Table Info

Table 1.

Demographic and serological data

Study group	mAb (n = 19)	Placebo (n = 12)	P-value
Gender, n (%)			> 0.999
Female	13 (68.42)	9 (75)
Male	6 (31.58)	3 (25)
Age (years), mean ± SD	48.65 ± 11.02	48.08 ± 12.04	0.670
Weight (kg), mean ± SD	78.15 ± 15.22	70.90 ± 13.44	0.044 (^*)
Height (m), mean ± SD	1.73 ± 0.06	1.68 ± 0.11	0.154
Smoking habits			> 0.999
Non-smoker, n (%)	15 (78.95)	10 (83.33)
Smoker, n (%)	4 (21.05)	2 (16.67)
Duration of thyroid autoimmunity (month), mean ± SD	4.37 ± 2.34	5.25 ± 2.14	0.269
Serology (baseline), mean ± SD
Serum albumin (32–55 g/L)	46.74 ± 2.45	47.92 ± 2.50	0.335
Cholesterol (0–119 mg/dL)	204.10 ± 52.95	206.90 ± 33.43	0.727
HDL (< 40 mg/dL)	62.32 ± 16.27	61.58 ± 15.08	0.696
LDL (0–129 mg/dL)	123.80 ± 46.89	125.70 ± 32.11	0.712
TG (0–199 mg/dL)	90.58 ± 59.12	100.80 ± 44.05	0.174
ASAT (0–41 U/L)	17.79 ± 4.54	17.50 ± 3.26	0.944
ALAT (0–45 U/L)	18.68 ± 10.27	14.92 ± 6.63	0.263
AP (35–104 U/L)	87.11 ± 29.52	78.17 ± 18.30	0.453
γGT (0–65 U/L)	25.00 ± 26.06	15.17 ± 5.11	0.772
Lymphocytes (abs.) (1–4 × 10E9/L)	1.90 ± 0.59	2.06 ± 0.67	0.787
Monocytes (abs.) (0.1–0.9 × 10E9/L)	0.38 ± 0.22	0.35 ± 0.07	0.745
Platelets (150–350 × 10E9/L)	260.40 ± 64.28	266.80 ± 58.58	0.735
WBC (4–10.7 × 10E9/L)	6.41 ± 1.75	6.31 ± 1.55	0.897
CH50 (79–187 uEq/mL)	111.90 ± 34.07	115.80 ± 25.88	0.757
C3c (0.9–1.8 g/L)	1.16 ± 0.17	1.17 ± 0.19	0.895

^* Significant difference. n: number of patients/events. γGT: gamma-glutamyltransferase; abs.: absolute number; ALAT: alanine aminotransferase; AP: alkaline phosphatase; ASAT: aspartate aminotransferase; C3c: complement factor 3c; CH50: complement factor CH50; HDL: high-density lipoprotein; LDL: low-density lipoprotein; mAb: monoclonal antibody; SD: standard deviation; TG: triglyceride; WBC: white blood cell

Supplementary materials

The supplementary material for this article is available at: https://www.explorationpub.com/uploads/Article/file/1003145_sup_1.pdf.

Declarations

Author contributions

JW: Conceptualization, Data curation, Visualization, Writing—original draft, Writing—review & editing. IK: Validation, Writing—review & editing. GJK: Conceptualization, Investigation, Validation, Writing—original draft, Writing—review & editing, Supervision.

Conflicts of interest

GJK consults for Immunovant, Inc., New York City, NY, USA. The other authors declare that they have no conflicts of interest.

Ethical approval

The ASCEND GO 2 study was approved by the leading Ethics Committee (Rhineland Palatinate, 2019-14297-AMG).

Consent to participate

Informed consent to participate in the study was obtained from all participants.

Consent to publication

Not applicable.

Availability of data and materials

The raw data supporting the conclusions of this manuscript will be made available by the authors, without undue reservation, to any qualified researcher.

Funding

The JGU Medical Center receives research-associated funding from Immunovant, Inc., New York City, NY, USA [lmmunovant IMV-02524]. The funders had no role in the design of the submitted study, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright

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