Janus kinase (JAK) inhibitors are effective anti-inflammatory agents for treatment of ulcerative colitis (UC).1 According to drug regulatory agencies and international guidelines, JAK inhibitors should be avoided during pregnancy and lactation.2-4 The existing evidence on safety of JAK inhibitors during pregnancy is scarce and almost exclusively limited to tofacitinib.4-7.
- MeSH
- dospělí MeSH
- fetální krev * chemie MeSH
- inhibitory Janus kinas terapeutické užití MeSH
- komplikace těhotenství farmakoterapie MeSH
- lidé MeSH
- mateřské mléko * chemie MeSH
- novorozenec MeSH
- piperidiny * terapeutické užití MeSH
- pyrimidiny * terapeutické užití MeSH
- těhotenství MeSH
- ulcerózní kolitida farmakoterapie krev MeSH
- výsledek těhotenství * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- novorozenec MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Klíčová slova
- upadacitinib,
- MeSH
- biologická terapie MeSH
- heterocyklické sloučeniny tricyklické aplikace a dávkování terapeutické užití MeSH
- lidé MeSH
- mladý dospělý MeSH
- ulcerózní kolitida * farmakoterapie terapie MeSH
- Check Tag
- lidé MeSH
- mladý dospělý MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- Klíčová slova
- filgotinib,
- MeSH
- biologická terapie MeSH
- dospělí MeSH
- glukokortikoidy aplikace a dávkování terapeutické užití MeSH
- inhibitory Janus kinas farmakologie terapeutické užití MeSH
- kombinovaná farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- triazoly * farmakologie terapeutické užití MeSH
- ulcerózní kolitida * farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
Crohnova choroba a ulcerózní kolitida jsou chronická, zánětlivá střevní onemocnění medikamentózně a chirurgicky nevy- léčitelná. V posledních 20 letech došlo k dramatickému vývoji především léčby medikamentózní. V biologické léčbě byly zavedeny nové preparáty s mechanismem účinku cíleným na molekuly s klíčovým postavením v patogenezi idiopatických střevních zánětů.
Crohn's disease and ulcerative colitis are chronic, inflammatory bowel disease medically and surgically incurable. In the last 20 years, there has been a dramatic development, especially of medicamentous treatment. In biological therapy, new agents have been introduced with a mechanism of action targeted on molecules of key role in the pathogenesis of inflammatory bowel disease.
- MeSH
- biologická terapie metody MeSH
- biosimilární léčivé přípravky terapeutické užití MeSH
- Crohnova nemoc farmakoterapie MeSH
- idiopatické střevní záněty * farmakoterapie MeSH
- individualizovaná medicína MeSH
- inhibitory interleukinu terapeutické užití MeSH
- inhibitory Janus kinas aplikace a dávkování terapeutické užití MeSH
- inhibitory TNF aplikace a dávkování terapeutické užití MeSH
- lidé MeSH
- molekuly buněčné adheze antagonisté a inhibitory MeSH
- receptory sfingosin-1-fosfátu antagonisté a inhibitory MeSH
- ulcerózní kolitida farmakoterapie MeSH
- Check Tag
- lidé MeSH
BACKGROUND AND AIMS: Tofacitinib (TFB) appears to be effective in the treatment of ulcerative colitis (UC); however, available real-world studies are limited by cohort size. TFB could be an option in the treatment of acute severe ulcerative colitis (ASUC). We aimed to investigate efficacy and safety of TFB in moderate-to-severe colitis and ASUC. METHODS: This retrospective, international cohort study enrolling UC patients with ≥6-week follow-up period was conducted from February 1 to July 31, 2022. Indications were categorized as ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Steroid-free remission (SFR), colectomy, and safety data were analyzed. RESULTS: A total of 391 UC patients (median age 38 [interquartile range, 28-47] years; follow-up period 26 [interquartile range, 14-52] weeks) were included. A total of 27.1% received TFB in ASUC. SFR rates were 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. The baseline partial Mayo score (odds ratio [OR], 0.850; P = .006) was negatively associated with week 12 SFR, while biologic-naïve patients (OR, 2.078; P = .04) more likely achieved week 52 SFR. The colectomy rate at week 52 was higher in ASUC group (17.6% vs 5.7%; P < .001) and decreased with age (OR, 0.94; P = .013). A total of 67 adverse events were reported, and 17.9% resulted in cessation of TFB. One case of thromboembolic event was reported. CONCLUSIONS: TFB is effective in both studied indications. TFB treatment resulted in high rates of SFR in the short and long terms. Higher baseline disease activity and previous biological therapies decreased efficacy. No new adverse event signals were found.
- MeSH
- dospělí MeSH
- indukce remise MeSH
- inhibitory proteinkinas terapeutické užití MeSH
- kolektomie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- piperidiny * terapeutické užití MeSH
- pyrimidiny * terapeutické užití MeSH
- retrospektivní studie MeSH
- stupeň závažnosti nemoci MeSH
- ulcerózní kolitida * farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
BACKGROUND: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited. AIM: Pooled analysis of randomised studies to compare efficacy and safety with IFX SC and VDZ in moderate-to-severe inflammatory bowel disease. METHODS: Parallel-group, randomised studies evaluating IFX SC and VDZ in patients with moderate-to-severe CD or UC were identified. Eligible studies reported ≥ 1 prespecified outcome of interest at Week 6 (reflecting treatment during the induction phase) and/or at 1 year (Weeks 50-54; reflecting treatment during the maintenance phase). Prespecified efficacy and safety outcomes considered in this pooled analysis included the proportions of patients achieving disease-specific clinical responses, clinical remission, or discontinuing due to lack of efficacy, and the proportions of patients experiencing adverse events (AEs), serious AEs, infections, serious infections, or discontinuing due to AEs. Data from multiple studies or study arms were extracted and pooled using a random-effect model; comparative analyses were performed separately for patients with CD and UC. RESULTS: We identified three eligible CD trials and four eligible UC trials that assigned over 1200 participants per disease cohort to either IFX SC or VDZ. In patients with CD, intravenous induction therapy with IFX demonstrated better efficacy (non-overlapping 95% confidence intervals [CIs]) compared with VDZ; during the maintenance phase, IFX SC showed numerically better efficacy (overlapping 95% CIs) than VDZ. A lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In patients with UC, efficacy profiles were similar with IFX SC and VDZ during the induction and maintenance phases, and a lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In both cohorts, safety profiles for IFX SC and VDZ were generally comparable during 1 year. CONCLUSION: IFX SC demonstrated better efficacy than VDZ in patients with CD, and similar efficacy to VDZ in patients with UC; 1-year safety was comparable with IFX SC and VDZ.
- MeSH
- Crohnova nemoc * farmakoterapie MeSH
- dospělí MeSH
- gastrointestinální látky škodlivé účinky MeSH
- humanizované monoklonální protilátky * MeSH
- indukce remise MeSH
- infliximab škodlivé účinky MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- ulcerózní kolitida * farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
