined as a Systemic Lupus Erythematosus Disease Activity Index 2000 increase ≥4 points, initiation of prednisone or immunosuppressive drugs, or new renal involvement) were studied with logistic regression, and associations with damage (first SLICC/American College of Rheumatology Damage Index [SDI] increase ≥1 point) and mortality with separate Cox proportional hazard models. Results: Of the 1,849 cohort participants, 660 patients (88% women) were included. Median (interquartile range) serum HCQ was 388 ng/mL (244–566); 48 patients (7.3%) had severe HCQ nonadherence. No covariates were clearly associated with severe nonadherence, which was, however, independently associated with both flare (odds ratio 3.38; 95% confidence interval [CI] 1.80–6.42) and an increase in the SDI within each of the first three years (hazard ratio [HR] 1.92 at three years; 95% CI 1.05–3.50). Eleven patients died within five years, including 3 with severe nonadherence (crude HR 5.41; 95% CI 1.43–20.39). Conclusion: Severe nonadherence was independently associated with the risks of an SLE flare in the following year, early damage, and five-year mortality. (Figure presented.).
(Less)
- author
- organization
- publishing date
- 2023-12
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Arthritis and Rheumatology
- volume
- 75
- issue
- 12
- pages
- 12 pages
- publisher
- John Wiley & Sons Inc.
- external identifiers
-
- pmid:37459273
- scopus:85171781248
- ISSN
- 2326-5191
- DOI
- 10.1002/art.42645
- language
- English
- LU publication?
- yes
- id
- 5abe1ce8-efbe-4d45-bf2d-fb72f16334e4
- date added to LUP
- 2024-01-15 11:11:34
- date last changed
- 2024-04-16 03:00:02
@article{5abe1ce8-efbe-4d45-bf2d-fb72f16334e4, abstract = {{<p>Objective: The goals of this study were to assess the associations of severe nonadherence to hydroxychloroquine (HCQ), objectively assessed by HCQ serum levels, and risks of systemic lupus erythematosus (SLE) flares, damage, and mortality rates over five years of follow-up. Methods: The Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort is an international multicenter initiative (33 centers throughout 11 countries). The serum of patients prescribed HCQ for at least three months at enrollment were analyzed. Severe nonadherence was defined by a serum HCQ level <106 ng/mL or <53 ng/mL for HCQ doses of 400 or 200 mg/day, respectively. Associations with the risk of a flare (defined as a Systemic Lupus Erythematosus Disease Activity Index 2000 increase ≥4 points, initiation of prednisone or immunosuppressive drugs, or new renal involvement) were studied with logistic regression, and associations with damage (first SLICC/American College of Rheumatology Damage Index [SDI] increase ≥1 point) and mortality with separate Cox proportional hazard models. Results: Of the 1,849 cohort participants, 660 patients (88% women) were included. Median (interquartile range) serum HCQ was 388 ng/mL (244–566); 48 patients (7.3%) had severe HCQ nonadherence. No covariates were clearly associated with severe nonadherence, which was, however, independently associated with both flare (odds ratio 3.38; 95% confidence interval [CI] 1.80–6.42) and an increase in the SDI within each of the first three years (hazard ratio [HR] 1.92 at three years; 95% CI 1.05–3.50). Eleven patients died within five years, including 3 with severe nonadherence (crude HR 5.41; 95% CI 1.43–20.39). Conclusion: Severe nonadherence was independently associated with the risks of an SLE flare in the following year, early damage, and five-year mortality. (Figure presented.).</p>}}, author = {{Nguyen, Yann and Blanchet, Benoît and Urowitz, Murray B. and Hanly, John G. and Gordon, Caroline and Bae, Sang Cheol and Romero-Diaz, Juanita and Sanchez-Guerrero, Jorge and Clarke, Ann E. and Bernatsky, Sasha and Wallace, Daniel J. and Isenberg, David A. and Rahman, Anisur and Merrill, Joan T. and Fortin, Paul R. and Gladman, Dafna D. and Bruce, Ian N. and Petri, Michelle and Ginzler, Ellen M. and Dooley, Mary Anne and Ramsey-Goldman, Rosalind and Manzi, Susan and Jönsen, Andreas and Alarcón, Graciela S. and Van Vollenhoven, Ronald F. and Aranow, Cynthia and Le Guern, Véronique and Mackay, Meggan and Ruiz-Irastorza, Guillermo and Lim, S. Sam and Inanc, Murat and Kalunian, Kenneth C. and Jacobsen, Søren and Peschken, Christine A. and Kamen, Diane L. and Askanase, Anca and Buyon, Jill and Costedoat-Chalumeau, Nathalie}}, issn = {{2326-5191}}, language = {{eng}}, number = {{12}}, pages = {{2195--2206}}, publisher = {{John Wiley & Sons Inc.}}, series = {{Arthritis and Rheumatology}}, title = {{Association Between Severe Nonadherence to Hydroxychloroquine and Systemic Lupus Erythematosus Flares, Damage, and Mortality in 660 Patients From the SLICC Inception Cohort}}, url = {{http://dx.doi.org/10.1002/art.42645}}, doi = {{10.1002/art.42645}}, volume = {{75}}, year = {{2023}}, }