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KNOW NOCEBO: PREDICTING PATIENT OUTCOMES IN A 32-MONTH ADALIMUMAB BIOSIMILAR SWITCH STUDY

Ciaran Mc Closkey 1, Louise Rabbitt 1, Sarah Monahan 1, Niamh Martin 1, Laurence Egan 1, Eoin Slattery 1

Affiliations

1 University Hospital Galway, Galway, Ireland

Summary

AI Generated

A 32-month follow-up study of 70 inflammatory bowel disease patients switching from adalimumab originator to biosimilar found no negative impact on clinical outcomes, though patients with more negative attitudes toward medicines were more likely to switch back, suggesting a nocebo effect.

At 32 months post-switch, 72.7% of patients remained on the biosimilar Amgevita, 9.1% switched back to Humira, 7.6% switched to another biologic, and 10.6% stopped biologic treatment
Median disease activity scores (HBI, IBDC8, IBDQ-VAS) showed no clinically meaningful deterioration at 8 weeks or 32 months post-switch compared to baseline
Patients who switched back to Humira had lower Beliefs about Medicines questionnaire scores, indicating more negative attitudes toward medicines and suggesting a nocebo effect
25.7% of patients reported adverse events post-switch, most commonly skin-related (8.6%), injection site reactions (5.7%), and headaches (2.8%), with 8.6% reporting perceived reduced efficacy without specific symptoms
The authors suggest enhanced patient education may help mitigate nocebo effects in future biosimilar switch programs

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Abstract

Introduction

While randomized studies have shown that Amgevita (an adalimumab biosimilar) and Humira (adalimumab originator) are equivalent, concerns persist among patients and prescribers as to its efficacy. Patients switching to a medicine they perceive as lower cost may experience a ‘nocebo’ effect, whereby expectations of poorer efficacy may lead to worse clinical outcomes, resulting in an unmeasured health economic burden.

Aims & Methods

70 patients partook in a biosimilar switch study at our centre in August 2020, undergoing a change in treatment from Humira to Amgevita. Baseline clinical data obtained included faecal calprotectin, drug and drug antibody levels, Harvey-Bradshaw (HBI) and Partial-Mayo scores. Patient-Reported Outcomes (PROs) were recorded through the IBD control-8 (IBDC8) and IBCD visual analogue scale (IBDQ-VAS). Patients took psychometric tests 8 weeks pre-switch, including the ‘Beliefs about Medicines’ questionnaire (BMQ), used to assess beliefs about prescribed medications, the ‘Health Anxiety Index’ (HAI), used to identify patients with high levels of concern about their health, and the EQ-5D questionnaire, used to measure health-related quality of life. The original study found no significant differences in clinical and PROs at 8-week follow-up. We planned to conduct a 32-month follow-up on these patients to examine for temporal changes in outcomes, and whether certain variables could predict the patients experiencing a ‘nocebo’ effect. Approval was obtained from the hospital ethics committee. Patient information from the original study was stored on an excel database. We retrospectively obtained clinical data from electronic records and lab data. Questionnaire results were obtained from clinic appointments.

Results

70 patients were included in the study. 41 male, 29 female. 54 patients had Crohn’s, 13 UC, and 4 indeterminate colitis. 25.7% of patients reported adverse events post-switch, with 33.3% of these patients switching back to Humira. The most common side effects were skin related (8.6%), injection site related (5.7%), and headaches (2.8%). 8.6% of patients felt the medication to be less effective without specific symptoms. 32-months post switch, 72.7% remained on Amjevita, 9.1% had switched back to Humira, 7.6% had switched to another biologic as clinical non-responders, 10.6% had stopped biologic treatment due to surgery or clinical remission.
Median scores were calculated at 8 weeks pre and post-switch, and at 32 months. HBI scores were 2, 1 and 1 respectively, with scores of 1, 0 and 0 in the switchback group. IBDC8 scores were 12, 13 and 14 overall, with scores of 12, 10 and 14 in the switchback group. IBDQ-VAS scores were 87, 80 and 90 overall, with scores of 100, 100 and 85 in the switchback group. Median HAI scores were lower in the switchback group; scoring 12 versus 17 overall. Median scores in four domains of the BMQ questionnaire; general harm, general overuse, specific concerns and specific necessity were lower in the switchback group. Scores were 12, 12, 8, 7, versus overall scores of 21, 14, 10, and 9 respectively, indicating more negative attitudes towards medicines in the switchback group.

Conclusion

Our study found no negative impact in clinical outcomes and PROs in patients switching from Humira to Amgevita at 32-months post-switch. Patients that had more negative attitudes to medicines in the BMQ questionnaire were more likely to switchback to Humira suggesting a nocebo effect. Enhanced patient education may help mitigate the nocebo effect observed in our study and enhance the success rate of future biosimilar switch trials.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

IBD: We treat them all - but how? (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

ESGE live endoscopy I (Complete Session)

UEG Presentation

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ESGE live endoscopy III (Complete Session)

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ESGE live endoscopy III (Complete Session)

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Abstract

Event

UEG Week Barcelona 2026

Topics

Endoscopy

Session

ESGE live endoscopy III

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

ESGE live endoscopy I (Complete Session)

UEG Presentation

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Understanding the mechanisms of extraintestinal manifestations of IBD

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Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz 1

Affiliations

1 Ludwig-Maximilians-University of Munich, Muniche, Germany

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Abstract

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine IBD

Session

Extraintestinal manifestations in IBD

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

ESGE live endoscopy I (Complete Session)

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MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

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MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Julian Heierle 1, Christian Eichhorn 1, Carole Marxer 2, Alexander Kutz 3,4, Flurina Gass 1, Jan Hendrik Niess 1,4, Petr Hruz 1, Anders Forss 2, Fahim Ebrahimi 1,2

Affiliations

1 University Hospital Basel, Basel, Switzerland

2 Karolinska Institutet, Stockholm, Sweden

3 Kantonsspital Aarau, Aarau, Switzerland

4 University of Basel, Basel, Switzerland

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Abstract

Introduction

Inflammatory bowel disease (IBD) commonly affects women of reproductive age. Although both pregnancy and IBD have been associated with an increased risk of major adverse cardiovascular events (MACE), the risk of MACE during pregnancy and after delivery among women with IBD is not well characterized.

Aims & Methods

We conducted a population-based cohort and case-control study including all women with a delivery resulting in live birth in Switzerland between 2012 and 2022. Women with and without IBD were followed from discharge after delivery hospitalization to assess the risk of MACE, defined as a composite of acute myocardial infarction, stroke, hospitalization for heart failure, or all-cause mortality. Follow-up was divided into a postpartum period (≤3 months) and long-term follow-up. Women were censored at the time of a subsequent pregnancy, an outcome event, or the end of the study period. Weighted hazard ratios (HR) were estimated using Cox regression. To study the MACE risk during pregnancy (divided into pregnancy period [defined as 10 months prior to delivery hospitalization excluding delivery hospitalization] and delivery hospitalization), we conducted a case-control study and estimated odds ratios (OR) using weighted logistic regression. In both analyses, stabilized inverse probability of treatment weighting (IPTW) was used to balance baseline covariates.

Results

Among 658,776 women with a delivery resulting in live birth, 1,831 had IBD (Crohn's disease, n=1,021; ulcerative colitis, n=810). During a median follow-up of 3.4 years, MACE occurred in 9 women with IBD (incidence rate [IR], 8.7 per 100,000 person-years) and 1,398 women without IBD (IR, 3.9 per 100,000 person-years), yielding a weighted HR of 2.21 (95% confidence interval [CI], 1.05-4.64). This association was primarily driven by stroke (HR, 3.06; 95% CI, 1.02-9.16), whereas no significant associations were observed for the other MACE components. Most events occurred beyond 3 months after delivery in both groups (women with IBD: 89%; women without IBD: 84%). No significant differences were observed according to IBD subtype or other predefined subgroups (age, multiple gestation, prior MACE, prior VTE). In the case-control analysis, IBD was not associated with increased MACE risk during pregnancy (odds ratio [OR], 0.73; 95% CI, 0.10-5.26) or at delivery hospitalization (OR, 1.62; 95% CI, 0.30-8.73).

Period	Events in Women with IBD	Events in Women without IBD	HR / OR	P-value
Period	N (%)	N (%)	(95% CI)	P-value
Pregnancy	1 (0.05)	88 (0.01)	0.73 (0.10-5.26)	0.76
Delivery Hospitalization	2 (0.11)	235 (0.04)	1.62 (0.30-8.73)	0.58
Postpartum Period	1 (0.05)	226 (0.03)	0.29 (0.04-2.03)	0.21
Long-term Follow-Up	9 (0.49)	1,398 (0.21)	2.21 (1.05-4.64)	0.04

Table 1: MACE risk across pregnancy and postpartum periods in women with and without IBD.
^{IPTW-adjusted. Pregnancy and delivery hospitalization: OR (weighted logistic regression); postpartum period and long-term follow-up: HR (weighted Cox regression).}

Conclusion

Among women with a delivery resulting in live birth, IBD was not associated with an increased MACE risk during pregnancy or the postpartum period. However, women with IBD had a more than twofold higher long-term risk of MACE after delivery, primarily driven by stroke. These findings support consideration of long-term cardiovascular risk assessment in women with IBD after pregnancy.

Event

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

Lessons from large IBD real-world cohorts

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

ESGE live endoscopy I (Complete Session)

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ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Atilla Akpinar 1, Oğuz Kağan Bakkaloğlu 1, Tugce Eskazan 1, volkan YILMAZ 2, Nalan Gulsen Ünal 3, Haluk Tarik Kani 4, Tugba Tolu 4, Sezen Genç Uluçeçen 5, PIRIL AKINCIOGLU 6, Hadis Vatansever 1, Dinç Dinçer 6, Ozlen Atug 4, Yusuf Ziya Erzin 1, Ali Ibrahim Hatemi 1, Filiz Akyüz 5, Murat Toruner 2, Aykut Ferhat Çelik 1

Affiliations

1 Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Türkiye

2 Ankara University Faculty of Medicine, Ankara, Türkiye

3 Ege University Faculty of Medicine, İzmir, Türkiye

4 Marmara University, Faculty of Medicine, Istanbul, Türkiye

5 Istanbul University Istanbul Faculty of Medicine, Istanbul, Türkiye

6 Akdeniz University, Faculty of Medicine, Antalya, Türkiye

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Abstract

Introduction

Anti-TNF reintroduction after discontinuation may yield variable efficacy and safety. This multicenter study evaluates treatment response, persistence, and adverse events of anti-TNF re-switch therapy in ulcerative colitis(UC) and Crohn’s disease(CD) patients.

Aims & Methods

We retrospectively evaluated 119 patients (81 infliximab [IFX], 38 adalimumab [ADL]) who underwent index anti-TNF reintroduction at six tertiary referral centers. Premedication was administered during re-switch in patients receiving IFX. Demographics, activity indexes (modified Mayo, CDAI), treatment-related data, and outcomes during the initial and re-switch periods were compared.

Results

Of the 119 patients, 96 (80.7%) had CD and 66 (55.5%) were male; the median age at diagnosis was 26(16) years, and the disease duration was 13(9) years. Of the total cohort, 68.1% were in the IFX re-switch group and 31.9% in the ADL re-switch group. Tables detail patient, treatment and outcome charecteristics. The clinical remission (CR) rate was 46.4% during the index period and 50.4% during the re-switch period (p=0.54). In both periods, CR rates also did not differ according to anti-TNF type (p=0.63; p=0.65) or diagnosis (UC-CD)(p=0.39, p=0.56). During the re-switch period, CRP reduction, steroid requirements, and surgery rates were similar between the IFX-ADL groups (p=0.66, p=0.44, and p=0.68, respectively). The duration of the first anti-TNF period correlated with that of the second period in the IFX group (r=0.331, p=0.003), but not for ADL group (r=0.222, p=0.18). Treatment discontinuation due to lack of response was main reason for both periods (1^stperiod: IFX %79, ADL %60.5; p:0.65), but differed significantly in favor of IFX at re-switch (ADL: 50% vs IFX: 30.8%, p=0.04). Also, anti-TNF non-response was more common in patients with UC in re-switch (65.2% vs 30.2%, p=0.001). In the IFX group, the second most common reason for discontinuation in re-switch group was allergy, observed in nearly one-quarter of patients (23.4% vs 0%, p<0.001). Overall, 34.5% of patients maintained anti-TNF persistence during the second period (IFX:35.8% vs ADL:31.6%, p=0.65). Interval duration between periods and adverse events during the second period were not related (30 [30.5] vs 23.5 [36], p=0.213). Immunomodulator use was also not associated with the frequency of adverse events in either period (p=0.95 and p=0.93). In the IFX re-switch group, the median delta CRP was -0.6 (IQR 20.3) during the first period and -2.9 (IQR 16.2) during the re-switch period, without a statistically significant difference (p=0.08). In patients with cPAF, the clinical remission rate increased from 16.1% (n=5) in the first period to 37.5% (n=12) in the second period, and this difference was statistically significant (p=0.05). High-dose treatment (p=0.006) and concomitant immunomodulator use (p=0.04) were associated with achievement of CR during the re-switch period, whereas standard-dose treatment was associated with poorer remission (p=0.03).

Conclusion

This study suggests that re-switching to index anti-TNF may be a feasible option in selected patients with IBD, especially CD with or without perianal fistula, after second-line biologic failure. Approximately 35% of patients remained on therapy after re-switch, with clinically meaningful improvements. Non-response to re-switch was higher in UC patients. Allergic reactions were mostly related to IFX re-switch. High-dose therapy and concomitant immunomodulator use were associated with achievement of CR, suggesting a potential role for treatment optimization before concluding treatment failure.

Conference

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

IBD (INCLUDING MICROSCOPIC COLITIS) (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

ESGE live endoscopy I (Complete Session)

UEG Presentation

New

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

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Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

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Abstract

Event

UEG Week Barcelona 2026

Topics

Nurses

Session

Innovative approaches in liver disease management – in cooperation with EASL nurses and AHP taskforce

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik

Liver nurses & allied health professions in Europe – the EASL Nurses and AHP Taskforce

ESGE live endoscopy I (Complete Session)

UEG Presentation

New

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

ESGE live endoscopy I (Complete Session)

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

ESGE live endoscopy I (Complete Session)

Summary

AI Generated

Summary is not available for this content yet.

Download PDF

Was this helpful?

Thanks for your feedback.

Abstract

Event

UEG Week Barcelona 2026

Topics

Endoscopy

Session

ESGE live endoscopy I

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

ESGE live endoscopy III (Complete Session)

Understanding the mechanisms of extraintestinal manifestations of IBD

Daniel Kotlarz

MAJOR ADVERSE CARDIOVASCULAR EVENTS DURING PREGNANCY AND POSTPARTUM IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A POPULATION-BASED COHORT AND CASE-CONTROL STUDY

Fahim Ebrahimi

ESCALATION TO HIGH-DOSE ANTI-TNF COMBINED WITH AN IMMUNOMODULATOR TREATMENT, IS REQUIRED BEFORE DECLARING TREATMENT FAILURE IN IBD; LONG-TERM OUTCOMES OF A MULTI-CENTRE RE-SWITCH STUDY

Aykut Ferhat Çelik