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1.	Deisenhammer, F, et al. (author) Prediction of natalizumab anti-drug antibodies persistency 2019 In: Multiple sclerosis (Houndmills, Basingstoke, England). - : SAGE Publications. - 1477-0970 .- 1352-4585. ; 25:3, s. 392-398 Journal article (peer-reviewed)abstract Anti-drug antibodies (ADA) against natalizumab develop early during treatment. ADA persistency is defined by two consecutive positive results as performed by the current qualitative ELISA assay (positive/negative). Very little is known about the magnitude of the natalizumab ADA response and persistency. Design/methods: We developed a highly sensitive natalizumab ADA titration assay on the Meso Scale Discovery (MSD) platform and a pharmacokinetic (PK) assay. We included 43 patients with a positive ELISA-ADA result within 6 months of treatment initiation (baseline) of whom a follow-up serum sample was available 12–30 months after treatment start. MSD-ADA titres and drug levels were measured. Results: Median MSD-ADA titre at baseline was 4881 and 303 at follow-up. A titre of >400 at baseline had a 94% sensitivity and 89% specificity to predict ADA persistency. Reversion to ADA negativity occurred in 10 patients with mean drug levels of 10.8 μg/mL. The median trough drug level in ADA-positive samples was 0 µg/mL. PK levels and ADA titres correlated strongly negatively ( r = −0.67). Conclusion: High baseline natalizumab ADA titres accurately predict persistency. Despite continuous treatment, the majority of patients with persistent ADA had no detectable drug levels indicating loss of efficacy in line with phase 3 study results.
2.	Hassler, S, et al. (author) Clinicogenomic factors of biotherapy immunogenicity in autoimmune disease: A prospective multicohort study of the ABIRISK consortium 2020 In: PLoS medicine. - : Public Library of Science (PLoS). - 1549-1676. ; 17:10, s. e1003348- Journal article (peer-reviewed)
3.	Pathak, GA, et al. (author) A first update on mapping the human genetic architecture of COVID-19 2022 In: Nature. - : Springer Science and Business Media LLC. - 1476-4687 .- 0028-0836. ; 608:7921, s. E1-E10 Journal article (other academic/artistic)

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Type of publication: journal article (3)

Type of content: peer-reviewed (2); other academic/artistic (1)

Author/Editor: Li, B. (1); Wang, X. (1); Oliveira, M. (1); Hottenga, JJ (1); Martin, H (1); Castano-Vinyals, G (1); show more...; Choi, S. (1); Cho, K. (1); Gupta, R. (1); Rizzi, M. (1); Beguin, Y (1); Hussain, S. (1); North, K (1); Khan, A. (1); Lee, S (1); Lee, PH (1); Smith, A (1); Russo, R. (1); Capasso, M. (1); Filipovic, M. (1); Roberts, G (1); Bartels, M (1); Hosseini, A. (1); Breen, G (1); Moreno, V (1); Ali, A. (1); Durand, M (1); Harris, JR (1); Sun, Y (1); Wilson, DJ (1); Wright, J (1); Ho, YL (1); Bianchi, F. (1); El-Sherbiny, YM (1); Knapp, C. (1); Walker, S (1); King, D. (1); Barbieri, C. (1); Soriano, A (1); Manson, J (1); Green, RC (1); Smoller, JW (1); Uitterlinden, AG (1); Ikram, MA (1); Crook, DW (1); Goldstein, J (1); Shrine, N (1); Tobin, MD (1); Hollox, EJ (1); Daly, M. (1); show less...

University: Karolinska Institutet (3); Uppsala University (1)

Language: English (3)

Research subject (UKÄ/SCB): Medical and Health Sciences (1)

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