Prognostic Factors of Biologic Therapy in Pediatric IBD
Abstract
:1. Introduction
2. Material and Methods
2.1. Study and Control Group Definition
2.2. Patients’ History, Symptoms, Growth, and Nutritional Status
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- Disease symptoms at diagnosis;
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- Family history of IBD (first-degree relatives);
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- Anthropometric measurements for nutritional status assessment based on percentile charts of the Polish OLAF study for children 7–18 years old [16] or WHO child growth standards in younger children [17]. Children were considered underweight if they met any of the following criteria: weight below the third percentile, weight percentile two channels lower than the height percentile, and BMI equivalent to the underweight percentile of the OLAF chart. Short stature was diagnosed in children below the third percentile for height and those with growth impairment as defined in the Paris classification [1];
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2.3. Additional Tests Results
2.4. Endpoint Definition
2.5. Statistical Analysis
3. Results
3.1. Crohn’s Disease
3.1.1. Crohn’s Disease—Paris Classification Parameters
3.1.2. Crohn’s Disease Activity
3.1.3. Crohn’s Disease—Clinical Manifestations
3.1.4. Crohn’s Disease—Laboratory Tests Results
3.2. Ulcerative Colitis
3.2.1. Ulcerative Colitis—Paris Classification Parameters and Disease Activity
3.2.2. Ulcerative Colitis—Demographic Data, Symptoms, and Additional Tests Results
3.3. IBD
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Data Availability Statement
Conflicts of Interest
References
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Location (Number of Patients) | L1 (64) | L2 (19) | L3 (36) |
---|---|---|---|
Of which biology demanding | 40.63% | 26.3% | 22.22% |
upper GI involvement | L4a (43) | L4b (14) | L4aL4b (6) |
biology demanding | 30.23% | 35.71% | 66.67% |
Disease behavior | B1 (85) | B complicated (B2/B3) (34) | |
biology demanding | 25.88% | 50% | |
Perianal disease | Perianal disease present (15) | No perianal disease (104) | |
biology demanding | 60% | 28.8% | |
Linear growth impairment | G0 (90) | G1 (29) | G2 (8) |
biology demanding | 31.11% | 37.93% | 50% |
Parameter (Number of Patients) | OR (95% CI) | RR (95% CI) | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | p |
---|---|---|---|---|---|---|---|
L1 (64) | 2.21 1.004–4.97 | 1.72 1.002–3.04 | 0.6667 0.5098–0.7937 | 0.5250 0.4170–0.6308 | 0.4063 0.2946–0.5285 | 0.7636 0.6365–0.8563 | 0.0534 |
L4a (43) | 0.83 0.37–1.88 | 0.88 0.50–1.49 | 0.3333 0.2063–0.4902 | 0.625 0.5155–0.7231 | 0.3023 0.186–0.4511 | 0.6579 0.5460–0.7546 | 0.6896 |
L4b (14) | 1.16 0.41–3.77 | 1.10 0.49–2.07 | 0.1282 0.056–0.2671 | 0.8875 0.7998–0.9397 | 0.3571 0.1634–0.6124 | 0.6762 0.5818–0.7581 | 0.7710 |
L4aL4b (6) | 4.457 0.99–23.95 | 2.15 0.93–3.41 | 0.1026 0.0406–0.2358 | 0.975 0.9134–0.9956 | 0.6667 0.3–0.9408 | 0.6903 0.5999–0.7681 | 0.0891 |
B complicated (34) | 2.86 1.28–6.54 | 1.93 1.16–3.12 | 0.4359 0.293–0.5902 | 0.7875 0.6858–0.8629 | 0.5 0.3407–0.6593 | 0.7412 0.6391–0.8224 | 0.0169 |
p+ (15) | 3.7 1.2–11.68 | 2.08 1.16–3.27 | 0.2308 0.1265–0.3834 | 0.925 0.8459–0.9652 | 0.6 0.3575–0.8018 | 0.7115 0.6182–0.7898 | 0.0356 |
Linear growth impairment (29) | 1.35 0.57–3.22 | 1.219 0.68–2.05 | 0.2821 0.1654–0.4378 | 0.775 0.6721–0.8527 | 0.3793 0.2269–0.56 | 0.6889 0.5872–0.7751 | 0.5034 |
G2 (8) | 2.17 0.59–7.76 | 1.59 0.66–2.79 | 0.1026 0.04–0.235 | 0.95 0.8784–0.9804 | 0.5 0.2152–0.7848 | 0.6847 0.5933–0.7637 | 0.4359 |
OR 95% CI | RR 95% CI | Sensitivity 95% CI | Specificity 95% CI | PPV 95% CI | NPV 95% CI | p | |
---|---|---|---|---|---|---|---|
Fever (22) | 2.46 0.94–6.45 | 1.73 0.94–2.79 | 0.2821 0.1654–0.4378 | 0.8625 0.7703–0.9215 | 0.5 0.3072–0.6928 | 0.7113 0.6145–0.7921 | 0.0777 |
Fatigue (74) | 1.22 0.54–2.78 | 1.14 0.67–2.02 | 0.6579 0.4989–0.7879 | 0.3875 0.2882–0.4971 | 0.3378 0.2405–0.4512 | 0.7045 0.5578–0.8184 | 0.6874 |
Aphthous stomatitis (4) | 6.58 0.94–86.36 | 2.39 0.93–3.64 | 0.07692 0.0265–0.2032 | 0.9875 0.9325–0.9994 | 0.75 0.3006–0.9872 | 0.6876 0.5973–0.7645 | 0.1024 |
EIM (7) | 0.33 0.03–2.14 | 0.42 0.075–1.58 | 0.02564 0.00132–0.1318 | 0.9250 0.8459–0.9652 | 0.1429 0.0073–0.5131 | 0.6607 0.5690–0.7418 | 0.4240 |
Weight loss (61) | 0.86 0.39–1.86 | 0.9 0.54–1.51 | 0.4872 0.3387–0.638 | 0.475 0.3692–0.583 | 0.3115 0.2094–0.4359 | 0.6552 0.5267–0.7644 | 0.8453 |
Underweight (44) | 1.27 0.59–2.82 | 1.17 0.69–1.94 | 0.4103 0.2708–0.5658 | 0.6456 0.5356–0.7420 | 0.3636 0.2378–0.5113 | 0.6892 0.5766–0.7831 | 0.6860 |
Overweight /obesity (7) | 0.81 0.156–4.1 | 0.87 0.24–2.08 | 0.0513 0.0091–0.1689 | 0.9375 0.8619–0.9730 | 0.2857 0.0508–0.6411 | 0.6696 0.5782–0.7499 | >0.999 |
Rectal bleeding (37) | 0.56 0.24–1.29 | 0.67 0.35–1.2 | 0.2308 0.1265–0.3834 | 0.65 0.5408–0.7455 | 0.2432 0.1336–0.4012 | 0.6341 0.5261–0.7302 | 0.2117 |
Diarrhea (77) | 0.5 0.23–1.14 | 0.64 0.39–1.06 | 0.5385 0.3857–0.6843 | 0.3 0.2106–0.4077 | 0.2727 0.1858–0.3812 | 0.5714 0.4221–0.7088 | 0.1032 |
Abdominal pain (79) | 0.86 0.38–1.92 | 0.9 0.54–1.56 | 0.641 0.4842–0.7726 | 0.325 0.2324–0.4336 | 0.3165 0.2245–0.4255 | 0.65 0.4951–0.7787 | 0.8365 |
OR 95% CI | RR 95% CI | Sensitivity 95% CI | Specificity 95% CI | PPV 95% CI | NPV 95% CI | p | |
---|---|---|---|---|---|---|---|
Hypoproteinemia (3) | 1.83 to infinity | 3.22 1.37–16.91 | 0.07692 0.0265–0.2032 | 1.0 0.9542–1 | 1.0 0.4385–1 | 0.6897 0.60–0.7666 | 0.0334 |
Elevated serum IgA (9) | 4.67 1.23–17.58 | 2.22 1.12–3.45 | 0.1538 0.0725–0.2973 | 0.9625 0.8955–0.9898 | 0.6667 0.3542–0.8794 | 0.7 0.6088–0.7777 | 0.0572 |
Anemia (32) | 2.316 0.99–5.34 | 1.69 1.01–2.75 | 0.3846 0.2489–0.541 | 0.7875 0.6858–0.8629 | 0.4688 0.3087–0.6355 | 0.7241 0.6223–0.8071 | 0.0768 |
Hypoalbuminemia (21) | 2.16 0.83–5.81 | 1.61 0.89–2.63 | 0.2564 0.1457–0.4108 | 0.8625 0.7703–0.9215 | 0.4762 0.2834–0.6763 | 0.7041 0.6074–0.7854 | 0.1285 |
CRP (79) | 1.447 0.62–3.2 | 1. 29 0.74–2.35 | 0.7179 0.5622–0.8346 | 0.3625 0.2657–0.4719 | 0.3544 0.258–0.4644 | 0.725 0.5717–0.8389 | 0.4160 |
Elevated serum IgG (8) | 2.17 0.59–7.76 | 1.59 0.66–2.79 | 0.1026 0.0406–0.2358 | 0.95 0.8784–0.9804 | 0.5 0.2152–0.7848 | 0.6847 0.5933–0.7637 | 0.4359 |
thrombocytopenia (27) | 1.23 0.57–2.76 | 1.15 0.67–1.9 | 0.3846 0.2489–0.541 | 0.6625 0.5536–0.7565 | 0.3751 0.2299–0.5083 | 0.6883 0.578–0.7807 | 0.6843 |
IgA ASCA (57) | 0.95 0.43–2.07 | 0.96 0.57–1.62 | 0.4737 0.3248–0.6274 | 0.5125 0.4049–0.6189 | 0.3158 0.21–0.4448 | 0.6721 0.5472–0.7766 | >0.9999 |
IgG ASCA (60) | 0.9 0.42–1.95 | 0.93 0.56–1.56 | 0.472 0.3387–0.638 | 0.4875 0.3811–0.5951 | 0.3167 0.2131–0.4423 | 0.661 0.5337–0.7686 | 0.8466 |
ASCA double positivity (42) | 1.23 0.57–2.76 | 1.15 0.67–1.9 | 0.3846 0.2489–0.541 | 0.6625 0.5536–0.7565 | 0.3571 0.2299–0.5083 | 0.6883 0.578–0.7807 | 0.6843 |
IgE elevation (42) | 1.04 0.47–2.34 | 1.03 0.59–1.71 | 0.359 0.2274–0.5158 | 0.65 0.5408–0.7455 | 0.3333 0.21–0.4845 | 0.6753 0.5646–0.7694 | >0.9999 |
IgE class ≥2 allergy (7) | 0.81 0.16–4.1 | 0.87 0.24–2.08 | 0.0513 0.0091–0.1689 | 0.9375 0.8619–0.973 | 0.2857 0.0508–0.6411 | 0.6696 0.5782–0.7499 | >0.9999 |
Eosinophilic infiltrates in GI mucosa (16) | 0.43 0.13–1.47 | 0.54 0.18–1.3 | 0.079 0.0265–0.2032 | 0.8375 0.7416–0.9025 | 0.1875 0.0659–0.4301 | 0.65 0.5545–0.7356 | 0.2594 |
Parameter (Number of Patients) | OR 95% CI | RR 95% CI | Sensitivity 95% CI | Specificity 95% CI | PPV 95% CI | NPV 95% CI | p |
---|---|---|---|---|---|---|---|
E4 (46) | 2.09 0.58–7.93 | 1.91 0.71–5.15 | 0.5714 0.3259–0.7862 | 0.6122 0.5133–0.7027 | 0.1739 0.0909–0.3072 | 0.9091 0.8155–0.9577 | 0.1913 |
Backwash ileitis (8) | 2.56 0.46–14.12 | 2.17 0.58–8.05 | 0.25 0.0319–0.6509 | 0.8846 0.8071–0.9389 | 0.1429 0.0178–0.4281 | 0.9387 0.8715–0.9772 | 0.2673 |
Linear growth impairment (14) | 1.29 0.33–5.16 | 1.26 0.39–4.09 | 0.15 0.032–0.3789 | 0.8804 0.7961–0.9388 | 0.2143 0.0466–0.508 | 0.8266 0.7379–0.8956 | 0.7091 |
Severe growth impairment (9) | 2.17 0.4–11.66 | 1.9 0.5–7.23 | 0.2222 0.0281–0.6 | 0.8835 0.8053–0.9383 | 0.1429 0.0178–0.4281 | 0.9286 0.8584–0.9708 | 0.3578 |
Parameter (Number of Patients) | OR 95% CI | RR 95% CI | Sensitivity 95% CI | Specificity 95% CI | PPV 95% CI | NPV 95% CI | p |
---|---|---|---|---|---|---|---|
Fatigue (18) | 11.6 3.34–40.27 | 6.89 2.72–17.47 | 0.4444 0.2153–0.6924 | 0.9355 0.8649–0.976 | 0.5714 0.2886–0.8234 | 0.8969 0.8186–0.9494 | <0.0001 |
Fever (8) | 0.99 0.11–8.7 | 0.99 0.15–6.64 | 0.125 0.0028–0.5265 | 0.8738 0.7939–0.931 | 0.0714 0.0016–0.3387 | 0.9278 0.8569–0.9704 | 0.992 |
Weight loss (33) | 1.94 0.62–6.13 | 1.77 0.67–4.71 | 0.1818 0.0698–0.3546 | 0.8974 0.8079–0.9547 | 0.4286 0.1766–0.7114 | 0.7216 0.6214–0.8079 | 0.2503 |
Underweight (28) | 1.23 0.35–4.29 | 1.2 0.41–3.53 | 0.1429 0.0403–0.3267 | 0.881 0.792–0.9414 | 0.2857 0.0839–0.581 | 0.7551 0.6579–0.8364 | 0.7414 |
Abdominal pain (56) | 1.36 0.44–4.22 | 1.31 0.49–3.53 | 0.611 0.3862–0.7969 | 0.4737 0.3654–0.5845 | 0.2157 0.1249–0.3463 | 0.8372 0.7003–0.9188 | 0.5921 |
Rectal bleeding (94) | 1.17 0.24–5.74 | 1.15 0.28–4.7 | 0.1277 0.0677–0.2124 | 0.8889 0.6529–0.9863 | 0.8571 0.5719–0.9822 | 0.1633 0.0963–0.2516 | 0.8459 |
Non-bloody diarrhea (19) | 1.39 0.35–5.58 | 1.34 0.41 4.3 | 0.1579 0.0338–0.3958 | 0.8817 0.7982–0.9395 | 0.2143 0.0466–0.508 | 0.8367 0.7485–0.9037 | 0.6342 |
Overweight/ obesity (13) | 1.32 0.26–6.69 | 1.27 0.32–5.05 | 0.1429 0.0178–0.4281 | 0.8878 0.808–0.9426 | 0.005 0.0012–0.0198 | 0.9962 0.9953–0.997 | 0.738 |
EIM (18) | 0.39 0.05–3.23 | 0.43 0.06–3.07 | 0.5882 0.0013–0.2869 | 0.8632 0.7774–0.9250 | 0.0714 0.002–0.3387 | 0.8367 0.7485–0.9037 | 0.37 |
PSC or PSC/AIH (14) | 0.2 0.01–3.56 | 0.23 0.01–3.62 | 0 0–0.2316 | 0.8571 0.7719–0.9196 | 0 0–0.2316 | 0.8571 0.7719–0.9196 | 0.1306 |
EIM other than PSC (4) | 2.44 0.24–25.19 | 2.08 0.35–12.22 | 0.25 0.0056–0.8059 | 0.8796 0.803–0.9343 | 0.0714 0.0016–0.3387 | 0.9694 0.9131–0.9936 | 0.4414 |
Hypoalbumi nemia (14) | 5.37 1.16–23.19 | 3.89 1.52–9.95 | 0.3571 0.1634–0.6124 | 0.9082 0.8346–0.9509 | 0.3571 0.1634–0.6124 | 0.9082 0.8346–0.9509 | 0.0049 |
Elevated CRP (16) | 1.78 0.44–7.26 | 1.64 0.51–5.23 | 0.1875 0.0405–0.456 | 0.8854 0.8042–0.9414 | 0.2143 0.0466–0.508 | 0.8673 0.7838–0.9274 | 0.4142 |
Hyperproteinemia (14) | 0.85 0.17–4.19 | 0.87 0.21–3.56 | 0.1111 0.0137–0.35 | 0.8723 0.79–0.93 | 0.1429 0.0178–0.4282 | 0.8367 0.7485–0.903 | 0.85 |
Eosinophilic infiltrates in GI mucosa (13) | 0.68 0.17–2.63 | 0.71 0.21–2.38 | 0.0967 0.0204–0.26 | 0.8642 0.77–0.93 | 0.2143 0.0466–0.508 | 0.7143 0.6142–0.801 | 0.58 |
Total IgG (13) | 0.98 0.19–4.88 | 0.98 0.24–4.05 | 0.1176 0.0146–0.3644 | 0.8804 0.7961–0.9388 | 0.1538 0.0192–0.3644 | 0.8804 0.7961–0.9388 | 0.98 |
Parameter (Number of Patients) | OR 95% CI | RR 95% CI | Sensitivity 95% CI | Specificity 95% CI | PPV 95% CI | NPV 95% CI | p |
---|---|---|---|---|---|---|---|
Fever (53) | 2.59 1.15–5.79 | 1.95 1.16–3.27 | 0.4 0.2266–0.5939 | 0.795 0.7323–0.8487 | 0.2264 0.1228–0.362 | 0.8983 0.844–0.9386 | 0.018 |
Fatigue (92) | 3.47 1.82–6.62 | 2.59 1.56–4.26 | 0.3586 0.2613–0.4654 | 0.8613 0.7919–0.9143 | 0.6346 0.4896–0.7638 | 0.6667 0.592–0.7356 | 0.0001 |
Hypoalbuminemia (34) | 3.28 1.53–7.05 | 2.28 1.42–3.66 | 0.4418 0.2719–0.6211 | 0.8061 0.7437–0.859 | 0.283 0.1679–0.4235 | 0.8927 0.8375–0.9341 | 0.0016 |
Hypoproteinemia (5) | 14.23 1.58–132.25 | 3.69 2.23–6.11 | 0.07547 0.0297–0.1821 | 0.9944 0.9691–0.9999 | 0.8 0.3136–0.9722 | 0.7835 0.725–0.8349 | 0.0105 |
↑CRP (95) | 2.51 1.34–4.69 | 2.02 1.26–3.25 | 0.5849 0.4509–0.7074 | 0.6404 0.5677–0.7073 | 0.3263 0.2404–0.4257 | 0.8382 0.7672–0.890 | 0.0042 |
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Buczyńska, A.; Grzybowska-Chlebowczyk, U. Prognostic Factors of Biologic Therapy in Pediatric IBD. Children 2022, 9, 1558. https://doi.org/10.3390/children9101558
Buczyńska A, Grzybowska-Chlebowczyk U. Prognostic Factors of Biologic Therapy in Pediatric IBD. Children. 2022; 9(10):1558. https://doi.org/10.3390/children9101558
Chicago/Turabian StyleBuczyńska, Anna, and Urszula Grzybowska-Chlebowczyk. 2022. "Prognostic Factors of Biologic Therapy in Pediatric IBD" Children 9, no. 10: 1558. https://doi.org/10.3390/children9101558