Anxiety and Perception of Disease Control in Multiple Sclerosis Subjects Treated with Natalizumab
Abstract
:1. Introduction
2. Methods
2.1. Study Population and Inclusion Criteria
2.2. Study Design and Setting
2.3. Assessment of Risk of PML
2.4. Assessment of Anxiety and Perception of Disease Control
2.5. Statistical Analysis
3. Results
3.1. Descriptive Analysis
3.2. Anxiety and Perception of Disease Control
4. Discussion
5. Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Risk Levels | JCV | N. Infusions | Time Interval | |||
---|---|---|---|---|---|---|
Neg | pos | ≤24 | >24 | 3T NMR | Infusions | |
Level 1 | • | 1 year | 4 weeks | |||
Level 2 | • | • | 6 months | 4 weeks | ||
Level 3 | • | • | 3 months | 6 weeks |
Risk Classification | |||
---|---|---|---|
Level 1 | Level 2 | Level 3 | |
Participants, n (%) | 36 (58.1) | 12 (19.3) | 14 (22.6) |
Males, n (%) | 5 (38.4) | 5 (38.5) | 3 (23.1) |
Age (years), mean ± SD | 43.5 ± 10.5 | 45.7 ± 8.4 | 42.1 ± 13.4 |
Risk rate, mean ± SD | 0.8 ± 2.4 | 2.7 ± 3.4 | 5.9 ± 4.0 |
Scores at Each Examination (Median [First–Third Quartile]) | One-Way Repeated Measures Analysis | Post Hoc Analysis | |||||
---|---|---|---|---|---|---|---|
T0 | T1 | T2 | Test (df) | p-Value | Significant Differences | p-Value | |
HAM-A Risk L1 | 19.5 [17.0–21.0] | 11.0 [10.0–14.0] | 6.5 [5.0–8.0] | 71.5 (2) | <0.001 | T1–T0 | <0.001 |
T2–T0 | <0.001 | ||||||
T2–T1 | <0.001 | ||||||
HAM-A Risk L2 | 14.5 [14.0–15.7] | 18.0 [9.7–12.2] | 6.0 [5.7–6.2] | 23.5 (2) | <0.001 | T1–T0 | 0.003 |
T2–T0 | 0.002 | ||||||
T2–T1 | 0.002 | ||||||
HAM-A Risk L3 | 17.0 [15.2–18.7] | 10.0 [10.0–13.2] | 6.0 [5.2–8.0] | 27.5 (2) | <0.001 | T1–T0 | 0.002 |
T2–T0 | 0.001 | ||||||
T2–T1 | 0.001 | ||||||
pdc Risk L1 | 3.0 [2.7–4.0] | 6.0 [5.0–6.0] | 8.0 [7.0–9.0] | 72.0 (2) | <0.001 | T1–T0 | <0.001 |
T2–T0 | <0.001 | ||||||
T2–T1 | <0.001 | ||||||
pcd Risk L2 | 3.5 [3.0–4.0] | 5.5 [5.0–7.2] | 8.0 [7.7–8.2] | 24.0 (2) | <0.001 | T1–T0 | 0.002 |
T2–T0 | 0.002 | ||||||
T2–T1 | 0.002 | ||||||
pcd Risk L3 | 3.0 [3.0–4.0] | 6.0 [6.0–6.0] | 8.0 [7.2–9.0] | 27.5 (2) | <0.001 | T1–T0 | <0.001 |
T2–T0 | <0.001 | ||||||
T2–T1 | 0.001 |
Sum Sq | Mean Sq | Test (df) | p-Value | ||
---|---|---|---|---|---|
HAM-A | Risk level | 19 | 19 | 1.97 (1) | 0.162 |
Assessment time | 4321 | 4321 | 444.66 (1) | <0.001 | |
Risk–time | 14 | 14 | 1.43 (1) | 0.233 | |
Residuals | 1769 | 10 | (182) | - | |
Perceived disease control | Risk level | 2.7 | 2.7 | 2.22 (1) | 0.138 |
Assessment time | 800.2 | 800.2 | 645.91 (1) | <0.001 | |
Residuals | 226.7 | 1.2 | (183) | - |
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Corallo, F.; Sessa, E.; Rifici, C.; De Cola, M.C.; Di Cara, M.; Cardile, D.; Venuti, G.; Bonfiglio, N.; D’Aleo, G.; Quartarone, A.; et al. Anxiety and Perception of Disease Control in Multiple Sclerosis Subjects Treated with Natalizumab. J. Clin. Med. 2024, 13, 13. https://doi.org/10.3390/jcm13010013
Corallo F, Sessa E, Rifici C, De Cola MC, Di Cara M, Cardile D, Venuti G, Bonfiglio N, D’Aleo G, Quartarone A, et al. Anxiety and Perception of Disease Control in Multiple Sclerosis Subjects Treated with Natalizumab. Journal of Clinical Medicine. 2024; 13(1):13. https://doi.org/10.3390/jcm13010013
Chicago/Turabian StyleCorallo, Francesco, Edoardo Sessa, Carmela Rifici, Maria Cristina De Cola, Marcella Di Cara, Davide Cardile, Giuseppe Venuti, Noemi Bonfiglio, Giangaetano D’Aleo, Angelo Quartarone, and et al. 2024. "Anxiety and Perception of Disease Control in Multiple Sclerosis Subjects Treated with Natalizumab" Journal of Clinical Medicine 13, no. 1: 13. https://doi.org/10.3390/jcm13010013