Introduction

Bowel urgency (BU) is a common, debilitating symptom among patients with ulcerative colitis (UC).¹ LUCENT-URGE is a Phase 3b, open-label, single-arm 28-week (W) study in adults with moderately-to-severely active UC and BU (Urgency Numeric Rating Scale [UNRS] ≥3) at baseline treated with mirikizumab (MIRI). Here, we report W28 results from LUCENT-URGE (NCT05767021).

Aims & Methods

Patients were treated with intravenous MIRI 300 mg at W0, 4 and 8, followed by 200 mg subcutaneous at W12, 16, 20, and 24. The primary objective was to assess improvement in UNRS at W12. Key secondary objectives included evaluating the improvement in UNRS at W28, the improvement in Stool Deferral Time (SDT) and Bowel Urgency Frequency (BUF) at W12 and W28, the proportion of participants achieving clinical remission and an UNRS score of ≤1 (BU remission) at W12 and W28, and the proportion of participants achieving clinical response and an improvement in UNRS score ≥3 (clinically meaningful improvement [CMI] of UNRS) at W12 and W28. UNRS and BUF was measured using a daily diary where patients recorded the number of times they experienced BU in the past 24 hours and was averaged over a 7-day period. SDT was reported in minutes (min), and the shortest weekly SDT was used. Baseline observation carried forward was used as the endpoint for the corresponding visit for all missing observations. Missing continuous data were treated as no change from baseline and binary endpoints were treated as nonresponse for participants that discontinue prior to the time point of interest.

Results

172 patients were enrolled from 8 countries. Baseline modified Mayo score (MMS; mean± standard deviation [SD]) was 6.8±1.3, and 64.0% patients had severe disease activity (MMS 7-9). Baseline mean duration of UC was 8.0 years, mean UNRS score was 6.9 and mean BUF was 6.9 times/day. Mean UNRS and BUF improved from baseline to W28 by 3.6 and 3.8, respectively. The proportion of patients with SDT defined as “≥15 min or no urgency” was 4.1% at baseline and improved to 29.7% at W28 (Table 1). At W12, 36 (20.9%) patients achieved clinical remission, 54 (31.4%) achieved endoscopic remission, and 92 (53.5%) achieved CMI of UNRS. At W28, 62 (36.1%) patients achieved clinical remission, 76 (44.2%) achieved endoscopic remission, and 100 (58.1%) achieved CMI of UNRS. 76 (44.2%) patients achieved both clinical response and CMI of UNRS at W12, and 86 (50.0%) patients at W28. At W12 and W28, 8 patients (4.7%) and 28 patients (16.3%) achieved both clinical remission and BU remission, respectively. The safety profile of MIRI observed in LUCENT-URGE was consistent with previous studies, with no death reported and similar frequency of treatment-emergent adverse events (TEAEs). Most common TEAEs were ulcerative colitis exacerbation (5.2%) and upper respiratory tract infection (5.2%).

Table 1. Change in Bowel Urgency Measures from Baseline at Week 12 and Week 28, BOCF

Conclusion

MIRI showed an early and sustained improvement on BU severity, frequency and stool deferral time through W28 in LUCENT-URGE. MIRI consistently improved clinical outcomes in patients with moderately-to-severely active UC.

References

Dubinsky M, et al. Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions. AJG 2023; 118(11): 1940-53.

Disclosure

SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli lilly and company, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor; lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.
AD reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Abivax, AbbVie, Bristol Myers Squibb, Dr Falk Foundation, Galapagos, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Alfasigma, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Sandoz, Stada, Takeda, Tillotts, and Vifor Pharma; payment from lectures including service on speakers bureaus from AbbVie, Alfasigma, Biogen, CED Service GmbH, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, High5MD, Janssen, Materia Prima, MedToday, MSD, Pfizer, Streamed-Up, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Abbvie, Falk Foundation, J & J, Takeda, Thieme, and UniMed Verlag.
DL declares counselling, boards, and transport or fees from AbbVie, Amgen, Biogen, Celltrion, Ferring, Alphasigma, Janssen, Lilly, MSD, Pfizer, Prometheus, Roche, Sandoz and Takeda.
JKL has received consultancy and speaker fees from AbbVie, Abivax, Arena, AlfaSigma, Bristol Myers Squibb, Biohit, Celltrion, Eli Lilly and Company, Ferring, Galapagos, Janssen, MSD, Pfizer, Takeda and Tillotts and research grants from AbbVie, Galapagos and Takeda.
RK reports lecture fees from Aboca S.p.A. Società Agricola, Ferring, AbbVie, and Eli Lilly and Company.
JDL consulted or served on an advisory board or data monitoring committee for Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Gilead, Janssen Pharmaceuticals, Merck, Pfizer, Protagonist Therapeutics, Sanofi. He has had research funding or in kind support from Nestle Health Science, Takeda, Janssen Pharmaceuticals, AbbVie and Eli lilly and company. He has had educational grants from Janssen. He has performed legal work on behalf of manufacturers of generic ranitidine and 3M. He owns stock in Dark Canyon Labs.
ZY has received research support from AbbVie, Axcella, Bristol Myers Squibb, CymaBay, Galectin, Intercept, Inventiva, Madrigal, NGM, Novo Nordisk, NST, Poxel, and Sagimet; has acted as a speaker for AbbVie, Intercept, and Bristol Myers Squibb; and as a consultant for Intercept and Madrigal.
EC reports advisory board and consultant for Pfizer, Takeda, and PRIME Education; speaker for AbbVie, Eli Lilly and Company, Janssen, and Takeda.
KA, WJE, TT, IR are employees and minor shareholders of Eli Lilly and Company.
DR reports grant support from Takeda and has served as a consultant for AbbVie, AltruBio, Arena Pharmaceuticals, Bristol Myers Squibb, Eli Lilly and Company, Genentech, Gilead Sciences, Iterative Scopes, Janssen, Pfizer, Prometheus Biosciences, Roche, Takeda, and Techlab.
MD reports consulting fees from AbbVie, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Genentech (Roche), Gilead Sciences, Janssen, Pfizer, Prometheus Biosciences, Roche, Takeda Pharmaceuticals, and UCB; contracted research from AbbVie and Janssen; stock interest in Trellus Health; and licensing fees from Takeda Pharmaceuticals.

Introduction

Currently three JAK inhibitors (JAKi) are licensed for use in UC. Establishing real-world data, via large multicentre cohorts is key in gaining a better understanding of their effectiveness and safety in day to day practice.

Aims & Methods

Our aims were to evaluate the real-world effectiveness and safety of the JAKi; upadacitinib, tofacitinib and filgotinib for the treatment of UC across Scotland, UK. We conducted a retrospective, multicentre, cohort study including data from 14 hospitals in Scotland, UK. Adult patients (>18 years) with a diagnosis of UC or IBDU favouring UC and minimum of 8-weeks follow up post initiation of JAKi for active disease were included. Patients receiving JAKi for indication of acute severe UC were excluded. The primary outcome was treatment persistence of each JAK-i (tofacitinib, upadacitinib, filgotinib) at week 24. Secondary endpoints included un-adjusted comparison of persistence (Kaplan-Meier survival analysis, log-rank test for comparison), predictors of JAKi persistence (multi-variable Cox regression analysis), corticosteroid-free clinical remission, biochemical remission (C-reactive protein ≤5 mg/L) and faecal calprotectin remission (<250 µg/g) at week 8 and 24. Patients who stopped therapy due to lack of efficacy prior to these time points were considered failures. Serious adverse events (SAE) (defined as events leading to to hospitalisation, cessation of drug, disability or death), adverse events (AE) of infection and AE of interest were also documented.

Results

A total of 480 patients (upadacitinib, n=71; tofacitinib, n=208; filgotinib, n=201) had received a JAKi between 2019 (2nd Quarter) and 2023 (4th Quarter) and also fulfilled our inclusion criteria. The median follow-up of the total cohort was 1.4 years (IQR 0.6-2.6 years). The median age and disease duration was 39.0 years (IQR 29.0-52.0 years) and 5.9 years (IQR 2.2-11.1 years), respectively. Cumulative treatment persistence was 83.3%, 76.5% and 80.8% at week 24 in the upadacitinib, tofacitinib and filgotinib cohorts, respectively. There was no significant difference in un-adjusted persistence at week 24 between the three types of JAKi (log-rank, p=0.69). Multi-variable Cox regression revealed that patients with mild (HR 0.5, 95% CI 0.3-0.9, p=0.02) and moderate (HR 0.6, 95% CI 0.4-1.0, p=0.046) clinical disease activity at baseline had a lower risk of treatment cessation, whilst female patients (HR 1.5, 95% CI 1.0-2.2, p=0.03) and current smokers (HR 3.2, 95% CI 1.1-7.4, p=0.02) had a greater risk of treatment cessation. Effectiveness outcomes were similar across the three JAKi cohorts (Table 1). SAEs and AE of infection were lowest in the filgotinib cohort, with a signal towards higher rates of Herpes Zoster with tofacitinib (Table 1).

Table 1. Effectiveness and safety outcomes of ScotJAK cohort.
(PGA, physician's global assessment; pMayo, partial Mayo score; SCCAI, simple clinical colitis acitivity index; MACE, major adverse cardiovascular events; VTE, venous thromboembolism).

Conclusion

We have shown in a large, multi-centre study, encompassing a broad range of hospital practices that all three JAK-i are effective at treating patients with UC in the real-world.

Introduction

Crohn’s disease (CD) is a chronic condition characterized by a relapsing-remitting course, often requiring intestinal resection. Postoperative management primarily aims to maintain clinical remission. The advent of biologic therapies has undoubtedly improved disease prognosis following initial surgery. However, access to this therapeutic class remains limited in lower-middle income countries such as Tunisia, necessitating the use of alternative agents, notably azathioprine (AZA), which has been widely used for this indication, albeit with controversial results.

Aims & Methods

This study aimed to evaluate the effectiveness of AZA in maintaining remission after a first intestinal resection in patients with ileal or ileocolonic Crohn’s disease, and to identify factors associated with treatment failure.
​We conducted a retrospective, descriptive, and analytical study in the gastroenterology department of Sahloul University Hospital in Sousse (Tunisia) over a 4-year period (2020–2024). We included all patients with ileal or right ileocolonic CD who underwent intestinal resection and received AZA in the postoperative period.

Results

A total of 66 patients were included, with a mean age at diagnosis of 31.50 ± 12.24 years and a male-to-female ratio of 1.06. The median interval between diagnosis and surgery was 21.5 months. During follow-up, AZA failure occurred in 63.6% of patients (n=42), with a mean time from surgery to failure of 44.71 ± 37.74 months. In univariate analysis, ileocolonic disease location (p=0.042), the total number of flares (p=0.007), and the number of severe flares (p<0.001) prior to surgery were significantly associated with AZA failure. Failure rates were also significantly higher in patients who underwent emergency surgery (p=0.007). Inflammatory resection margins (p<0.001) and severe inflammatory activity (p=0.007) were also significantly associated with treatment failure. In multivariate analysis, three independent risk factors were identified: the number of severe flares before surgery (p=0.031), preoperative inflammatory syndrome (p=0.008), and histopathological evidence of disease at the resection margins (p=0.004).

Conclusion

Our findings suggest that thiopurines remain a valuable therapeutic option in the management of Crohn’s disease, particularly in our setting, where access to alternative therapies is limited and associated with high costs.

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.

Introduction

The use of biologics has become an increasingly common treatment option for inflammatory bowel disease (IBD). However, data on maternal and fetal exposure to ustekinumab (UST) and vedolizumab (VDZ) remain scarce.

Aims & Methods

This systematic review and meta-analysis aimed to assess the safety of UST and VDZ in pregnant women with IBD. We systematically searched PubMed, Embase, and Cochrane Library databases in March 2025. The inclusion criteria were randomized and non-randomized studies comparing UST and VDZ for the treatment of IBD in pregnant patients and evaluating at least one predefined outcome of interest. Primary outcomes were spontaneous abortion and preterm delivery. Secondary outcomes included live birth, low birth weight, serious infections, neonatal intensive care unit (NICU) admission, and malignancies. Statistical analysis was performed using RStudio, applying a random-effects model to calculate the pooled risk ratios (RRs) for binary outcomes.

Results

This systematic review included six studies. Median maternal age ranged from 30 to 33 years, with similar distributions between groups. The average disease duration ranged from 8 to 14 years. Crohn’s disease was more prevalent in the ustekinumab group, while ulcerative colitis was more common in the vedolizumab group. No statistically significant differences were observed in spontaneous abortion (RR 1.66; 95% CI 0.89–3.10), preterm delivery (RR 0.60; 95% CI 0.31–1.16), live birth (RR 0.97; 95% CI 0.90–1.05), low birth weight (RR 0.65; 95% CI 0.31–1.40), serious infections (RR 1.34; 95% CI 0.39–4.66), NICU admission (RR 1.02; 95% CI 0.56–1.85), or malignancies (RR 1.25; 95% CI 0.67–2.32) between UST and VDZ treatments.

Conclusion

No significant differences were observed across the outcomes analyzed when comparing ustekinumab and vedolizumab for the treatment of pregnant patients with IBD.

Introduction

Resolution of pain, fatigue and other symptoms are key treatment goals for many patients (pts) with Crohn’s disease (CD);^1,2 however, time to symptomatic improvement in pts treated with vedolizumab (VDZ) has not been formally evaluated.

Aims & Methods

VOICE (NCT06249555) is a prospective, observational study in pts with CD aged ≥18 years initiating VDZ or anti-IL-23 antagonist treatment (tx) per product labelling as part of standard of care, with the main objective to explore the time course of response to VDZ as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) domain Short Form (SF) scores. Inclusion criteria include baseline PROMIS Pain Interference (PI)-SF T-score ≥55 (0.5 SD above general population). We enrolled pts via Takeda pt support program in Canada, with additional pts enrolled at US and Canada sites. Planned sample size is 300 pts (VDZ, 200; anti-IL-23 antagonist [reference group not for formal comparison], 100); planned follow-up is 52 weeks (wks), with PROMIS PI data reported weekly for the first 14 wks. The primary endpoint is time to the first meaningful clinical improvement in PROMIS PI-SF T-score, defined as ≥2-point decrease in PROMIS PI-SF T-score from baseline. We also collect data on improvement in 7 PROMIS domains with clinical improvement defined as 5-point (0.5 SD)³ change in T-score from baseline, Short Inflammatory Bowel Disease Questionnaire (SIBDQ; including SIBDQ improvement [≥9 point increase from baseline] and SIBDQ remission [score of ≥60]) and safety. Here, we report the results from pts with ≥1 VDZ dose and ≥1 post-baseline PI assessment included in the interim analysis (IA; prespecified to occur after 50 pts from VDZ group completed or discontinued before the wk 14 assessment to provide an early evaluation of tx response and safety).

Results

Overall, 64 pts with ≥1 VDZ dose and ≥1 post-baseline PROMIS PI assessment (mean±SD age, 43.1±17.0 years, 35.9% male, 92.2% White) were included in the IA. Disease duration (mean±SD) was 6.4±12.1 years; 84.4% of pts were anti-TNF-naïve. Data collection is ongoing for 57 pts (49 with and 8 without completed wk 14 PROMIS PI questionnaire); 7 pts discontinued from the study. The median time to achieve the first ≥2_-point decrease in PROMIS PI-SF T-score (in n=56 pts) was 12 days (95% CI, 6-13). Baseline PROMIS domain scores indicated notable impairment; by wk 14, improvements in mean PROMIS scores from baseline were observed in all 7 measured domains, with ≥5-point improvements in 4/7 domains (Table). At wk 14, 37.5% (24/64) and 7.8% (5/64) pts achieved SIBDQ improvement and remission, respectively. One pt had serious adverse events of appendicitis and diverticulitis, and another pt had a fatal event; none of these were related to VDZ tx.

Table. Summary of PROMIS domain T-scores

Conclusion

The IA results through wk 14 show an early improvement across multiple symptom domains and quality of life in pts with CD starting VDZ tx. Time to first ≥2-point decrease in PROMIS PI-SF T-score was short, with a benefit observed after 12 days from VDZ initiation. Study recruitment and data collection are ongoing.

References

1. Keefer L, et al. Gastroenterology. 2022;162(5):1439-1451.
2. Kitchen H, et al. Crohns Colitis 360. 2020;2(2):otaa033
3. Cella D, et al. Value Health. 2019;22(5):537-544.
4. Shaw BE, et al. Cancer. 2018;124(4):841-849.

Disclosure

This study was sponsored by Alimentiv, Inc.
V. Jairath reports consulting/advisory board fees from AbbVie, Alimentiv, Anaptyis Bio, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly, Endpoint Health, Enthera, Ensho, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, Gilde Healthcare, GlaxoSmithKline, Genentech, Gilead, Innomar, JAMP, Janssen, Merck, Metacrine, Mylan, MRM Health, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus Biosciences, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Sorriso, Spyre, Synedgen, Takeda, TD Securities, Teva, Topivert, Ventyx, Vividion; speaker’s fees from, Abbvie, Ferring, Bristol Myers Squibb, Galapagos, Janssen Pfizer Shire, Takeda, Tillotts and Fresenius Kabi.
M. Long reports consulting fees from AbbVie, Alimentiv, Bristol Myers Squibb, Intercept, Janssen, Lilly, Pfizer, Prometheus, Roivant, Syneos Health and Takeda; and research support from Lilly, Pfizer and Takeda.
M.D. Kappelman reports being a consultant to Eli Lilly and Takeda.
G. Radulescu and N. Li are employees of Alimentiv.
J.J. Wu, I. Romo Bautista, A. Insogna and C. Agboton are employees of Takeda and hold stock and/or share options in Takeda.
N. Narula has received advisory board/consulting honoraria from Abbvie, Amgen, Eli Lilly and Company, Ferring, Fresinius Kabi, Innomar Strategies, Iterative Health, Janssen, Novartis, Organon, Pfizer, Sandoz and Takeda.