Introduction

Vedolizumab (VDZ) is a gut-selective anti-lymphocyte trafficking agent and is approved for treating patients with moderate to severe active UC (ulcerative colitis) and CD (Crohn’s disease) intravenously (IV) or subcutaneously (SC). The LISTEN II study determines patient characteristics and effectiveness in VDZ-treated patients in clinical routine with focus on patient reported outcomes (PROs).

Aims & Methods

LISTEN II is a multicentre, prospective, non-interventional study in Germany. Adult patients with UC or CD who either initiate VDZ IV or switch from IV to SC formulation, are enrolled. Data on patient characteristics, modalities of VDZ use and disease activity (pMayo and HBI) are followed up quarterly for up to one year per routine care. Electronic assessments of PROs are recorded weekly via a study-specific app (ePRO). Here, interim data up to 6 months follow-up are presented.

Results

Data of 242 UC (52% female, mean age 41 years) and 149 CD patients (60% female, mean age 40 years) were included in this analysis. VDZ treatment was newly initiated IV (start) in 206 UC and 127 CD patients and switched from IV to SC application (switch) by 36 UC and 22 CD patients at baseline. After 6-month's treatment, total mean pMayo score decreased in UC start-patients from 5.0±2.1 to 2.1±2.0 and remained at 1.0±1.3 in switch-patients. In CD-start patients HBI score decreased from 5.6±4.2 to 2.9±3.5 and from 3.0±3.5 to 2.5±2.9 in switch-patients.
The ePRO was initially used by 74% of UC and 73% of CD patients. The mean age was 39 years and the majority (84%) had newly started VDZ treatment. The initial high willingness to ePRO use declined to approx. 40% usage within the second quarter and to 30% during further follow-up. When looking at sustained usage per patient (percentage of patients who completed at least one question of ≥80% of all questionnaires available to them), 62% of UC and 55% of CD patients were sustained ePRO users. Most of UC patients (82%) and CD patients (88%) used a support program for the first time.
ePRO users with UC more frequently reported high burden of disease at study inclusion compared to those with CD (55% versus 25%; high burden of disease defined for UC as pMayo >4 and CD as HBI >7), with a mean pMayo score of 4.4±2.5 for UC and mean HBI score of 5.3±4.2 for CD patients. Overall, mean scores for ePRO symptoms declined within the follow-up period from baseline to 6 months. The absolute decline was most pronounced for symptoms impact on work productivity (3.9 to 1.9 points) in UC patients and sick leave (1.2 to 0.6 points) for CD patients (table).

Table: ePRO progression of UC and CD patients

Conclusion

LISTEN II real-world data support the effectiveness of VDZ treatment in UC and CD patients. Patients, newly starting VDZ IV showed a decrease in disease activity under VDZ treatment, while for patients switching from existing VDZ IV to SC maintained therapeutic effectiveness was observed. UC and CD patients reported a steady improvement of relevant symptoms under VDZ treatment using the ePRO, however app adherence declined to 30% during follow-up.

Disclosure

Hermann Schulze, Andreas Stallmach and Niels Teich are involved in the data collection for this study and Andreas Stallmach is the Scientific Lead of the study. Hermann Schulze and Niels Teich receive payments from Takeda Pharma Vertrieb GmbH & Co. KG for their participation as advisory members of the study steering committee of this study. Sonja Henneberger participated in this study as a staff member of Institut Dr. Schauerte GmbH (IDS). The work of IDS was funded by Takeda Pharma Vertrieb GmbH & Co. KG. Taner Cavlar and Jana Knop are employees of Takeda Pharma Vertrieb GmbH & Co. KG. Taner Cavlar is owner of Takeda shares.

Introduction

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory diseases of digestive tract, and anti-inflammatory drugs, such as vedolizumab, have central role in their treatment. Intravenous form of vedolizumab is approved for induction and maintenance of remission in patients with CD and UC. Recently, subcutaneous form of vedolizumab was approved as a maintenance therapy after the induction with, at least, two intravenous doses.

Aims & Methods

The aim of this study was to show how the switch from intravenous to subcutaneous vedolizumab in a real-life setting in inflammatory bowel disease (IBD) patients on stable maintenance therapy affects vedolizumab serum concentration and clinical outcomes. IBD patients treated with intravenous vedolizumab and planned to switch to subcutaneous vedolizumab at the Department of Gastroenterology and Hepatology in the University Hospital Centre Osijek were included in the study. Patients were in remission at the time of transition (based on clinical symptoms, fecal calprotectin level or endoscopy scores). Data on vedolizumab serum trough concentration and clinical outcomes (remission rate, fecal calprotectin level, clinical scores, hospitalization rate, rate of surgical procedures, change of therapy, and adverse events) were collected prior to and after the switch from intravenous to subcutaneous vedolizumab.

Results

In total, 31 patients, 17 with CD and 14 with UC, were included in final analysis. Median follow up was 12 months (interquartile range, IQR 9-12). Median duration of therapy with intravenous vedolizumab prior to switch was 14 months (IQR 6-32). Mean serum trough concentration of intravenous vedolizumab was significantly lower than mean serum trough concentration of subcutaneous vedolizumab (25.62 mg/L±14.29 vs. 34.93±14.59 mg/L; p=0.002). This rise in vedolizumab serum concentration after the switch to subcutaneous drug, was more evident in CD (Δ11.8 mg/L) than in UC (Δ5.79 mg/L) patients. There was no significant difference between fecal calprotectin level in all patients, as well as fecal calprotectin and Harvey–Bradshaw index in CD patients prior to or after the transition to subcutaneous vedolizumab. In UC patients, fecal calprotectin and Partial Mayo score were significantly higher (p= 0.011 and p=0.018, respectively) after the switch to subcutaneous vedolizumab, although this difference was not clinically significant. There was a significant difference in remission rate before and after the transition to subcutaneous vedolizumab in all patients (100% vs 71%; p=0.004), and in UC patients (100% vs. 57.1%; p=0.031). During the follow up, one (3.2%) CD patient was hospitalized and had a surgical procedure due to IBD. In 7 (22.6%) patients, the therapy was discontinued during the follow-up period with a median of 8 months. In all patients, therapy was discontinued due to loss of response. In total, 27 adverse events were reported by 17 patients, and the most common adverse event was COVID-19. One serious adverse event was reported (a patient was hospitalized for subileus).

Conclusion

Despite the rise in serum vedolizumab trough concentration after the switch from intravenous to subcutaneous vedolizumab, total remission rate was significantly lower in all patients and in the subgroup of UC patients. No new safety signals were observed in patients after the switch to subcutaneous vedolizumab.

Disclosure

Vlasta Oršić Frič has received speaker honoraria from Takeda, Janssen, Merck Sharp & Dohme, Sandoz, Ferring, Oktal Pharma, Abbvie, Viatris-Mylan and has been a member of advisory board for Janssen. Vladimir Borzan has received speaker honoraria from Takeda, Janssen, Sandoz, Merck Sharp & Dohme, Abbvie, Oktal Pharma, Viatris-Mylan, Ferring and has been a member of advisory board for Takeda, Sandoz, Abbvie, Viatris-Mylan, Merck Sharp & Dohme. Other authors declare no conflict of interest.

Introduction

Vedolizumab is a humanised monoclonal antibody whose mechanism of action is inhibition of the α4β7 integrin of T leukocytes. It is indicated for moderate or severe flare of inflammatory bowel disease. Subcutaneous (SC) vedolizumab, a new formulation recently approved, is a major advantage for patients for home administration.

Aims & Methods

Analyse the percentage of clinical and biochemical remission in patients on treatment with intravenous (IV) vedolizumab after switching to SC vedolizumab. In addition, the relationship between a treatment with intensified IV vedolizumab and subsequent drug levels versus patients without intensification.
Single-center, descriptive, observational, and retrospective study of a cohort of all of 19 patients diagnosed with ulcerative colitis (UC) and crohn disease (CD) teatred with IV vedolizumab in January 2022, who underwent a switch to SC vedolizumab. Analyse of clinical and analytical parameters (faecal calprotectin (FC), concomitant treatment, vedolizumab levels during follow-up, need for intensified intravenous treatment, ocurrence of adverse effects or loss of response) in patients on IV vedolizumab treatment and subsequent switch to SC vedolizumab with follow-up during weeks 4, 12, and 24.

Results

Ten patients (22.6%) were diagnosed with UC and 9 patients (47.3%) with CD. The baseline characteristics of the patients are described in table 1. 68% of patients were exposed to anti-TNF when initiating IV Vedolizumab due to loss of response, and 15,7% had been exposed to >1 anti-TNF. 31% (6 patients) were naive to Anti-TNF, 4 patients (21%) IV vedolizumab was started as the first line of treatment due to the increased risk of infections and a previous history of neoplasia and in 2 patients with CD (10.5%) vedolizumab was started as prevention of recurrence. Up to 8 patients (42.1%) were on an intensified IV vedolizumab prior to switching to SC vedolizumab. Biochemical remission (FC < 150 µg/g) was achieved in 14 patients (77.7%) at week 24 of follow-up. All 19 patients (100%) achieved clinical remission. It was noted that biochemical remission was not achieved in up to 50% of patients on the intensified regimen with IV vedolizumab. Mean baseline intravenous vedolizumab levels were 12.1 μg/ml. After switching to SC vedolizumab, the mean levels were 13.1 μg/ml at week 4, 19.9 μg/ml at week 12 and 22.9 μg/ml at week 24 (p= 0.001). There was no statistically significant difference in biochemical remission between patients who received an intensive IV vedolizumab regimen and those who did not. One adverse event (paraesthesia) was described in one patient (5.2%) in relation to IV vedolizumab.

Table 1. Baseline characteristics.

Conclusion

78% of patients after switching from IV vedolizumab to SC vedolizumab, reached clinical and biochemical remission at 6 months of follow-up. In addition, vedolizumab levels increased progressiively after switching IV vedolizumab to SC treatment. These findings confirm that SC vedolizumab is a good therapeutic option for long-term maintenance.

References

• Ventress E, Young D, Rahmany S, Harris C, Bettey M, Smith T, Moyses H, Lech M, Gwiggner M, Felwick R, Cummings JRF. Transitioning from Intravenous to Subcutaneous Vedolizumab in Patients with Inflammatory Bowel Disease [TRAVELESS]. J Crohns Colitis. 2022 Jul 14;16(6):911-921. doi: 10.1093/ecco-jcc/jjab224.
• Vermeire S, D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV, Bhatia S, Agboton C, Rosario M, Chen C, Zhang W, Kisfalvi K, Sandborn WJ. Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial. J Crohns Colitis. 2022 Jan 28;16(1):27-38. doi: 10.1093/ecco-jcc/jjab133.
• Bergqvist V, Holmgren J, Klintman D, Marsal J. Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2022 Jun;55(11):1389-1401. doi: 10.1111/apt.16927.

Introduction

Subcutaneous vedolizumab has become available for the treatment of inflammatory bowel diseases in 2021 after intravenous induction. The aim of this multicentre prospective study was to evaluate treatment persistence, efficacy and tolerance after switching from intravenous (IV) to subcutaneous (SC) vedolizumab (VDZ) in stable patients.

Aims & Methods

All consecutive patients with either ulcerative colitis (UC) or Crohn’s disease (CD), in clinical remission for at least 3 months and switching from IV to SC-VDZ, were included in this multicentre cohort study. Inclusion could take place prospectively or within 3 months after switch. Clinical remission was defined by partial Mayo score ≤2 for UC or Harvey Bradshaw index ≤4 for CD; concomitant 5-amonisalycilate or immunosuppressive treatment was allowed at stable doses. Concomitant biologic or JAK-inhibitor treatments were not permitted during the study period, which lasted for 12 months after switch. SC-VDZ was started at 108 mg every other week. Primary endpoint was SC-VDZ treatment persistence at 54 weeks (W54) after switch; need for surgery, prolonged corticosteroid courses (>14 days) and loss of follow-up were considered as treatment failure. This is an analysis based on early 6-months (M6) results, reporting rates of treatment persistence, need for optimisation, switch-back to IV-VDZ and adverse events.

Results

Overall, 337 patients were analysed of 348 included, after removal of 10 patients who had an active disease and one an active infection: 246 patients (73%) had UC, 91 (27%) had CD, with a median disease duration of 9 years [interquartile range: 4-17] in UC and 13 [8-19] years in CD. Patients with UC had been on IV-VDZ for a median time of 1.4 years [0.4-3.3] prior to switch, compared to 3.1 [1.3-6.1] for CD patients, with 205 patients overall (62%) on standard IV-VDZ regimen (300mg 8-weekly).
At M6, the SC-VDZ discontinuation-free survival rate was 93.9% [95% confidence interval: 91.3 - 96.5], with no significant difference between CD and UC (p=0.6). During follow-up, 33 patients (10%) had SC-optimisation, with similar rates in both diseases. Among them, 63% has an optimised IV-VDZ regimen prior to switch. In total, 13 (4%) patients switched-back to IV-VDZ: 3 due to loss of response despite SC-VDZ optimisation, 7 for injection site reaction and 3 for various non severe adverse-events. 181 (54%) patients declared adverse events, the most frequent being injection site reactions (20%) and infections (17%). Only one serious adverse event potentially related to treatment was reported (a digestive infection that led to hospitalisation with negative testing), though it did not lead to treatment discontinuation.

Conclusion

In this multicentre prospective cohort of patients with CD or UC in clinical remission who switched from IV to SC vedolizumab, drug persistence rate at 6 months was over 90%, with good safety results. 12-month results are pending.

Disclosure

Financial support: Takeda

Introduction

Vedolizumab (VDZ) is a monoclonal antibody approved for use in both Crohn’s Disease (CD) and Ulcerative Colitis (UC). Some patients treated with VDZ have suboptimal disease response to induction and 8-weekly maintenance dosing. Dose intensification (DI) by shortening the dosing interval is a strategy used to improve response to treatment. This study aims to identify factors associated with DI in an Asian cohort of IBD patients.

Aims & Methods

This was a retrospective cohort study performed in a single tertiary center in Singapore. Patients who received VDZ between Sept 2016 to Sept 2022 were identified from a prospectively maintained registry. Patient demographics, disease phenotype, treatment history and biochemical parameters were retrieved. Factors predictive of requiring DI were analysed. Statistical analysis was performed using SPSS v23.0.

Results

A total of 69 IBD patients who received VDZ were identified. Mean age was 57.1 years (SD=20.1). Males made up 63.1% of the cohort, with 3 patients (4.6%) being active smokers. Thirty-nine patients (60.0%) had prior exposure to immunomodulators, 32 patients (49.2%) had prior anti-tumour necrosis factor-alpha inhibitor exposure, 5 patients (7.7%) had prior ustekinumab exposure. None of the patients had prior exposure to small molecules.
A total of 4 patients (6.2%) had prior exposure to 2 biologic agents, 30 patients (45.2%) had prior exposure to 1 biologic agent, and 31 patients (47.7%) were biologic-naïve. Disease duration prior to VDZ use was 8.4 years (SD=8.0). VDZ treatment duration was 24.4 months (SD=19.2).
A total of 25 patients (10 CD, 15 UC) underwent DI. Time from induction to DI was 384.4 days (SD=301.2). Gender, active smoking status, age of diagnosis, previous treatment or biologic exposure, higher pre-induction C-reactive protein and stool calprotectin did not predict for need for DI. (Figure 1)
Four patients achieved clinical remission post induction but subsequently required DI. Fourteen patients underwent DI to Q6W dosing and 11 patients received Q4W dosing. Patient demographics are shown in Figure 2a.
Outcomes of DI at 52-weeks post DI is shown in Figure 2b. Eight patients (32.0%) achieved treatment endpoints of corticosteroid-free remission (n=2), biochemical remission (n=2) and endoscopic remission (n=4). Mean duration on VDZ with DI in CD was 9.9months (SD=9.1), and 35.9months (SD=19.9) in UC.
Ten patients were switched to another biologic. Five (2 UC, 3 CD) patients required surgery despite DI. One patient had recurrent Clostridium difficile infections while on VDZ. There were no other complications or hospitalizations associated with DI.

Conclusion

This is the first VDZ DI study in Asia. One third of patients who receive VDZ required DI, of which a third achieved remission by week 52. Some Asian patients with IBD may require DI to achieve remission.

Introduction

Vedolizumab (VDZ) is an anti α4β7 integrin antibody therapy that inhibits migration of T-lymphocytes to the gastrointestinal epithelium through mucosal addressin cell adhesion receptor^1. As a licensed treatment for inflammatory bowel disease (IBD), it is now available as a subcutaneous (SC) formulation. The efficacy and safety of SC VDZ was comparable to intravenous (IV) therapy in two randomised controlled trials (VISIBLE 1 and 2) in ulcerative colitis (UC)² and Crohn disease (CD)². SC biologic preparations offer patients flexibility to self-administer therapy and reduce hospital visits.

Aims & Methods

Objective is to evaluate the efficacy of SC to IV VDZ in IBD and to assess impact on costs.
Patients receiving IV VDZ infusions at a single tertiary centre were assessed for eligibility to switch to SC formulation. Between February 2021 to February 2023, all patients switch and remaining on IV were included. Baseline data was collected with follow-up at 6 and 12 months. The primary outcome was maintenance of clinical remission, defined as HBI<4 for CD and SCCAI<3 for UC at 6 and 12 months. Secondary outcomes included serum CRP, faecal calprotectin (FCP), drug persistence at 6 and 12 months and potential savings calculated using the drug price and bed costs.
Results expressed as rates and odds ratio (OR) were analysed with GraphPad prism using one-way ANOVA, mixed-effect analyses (q value) and chi-squared test. Benjamini-Hochberg false discovery rate (FDR) adjustment was used for P value correction

Results

246 patients on IV VDZ were identified. 29 were not suitable to switch: 20/29 due to disease phenotype remained in the IV group, 11 patients on escalated dose regimen were excluded from both groups.
Of the 195 included patients, 175 were eligible to switch: 80/175 declined SC treatment due to preferences and continued IV therapy. In the SC switch group (n =95, 54%) median age was 54.5 years, 43% (n=41) were females, 63% (n=60) had UC, 37% (n=35) had CD. The commonest CD phenotype was ileal disease (N=15/35). Compared to the IV group (n =100, 51%) median age was 46 years, 42% (n=42) were females, 63% (n=63) had UC, 37% (n=37) had CD. The commonest CD phenotype was ileocolonic disease (N=11/37).
The primary outcomes are shown in Table 1 which demonstrated statistical significance in maintenance of remission with SC VDZ. The odd for remission with SC VDZ at 6 and 12 months were 1.1 [CI] (p0.7) and 3.6 [CI} (p0.006) at 12 months.
There were no statistically significant differences in CRP and FCP between baseline,6, or 12 months for the IV and SC groups. For CRP, 80% and 75% of patients maintained biochemical remission 6 and 12 months and for FCP 78% at 6 and 81% at 12 months.
Drug persistence for SC at 6 and 12 months were 93% and 87%, respectively. 4% (N=4) patients switched to a different drug due to loss of response, 8% (n=8) switched back to IV VDZ due to adverse events, issues with homecare or symptom control.
Based on this cohort of patients, an expected reduction of £ 72,010 per annum is likely to be achieved.

Conclusion

Transitioning patients from IV to SC VDZ was associated with low drug discontinuation rate. We observed higher remission rates at 12 compared with 6 months for SC group in comparison to patients who remained on IV VDZ. These findings should be used to encourage uptake of switching strategies.

References

1. Feagan, B. G., et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013; 369(8): 699-710.
2. Sandbom WJ, Wolf D, D'haens G, et al. P510 Dose escalation of subcutaneous vedolizumab in patients With ulcerative colitis: A post hoc analysis of the VISIBLE trial data. Journal of Crohn’s and Colitis. 2020; 14 (Supplement_1): S442-S443

Disclosure

Nil

Introduction

Vedolizumab (VDZ) is approved for moderate-to-severe inflammatory bowel disease (IBD; ulcerative colitis [UC] & Crohn’s disease [CD]).^1,2 While the subcutaneous (SC) formulation of VDZ is effective as maintenance treatment (mTx) in patients (pts) responding to intravenous (IV) VDZ induction treatment (Tx),^1,3 real-world data on Tx patterns of pts switching mTx from VDZ IV to SC or initiating mTx VDZ SC after IV induction are limited.

Aims & Methods

This prospective, non-interventional, multicentre (NCT05384080) study (conducted under the umbrella VARIETY protocol) enrolled adults with UC or CD initiating/undergoing induction with VDZ IV or continuing VDZ IV mTx, with the option to switch to VDZ SC mTx. The primary endpoint was real-world Tx patterns with VDZ, including Tx persistence. Additional endpoints assessed pt characteristics, pt-reported outcomes, and safety (adverse events [AEs]). Data were descriptively analysed.

Results

Overall, 162 enrolled pts (August 2022–June 2023; UC, n=103; CD, n=59) were included in the interim analysis. At enrolment, 127 (78.4%) received VDZ mTx (UC, n=78; CD, n=49) and 35 (21.6%), VDZ induction (UC, n=25; CD, n=10). The mean (SD) age was 38.2 (12.3) yrs, and time since IBD diagnosis was 10.7 (11.1) yrs. Majority of pts were male (96 [59.3%]), currently employed (124 [76.5%]), had never smoked (109 [67.3%]), and reported previous biologic therapy (95 [58.6%]). Demographic and IBD Tx history data were consistent across cohorts. At baseline, in pts with UC, the mean (SD) partial Mayo score was 1.8 (2.7); in pts with CD, the mean (SD) Crohn’s Disease Activity Index (CDAI) score was 90.6 (70.1). During the 1-yr study period, 20.0% (n=7; UC, n=2; CD, n=5) of pts in the induction and 51.2% (n=65; UC, n=40; CD, n=25) in the mTx cohort switched to VDZ SC. At week (W) 52, Tx persistence was 40.0% (n=14; UC, n=11; CD, n=3) and 77.2% (n=98; UC, n=61; CD, n=37) in the induction and mTx cohorts, respectively, and highest overall in mTx pts who switched to VDZ SC (86.2%; n=56; Table). The most common reason for Tx discontinuation was investigator decision (64.7%; n=33). For VDZ IV and SC, the mean (SD) number of doses per pt was 10.5 (7.6) and 23.8 (15.0), respectively. The median time from VDZ Tx initiation to SC Tx was 383 days (induction: 98 days; mTx: 434 days). In the induction cohort, the mean (SD) Work Productivity & Activity Impairment (WPAI) scores improved from 32.7 (24.1) at baseline (n=21) to 21.5 (31.2) at W52 (n=11), and the Short IBD Questionnaire (SIBDQ) scores improved from 44.1 (10.0) at baseline (n=34) to 51.0 (12.9) at W52 (n=15). In the mTx cohort, WPAI and SIBDQ results remained consistent over time. Fifty-three AEs were reported, including 4 serious AEs (malignancy, IBD flare requiring hospitalization, abdominal abscess, and unconsciousness). One AE of special interest (hypersensitivity reaction) was considered VDZ-related.

Conclusion

In this Polish real-world study, high Tx persistence was reported, especially in pts who switched to VDZ SC. No new safety signals were noted. Overall, the results were consistent with those from other VARIETY cohorts,⁴ although lower persistence was observed during induction. The small size of the induction cohort was a limitation of this study.

References

1. Sandborn WJ, et al. Gastroenterology. 2020;158:562–72.e12.
2. Loftus EV Jr, et al. Aliment Pharmacol Ther. 2020;52:1353–65.
3. Vermeire S, et al. J Crohns Colitis. 2022;16:27–38.
4. Novacek G, et al. J Crohns Colitis. 2024;18(suppl 1):i1506–7

Disclosure

Conflicts of interest: Agata Michalak received lectures fees and/or travel grants from AbbVie, Bayer, Biocodex and Takeda. Katarzyna Karłowicz received lecture fees, consultancy fees or travel educational grants from Bristol Myers Squibb, AbbVie, Polpharma, Takeda and Pfizer. Renata Talar-Wojnarowska received lecture fees and/or travel grants from AbbVie, Astellas, Ferring, Janssen and Takeda. Adam Fabisiak received fees and/or travel grants from Bristol Myers Squibb, Pro. Med. CS, Pfizer and Polpharma. Magdalena Achtenberg received lecture fees from Ferring. Piotr Eder received lecture fees and/or travel grants from Takeda, Ferring, Astellas, Pfizer and Janssen. Maria Kłopocka received payment for lectures from Janssen, Takeda, Ferring, Alfasigma and Pharmabest and travel/accommodation/meeting expenses from Ferring, Janssen, Takeda, Alfasigma and Pharmabest. Maciej Gonciarz received compensation and/or research/educational grants from Pfizer, Polfarma, Abbvie, BMS, Ewoppharma, Ferring, Astellas, Takeda, Jansen-Cilag, Celtrion, Johnson & Johnson, and Sanofi. Grażyna Rydzewska received speaker and consultant fees from AbbVie, AlfaSigma, AstraZeneca, Bayer, Biocodex, Bristol Myers Squibb, Ferring, Janssen, Lilly, Pro. Med. Pl., Recordati, Sanprobi, SOBI and Takeda and travel/accommodation meeting expenses from AbbVie, Ferring and Takeda. Eliza Majewska is a permanent employee of Takeda Pharma Sp. z o.o. Maria Kopertowska-Majchrzak, Tomasz Romańczyk, Halina Cichoż-Lach, Małgorzata Zwolińska-Wcisło, and Elżbieta Poniewierka declare no conflicts of interest.
Funding: The study was funded by Takeda Pharma Sp. z o.o.
Acknowledgements: Medical writing support was provided by Michelle Rebello, PhD, of Cactus Life Sciences (part of Cactus Communications) and funded by Takeda Pharma Sp. z o.o.