Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn’s Disease: Results from an Early Access Program in Brazil
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Assessments
2.3. Statistical Analysis
2.4. Ethical Considerations
3. Results
3.1. Baseline Demographics and Disease Characteristics
3.2. Safety Outcomes
3.3. Treatment Effectiveness
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Total (n = 44) | |
---|---|
Age (years) | |
N (%) | 44 (100) |
Mean (standard deviation) | 39.93 (13.81) |
Gender, n (%) | |
N (%) | 44 (100) |
Female | 23 (52.3) |
Male | 21 (47.7) |
Body mass index (kg/m2) | |
Mean (standard deviation) | 23.71 (4.90) |
HBI score | |
N (%) | 41 (93.2) |
Mean (standard deviation) | 11.54 (4.43) |
CDAI score (points) | |
N (%) | 44 (100) |
Mean (standard deviation) | 287.67 (67.99) |
C-reactive protein levels (mg/L) | |
N | 42 (95.5) |
Mean (standard deviation) | 17.67 (20.73) |
Previous intestinal resections | |
N (%) | 8 (18.2) |
Participants (n = 44) n (%) | nAEs | |
---|---|---|
Adverse event, n (%) | 41 (93.2) | 249 |
95% CI (%) | 85.7, 100.0 | |
Relationship with program, n (%) | ||
Not related | - | 176 (71.0) |
Doubtful | - | 29 (11.7) |
Possible | - | 30 (12.1) |
Probable | - | 7 (2.8) |
Very Likely | - | 6 (2.4) |
Severity, n (%) | ||
Mild | 171 (68.7) | |
Moderate | 69 (27.7) | |
Severe | 9 (3.6) | |
Action taken with program patient, n (%) | ||
None | - | 114 (45.8) |
Pharmacological treatment | - | 108 (43.4) |
Non-pharmacological treatment | - | 10 (4.0) |
Hospitalization or prolongation of existing hospitalization | - | 13 (5.2) |
Other | - | 4 (1.6) |
Action taken with program drug, n (%) | ||
None | - | 232 (93.2) |
Dose adjustment | - | 6 (2.4) |
Temporary treatment discontinuation | - | 7 (2.8) |
Permanent treatment discontinuation | - | 3 (1.2) |
Other | - | 1 (0.4) |
Serious, n (%) | ||
Yes | - | 14 (5.6) |
Required inpatient hospitalization or prolongation of existing hospitalization | - | 14 (100) |
No | - | 235 (94.4) |
Ongoing, n (%) | ||
Yes | - | 45 (18.1) |
Recovering/Resolving | - | 13 (28.9) |
Not recovered/Not resolved | - | 31 (68.9) |
Unknown | - | 1 (2.2) |
No | - | 204 (81.9) |
Recovered/Resolved | - | 203 (100.0) |
SAE, n (%) | 9 (20.5) | 14 |
95% CI (%) | 8.5, 32.4 | |
Gastrointestinal disorders | 4 (9.1) | 4 |
Infections and infestations | 4 (9.1) | 5 |
Surgical and medical procedures | 2 (4.5) | 2 |
Cardiac disorders | 1 (2.3) | 1 |
Injury, poisoning, and procedural complications | 1 (2.3) | 1 |
Renal and urinary disorders | 1 (2.3) | 1 |
Non-SAE, n (%) | 41 (93.2) | 235 |
ADR, n (%) | 19 (44.2) | 43 |
95% CI (%) | 29.3, 59.0 | |
Serious ADR, n (%) | 4 (9.3) | 6 |
Infections and infestations | 4 (9.1) | 5 |
Renal and urinary disorders | 1 (2.3) | 1 |
Non-serious ADR, n (%) | 18 (41.9) | 37 |
SAE or non-serious ADR, n (%) | 23 (53.5) | 51 |
95% CI (%) | 38.6, 68.4 | |
Gastrointestinal disorders | 11 (25.0) | 17 |
Infections and infestations | 11 (25.0) | 15 |
Cardiac disorders | 2 (4.5) | 2 |
Investigations | 2 (4.5) | 2 |
Musculoskeletal and connective tissue disorders | 2 (4.5) | 2 |
Reproductive system and breast disorders | 2 (4.5) | 2 |
Surgical and medical procedures | 2 (4.5) | 2 |
Hepatobiliary disorders | 1 (2.3) | 1 |
Immune system disorders | 1 (2.3) | 1 |
Injury, poisoning and procedural complications | 1 (2.3) | 1 |
Nervous system disorders | 1 (2.3) | 2 |
Psychiatric disorders | 1 (2.3) | 1 |
Renal and urinary disorders | 1 (2.3) | 1 |
Skin and subcutaneous tissue disorders | 1 (2.3) | 2 |
At Baseline (n = 44) | Week 8 (n = 44) | Week 16/20 (n = 42) | Week 40/44 (n = 41) | At Week 80 (n = 34) | |
---|---|---|---|---|---|
Hematology | |||||
Red blood cell count performed, n (%) | 44 (100.0) | 44 (100.0) | 42 (100.0) | 40 (97.6) | 33 (97.1) |
Mean (SD), (106/mm3) | 4.43 (0.52) | 4.46 (0.55) | 4.51 (0.52) | 4.60 (0.54) | 4.74 (0.52) |
Median (Q1–Q3), (106/mm3) | 4.39 (4.02−4.69) | 4.39 (4.07−4.88) | 4.49 (4.24−4.78) | 4.54 (4.26−5.05) | 4.77 (4.45−5.00) |
Normal, n (%) | 28 (63.6) | 31 (70.5) | 31 (73.8) | 29 (72.5) | 26 (78.8) |
Abnormal (clinically significant), n (%) | 3 (6.8) | 1 (2.3) | 2 (4.8) | 1 (2.5) | 0 (0.0) |
White blood cell performed, n (%) | 44 (100.0) | 44 (100.0) | 42 (100.0) | 40 (97.6) | 33 (97.1) |
Mean (SD), (103/mm3) | 8.71 (2.96) | 8.25 (2.63) | 8.37 (3.09) | 7.78 (2.81) | 7.59 (2.58) |
Median (Q1–Q3), (103/mm3) | 8.30 (7.05−9.99) | 7.17 (6.36−10.35) | 7.61 (6.10−9.60) | 7.10 (5.83−9.26) | 6.85 (6.00−9.28) |
Normal, n (%) | 34 (77.3) | 38 (86.4) | 36 (85.7) | 33 (82.5) | 26 (78.8) |
Abnormal (clinically significant), n (%) | 1 (2.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Platelet count performed, n (%) | 43 (97.7) | 44 (100.0) | 42 (100.0) | 40 (97.6) | 33 (97.1) |
Mean (SD), (103/mm3) | 311 (123) | 294 (110) | 295 (107) | 271 (915) | 272 (871) |
Median (Q1–Q3), (103/mm3) | 310 (219−383) | 273 (225−344) | 274 (230−344) | 266 (214−326) | 277 (200−336) |
Normal, n (%) | 33 (76.7) | 37 (84.1) | 33 (78.6) | 34 (85.0) | 29 (87.9) |
Abnormal (clinically significant), n (%) | 1 (2.3) | 2 (4.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
BMI, n (%) | 41 (93.2) | 37 (84.1) | 38 (90.4) | 36 (87.8) | 33 (97.1) |
Mean (SD), (kg/m2) | 23.71 (4.90) | 24.61 (5.36) | 24.74 (5.19) | 25.32 (5.58) | 25.88 (5.50) |
Median (Q1–Q3), (kg/m2) | 22.19 (20.59−25.82) | 23.47 (20.75−27.88) | 23.90 (20.90−28.84) | 24.65 (21.85−29.71) | 24.43 (22.54−28.68) |
Categories, n (%) | |||||
Underweight | 5 (12.2) | 4 (10.8) | 3 (7.9) | 3 (8.3) | 1 (3.0) |
Normal weight | 24 (58.5) | 18 (48.6) | 18 (47.4) | 17 (47.2) | 17 (51.5) |
Pre-obesity | 8 (19.5) | 8 (21.6) | 9 (23.7) | 7 (19.4) | 8 (24.2) |
Obese | 4 (9.8) | 7 (18.9) | 8 (21.1) | 9 (25.0) | 7 (21.2) |
CRP, n (%) | 42 (95.5) | - | 42 (100.0) | 40 (97.6) | 32 (94.1) |
Mean (SD) (mg/L) | 17.67 (20.73) | - | 11.38 (13.40) | 15.78 (21.47) | 9.47 (12.51) |
Normal, n (%) | 14 (33.3) | - | 16 (38.1) | 13 (32.5) | 16 (50.0) |
Abnormal ¹, n (%) | 28 (66.7) | - | 26 (61.9) | 27 (67.5) | 16 (50.0) |
95% CI (%) | [23.6%; 54.4%] | [18.6%; 49.1%] | 31.9%; 68.1%] | ||
Fecal calprotectin, n (%) | 37 (84.1) | - | 33 (78.6) | 32 (78.0) | 29 (85.3) |
Mean (SD) (mg/L) | 1,055.66 (1141.46) | - | 762.79 (768.08) | 997.46 (1465.16) | 805.25 (1195.55) |
Normal, n (%) | 6 (16.2) | - | 8 (24.2) | 12 (37.5) | 12 (41.4) |
Abnormal ², n (%) | 31 (83.8) | - | 25 (75.8) | 20 (62.5) | 17 (58.6) |
95% CI (%) | - | [11.1%; 42.3%] | [21.1%; 56.3%] | [23.5%; 61.1%] | |
CDAI, n (%) | 44 (100.0) | 42 (95.5) | 38 (90.5) | 38 (92.7) | 32 (94.1) |
Mean (SD) (points) | 287.67 (67.99) | 134.03 (78.01) | 137.32 (97.65) | 99.63 (90.22) | 75.26 (70.02) |
Clinical response 3 | - | 31 (73.8) | 28 (73.7) | 35 (92.1) | 30 (93.8) |
95% CI (%) | - | [56.9%; 86.6%] | [78.6%; 98.3%] | [79.2%; 99.2%] | |
HBI, n (%) | 41 (93.2) | 44 (100.0) | 38 (90.5) | 41 (100.0) | 33 (97.1) |
Mean (SD) (points) | 11.54 (4.43) | 4.25 (3.21) | 4.87 (4.70) | 3.61 (3.79) | 2.18 (2.48) |
Clinical response 4 | - | - | 26 (74.3) | 35 (92.1) | 31 (100.0) |
95% CI (%) | - | [56.7%; 87.5%] | [78.6%; 98.3%] | [88.8%; 100.0%] | |
Clinical remission 5, n (%) | - | 44 (100.0) | 38 (90.5) | 41 (100.0) | 33 (97.1) |
Mean (SD) (points) | - | 33 (75.0) | 29 (76.3) | 33 (80.5) | 29 (87.9) |
95% CI (%) | - | [59.8%; 88.6%] | [65.1%; 91.2%] | [71.8%; 96.6%] |
Result (n = 44) | |
---|---|
Colonoscopy, n (%) | 30 (68.2%) |
Suggestive of inadequate control of activity, n (%) | 10 (37.0%) |
Endoscopic improvement, n (%) | 17 (63.0%) |
Electrocardiogram, n (%) | 44 (100.0%) |
Normal | 30 (68.2%) |
Abnormal (clinically non-significant) | 13 (29.5%) |
Abnormal (clinically significant) | 1 (2.3%) |
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Chebli, J.M.F.; Parra, R.S.; Flores, C.; Moraes, A.C.; Nones, R.B.; Gomes, T.N.F.; Perdomo, A.M.B.; Scapini, G.; Zaltman, C. Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn’s Disease: Results from an Early Access Program in Brazil. J. Clin. Med. 2022, 11, 6481. https://doi.org/10.3390/jcm11216481
Chebli JMF, Parra RS, Flores C, Moraes AC, Nones RB, Gomes TNF, Perdomo AMB, Scapini G, Zaltman C. Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn’s Disease: Results from an Early Access Program in Brazil. Journal of Clinical Medicine. 2022; 11(21):6481. https://doi.org/10.3390/jcm11216481
Chicago/Turabian StyleChebli, Julio Maria Fonseca, Rogério Serafim Parra, Cristina Flores, Antonio Carlos Moraes, Rodrigo Bremer Nones, Tarcia Nogueira Ferreira Gomes, Ana Maria Bravo Perdomo, Gustavo Scapini, and Cyrla Zaltman. 2022. "Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn’s Disease: Results from an Early Access Program in Brazil" Journal of Clinical Medicine 11, no. 21: 6481. https://doi.org/10.3390/jcm11216481
APA StyleChebli, J. M. F., Parra, R. S., Flores, C., Moraes, A. C., Nones, R. B., Gomes, T. N. F., Perdomo, A. M. B., Scapini, G., & Zaltman, C. (2022). Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn’s Disease: Results from an Early Access Program in Brazil. Journal of Clinical Medicine, 11(21), 6481. https://doi.org/10.3390/jcm11216481