Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a Phase 3 study

Background Ferric maltol was effective and well-tolerated in iron deficiency anaemia patients with inflammatory bowel disease during a 12-week placebo-controlled trial. Aim To perform a Phase 3 extension study evaluating long-term efficacy and safety with ferric maltol in inflammatory bowel disease patients in whom oral ferrous therapies had failed to correct iron deficiency anaemia. Methods After 12 weeks of randomised, double-blind treatment, patients with iron deficiency anaemia and mild-to-moderate ulcerative colitis or Crohn's disease received open-label ferric maltol 30 mg b.d. for 52 weeks. Results 111 patients completed randomised treatment and 97 entered the open-label ferric maltol extension. In patients randomised to ferric maltol ('continued'; n = 50), mean +/- s.d. haemoglobin increased by 3.07 +/- 1.46 g/dL between baseline and Week 64. In patients randomised to placebo ('switch'; n = 47), haemoglobin increased by 2.19 +/- 1.61 g/dL. Normal haemoglobin was achieved in high proportions of both continued and switch patients (89% and 83% at Week 64, respectively). Serum ferritin increased from 8.9 lg/L (baseline) to 26.0 lg/L (Week 12) in ferric maltol-treated patients, and to 57.4 lg/L amongst all patients at Week 64. In total, 80% of patients reported = 1 adverse event by Week 64. Adverse events considered related to ferric maltol were recorded in 27/111 (24%) patients: 8/18 discontinuations due to adverse events were treatment-related. One patient was withdrawn due to increased ulcerative colitis activity. Conclusions Normal haemoglobin was observed in = 80% of patients from weeks 20-64 of long-term ferric maltol treatment, with concomitant increases in iron storage parameters. Ferric maltol was well-tolerated throughout this 64-week study

Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program

BACKGROUND: Iron deficiency anemia (IDA) is frequently seen in inflammatory bowel disease. Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. This multicenter phase-3 study tested the efficacy and safety of ferric maltol, a complex of ferric (Fe) iron with maltol (3-hydroxy-2-methyl-4-pyrone), as a novel oral iron therapy for IDA. METHODS: Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn's disease, mild-to-moderate IDA (9.5-12.0 g/dL and 9.5-13.0 g/dL in females and males, respectively), and documented failure on previous oral ferrous products received oral ferric maltol capsules (30 mg twice a day) or identical placebo for 12 weeks according to a randomized, double-blind, placebo-controlled study design. The primary efficacy endpoint was change in hemoglobin (Hb) from baseline to week 12. Safety and tolerability were assessed. RESULTS: Of 329 patients screened, 128 received randomized therapy (64 ferric maltol-treated and 64 placebo-treated patients) and comprised the intent-to-treat efficacy analysis: 55 ferric maltol patients (86%) and 53 placebo patients (83%) completed the trial. Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4, 8, and 12: mean (SE) 1.04 (0.11) g/dL, 1.76 (0.15) g/dL, and 2.25 (0.19) g/dL, respectively (P < 0.0001 at all time-points; analysis of covariance). Hb was normalized in two-thirds of patients by week 12. The safety profile of ferric maltol was comparable with placebo, with no impact on inflammatory bowel disease severity. CONCLUSIONS: Ferric maltol provided rapid clinically meaningful improvements in Hb and showed a favorable safety profile, suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease

Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort

Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn’s disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. Results: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [ p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. Conclusions: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions

Prediction of short- and medium-term efficacy of biosimilar infliximab therapy. Do trough levels/antidrug antibody levels or clinical/biochemical markers play a more important role?

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Long term efficacy, safety and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort

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A terápiás adherencia, valamint a komplementer és alternatív gyógymódok használata gyulladásos bélbetegek kezelésében = Treatment adherence and use of complementary and alternative medicine in patients with inflammatory bowel disease

Az utóbbi évek tanulmányai a komplementer és alternatív gyógymódok (CAM) egyre gyakoribb alkalmazásáról tudósítanak gyulladásos bélbetegségben (IBD). Ugyanakkor az is egyre nyilvánvalóbb, hogy a betegek jelentős hányada nem tartja be az orvos előírásait. A tanulmány célja a terápiás nonadherencia és a CAM-alkalmazás gyakoriságának felmérése volt hazai IBD-betegekben. Módszer: multicentrikus vizsgálatban 655 IBD-beteg [Crohn-beteg (CD): 344, átlagos életkor: 38,2 (SD 12,9) év; colitis ulcerosa (UC): 311, átlagos életkor: 44,9 (SD 15,3) év] töltött ki a szokásos szakorvosi vizit során a demográfiai adatokra, gyógyszer-adherenciára és CAM-ra vonatkozó kérdőívet. A klinikai adatokat a kezelőorvos egészítette ki a betegdokumentáció alapján. Amennyiben a beteg az előírt gyógyszerek több mint 80%-át bevette, adherensnek tekintettük. Eredmények: a betegek által önként jelzett nonadherencia (CD: 20,9%, UC: 20,6%) és CAM (CD: 31,7%, UC: 30,9%) használata CD-ben és UC-ben nem tért el. A nonadherencia leggyakoribb okai: feledékenység (47,8%), túl sok/feleslegesnek gondolt gyógyszer (39,7%), mellékhatásoktól való félelem (27,9%), túl gyakori adagolás. A CAM leggyakoribb formája a gyógytea (47,3%), a homeopátia (14,6%), a speciális diéta (12,2%) és az akupunktúra (5,8%) volt. CD-ben a betegségtartam, az utolsó vizittől eltelt idő, az alacsonyabb iskolázottsági szint és a megelőző műtétek voltak a nonadherenciára hajlamosító tényezők. Az alternatív módszerek használata fiatalabb életkorban, magasabb iskolázottsági szint és immunszuppresszív szer szedése esetén volt jellemző. UC-ben ezenfelül a CAM igénybevétele gyakoribb volt nők és pszichiátriai/pszichológiai kezelés alatt állók körében. Következtetés: a nonadherencia és az alternatív gyógymódok igénybevétele gyakori IBD-ben. Az ellenőrző vizitek során különös figyelmet kell fordítani a hajlamosító tényezők feltárására, a betegek együttműködésének és az orvos–beteg kapcsolatnak a javítására. | Previous studies have suggested an increasing use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). Furthermore, a significant number of IBD patients fail to comply with treatment. The aim of our study was to evaluate the prevalence of non-adherence the use of CAM in Hungarian patients with IBD. Methods: A total of 655 consecutive IBD patients (Crohn’s disease [CD]: 344, age: 38.2±12.9 years; ulcerative colitis [UC]: 311, age: 44.9±15.3 years) were interviewed during the visit at specialists by self-administered questionnaire including demographic and disease-related data, as well as items analyzing the extent of non-adherence and CAM use. Patients taking more then 80% of each prescribed medicine were classified as adherent. Results: The overall rate of self reported non-adherence (CD: 20.9%, UC: 20.6%) and CAM (CD: 31.7%, UC: 30.9%) use was not different between CD and UC. The most common causes of non-adherence were: forgetfulness (47.8%), too many/unnecessary pills (39.7%), being afraid of side effects (27.9%) and too frequent dosing. Most common forms of CAM were herbal tee (47.3%), homeopathy (14.6%), special diet (12.2%), and acupuncture (5.8%). In CD, disease duration, date of last follow-up visit, educational level and previous surgeries were predicting factors for non-adherence. Alternative medicine use was associated in both diseases with younger age, higher educational level and immunosuppressant use. In addition, CAM use in UC was more common in females and in patients with supportive psychiatric/psychological therapy. Conclusions: Non-adherence and CAM use is common in patients with IBD. Special attention should be paid to explore the identified predictive factors during follow-up visits to improve adherence to therapy and improving patient-doctor relationship

Válságban a világ. Pénzügyi és számviteli kihívások

A VI. Bosnyák János Emlékkonferencia előadásainak szerkesztett cikkei olvashatók a kötetben

A metallothionein-expresszió melanomában: tumorbiológiával és immunválasszal összefüggést mutató független biomarker

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