Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study

被引:1
作者
Harnik, Sivan [1 ]
Abitbol, Chaya M. [1 ]
Haj Natour, Ola [1 ]
Yavzori, Miri [1 ]
Fudim, Ella [1 ]
Picard, Orit [1 ]
Naftali, Timna [2 ]
Broide, Efrat [3 ]
Hirsch, Ayal [4 ]
Selinger, Limor [1 ]
Shachar, Eyal [1 ]
Yablecovitch, Doron [1 ]
Albshesh, Ahmad [1 ]
Coscas, Daniel [1 ]
Kopylov, Uri [1 ]
Eliakim, Rami [1 ]
Ben-Horin, Shomron [1 ]
Ungar, Bella [1 ]
机构
[1] Tel Aviv Univ, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Dept Gastroenterol, Tel Aviv, Israel
[2] Tel Aviv Univ, Sackler Sch Med, Meir Med Ctr, Dept Gastroenterol, Tel Aviv, Israel
[3] Tel Aviv Univ, Sackler Fac Med, Assaf Harofeh Med Ctr, Kamila Gonczarowski Inst Gastroenterol, Tel Aviv, Israel
[4] Tel Aviv Univ, Sackler Fac Med, Tel Aviv Sourasky Med Ctr, Dept Gastroenterol & Hepatol, Tel Aviv, Israel
关键词
Adalimumab; ulcerative colitis; drug-antibodies; CROHNS-DISEASE; EFFICACY; MODERATE; MAINTENANCE; ASSOCIATION; PREDICTORS; REMISSION; SAFETY;
D O I
10.1093/ecco-jcc/jjad156
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background and Aims: Home self-injection of the human anti-tumour necrosis alpha [anti-TNF alpha] monoclonal adalimumab complicates prospective serial-sampling studies. Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease [CD] patients, prospective real-world data from ulcerative colitis [UC] patients are lacking.Methods: A three-monthly home-visit programme from induction was established prospectively for UC patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab-treated CD patients [POETIC1].Results: Fifty UC patients starting adalimumab [median follow-up 28 weeks] were compared to 98 adalimumab-treated CD patients [median follow-up 44 weeks]. Only 11/50 UC patients [22%] continued treatment to the end of the follow-up compared with 50/98 [51%] CD patients (odds ratio [OR] = 0.27, p = 0.001). Loss of response was significantly more common in UC patients [OR = 3.2, p = 0.001]. Seventeen patients [34%] in the UC cohort developed anti-adalimumab antibodies, 9/17 [52.9%] as early as week 2. There was no difference between patient cohorts in the overall development of anti-adalimumab antibodies [34% vs 30.6%, respectively, OR = 1.67, p = 0.67], nor was there a difference in early immunogenicity [OR = 1.39, p = 0.35]. There was no difference in low drug levels [<3 mu g/mL] between the two cohorts [OR = 0.87, p = 0.83].Conclusions: Loss of response to adalimumab therapy was significantly more common in the UC compared to the CD cohort and was driven by a higher rate of non-immunogenic, pharmacodynamic parameters.
引用
收藏
页码:341 / 348
页数:8
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