Introduction

The Epi-IBD cohort is a prospective European population-based cohort of 1,390 patients diagnosed in 2010 and 2011 with inflammatory bowel disease (IBD) according to Copenhagen criteria in centres from Eastern and Western European countries.

Aims & Methods

The study aims at describing differences in incidence, treatment strategies, disease course and prognosis of Crohn’s disease (CD) across Eastern and Western Europe. CD patients were followed prospectively from the time of diagnosis until December 31^st, 2020, death, emigration or loss of follow-up. Clinical data on surgery, hospitalizations, and medical treatment, were captured throughout the follow-up period and entered into a validated web-database, www.epi-ibd.org. Associations between surgery and covariates were analysed by multivariate Cox regression analyses.

Results

In total, 482 CD patients aged ≥15 years from 21 centres in 5 Eastern and 11 Western European countries were included. At 10-years follow-up, 101 (21%) patients underwent first intestinal resection and 11 out of these 101 patients (11%) underwent additional resections. Furthermore, 176 (37%) patients had at least one CD related hospitalization. Cancer was diagnosed in 21 (4%) patients, including 4 gastrointestinal cancers. The use of IBD medication was comparable between Eastern and Western European centres apart from 5-aminosalicylic acid agents (Table 1).
During follow-up, 60 out of 360 patients (17%) progressed from non-stricturing-non-penetrating disease (B1) at diagnosis to stricturing or penetrating disease (B2 or B3) while 13 out of 83 patients (16%) with stricturing disease (B2) progressed to penetrating disease (B3). The median time to progression was 28 (IQR: 9-64) months from diagnosis. No patients from Eastern Europe were exposed to biological therapy prior to change in behaviour, compared to 23 out of 66 patients (35%) from Western Europe.
Multivariate Cox regression analysis showed no difference in risk of surgery according to European region (Eastern vs. Western Europe, HR: 0.54, 95%CI: 0.24-1.21). Early intervention with biological therapy (within 6 months) did not influence the risk of surgery (HR:0.75, 95%CI: 0.31-1.83), however early introduction of immunomodulators reduced the risk significantly (HR:0.54, 95%CI: 0.30-0.98). Progression in behaviour from B1 was associated with higher risk of surgery (HR:7.62, 95%CI: 3.91-14.87).

Conclusion

After 10 years of follow-up, 21% underwent intestinal resection and 10% required additional resections. Despite the widespread use of immunomodulators and biological therapy, 16% of the patients had disease behavioural progression, which was associated with higher risk of surgery. Early introduction of immunomodulators was found to be beneficial.

Introduction

Etrasimod is an investigational, oral, once-daily, selective sphingosine 1‑phosphate (S1P)_1,4,5 receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC).

Aims & Methods

The study design for phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) trials has been described previously.¹ ELEVATE UC 52 comprised a 12‑week (wk) induction period followed by a 40‑wk maintenance period with a treat-through design. ELEVATE UC 12 comprised a 12‑wk induction period. Patients (pts) had a documented history of inadequate response/loss of response/intolerance to ≥ 1 treatment for UC. This subgroup analysis evaluated the efficacy and safety of etrasimod 2 mg once daily vs placebo (PBO) in adults with UC by prior exposure to advanced (biologic/Janus kinase inhibitor [bio/JAKi]) therapy. We present subgroup efficacy analyses of the primary and select secondary endpoints at Wk 12 and Wk 52 in ELEVATE UC 52 and Wk 12 in ELEVATE UC 12 in pts naïve to, or with prior exposure to, ≥ 1 bio/JAKi therapy. Additional symptomatic endpoints were analysed by study visit to Wk 12 (pooled ELEVATE UC 52 and ELEVATE UC 12).

Results

In ELEVATE UC 52 and ELEVATE UC 12, respectively, 274 and 222 pts with a baseline modified Mayo score 5–9 were treated with etrasimod, and 135 and 112 pts with PBO. Pts treated with etrasimod vs PBO, in both bio/JAKi‑naïve and -exposed subgroups, achieved statistically significant improvements in clinical remission, clinical response and endoscopic improvement at Wks 12 and 52 in ELEVATE UC 52 (Table). In ELEVATE UC 12, bio/JAKi-naïve pts achieved statistically significant improvements in all endpoints, while pts in both subgroups achieved statistically significant improvements in clinical response (Table). In bio/JAKi‑naïve and -exposed pts, respectively, pooled data showed the earliest significant improvements were during Wks 2 and 12 for symptomatic response and Wks 4 and 2 for symptomatic remission (Table).

Conclusion

In ELEVATE UC 52, both bio/JAKi-naïve and -exposed pts treated with etrasimod showed statistically significant improvements in induction and maintenance efficacy endpoints vs PBO. In ELEVATE UC 12, etrasimod demonstrated statistically significant improvements vs PBO in induction in bio/JAKi-naïve pts. For symptomatic response in the pooled analysis, a significant treatment difference occurred later for bio/JAKi-exposed than -naïve pts.

References

1. Sandborn WJ et al. Lancet 2023; 401: 1159–1171

Disclosure

SV: research: AbbVie, MSD, Pfizer, Galapagos, Takeda; consultancy/advisory: AbbVie, AbolerIS, Alimentiv, Arena, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Dr. Falk, Eli Lilly, Ferring, Galapagos, Genentech/Roche, Gilead, Hospira, Imidomics, Janssen, J&J, MateriaPrima, MiroBio, Morphic, MrMHealth, MSD, Mundipharma, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillotts, Zealand; speaker: AbbVie, Dr. Falk, Ferring, Hospira, MSD, Takeda, Tillotts.
BES: research: Arena, Janssen. Speaker: BMS, Janssen, Lilly, Pfizer, Takeda. consultancy/advisory: AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Boehringer-Ingelheim, BMS, Celltrion, Fresenius Kabi, Genentech, GSK, Janssen, Lilly, Merck, Pfizer, Prometheus, Sun, Takeda, Teva. Stock: Ventyx. Non-financial: Janssen, Lilly, Pfizer, Takeda.
LPB: research: Takeda, Fresenius Kabi, Celltrion; consultancy: AbbVie, Alimentiv, Alma Bio, Amgen, AppliedMolecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer, GSK, HAC, IAG Image Analysis, Index, Inotrem, Janssen, Eli Lilly, Medac, Mopac, Morphic, MSD, Norgine, Novartis, OM, ONO, OSE, Pandion, Par'Immune, Pfizer, Prometheus, Protagonist, Roche, Sandoz, Takeda, Theravance, Thermo Fisher, TiGenix, Tillotts, Viatris, Vifor, Ysopia, Abivax; speaker: Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillotts, Celltrion, Takeda, Pfizer, Sandoz, Biogen, MSD, Amgen, Vifor, Arena, Eli Lilly, Gilead, Viatris, Medac, Sanofi; stock: CTMA.
GD’H: advisor: AbbVie, AstraZeneca, Alimentiv, BMS, Boehringer Ingelheim, Celltrion, Cosmo, Eli Lilly, Galapagos, GSK, J&J, Takeda, Pfizer, Polpharma, Prometheus, Tillotts, Ventyx; speaker: AbbVie, Boehringer Ingelheim, Celltrion, J&J, Takeda, Pfizer, Tillotts.
JP: personal: AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Galapagos, Genentech/Roche, GSK, Immunic, Janssen, Mirum, Morphic, Nestlé, Origo, Pandion, Pfizer, Progenity, Revolo, Takeda, Theravance, Wassermann; grants: AbbVie, Pfizer.
AJY: consultancy: Pfizer, Arena, Takeda, BMS; speaker: BMS.
DW: research grants: AbbVie, Arena, BMS, Janssen, Pfizer, Takeda, Ventyx; speaker: AbbVie, BMS, Janssen, Pfizer, Takeda; consultant: AbbVie, Arena, BMS, Janssen, Pfizer, Takeda.
TR: speaker: Takeda, Janssen, Pfizer, BMS, AbbVie, Lilly; Data Adjudication: Ferring/Rebiotix; Advisory boards: AbbVie, Ardelyx, Arena, Boehringer Ingelheim, BMS/Celgene, Ferring, Genentech/Roche, Gilead, Intercept, Iterative Scopes (shareholder), Janssen, Lilly, Pfizer, Prometheus, Sanofi, Takeda, Nestle/Seres
SS: speaker: AbbVie, Arena, Biogen, BMS, Celgene, Celltrion, Dr. Falk, Fresenius, Janssen, MSD, Pfizer, Takeda; consultancy/advisory: AbbVie, Arena, Biogen, BMS, Celgene, Celltrion, Dr. Falk, Fresenius, Gilead, IMAB, Janssen, MSD, Mylan, Pfizer, Protagonist, Provention, Takeda, Theravance.
KS, CJR: employees & shareholders of Pfizer.
MVC: grants: Pfizer, Janssen, Novartis, BMS; consultancy: AbbVie, Arena, BMS, Medtronic, Pfizer, Prometheus, Eli Lilly, Janssen, Takeda; speaker: AbbVie, Janssen, Medtronic, Pfizer, BMS, Takeda.
FB: research: AbbVie, Amgen, Janssen, Takeda; speaker: AbbVie, Arena, Celltrion, Ferring, Galapagos, Janssen, MSD, Pfizer, Takeda; consultancy: AbbVie, Amgen, Arena, Celgene, Celltrion, Ferring, Fresenius Kabi, Janssen, MSD, Pfizer, Sandoz.
MCD: research: Janssen; consultancy: AbbVie, Arena, BMS, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, Janssen, Pfizer, Prometheus, Takeda, Trellus Health, UCB; stock: Trellus; directorship/ownership interests: Trellus.
MG: employee & shareholder of Pfizer AG.
SD: consultancy/advisory: AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Gilead, Hospira, Janssen, J&J, MSD, Mundipharma, Pfizer, Roche, Sandoz, Takeda, TiGenix, UCB, Vifor; speaker: AbbVie, Amgen, Ferring, Gilead, Janssen, Mylan, Pfizer, Takeda; directorship/ownership interests: Gastroenterology and Endoscopy.
BGF: consultant/advisory board: AbbVie, AbolerIS, AgomAB, AllianThera, Amgen, AnaptysBio, AppliedMolecular Transport, Arena, Avoro Capital, Atomwise, BIOJAMP, Biora, Boehringer Ingelheim, Boxer, Celsius, Celgene/BMS, Connect, Cytoki, Disc Medicine, Duality, EcoR1, Eli Lilly, Equillium, Ermium, First Wave, FirstWord, Galapagos, Galen Atlantica, Genentech/Roche, Gilead, Gossamer, GSK, Hinge, HotSpot, InDex, Imhotex, Immunic, JAK, Janssen, Japan Tobacco, Kaleido, Landos, Leadiant, L.E.K., Lenczner Slaght, LifeSci, Lument AB, Millennium, MiroBio, Morgan Lewis, Morphic, Mylan, OM, Origo, Orphagen, Pandion, Pendopharm, Pfizer, Prometheus, Diagnostics, Play to Know AG, Progenity, Protagonist, PTM, Q32, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres, Silverback, Surrozen, Takeda, Teva, Thelium, TiGenix, Tillotts, Ventyx, VHSquared, Viatris, Ysios, YSOPIA, Zealand; speaker: AbbVie, Janssen, Takeda; Alimentiv Senior Scientific Director (central reading services; not a company employee, no equity); shareholder: Gossamer

Introduction

The POWER study evaluated efficacy and safety of a single intravenous (IV) re-induction ustekinumab (UST) dose vs placebo on a background of continued UST subcutaneous (SC) treatment in Crohn’s disease (CD) patients (pts) with secondary loss of response (LoR) to standard q8w UST maintenance therapy. This subgroup analysis reports primary and major secondary endpoints up to week (W)16 in pts with/without a history of inadequate response or intolerance to prior biologics.

Aims & Methods

Adults with moderately–severely active CD who initially responded to UST IV induction therapy per label and later experienced LoR were included. LoR was defined as CD Activity Index (CDAI) score of ≥220 and ≤450, plus either elevated C-reactive protein (CRP; >3mg/L), faecal calprotectin (fCal; >250mg/kg), or endoscopy performed ≤3 months before W0 with evidence of active CD. At W0 randomised pts received ~6mg/kg IV UST/SC placebo (IV arm) or IV placebo/SC UST 90mg (SC arm) followed by 90mg SC UST at W8/16. Clinical/biomarker assessments occurred at W0/8/16. Primary endpoint: W16 clinical response (CRes; decrease of ≥100 points from W0 or CDAI <150). Secondary endpoints: CRes; clinical remission (CRem); normalisation of CRP and/or fCal at W8/16.

Results

The full analysis set comprised 215 pts at W0 (SC, n=107; IV, n=108). At W16, 86.0% (SC) and 92.6% (IV) of pts completed treatment. Most pts (SC, 92.5%; IV, 88.9%) had a history of inadequate response/intolerance to prior biologics. At W16, while CRes did not statistically differentiate between arms, secondary outcomes indicated a difference in the IV vs SC arm. In this analysis, differences were seen in bionaïve pts and those with inadequate response/intolerance to <3 biologics. A numerically greater proportion of pts achieved CRes in the IV vs SC arms in all groups except pts with ≥3 prior biologics, with a nominal difference in pts with 1 prior biologic (p=0.043; Table). A similar trend was observed for pts achieving W16 CRem, albeit the nominal threshold was not reached. A numerically greater proportion of pts in the IV vs SC arm achieved normalisation of CRP and/or fCal at W16, except those with ≥3 prior biologics, and with a nominal difference in pts with 1 prior biologic (p<0.001).

Conclusion

POWER is the first trial to assess the efficacy and safety of UST IV re-induction in pts with secondary LoR. This analysis suggests that both naïve pts and those with prior inadequate response or intolerance to biologics may benefit from UST re-induction therapy.

Disclosure

S. Schreiber has received personal fees from AbbVie, Amgen, Arena, Biogen, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Dr. Falk Pharma, Fresenius, Galapagos/Gilead, Hikma, I-Mab, Janssen, MSD, Mylan, Pfizer, Protagonist, ProventionBio, Takeda and Theravance Biopharma. S. Lee served as a consultant for Applied Molecular Transport, Arena, Boehringer Ingelheim, Bridge Biotherapeutics, Bristol-Myers Squibb, Celgene, Celltrion Healthcare, Cornerstones Health, Eli Lilly and Company, Janssen, KCRN Research, Samsung Bioepis and UCB; and received research grants from AbbVie, AbGenomics, Arena, Celgene, Janssen, Salix, Takeda and UCB. C.J. van der Woude received grant support from Falk Ben-elux, Ferring and Pfizer; received speaker fees from AbbVie, Takeda, Ferring, Dr Falk Pharma and Pfizer; and served as a consultant for Janssen. I Marín-Jiménez has served as a consultant, advisory member, speaker or has received research funding from Abbvie, Chiesi, Faes Farma, FalkPharma, Ferring, Gebro Pharma, Hospira, Janssen, MSD, Otsuka Pharmaceutical, Pfizer, Shire, Takeda, Tillots and UCB Pharma. D. Wolf has received honoraria as a speaker, consultant and/or advisory board member from AbbVie, Arena, Celgene/Bristol Myers Squibb, Janssen, Pfizer and Takeda. E. Schnoy has received personal fees from AbbVie, Bristol Myers Squibb, Celltrion Healthcare, Dr. Falk Pharma, Galapagos/Gilead, I-Mab, Janssen, Lilly, Pfizer, Pharmacosmos, Takeda and Tillotts Pharma. B. Salzberg served as a consultant for Johnson and Johnson and has received honoraria as a speaker from AbbVie, Bristol-Myers Squibb and Johnson and Johnson. M. Nazar is an employee of Janssen-Cilag Polska Sp. z o.o. and has restricted stocks. C. Busse, W. Langholff, C. Gasink, T. Baker and B. Godwin report employment with/funding by Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson, and stock ownership in Johnson & Johnson. B. Feagan received grant/research support from AbbVie Inc., Amgen Inc., AstraZeneca/MedImmune Ltd., Atlantic Pharmaceuticals Ltd., Boehringer-Ingelheim, Celgene Corporation, Celltech, Genentech Inc/Hoffmann-La Roche Ltd., Gilead Sciences Inc., GlaxoSmithKline (GSK), Janssen Research & Development LLC., Pfizer Inc., Receptos Inc./Celgene International, Sanofi, Santarus Inc., Takeda Development Center Americas Inc., Tillotts Pharma AG and UCB; was a consultant for Abbott/AbbVie, AdMIRx Inc., Akebia Therapeutics, Allergan, Amgen, Applied Molecular Transport Inc., Aptevo Therapeutics, Asta Pharma, Astra Zeneca, Atlantic Pharma, Avir Pharma, Biogen Idec, BioMx Israel, Boehringer-Ingelheim, Boston Pharmaceuticals, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Galapagos, Galen/Atlantica, GiCare Pharma, Gilead, Gossamer Pharma, GSK, Inception IBD Inc, Intact Therapeutics, JnJ/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nestles, Nextbiotix, Novonordisk, ParImmune, Parvus Therapeutics Inc., Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Qu Biologics, Rebiotix, Receptos, Roche/Genentech, Salix Pharma, Shire, Sienna Biologics, Sigmoid Pharma, Sterna Biologicals, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd. and Zyngenia; was a member of the speakers bureau for Abbott/AbbVie, JnJ/Janssen, Lilly, Takeda, Tillotts and UCB Pharma; a member of the scientific advisory board for Abbott/AbbVie, Allergan, Amgen, Astra Zeneca, Atlantic Pharma, Avaxia Biologics Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Galapagos, Genentech/Roche, JnJ/Janssen, Merck, Nestles, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Sterna Biologicals, Takeda, Teva, TiGenix, Tillotts Pharma AG and UCB Pharma; and was a Senior Scientific Officer for Robarts Clinical Trials Inc.

Introduction

Tumor necrosis factor–like cytokine 1A (TL1A) is a mediator of inflammation and fibrosis in CD. Tulisokibart, an anti-TL1A monoclonal antibody, demonstrated robust efficacy without adverse safety signals during the 12-week induction period in adults with moderately to severely active CD in the multicenter, open-label, phase 2a APOLLO-CD study.¹ We report long-term efficacy and safety data for tulisokibart from the APOLLO-CD open-label extension (OLE).

Aims & Methods

Responders to tulisokibart induction at 12-weeks (defined as a decrease from baseline in CD activity index [CDAI] of ≥100 points or CDAI <150 at week 12) were given the opportunity to enter the OLE study, whereas 12-week non-responders discontinued the study. At week 14, responders were randomized to receive intravenous tulisokibart 100 mg or 250 mg every 4 weeks until week 170. Reported here are the endoscopic, clinical, and biomarker endpoints through week 50 in the intention-to-treat population. Safety was evaluated in all patients who received ≥1 dose of tulisokibart. Descriptive statistics were used to summarize observed data.

Results

53 of 55 patients completed the 12-week induction period, 37 were considered induction responders and were randomized to receive tulisokibart 100 mg (n=19) or 250 mg (n=18). A greater proportion of patients who were biologic-naive entered the OLE in the tulisokibart 250 mg vs 100 mg group (44% vs 21%). Improvements in clinical, endoscopic, and biomarker outcomes observed were generally maintained through week 50 in both dose groups. At week 50, a greater proportion of patients achieved clinical and endoscopic outcomes with tulisokibart 250 mg vs 100 mg (Table). In addition, normalization of high-sensitivity C-reactive protein (hsCRP) favored the 250 mg dose vs the 100 mg dose. During the 12-week induction period, 78% of patients reported AEs. At week 50, AEs were reported in 83% and 84% of patients receiving tulisokibart 250 mg and 100 mg, respectively, and were mostly mild-to-moderate in severity. Serious AEs occurred in 6% of patients receiving tulisokibart 250 mg and 11% of patients receiving tulisokibart 100 mg. The most frequently occurring AEs of special interest (>10% of patients in either dose group) were urinary tract infection (11% vs 16%), COVID-19 (11% vs 11%), upper respiratory tract infection (6% vs 16%), bronchitis (11% vs 0%), clostridium difficile infection (11% vs 0%), and influenza (0% vs 11%).

Conclusion

At week 50, maintenance of treatment efficacy was generally observed in 12-week induction responders. A trend for higher maintenance efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no safety signals identified through 50 weeks of treatment. Larger trials are needed to confirm these findings.

References

1. Feagan BG, et al. J Crohns Colitis. 2023;17(Supplement_1):i162-i164.

Disclosure

CAS is a consultant/advisory board for AbbVie, BMS, Boomerang, Buhlmann, Janssen, Lilly, Napo Pharmaceuticals, Pfizer, Prometheus Biosciences, Prometheus Labs, Roivant, Takeda, Trellus Health; speaker for CME activities for AbbVie, Janssen, Pfizer, Takeda; grant support from AbbVie, Janssen, Pfizer, Takeda.
RWL reports advisory board membership for AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda; research grant recipient: Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, Joanna Tiddy grant, McKusker Charitable Foundation.
JKA, BD, and MY are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
BES reports consulting fees from AbbVie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, Astra Zeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Envied Biosciences, Evommune, Ferring, Fresenius Kabi, Fiat, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck & Co., Inc., Rahway, NJ, USA, Microba, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Spyre Therapeutics, Sun Pharma, Surrozen, Target RWE,Teva, TLL Pharmaceutical, Tr1X, Union Therapeutics, Ventyx Biosciences; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; research grants, consulting and speaking fees and other support from Bristol Myers Squibb, Janssen, Pfizer, Takeda; research grants and consulting fees from Theravance Biopharma; and stock/stock options from Ventyx Biopharma.
SD has received consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Dr. Falk Pharma, Eli Lilly and Company, Enthera, Ferring, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, and Vifor and lecture fees from AbbVie, Amgen, Ferring, Gilead, Janssen, Mylan, Pfizer, and Takeda.
BGF is a consultant for AbbVie, AbolerIS, AgomAB Therapeutics, Allianthera, Amgen, AnaptysBio, Applied Molecular Transport Inc., Arena Pharma, Atomwise, Avoro Capital Advisors, BioJamp, Biora Therapeutics, Boehringer Ingelheim, Boxer, Bristol Myers Squibb/Celgene, Celsius Therapeutics, Connect BioPharma, Cytoki, Disc Medicine, Duality, EcoR1 Capital, Equillium, Ermium, First Wave, First Word Group, Galapagos, Galen Atlantica, Genentech/Roche, Gilead, GlaxoSmithKline, Gossamer Pharma, Hinge Bio, Hot Spot Therapeutics, Imhotex, Immunic Therapeutics, InDex Pharmaceuticals, JAKAcademy, Janssen, Japan Tobacco Inc., Kaleido Biosciences, Landos Biopharma, Leadiant, L.E.K. Consulting, Lenczner Slaght, LifeSci Capital, Lilly, Lument AB, Millennium, MiroBio, Morgan Lewis, Morphic Therapeutics, Mylan, OM Pharma, Origo BioPharma, Orphagen, Pandion Therapeutics, Pendopharm, Pfizer, Play to Know AG, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, PTM Therapeutics, Q32 Bio, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres Therapeutics, Silverback Therapeutics, Surrozen Inc., Takeda, Teva, Thelium, Tigenix, Tillotts, Ventyx Biosciences, VHSquared Ltd., Viatris, Ysios, Ysopia, and Zealand Pharma; on the Speakers’ Bureau for AbbVie, Janssen, and Takeda; and on advisory boards for AbbVie, Amgen, AMT, AnaptysBio, Axio Research, Boehringer Ingelheim, Bristol Myers Squibb/Celgene, EcoR1 Capital, Genentech/Roche, GlaxoSmithKline, InDex Pharmaceuticals, Janssen, Lilly, MiroBio, Morphic, Origo BioPharma, Pfizer, Progenity, Prometheus, REDX Pharma, Sanofi, Takeda, Teva, and Tillotts Pharma.

Introduction

Work-life integration is a critical issue many individuals face in the workforce, particularly in professions with high demands, such as healthcare. Physicians, in particular, experience significant challenges in managing their professional and personal lives due to long work hours, unpredictable schedules, and the emotional toll of caring for patients. The resulting work-life conflicts can negatively impact their well-being, job satisfaction, and patient care. Despite recognizing this issue, there is still a lack of research on the extent of work-life conflicts and their effects on physicians.

Aims & Methods

We distributed a voluntary and anonymous survey via e-mail to all members of the German Society for Digestive and Metabolic Diseases (DGVS - Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselerkrankungen). Sociodemographics and data on parental status, number of children, and used support structures were gathered. The Work-Family Conflict Scale (ISSP) was used to measure the compatibility of family and job. Query logic branched depending on responses, and single and multiple-choice questions were used, as well as Likert scales.

Results

At the point of this interim analysis, 586 respondents finished the survey and were included for statistical analysis. Of the respondents, 45% were women, 71% were parents, and 60.3% had children living in the household. The mean age was 47 years (SD 11,0). In most cases, respondents lived with a working partner (93%), with male respondents more likely to have a stay-at-home partner (8,9% versus 2,9%). A corresponding trend was observed in partners working part-time (Overall: 41.5%. Partners of male physicians 58,9%, partners of female physicians 17,2%). In the ISSP, there were high levels of work-life conflict (scale 1-4, average work/life 3,06 life/work 1,79). Female respondents reported statistically significantly higher work/life, but only numerically higher life/work conflicts than male respondents. (work/life 3,18 versus 2,94, p ˂ 0.001; life/work 1,88 versus 1,77 p = 0.080; two tailed Chi Square). Parents were affected significantly more often by work-life and life-work conflicts.

Conclusion

This study provides valuable insights into the challenges faced by physicians in balancing their professional and personal lives. Finding ways to manage work-life conflicts and maintain a healthy balance is critical for the well-being and longevity of physicians, as well as the quality of care they provide to their patients. Healthcare employers should support their employees in achieving a satisfactory work-life balance.