Cost Consequence Analysis of Belimumab versus Standard of Care for the Management of Systemic Lupus Erythematosus in Saudi Arabia: A Retrospective Cohort Study
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Population
2.2. Statistical Analysis
2.3. Ethical Considerations
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | Belimumab (n = 15) | Standard of Care (SoC) (n = 41) | p-Value | Total (n = 56) |
---|---|---|---|---|
Age in yrs., (mean ± SD) | 34.54 ± 7.70 | 39.93 ± 10.95 | 0.0861 | 38.48 ± 10.40 |
Gender, (n, %) | ||||
Male | 1 (6.67) | 4 (9.76) | 0.7196 | 5 (8.93) |
Female | 14 (93.33) | 37 (90.24) | 51 (91.07) | |
Disease duration in years, (mean ± SD) | 12.40 ± 7.05 | 13.37 ± 6.02 | 0.6118 | 13.11 ± 6.26 |
Duration of therapy in months, (mean ± SD) | 10.00 ± 7.19 | 9.97 ± 3.03 | 0.9900 | 9.98 ± 4.45 |
Proteinuria, (n, %) | 1 (6.67) | 5 (12.20) | 0.5536 | 6 (10.71) |
Hypertension (HTN), (n, %) | 1 (6.67) | 6 (14.63) | 0.5879 | 7 (12.50) |
Hematuria, (n, %) | 1 (6.67) | 2 (4.88) | 0.7924 | 3 (5.36) |
Hemolytic anemia, (n, %) | 2 (13.33) | 1 (2.44) | 0.201 | 3 (5.36) |
Leukopenia, (n, %) | 1 (6.67) | 7 (17.07) | 0.4276 | 8 (14.29) |
Arthritis, (n, %) | 10 (66.67) | 17 (41.46) | 0.1334 | 27 (48.21) |
Serositis, (n, %) | 1 (6.67) | 3 (7.32) | 0.9333 | 4 (7.14) |
Lupus nephritis, (n, %) | 4 (26.67) | 21 (51.22) | 0.0902 | 25 (44.64) |
Thrombocytopenia, (n, %) | 1 (6.67) | 6 (14.63) | 0.6607 | 7 (12.50) |
Diabetes, (n, %) | 0 (0.00) | 3 (7.32) | 0.5563 | 3 (5.36) |
Dyslipidemia, (n, %) | 2 (13.33) | 4 (9.76) | 0.7793 | 6 (10.71) |
Alopecia, (n, %) | 5 (33.33) | 4 (9.76) | 0.0479 | 9 (16.07) |
Myositis, (n, %) | 1 (6.67) | 3 (7.32) | 0.9333 | 4 (7.14) |
Chronic cutaneous lupus, (n, %) | 9 (60.00) | 5 (12.20) | 0.0011 | 14 (25.00) |
Acute or subacute cutaneous lupus, (n, %) | 8 (53.33) | 12 (29.27) | 0.1218 | 20 (35.71) |
Baseline systemic lupus erythematosus disease activity index (SLEDAI-2K) | ||||
No activity (SLEDAI = 0) | 0 (0.00) | 10 (24.39) | 0.1598 | 10 (17.86) |
Mild activity (SLEDAI = 1 to 5) | 5 (33.33) | 15 (36.59) | 20 (35.71) | |
Moderate activity (SLEDAI = 6 to 10) | 5 (33.33) | 9 (21.95) | 14 (25.00) | |
High activity (SLEDAI = 11 to 19) | 5 (33.33) | 6 (14.63) | 11 (19.64) | |
Very high activity (SLEDAI ≥ 20) | 0 (0.00) | 1 (2.44) | 1 (1.79) |
Belimumab | SoC | Mean Difference (95% Confidence Interval) | |
---|---|---|---|
Cost of treatment (USD), mean ± SD | 8556.64 ± 6189.75 | 3253.48 ± 987.86 | 5303.16 (2735.61–7802.52) |
Difference between baseline and follow–up SLEDAI–2K score, mean ± SD | 3.33 ± 4.59 | −0.0487 ± 5.48 | 3.378 (1.769–6.831) |
Variable | Regression Coefficient (β-Estimate) | p-Value | 95% Confidence Interval |
---|---|---|---|
Belimumab vs. SoC | 3.6400 | 0.0409 * | 0.15735–7.1227 |
Baseline SLEDAI-2K score | 0.0932 | 0.4647 | −0.1610–0.3474 |
Duration of treatment | 0.9336 | 0.3079 | −0.8873–2.7546 |
Age | 0.0418 | 0.5736 | −0.1065–0.1902 |
Female vs. male | 1.5707 | 0.5496 | −3.6681–6.8095 |
Duration of illness | −0.6195 | 0.5796 | −2.8520–1.6130 |
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Alsuwayegh, A.; Almaghlouth, I.A.; Almasaoud, M.A.; Alzaid, A.S.; Alsuhaibani, A.A.; Almana, L.H.; Alabdulkareem, S.M.; Abudahesh, J.A.; AlRuthia, Y. Cost Consequence Analysis of Belimumab versus Standard of Care for the Management of Systemic Lupus Erythematosus in Saudi Arabia: A Retrospective Cohort Study. Int. J. Environ. Res. Public Health 2023, 20, 1917. https://doi.org/10.3390/ijerph20031917
Alsuwayegh A, Almaghlouth IA, Almasaoud MA, Alzaid AS, Alsuhaibani AA, Almana LH, Alabdulkareem SM, Abudahesh JA, AlRuthia Y. Cost Consequence Analysis of Belimumab versus Standard of Care for the Management of Systemic Lupus Erythematosus in Saudi Arabia: A Retrospective Cohort Study. International Journal of Environmental Research and Public Health. 2023; 20(3):1917. https://doi.org/10.3390/ijerph20031917
Chicago/Turabian StyleAlsuwayegh, Aseel, Ibrahim A. Almaghlouth, Majed Ali Almasaoud, Abdullah Sulaiman Alzaid, Adel Abdulaziz Alsuhaibani, Lyan Hassan Almana, Sara Mohammed Alabdulkareem, Joud Abdullah Abudahesh, and Yazed AlRuthia. 2023. "Cost Consequence Analysis of Belimumab versus Standard of Care for the Management of Systemic Lupus Erythematosus in Saudi Arabia: A Retrospective Cohort Study" International Journal of Environmental Research and Public Health 20, no. 3: 1917. https://doi.org/10.3390/ijerph20031917
APA StyleAlsuwayegh, A., Almaghlouth, I. A., Almasaoud, M. A., Alzaid, A. S., Alsuhaibani, A. A., Almana, L. H., Alabdulkareem, S. M., Abudahesh, J. A., & AlRuthia, Y. (2023). Cost Consequence Analysis of Belimumab versus Standard of Care for the Management of Systemic Lupus Erythematosus in Saudi Arabia: A Retrospective Cohort Study. International Journal of Environmental Research and Public Health, 20(3), 1917. https://doi.org/10.3390/ijerph20031917