Originator Adalimumab Research Articles

P797 Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with Inflammatory Bowel Disease: Results of a multicenter survey

Abstract Background Several studies have proven similarity in terms of efficacy and safety between infliximab (IFX) or adalimumab (ADA) biosimilars and their corresponding originators. However, there is still a paucity of data on the impact of switching from an originator to a biosimilar on patients’ subjective disease control in clinical practice. In Hungary, a mandatory non-medical switch program regarding anti-TNFs was launched in 2021. We aimed to assess symptom control and perception of adverse events following non-medical switch in patients with inflammatory bowel disease (IBD). Methods In this cross-sectional, questionnaire-based study, Hungarian patients with IBD who switched from infliximab originator to biosimilar GP1111 or from adalimumab originator to biosimilar GP2017 after receiving at least one dose of biosimilar were interviewed. The subjective efficacy was measured using a 10-point interval rating scale, and adverse events were assessed. The difference in efficacy before and after the switch was calculated and compared within and between the two drugs. All statistical analysis was performed using R Statistical Software. Results A total of 179 patients were interviewed (median age 41 years, interquartile range 32 to 47; 135 and 44 patients with Crohn’s disease and ulcerative colitis, respectively). There were 73 ADA and 106 IFX switches in our cohort. The subjective efficacy of IFX biosimilar was rated lower compared to IFX reference product (8.72±1.68 vs. 7.77±2.34; p=0.001). The ADA biosimilar was rated higher than their reference product (9.02±1.61 vs. 8.42±1.93; p=0.017). Comparing the satisfaction of non-medical switch between biosimilar groups, patients receiving ADA were more satisfied with the new treatment as patients in the IFX group (p=0.032). The incidence of new perceived adverse events was 85 % in the ADA and 55 % in the IFX group (p<0.001). 66 % of patients on ADA treatment reported pain at the subcutaneous injection site. Conclusion Our study confirmed the efficacy of the switch to a biosimilar in the case of ADA, while reduced efficacy was experienced with IFX biosimilar. Based on the different adverse event profiles of biosimilars, the importance of switching the product for medical reasons should be emphasized.

P709 Endoscopic healing and clinical remission after administration of adalimumab to patients with Crohn’s disease of the small intestine

Abstract Background In patients with Crohn’s disease (CD) localized in the small intestine, endoscopic healing can be assessed by small bowel capsule endoscopy (SBCE). We aimed to investigate the rate of achieving deep remission, i.e. endoscopic healing and clinical remission in patients with CD of the small intestine, after treatment with adalimumab. Methods Retrospective analysis of prospectively collected data from all patients who were subjected to SBCE in our department from 1/3/2003 to 30/9/2022. Out of the patients who were subjected to the test for the investigation of suspected or confirmed CD of the small intestine we sought those who were treated with adalimumab (originator or biosimilar) and underwent repetitive SBCE at least 24 weeks after the start of treatment. Endoscopic healing was defined as a Lewis score < 350, while clinical remission was defined as Harvey Bradshaw index ≤ 4. Results During the study period, 102 patients (men/women: 54/48, mean age ± SD: 31.2±14.1 years) were subjected to SBCE before and after administration of adalimumab for the treatment of small intestinal CD. Of these patients, 11 (10.7%) also had extra-intestinal manifestations (arthritis: n=9, erythema nodosum: n=1, uveitis: n=1). After a mean period of 104 weeks (range 24-416 weeks), endoscopic healing was observed in 49 patients (48.0%). All patients who experienced endoscopic healing were also in clinical remission. There was no statistically significant difference in patients with endoscopic healing between those receiving adalimumab originator or biosimilar (36 out of 73, 49.3% vs 13 out of 29, 44.8%, p=NS). Conclusion Small bowel capsule endoscopy can help us to identify endoscopic healing, which is observed in about half of patients with CD of the small intestine treated with adalimumab.

Switching from adalimumab originator to biosimilar: a 3-year retrospective cohort analysis.

Our three year retrospective cohort study demonstrated that the vast majority of patients tolerated the switch from adalimumab originator to adalimumab biosimilar, with a 19% switchback rate. All patients who switched back to originator from biosimilar recovered from loss of efficiency and reported adverse events. Physicians therefore should be confident in switching patients with well controlled psoriasis to adalimumab biosimilars.

Treatment with adalimumab in patients with chronic inflammatory rheumatic diseases: a study of treatment trajectories on a patient level in routine care.

Previous experiences with non-medical switching of adalimumab (ADA) in patients with chronic inflammatory rheumatic diseases (CIRD) come mainly from phase III extension of randomised clinical trials and little from routine care. To analyse treatment trajectories over 2 years in patients with CIRD conducting a non-medical switch from originator to biosimilar ADA. A retrospective observational cohort study was conducted with data from a third-level rheumatology centre in Germany. CIRD patients on originator ADA who switched to ADA biosimilar from October 2018 onwards were identified and followed until September 2020. Patients' characteristics were compared between the four a priori defined treatment trajectories 'continued biosimilar ADA therapy', 'back-switch to originator ADA therapy', 'switch to another biological disease-modifying anti-rheumatic drug (bDMARD) therapy' and 'stopped bDMARD therapy/death/drop out'. Factors associated with continuing biosimilar ADA therapy were analysed using Cox proportional hazards regression analyses. A total of 121 CIRD patients were included. Most patients (66.9%) continued therapy with biosimilar ADA over 2 years, with a treatment retention rate of 73.1%. Whereas 21 patients (17.4%) switched back to originator ADA, mainly due to adverse events, and 8 patients (6.6%) switched to a different bDMARD, mainly due to lack of effect. The estimated risk of withdrawal was lower for longer prior duration on originator ADA [hazard ratio (HR): 0.82; 95% CI: 0.69-0.97] and higher for higher C-reactive protein levels at baseline (HR: 1.18; 95% CI: 1.00-1.39). Male patients, older patients and those for whom originator ADA was their first bDMARD tended to have a lower risk of withdrawal. Our results indicated that three of four patients continue biosimilar ADA over 2 years with lower risks of withdrawal for male sex, older age, longer prior duration on originator ADA and originator ADA as first bDMARD.

Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason. A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars. 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild. No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.

Comparison of Efficacy and Safety of Original and Biosimilar Adalimumab in Active Rheumatoid Arthritis in a Real-World National Cohort.

Background and Objectives: Real-world evidence should reflect the evidence obtained from controlled trials; therefore, the study aimed to compare biosimilar adalimumab (bADA) to original adalimumab (oADA) in terms of efficacy and safety in a real-life national cohort of rheumatoid arthritis (RA) patients. Materials and Methods: The following study is a prospective observational study in which we analyzed patients treated with reimbursed biologics from the Romanian Registry of Rheumatic Diseases (RRBR). RA cases must fulfill the 2010 classification criteria, as well as specific inclusion and exclusion criteria. The RRBR database was queried for all RA patients starting oADA or bADA (FKB327, GP2017, MSB11022, SB5 available) from 2 May 2019 (the first bADA initiation) until 26 March 2022 (study search date). Results: The study included 441 patients who started oADA (48.3%) or bADA (51.7%) in the same time period. At baseline, patients starting bADA had a significantly higher mean age and lower prevalence of women. After the first six months of treatment, there were no significant differences between the oADA and bADA regarding rates of Boolean (15.0% vs. 12.3%, p = 0.401), DAS28-CRP (32.4% vs. 34.2%, p = 0.686) and SDAI (16.4% vs. 14.0%, p = 0.483) remission rates. There were 107 cases of adverse events (AE): 81.3% on oADA and 18.7% on bADA. Notably, 51.4% of AE were infections. Regarding severity, 49.5% of AEs were mild, 34.6% were moderate, and 15.9% were severe. Conclusion: Biosimilar adalimumab showed similar efficacy and safety to original adalimumab after the first six months of treatment in RA patients from a national registry.

Cost per responder of Adalimumab biosimilars MSB11022 and ABP 501 versus the originator and methotrexate in chronic plaque psoriasis

ABSTRACT Background Pharmacoeconomic studies comparing the cost of adalimumab biosimilars versus the originator and conventional drugs in psoriasis are lacking. Research design and methods To assess the cost per responder of adalimumab biosimilars versus the originator and methotrexate for psoriasis treatment. A cost per responder analysis comparing adalimumab biosimilars MSB11022 (Idacio®) and ABP 501 (Amgevita®), and methotrexate to the originator (Humira®) was performed. The incremental cost per responder was calculated by multiplying the cost of treatment based on the perspective of the National Healthcare System and number needed to treat for each therapy. Results Considering the PASI75 response rate at 16 weeks, the cost per responder for MSB11022 and ABP 501 compared to the originator was € 500 versus 1,831 and € 968 versus 1,949, respectively. For the same endpoint, the cost per responder for subcutaneous or oral methotrexate was € 543 or 34 compared to 2,117 for adalimumab originator. At an indirect comparison among methotrexate, MSB11022 and ABP 501, the costs per PASI75 responder at week 16 were 2%, 26%, 27% and 50% of that of the originator, respectively. Conclusions The use of biosimilars was confirmed as a valuable pharmacoeconomic strategy to lower healthcare cost in patients with psoriasis.

Evaluation of the safety and effectiveness after switch from adalimumab originator to biosimilar SB5 in patients with inflammatory bowel disease in a real-life setting.

Prospective data are lacking on evolution of trough levels, effectiveness, acceptance rate and patient satisfaction after switch from the adalimumab originator to a biosimilar in patients with inflammatory bowel disease. Patients in clinical remission or stable response and treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, prospective trial in which patients were switched to adalimumab biosimilar SB5. The primary outcome was the description of adalimumab trough levels over time. Secondary outcomes were secondary loss of response, disease activity, patient satisfaction score and drug persistence over 12 months. The study included 110 patients. Mean baseline adalimumab trough level was 9.21 μg/ml. Concentration remained within the therapeutic range over time. No changes were observed in disease activity scores nor in biochemical parameters over time. The acceptance rate of switch was 84.6%. By month 12, 74.5% was still treated with SB5. The most frequent reason for discontinuation was occurrence of adverse events. 50% of these adverse events were injection site pain. The local discomfort was only significant the first 30 minutes after injection. Satisfaction with the decision to switch to SB5 was high and remained stable over time. After being well informed the great majority of patients treated with the adalimumab originator is willing to switch to biosimilar SB5. In our study, there was a persistence rate of 75% over one year. The trough levels remained within the therapeutic range and no change in disease activity was seen over time.

Plain Language Summary of the VOLTAIRE-CD Study in People with Moderately to Severely Active Crohn’s Disease

This is a summary of the VOLTAIRE-CD study originally published in The Lancet Gastroenterology and Hepatology. BI 695501 is a medicine being developed to treat people with moderately to severely active Crohn's disease, a chronic inflammatory condition that usually affects the small bowel and colon. BI 695501 is a biosimilar, which means that it is designed to be highly similar to the original drug. The VOLTAIRE-CD study aimed to show whether BI 695501 is just as effective and safe as the original drug, adalimumab (Humira®) in treating Crohn's disease. Participants in the VOLTAIRE-CD study took either the original adalimumab product for 24weeks followed by BI 695501 for the next 22weeks, or just the biosimilar BI 695501 for the entire 46-week treatment period. Similar improvements in Crohn's disease symptoms and the number of participants with side effects were similar, regardless of whether they received the original drug or BI 695501. These results show that both drugs could be used in the treatment of people with Crohn's disease, with similar efficacy and safety.

Adalimumab Originator vs. Biosimilar in Hidradenitis Suppurativa: A Multicentric Retrospective Study.

This study aimed to compare adalimumab originator vs. biosimilar in HS patients, and to evaluate the effect of a switch to a biosimilar, or a switch back to the originator, in terms of treatment ineffectiveness. Patients with a diagnosis of HS were enrolled from 14 Italian sites. Treatment ineffectiveness was measured using Hurley score. The major analyses were 1) comparison between the two treatment groups (non-switcher analysis), and 2) the cross-over trend of Hurley score between treatment switchers (switcher analysis). Cox and Poisson regression models were used to compare the treatment ineffectiveness between groups. A total of 326 patients were divided into four groups: 171 (52.5%) taking originator; 61 (18.7%) patients taking biosimilar; 66 (20.2%) switchers; 28 (8.6%) switchers from originator to biosimilar and switched. A greater loss of efficacy was observed in the group allocated to the biosimilar than the originator group. The switcher analysis showed an effectiveness loss in the biosimilar compared to the originator. These results seem to indicate that a switch from one drug to the other may lead to a greater risk of inefficacy. A return to the previous treatment also does not ensure efficaciousness.

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest.

Since 2021, adalimumab biosimilar ABP 501 can be used alternatively to adalimumab originator (ADAO) in the treatment of hidradenitis suppurativa (HS). Effectiveness and safety data remain scarce. We investigated the impact of switching from ADAO to ABP 501 on disease severity and the occurrence of adverse events (AEs) in patients with HS. We analyzed clinical data on patients enrolled in the German HSBest registry. Evaluation outcomes were assessed at three time points (baseline of originator (t0), prior to switching to biosimilar (t1) and 12 to 14 weeks after switching (t2)) and included patient-reported AEs and disease severity using the International Hidradenitis Suppurativa Severity Score System (IHS4) score. In total, 94 patients were switched from ADAO to ABP 501. Overall, 33.3% (n = 31/94) of the patients developed AEs and/or loss of response (LoR) within 12 to 14 weeks after switching. Of these, 61.3% (n = 19/31) experienced LoR but no AEs, 22.6% (n = 7/31) LoR combined with AEs and 16.1% (n = 5/31) AEs only. Our study showed that switching HS patients from ADAO to ABP 501 does significantly affect treatment effectiveness. Switching patients who are on remission maintenance therapy should be viewed critically.

P66 Adalimumab originator versus biosimilar in children and young people with JIA

Introduction/BackgroundBiosimilar therapies are considered to have comparable efficacy to their originators and prescribing is encouraged in the UK for significant cost-savings to the NHS. However, real-world evidence comparing originators and biosimilars is limited, particularly in children and young people. The objective of this analysis was to compare the effectiveness of the anti-TNF adalimumab originator and a biosimilar in the treatment of JIA in children and young people, by comparing change in disease activity after six months.Description/MethodThis analysis included children and young people with JIA from the Biologics for Children with Rheumatic Diseases (BCRD) study. Data are collected at the point of starting biologic therapy, and after 6 months, including patient demographics, biologic therapy, and disease activity. Patients were included if they were starting adalimumab (originator or biosimilar) as their first biologic. Patients with follow-up data at 6 months were assessed for outcomes at 6 months. Change in Juvenile Arthritis Disease Activity Score (JADAS-71) from baseline to 6 months was calculated and compared between therapies using linear regression. Multivariable logistical regression was used to compare remission (JADAS-71 ≤1) at 6 months between therapies. Both regression models were adjusted for baseline characteristics at the start of biologic therapy: age, gender, disease duration, ILAR category, history of uveitis, number of comorbidities (0/1/2+), and JADAS-71. Multiple imputation was used to account for missing data.Discussion/ResultsA total of 457 patients were registered starting adalimumab as their first biologic: 413 on originator, 44 on biosimilar (Table). Of these, 63% were female, median age at start of therapy was 11 years old (IQR 6, 14), and median disease duration was 2 years (IQR 1, 5). The majority of patients had RF-negative polyarticular JIA (29%), persistent oligoarticular (20%) or extended oligoarticular JIA (18%). There were 47% of patients who had a history of uveitits when starting biologic therapy, and 68% reported at least one comorbidity. Baseline characters were similar between both therapies. There were 429 patients with follow-up data after six months of treatment: 393 on originator and 36 on biosimliar. The median JADAS-71 improved by -4.4 (IQR -9.9, -0.2) with no difference seen between the originator and the biosimilar patients (adjusted b-coefficient: -0.4; 95% CI -2.6, 1.8; p = 734). There were 36% of patients in remission, with no difference between the two therapies (odds ratio 1.2; 95% CI 0.5, 2.9; p = 0.543).P66 Table:Baseline characteristics and 6-month outcomes All patients Originator Biosimilar Baseline Characteristics Patients 45741344 Gender 290 (63%)257 (62%)33 (75%) Age 11 (6, 14)11 (6, 14)11 (6, 13) Disease duration 2 (1, 5)2 (1, 5)3 (1, 6)N = 446N = 403N = 43 ILAR Category Persistent Oligoarticular20%19%27%Extended Oligoarticular 18%17%20%RF- Polyarticular 29%29%30%RF+ Polyarticular7%7%5%Systemic<1%<1%2%Psoriatic6%6%7%Enthesitis-related15%16%7%Undifferentiated / missing4%5%2% History of Uveitis 47%48%35%N = 448N = 405N = 43 Comorbidities 032%31%41%144%45%41%2+24%25%18% 6-month outcomes Patients 42939336 JADAS-71 (0-101) Baseline, median (IQR)7.8 (4.1, 14)7.8 (4.0, 14)8.3 (4.5, 11)6 months, median (IQR)2.5 (0.4, 5.6)2.4 (0.4, 5.5)3.7 (0.8, 5.7)Change, median (IQR)−4.4 (-9.9, -0.2)−4.5 (-10, -0.2)−3.9 (-6.9, -1.2)Coef. (95% CI)–−1.8 (-5.5, 2.0)Reference. Adjusted* coef. (95% CI)–−0.4 (-2.6, 1.8)Reference. JADAS-71 Remission 6 months, %36%36%32%Odds ratio (95% CI)–1.2 (0.5, 2.9)Reference.Adjusted* odds ratio (95% CI)–1.3 (0.5, 3.4)Reference.Key learning points/ConclusionThere was no significant difference in disease activity response between children and young people with JIA treated with adalimumab originator versus biosimilar. These results support that the adalimumab biosimilar is similar in effectiveness to the originator in treating JIA, although more research is needed regarding safety and tolerability.

Real-life data on efficacy and safety of original Adalimumab and biosimilar Adalimumab (ABP 501) in pediatric rheumatic diseases

ABSTRACT Background We aimed to compare the efficacy and safety of the original product (OP) and biosimilar product (BP) of adalimumab in pediatric rheumatic diseases. Research design and methods The study group consisted of patients who had received original or biosimilar adalimumab (ABP 501) therapy for at least 3 months. The patients were divided into uveitis and arthritis groups based on the indication of adalimumab treatment. Assessment of disease activity was performed by Juvenile Arthritis Disease Activity Score in patients with juvenile idiopathic arthritis, and by standardization of uveitis nomenclature criteria in patients with uveitis. Results The study included 140 patients, of which 87 were treated with OP and 53 with BP. In the arthritis group, 26 (63.4%) and 20 (57.1%) patients reached inactive disease according to JADAS-27 in the original and biosimilar adalimumab groups, respectively. In the uveitis group the mean number of exacerbations throughout the treatment period was 0.84 ± 1.07 in the OP group, and 0.58 ± 0.79 in the BP group. There were 71 treatment-emergent adverse events in the OP group and 38 in the BP group. Conclusion There was no significant difference between the biosimilar and the original product in efficacy and safety.

Switching from adalimumab originator to biosimilars in hidradenitis suppurativa: What's beyond cost-effectiveness?

In the last years, adalimumab biosimilars have represented a commonly used alternative to the originator agent in the treatment of moderate to severe hidradenitis suppurativa. As of today, studies investigating the switch from adalimumab originator to biosimilar, following pharmacoeconomic policies, are lacking. Herein we present a real-life setting retrospective study aimed at assessing the safety and efficacy of this switch in 37 patients, evaluated for 12 months in terms of IHS4 (International Hidradenitis Suppurativa Severity Score System) and HiSCR (Hidradenitis Suppurativa Clinical Response). Overall, no significant differences emerge between adalimumab originator and biosimilar in terms of clinical response following non-medical switch. High discontinuation rates (43.2%) raise questions on patients' compliance to the new drug regimen, as severe pain at the injection site represents a substantial cause of biosimilar discontinuation (i.e., 31.5% of the cases). In selected cases, rechallenge with adalimumab originator may represent a valid option, as 66.6% (n=8) of the patients who switched back to the former agent have benefited in terms of tolerability and efficacy. Carefully integrating pharmacoeconomic policies with a thorough assessment regarding the benefit-risk ratio of a nonmedical switch from originator to biosimilars remains essential to provide each HS patient with the best therapeutic option.

Adalimumab Biosimilar GP2017 versus Adalimumab Originator in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study.

The approval of adalimumab (ADA) biosimilars for inflammatory bowel disease (IBD) has reduced the cost of treatment. While several ADA biosimilars are currently available, comparative data on the ADA biosimilar GP2017 (HyrimozTM) and its originator (HumiraTM) in IBD are lacking. We compared the efficacy and safety of GP2017 versus originator in IBD outpatients in an Italian real-life setting. This retrospective analysis enrolled consecutive IBD patients with complete clinical, laboratory, and endoscopic data. Clinical activity was assessed with the Mayo score in ulcerative colitis (UC) and the Harvey–Bradshaw Index in Crohn’s disease (CD). The primary endpoints were the induction of remission and the safety of GP2017 versus ADA originator. One hundred and thirty-four patients (30.6% with UC and 69.4% with CD, median age 38 years) were enrolled: 62 (46.3%) patients were treated with GP2017, and 72 (53.7%) with ADA originator; 118 (88.1%) patients were naïve to ADA. Clinical remission was obtained in 105 (78.4%) patients, during a median follow-up of 12 months, 82.3% and 75% in the GP2017 and ADA originator groups, respectively (p = 0.311). Treatment was well tolerated in both groups. This analysis of real-world data suggests that GP2017 and its originator are equivalent in terms of efficacy and safety in patients with IBD.

Impact of a clinical pharmacist in a multidisciplinary consultation on the switch to a biosimilar for inflammatory rheumatic diseases.

Despite several studies proving the efficacy and safety of biosimilars compared with original drugs, switching to a biosimilar remains challenging when the decision is at the discretion of physicians with mandatory consent from patients. Educating patients about biosimilars seems important to increase the prescription rate of biosimilars. This study aimed to evaluate the impact of a clinical pharmacist consultation on the switch to and retention rate of a biosimilar for patients with inflammatory rheumatic diseases. This retrospective study compared 2 groups of adult patients receiving (intervention) or not (control) a consultation with a pharmacist right before the rheumatologist consultation. The primary outcome was the frequency of patients who switched to a biosimilar at the end of the rheumatologist visit. We analysed 141 patients (50% women, 50±15years old, on original adalimumab (62%) or etanercept (38%)) who had never used biosimilars: 85 in the intervention group and 56 in the control group. The switch rate to a biosimilar significantly differed between the groups: 69.4% versus 41.1% in the intervention group versus the control group respectively (P<0.01). After a 1-year follow-up period, 72.5% versus 81.3% of patients who switched were still on biosimilar in the intervention versus control group respectively. This study highlights the positive impact of a pharmacist consultation before the physician's one on switching to a biosimilar, but more studies are needed to assess the impact of this pharmacist consultation on preventing the nocebo effect and therefore on improving the retention rate of biosimilars.

Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis.

The recent introduction of ABP 501, an adalimumab biosimilar, in the treatment of rheumatic diseases was supported by a comprehensive comparability exercise with its originator. On the other hand, observational studies comparing adalimumab and ABP 501 in inflammatory arthritis are still lacking. The main aim of this study is to compare the clinical outcomes of the treatment with adalimumab, both the originator and ABP 501, in a large cohort of patients affected by autoimmune arthritis in a real life setting. We retrospectively analysed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of adalimumab (originator or ABP 501) from January 2003 to December 2020. We stratified the study population according to adalimumab use: naive to original (oADA), naive to ABP 501 (bADA) and switched from original to ABP 501 (sADA). The oADA, bADA and sADA groups included, respectively, 724, 129 and 193 patients. In each group, the majority of patients had a diagnosis of rheumatoid arthritis. The total observation period was 9805.6 patient-months. The 18-month retentions rate in oADA, bADA and sADA was, respectively, 81.5%, 84.0% and 88.0% (p > 0.05). The factors influencing the adalimumab retention rate were an axial spondylarthritis diagnosis (Hazard Ratio (HR) 0.70; p = 0.04), switch from oADA to ABP 501 (HR 0.53; p = 0.02) and year of prescription (HR 1.04; p = 0.04). In this retrospective study, patients naive to the adalimumab originator and its biosimilar ABP 501 showed the same retention rate. Patients switching from the originator to biosimilar had a higher retention rate, even though not statistically significant, when compared to naive.

Switching from Adalimumab Originator to Biosimilar: Clinical Experience in Patients with Hidradenitis Suppurativa.

Adalimumab is currently the only biological medicine approved by the FDA for the treatment of hidradenitis suppurativa (HS). The breakout of biosimilar drugs made them more accessible due to their impact on pharmacoeconomics. However, packaging, formulation, or excipients are unique characteristics of each drug. In that way, switching from adalimumab originator to biosimilar and between biosimilars could have implications in the clinical practice. The objective of this study is to describe our clinical experience in switching from adalimumab originator to biosimilar and switching back again. A single-center retrospective cohort study was conducted that included seventeen patients with HS treated with adalimumab originator in the maintenance phase, and that achieved Hidradenitis Suppurativa Clinical Response (HiSCR), who were switched to adalimumab biosimilar for no medical reasons. The reason for the change was to improve pharmacoeconomic efficiency, following our hospital policies on biologics. Median duration with adalimumab originator treatment before switching was 48 weeks. After switching, 41.2% of patients maintained HiSCR response without additional issues, while 58.8% (10/17) reported problems after the change. Switching from adalimumab originator to biosimilar in well-controlled patients could imply problems in efficacy and adherence. Switching back to adalimumab originator appears to solve most of the problems, but some patients can lose confidence in the drug and discontinue it. It would be worthwhile to evaluate the benefit–risk ratio individually when switching an HS patient to adalimumab biosimilar.

P578 Non-medical switch between adalimumab biosimilars and from the originator adalimumab to biosimilars in inflammatory bowel disease patients – a multicentre study on efficacy and drug sustainability

Abstract Background The use of biosimilar adalimumab (ADA) is effective and safe in inflammatory bowel disease (IBD), although clinical data on switching between ADA biosimilars is still rare. At the end of 2020, a non-medical switch to biosimilar ADA became mandatory in Hungary due to reimbursement policy changes of the National Health Insurance Fund of Hungary (NEAK). The aim of the present study was to evaluate short- and medium term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. Methods 246 consecutive patients on maintenance ADA therapy (n=181 Crohn’s disease [CD] and n=65 ulcerative colitis [UC], male/female: 44%/56%, median disease duration: 10years(y) (IQR: 10–16)) were included from 4 IBD centers between September 2019 and December 2020. Data on clinical efficacy, using Crohn’s Disease Activity Index (CDAI) and partial Mayo Score (pMayo), laboratory parameters (C-reactive protein – CRP) and adverse events were collected at 8–12 weeks prior switch, at baseline, and 8–12 weeks, 20–24 weeks after switch. Drug sustainability following the switch was evaluated after a median of 41 weeks (IQR: 35–42) follow-up time. Results A total of 246 IBD patients (n=153 patients [115CD/38UC, median age: 38y(IQR: 27–45)] and n=93 patients [66CD/27UC, 32y(IQR: 26–40.5)] underwent a non-medical switch from the originator to a biosimilar, and biosimilar to biosimilar. Clinical disease activity based on CDAI and pMayo scores are presented in Figures 1 and 2. No significant difference was found in the proportion of patients in clinical remission at week 8–12 prior switch / switch / week 8–12 and week 20–24 in either patients switched from originator to biosimilar (86.8% / 88.2% / 86.0% / 85.0%; p=0.87 among groups) or biosimilar to biosimilar (72.0% / 77.4% / 84.9% / 77.6%; p=0.21). 89.2% and 83.1% of patients who were in clinical remission at switch/baseline sustained clinical remission up to week 20–24 in the first and second cohorts. Mean CRP levels were also unchanged during follow-up in both cohorts (p=0.71 and p=0.94). Drug survival was similar between originator to biosimilar and biosimilar to biosimilar switch cohorts, with a probability of 90.6% (SE: 2.4) and 85.8% (SE:3.7) to stay on drug after 40 weeks (log-rank: p=0.271). Figure 3. Two cases of skin reactions were registered as adverse events, one leading to treatment discontinuation. Conclusion Clinical remission was sustained following non-medical switch from originator or biosimilar adalimumab to a biosimilar in IBD patients. Medium-term drug sustainability following the switch was high, and comparable between patients with an originator to biosimilar and a biosimilar to biosimilar switch.

P411 Stable pharmacokinetics and biochemical markers of inflammatory bowel disease activity: Results from a real-world adalimumab biosimilar switching program

Abstract Background Biosimilars have delivered significant cost savings, increasing access to biologics for many patients. While numerous studies have demonstrated no difference in efficacy between originators and biosimilars, the impact of switching between originator and biosimilar adalimumab on drug levels and disease activity in real world cohorts remains largely unknown. Methods We conducted a retrospective observational cohort study of, 392 patients with IBD (347 (89%) CD, 45 (11%) UC) who had switched from Humira to the biosimilar, Idacio, between February - November, 2021. Therapeutic drug monitoring was carried out using a commercially available, drug sensitive ELISA (LISA TRACKER, Theradiag). Therefore, antidrug antibodies could only be detected in the setting of low or absent serum drug concentrations. Drug level data was parametric and analysed by paired student t test and Pearson correlation coefficient. CRP data was analysed by Wilcoxon test. Data was analysed using GraphPad Prism. Results The baseline characteristics of the study participants are presented in the table., 96 patients had paired adalimumab drug levels before and after the switch. There was no difference between median adalimumab drug levels before and after the switch (9.5 vs, 9.2 ug/mL, p=0.67). Furthermore, drug levels were positively correlated before and after switching demonstrating similar levels at both time points for most patients (correlation co-efficient, 0.47, p &amp;lt;, 0.0001) (Figure, 1). Prior to switching, no patients had detectable antidrug antibodies. Following switch, one patient (1%) developed high-titre antidrug antibodies and undetectable drug levels. Prior to switch their levels were, 14, without detectable antidrug antibodies CRP levels were available for, 163 patients before and after the switch, with no difference in median CRP at either time point (1 vs, 1mg/L p=0.60). 33 (8%) patients experienced injection site pain with Idacio and therefore, switched back to Humira. The annual cost saving to the UK National Health Service for patients on weekly and every other week switched to Idacio is £5096 and £2548, respectively Conclusion Our study demonstrates stable pharmacokinetics and biochemical disease activity amongst a significant cohort of patients switching from originator to biosimilar adalimumab as part of a real-world switching program. However, a small proportion of patients did not tolerate Idacio due to injection site pain. There are clear financial benefits in carrying out non-medical, biosimilar switching programs but further work is needed to evaluate the effect on clinical and endoscopic disease activity in a real-world setting.