Table 3.
Comparison of primary and secondary end points within groups A and B, and between group A and group B.
| Variables | Group A, Cyclosporine | Difference (95% CI of difference) | Group B, Azathioprine | Difference (95% CI of difference) |
|---|---|---|---|---|
| Within group comparisons | ||||
| Mean UAS7 (baseline) | 28.70 ± 4.42 | 28.88 ± 4.25 | ||
| Mean UAS7 (90th day) | 5.43 ± 5.12 | −23.27 (−25.33 to −21.22) | 7.0 ± 4.48 | −21.87 (-23.78 to -19.96) |
| Mean UAS7 (180th day) | 9.98 ± 5.46 | 4.55 (2.98–6.12) | 7.88 ± 5.53 | 0.88 (−0.82 to 2.57) |
| Number of patients having ≥75% reduction in UAS7 on 90th day | n = 31 (77.5%) | 30% (8.78–47.77) | n = 32 (80%) | 20% (−0.10 to 38.10) |
| Number of patients having ≥75% reduction in UAS7 on 180th day | n = 19 (47.5%) | n = 24 (60%) | ||
| Mean OSS at 15th day | 2.85 ± 1.03 | 2.70 ± 0.91 | ||
| Mean OSS, 90th day | 4.25 ± 0.70 | 1.40 (1.06–1.74) | 4.05 ± 0.59 | 1.35 (1.06 to 1.65) |
| Mean OSS, 180th day | 3.59 ± 0.78 | −0.68 (−0.89 to −0.45) | 3.87 ± 0.79 | −0.18 (−0.41 to 0.06) |
| Number of patients having positive ASST (Baseline) | n = 16 (40%) | 5% (17.15–50.82) | n = 12 (30%) | 15% (−3.45 to 32.35) |
| Number of patients having positive ASST (90th day) | n = 2 (5%) | n = 6 (15%) | ||
| Number of patients having positive APST (Baseline) | n = 2 (5%) | 5% (−4.48 to 16.50) | n = 2 (5%) | 5% (−4.48 to 16.50) |
| Number of patients having positive APST (90th day) | n = 0 | n = 0 | ||
| S.IgE IU/ml, Baseline Median (IQR) |
91.35 (50.27–248.7) |
−27.65 (−64.35 to −10.10) (Hodges – Lehman median difference) |
243 (78.27–654.0) |
−88.57(-209.50 to -28.70) (Hodges – Lehman median difference) |
| S.IgE IU/ml, 90th day) Median (IQR) |
72.5 (40.5–147.50) |
164.15 (60.0–515.0) |
||
| Variables |
Group A, cyclosporine n (%) |
Group B, azathioprine n (%) |
Difference |
(95% CI of difference) |
| Comparison between group A and B | ||||
| Mean UAS7 (baseline) | 28.70 ± 4.42 | 28.88 ± 4.25 | −0.18 | −2.11 to1.76 |
| Mean UAS7 (90th day) | 5.43 ± 5.13 | 7.0 ± 4.48 | −1.57 | −3.72 to 0.57 |
| Mean UAS7 (180th day) | 9.98 ± 5.46 | 7.88 ± 5.53 | 2.10 | −0.35 to 4.55 |
| Number of patients who achieved ≥75% reduction in UAS7 on 90th day | 31 (79.5%) | 32 (80%) | −0.5% | −17.13 to 18.09 |
| Number of patients who could maintain ≥75% reduction in UAS7 on 180th day | 19 (47.5%) | 24 (60%) | −12.5% | −9.00 to 32.46 |
| Number of patients who could not maintain >75% reduction in UAS7 at 180th day | 12 (52.5%) | 8 (40%) | 12.5% | −9.00 to 32.46 |
| OSS, 90th day, Median (IQR) | 4 (4–5) | 4 (4–4.0) | 0.00(Hodges – Lehman median difference) | 0.00 to 0.00 |
| No improvement per OSS | – | – | – | – |
| Minimal improvement | 4/40 (10%) | – | 10% | −0.64 to 23.05 |
| Moderate improvement | 4/40 (10%) | 3/40 (7.5%) | 2.5% | −11.26 to 16.45 |
| Marked improvement | 19/40 (47.5%) | 29/40 (72.5%) | 25% | 3.54 to 43.49 |
| Clearance | 13/40 (32.5%) | 8/40 (20%) | 12.5% | −6.79 to 30.66 |
|
OSS, 180th day Median (IQR) |
4 (3–4) | 4 (3–4.0) | 0.00(Hodges – Lehman median difference) | −1.00 to 0.00 |
| No improvement per OSS | 1/40 (2.5%) | – | 2.5% | −6.50 to 12.88 |
| Minimal improvement | 5/40 (12.5%) | 1/40 (2.5%) | 10 | −2.54 to 23.77 |
| Moderate improvement | 15/40 (37.5%) | 9/40 (22.5%) | 15% | −5.03 to 33.52 |
| Marked improvement | 16/40 (40%) | 21/40 (52.5%) | 12.5% | −9.00 to 32.46 |
| Clearance | 3/40 (7.5%) | 9/40 (22.5%) | 15% | −1.02 to 30.79 |
| Number of patients with positive ASST (Baseline) | 16 (40%) | 12 (30%) | 10% | −10.60 to 29.48 |
| Number of patients with positive ASST (90th day) | 2 (5%) | 6 (15%) | 10% | −3.97 to 24.53 |
| Number of patients with positive APST (Baseline) | 2 (5%) | 2 (5%) | 0.0% | −12.06 to 12.06 |
| Number of patients with positive APST (90th day) | 0 | 0 | 0.0% | – |
| S.IgE (IU/ml, Baseline) Median (IQR) |
91.35 (50.2–248.75) | 243 (78.27–654.0) | −105.15@ | −308.0 to -16.8 |
| S.IgE (IU/ml, 90th day) Median (IQR) |
72.5 (40.5–147.5) | 164.15 (60.0–515.0) | −82.95@ | −228.0 to -19.50 |
@: (Hodges – Lehman median difference).
IQR – Interquartile range.
ASST – Autologous serum skin test.
APST – Autologous plasma skin test.
OSS – outcome scoring scale.
UAS – Urticaria activity score.
sIgE – serum Immunoglobulin E.
n = number of patients.
CI – Confidence Interval.
Bold numerical values show significant CIs.