Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies
Abstract
:1. Introduction
2. Results
2.1. Adalimumab Switching Studies
2.2. Etanercept Switching Studies
2.3. Infliximab Switching Studies
3. Materials and Methods
3.1. Literature Search
3.2. Study Selection
3.3. Data Extraction, Quality Assessment, and Analysis
4. Discussion
5. Strengths and Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Reference (First Author, Year [Number of Reference]) | Drug/Biosimilar | Study Design | Country | Dermatologic Disorder | Total Number of Patients | Number of Patients with a Dermatologic Disorder (Number of Switchers and Type of Switch) | Study/Follow-Up Duration | Disease Duration among Switchers (Median and IQR or Mean ± SD, Years) |
---|---|---|---|---|---|---|---|---|
Becciolini A, 2022 [13] | Adalimumab/ABP501 | Retrospective observational study (BIRRA) | Italy | PsA | 1046 | 316 (48 O-to-B) | 9805.6 patient-months (12.9 months for switchers) | 12.6 (5.8–19.1) |
Benucci M, 2022 [35] | Etanercept/SB4 | Prospective study | Italy | PsA | 124 | 47 (28 O-to-B) | 12 months | 8.36 (±3.38) |
Bonifati C, 2019 [32] | Etanercept/SB4 | Prospective study | Italy | PsA | 87 | 87 (87 O-to-B) | 12 months | n.a. |
Boone NW, 2018 [41] | Infliximab/n.a. | Pragmatic trial | The Netherlands | PsA | 125 | 5 (5 O-to-B) | 12 months | n.a. |
Bruni C, 2020 [14] | Adalimumab/SB5 | Retro-prospective observational study | Italy | PsA | 82 | 28 (28 O-to-B) | 6 months | n.a. |
Bruni C, 2021 [15] | Adalimumab/SB5 | Retrospective study | Italy | PsA | 172 | 59 (59 O-to-B) | 18 months | n.a. |
Bruni C, 2020 [31] | Etanercept/SB4 | Retrospective study | Italy | PsA | 220 | 81 (81 O-to-B) | 24 months | n.a. |
Burlando M, 2022 [21] | Adalimumab/n.a. | Retrospective study | Italy | HS | 326 | 326 (66 O-to-B and 28 B-to-O) | 13 months (1670 months of observation for switchers) | 10 (5, 19) |
Dapavo P, 2016 [39] | Infliximab/n.a. | Prospective study | Italy | Pso | 35 | 35 (30 O-to-B) | 23 weeks | n.a. |
Di Cesare A, 2020 [49] | Adalimumab/SB5 | Prospective, observational cohort study | Italy | Pso and PsA | 23 | 20 (20 O-to-B) | 12 weeks | 18.3 ± 11.11 (2–35) |
Ditto MC, 2020 [29] | Etanercept/SB4 | Prospective study | Italy | PsA | 87 | 26 (* O-to-B) | 12 months | n.a. |
Felis-Giemza A, 2019 [30] | Etanercept/SB4 | Prospective study | Poland | PsA | 162 | 13 (13 O-to-B) | 6 months | n.a. |
Gallo G, 2021 [16] | Adalimumab/n.a. | Prospective study | Italy | Pso | 73 | 73 (73 O-to-B) | 6 months | n.a. |
Gisondi P, 2020 [47] | Infliximab/CT-P13 and SB2 | Prospective, observational cohort study | Italy | Pso | 96 | 96 (96 O-to-B and B-to-B) | 6 months | n.a. |
Giunta A, 2021 [17] | Adalimumab/ABP501 | Retrospective study | Italy | Pso and PsA | 94 | 46 psoriasis (21 O-to-B) and 48 PsA (25 O-to-B) | 24 weeks | n.a. |
Glintborg B, 2017 [42] | Infliximab/CT-P13 | Registry-based study (DANBIO) | Denmark | PsA | 802 | 120 (92 O-to-B) | 1 year | n.a. |
Glintborg B, 2019 [33] | Etanercept/SB4 | Registry-based study (DANBIO) | Denmark | PsA | 2061 | 407 (351 O-to-B) | 1 year | n.a. |
Goll GL, 2019 [38] | Infliximab/CT-P13 | Extension of the NOR-SWITCH | Norway | Pso and PsA | 380 | 20 PsA (11 O-to-B) and 31 psoriasis (15 O-to-B) | 78 weeks | 17.3 (10.4) |
Jørgensen KK, 2017 [37] | Infliximab/CT-P13 | Randomized, non-inferiority, double-blind, phase 4 trial (NOR-SWITCH) | Norway | Pso and PsA | 482 | 30 PsA (16 O-to-B) and 35 psoriasis (17 O-to-B) | 52 weeks | 17·5 (10·5) |
Kilts U, 2022 [26] | Etanercept/SB4 and GP2015 | Retrospective chart review study | Germany | PsA | 100 | 19 (19 O-to-B-to-B) | 1 year | 9.7 (8.9) |
Kirsten N, 2022 [22] | Adalimumab/ABP501 | Registry-based study (German HSBest registry) | Germany | HS | 94 | 94 (94 O-to-B) | 14 weeks | n.a. |
Lauret A, 2020 [48] | Infliximab/CT-P13 and SB2 | Prospective, observational cohort study | France | PsA | 309 | 26 (22 O-to-B and 4 B-to-B) | 3 years | 7 ± 6 |
Loft N, 2021 [18] | Adalimumab/GP2017 and SB5 | Registry-based study (DERMBIO) | Denmark | Pso and PsA | 470 ** | 133 PsA (O-to-B) and 215 PsO (O-to-B) | 1 year | 30.6 (12.6) |
Montero-Vilchez T, 2022 [23] | Adalimumab/n.a. | Retrospective observational study | Spain | HS | 17 | 17 (17 O-to-B) | Evaluation every 12 weeks after switching | n.a. |
Morita A, 2022 [45] | Infliximab/CT-P13 | Prospective study | Japan | Pso and PsA | 165 | 165 (*** O-to-B) | 32 weeks | 18.5 ± 11.4 |
Nabi H, 2021 [20] | Adalimumab/GP2017 and SB5 | Registry-based study (DANBIO) | Denmark | PsA | 1318 | 321 (321 O-to-B) | 1 year | 13 (9–17) (GP2017) and 14 (9–20) (SB5) |
Nabi H, 2022 [36] | Infliximab/CT-P13 and GP1111 | Registry-based study (DANBIO) | Denmark | PsA | 1605 | 314 (70 B-to-B) | 1 year | 16 (12–25) |
Pescitelli L, 2019 [28] | Etanercept/SB4 | Prospective study | Italy | Pso and PsA | 44 | 32 (32 O-to-B) | 24 weeks | 27.34 + 12.13 (PsO) and 12.61 + 4.31 (PsA) |
Piaserico S, 2021 [27] | Etanercept/SB4 and GP2015 | Prospective, observational cohort study | Italy | Pso | 76 | 75 (75 O-to-B-to-B) | 12 months | n.a. |
Provenzano G, 2021 [46] | adalimumab, etanercept and infliximab/n.a. | Prospective study | Italy | PsA | 145 | 45 (14 O-to-B adalimumab) (28 O-to-B etanercept) (3 O-to-B infliximab) | 17.5 months (range 12–23) | n.a. |
Ricceri F, 2020 [19] | Adalimumab/SB5 | Retrospective study | Italy | HS | 11 | 11 (7 O-to-B) | 36 weeks | 15.6 ± 11.8 |
Roccuzzo G, 2022 [24] | Adalimumab/n.a. | Retrospective study | Italy | HS | 37 | 37 (37 O-to-B) | 12 months | n.a. |
Scherlinger M, 2018 [40] | Infliximab/CT-P13 | Prospective cohort study | France | PsA | 89 | 12 (O-to-B) | median follow-up of 33 weeks | 16.0 (9.9) |
Scrivo R, 2022 [25] | Adalimumab/ABP501 and SB5 | Prospective, observational cohort study | Italy | PsA | 150 | 65 (40 O-to-B and 25 B-to-B) | 4 months | n.a. |
Tweehuysen L, 2018 [43] | Infliximab/CT-P13 | Prospective, observational cohort study | The Netherlands | PsA | 192 | 50 (50 O-to-B) | 6 months | 13 (8–18) |
Tweehuysen L, 2018 [34] | Etanercept/SB4 | Prospective, observational cohort study (BIO-SPAN) | The Netherlands | PsA | 635 | 128 (128 O-to-B) | 6 months | 9 (4–16) |
Valido A, 2019 [44] | Infliximab/CT-P13 | Prospective, observational cohort study | Portugal | PsA | 60 | 8 (8 O-to-B) | 12 months | 16 (10–22) |
Drugs | First Author, Ref. n. | Main Outcomes | Main Results |
---|---|---|---|
ADA | Becciolini, [13] | Retention rate in naive patients and in switchers | The BIRRA study enrolled 1046 patients treated with adalimumab (193 patients switched from the originator to the biosimilar ABP 501). Among all switchers, 9 interrupted the treatment due to primary inefficacy, 8 due to secondary inefficacy, and 3 due to AEs. In the overall cohort of patients (RA, PsA, and axSpA), switchers were more persistent than patients receiving the originator and naïve patients receiving the biosimilar (88.0%, 81.5%, and 84.0%, respectively; p > 0.05) |
Bruni, [14] | Efficacy (ESR, RCP, VAS pain, patient fatigue VAS, HAQ, DAS28(ESR), DAS28(CRP), DAPSA) and safety (AEs) | Among PsA patients, at 6 months, no differences were found in efficacy markers compared to baseline. Most frequent AEs were infection and joint disease relapses, while no serious AE was recorded | |
Bruni, [15] | Efficacy (persistence on treatment with adalimumab biosimilar and predictors of drug interruption) and safety (AEs and prevalence) | The treatment persistence was considered satisfactory and the predictive factors of treatment discontinuation were found to be concomitant NSAIDs (HR 2.876, 95% CI 1.229–6.727, p = 0.015) or CCS (HR 3.209, 95% CI 1.193–8.635, p = 0.021) as baseline treatment. In total, 65 patients experienced at least one AE (1 serious), while 46 patients reported a loss of efficacy, resulting in 42 articular, 7 cutaneous, 5 gastrointestinal, and 3 ocular disease flares | |
Burlando, [21] | Treatment ineffectiveness | The incidence of ineffectiveness was 4.9 per 100 person-months (95% CI 3.6–6.3) for originators vs. 10.7 per 100 person-months (95% CI 8.3–13.5) for biosimilars. A greater loss of effectiveness was observed in the biosimilar group compared to the originator group (IRR = 2.2; 95% CI 1.5–3.2, p < 0.001) | |
Gallo, [16] | Efficacy (PASI and VAS) and safety (AEs) | No significant differences were observed in the PASI and VAS scores between the switch moment to the biosimilar and at the 3-month and 6-month follow-ups. VAS at 3 months from the switch was significantly higher compared to the switch moment only in the subgroup of patients with BMI > 25 (p = 0.04). Seven patients (9.6%) experienced mild expected AEs (recurrent candida cheilitis, asthmatic-like symptoms, asthenia, gastrointestinal symptoms, and pain at the injection site) | |
Di Cesare, [49] | Efficacy (PASI) and safety (AEs) | No changes in the PASI score were observed in 90% of patients who were switched from originators. In 20 patients, the loss of efficacy on cutaneous symptoms was reported. Six patients reported injection site reactions | |
Giunta, [17] | Efficacy (PASI, pain-VAS, ESR, CRP, DAS28-ESR) and safety (AEs) | In the cohort of switchers, the mean PASI was 0.45, 0.39, and 0.45 at week 16 before the switch, at the switch, and 24 weeks after the switch, respectively (no statistically significant differences). Similarly, no differences were observed in PsA patients in the mean DAS-28 ESR. No safety concerns were reported in the cohort of switchers. One patient switched back to the adalimumab originator at week 8 for primary inefficacy | |
Kirsten, [22] | Efficacy (IHS4 and HiSCR) and safety (AEs) | A total of 33% of patients (n = 31) experienced AEs or loss of response (defined as an increase in the HIS4 score of at least 50%) within 12 to 14 weeks after switching to the biosimilar. All AEs were mild and limited to injection site reactions, fatigue, and pruritus. Significant differences between t1 (switch) and t2 (12–14 weeks after the switch) were identified for the IHS4 score (p < 0.001) in both patient groups (with and without loss of efficacy) | |
Loft, [18] | The 1-year drug retention and risk of treatment discontinuation from all causes, AEs, lack and loss of effectiveness (PASI and Dermatology Life Quality Index) in the switchers cohort compared with the adalimumab originator cohort before the switch | No significant results (crude HRs) were found between switchers and non-switchers in terms of drug discontinuation for all causes, insufficient effect, or AEs. Twenty-nine patients in the switcher cohort (9.1%) and eighteen patients in the adalimumab originator cohort (5%) experienced AEs (p = 0.04) | |
Montero-Vilchez, [23] | Efficacy (HiSCR) and safety outcomes | After the switch, 4 patients had severe pain at the injection site, 4 patients experienced loss of the HiSCR response, 1 patient had pain and loss of response simultaneously, and 1 patient reported dizziness and nausea. Of these 10 patients, 8 switched back to the originator | |
Nabi, [20] | One-year treatment withdrawal, disease remission at 6 months, reasons for withdrawal, changes in disease activity at 6 months, and frequency of back-switch | No significant changes in disease activity were found 6 months before and after the switch. At 1 year, treatment withdrawal occurred in 8.5% of patients treated with GP2017 and 12.9% of patients receiving SB5. The main reasons of treatment discontinuation were the loss of efficacy and AEs. Patients who withdrew biosimilars were more commonly women, had higher disease activity, and had received fewer prior biologic therapies | |
Ricceri, [19] | Efficacy (IHS4, HS-PGA, HiSCR, DLQI) and safety (AEs) | No patient had to interrupt the treatment. After 36 weeks, the rates of clinical remission were similar to those before the switch. No statistically significant differences were found in the incidence of AEs before and after the switch | |
Roccuzzo, [24] | Efficacy (IHS4, HiSCR) and safety (AEs) | No significant differences were found between adalimumab originators and biosimilars in terms of the clinical response following nonmedical switch. At the 1-year follow up, 16 patients (43.2%) discontinued the treatment (8 due to treatment inefficacy, 5 due to severe injection site pain, and 3 for unspecified reasons) | |
Scrivo R, [25] | Efficacy (ESR, RCP, VAS pain, patient fatigue VAS, HAQ, DAS28(ESR), DAS28(CRP), DAPSA) and safety (AEs) | A total of 110 patients (40 with PsA) switched from the adalimumab originator to the SB5 biosimilar and 40 patients (25 with PsA) switched from the ABP501 biosimilar to the SB5 biosimilar. No differences were observed in disease activity scores for rheumatic diseases, even though PsA patients belonging to the first group experienced worsening pain [detected through the VAS (p = 0.02) and the HAQ (p = 0.03)] | |
ETA | Benucci M, [35] | Efficacy (ESR, CRP, IL-6, TNF, serum calprotectin MRP, DAS28, ASDAS, DAPSA, HAQ) and safety (drug levels, ADA, and AEs) | Out of 79 patients undergoing non-medical switching, 53 successfully completed the 12-months of follow-up of the study, while 26 patients interrupted SB4 treatment prematurely (19 cases of loss of efficacy of the drug and 7 cases of AEs, which included psoriasis, hypertension, cancer, and lower respiratory tract infection). Among naïve patients, 33 after 1 year were responders while 12 were non-responders (of these patients, 10 reported a loss of efficacy and 2 experienced AEs) |
Bonifati C, [32] | Efficacy (cDAPSA after 1 year and 6 months; 1-year and 6-month drug retention; reasons for SB4 discontinuation) and safety (AEs) | After 12 months from switching, 12.4% of patients failed to maintain a cDAPSA score ≤ 13. Three patients dropped out of the study during SB4 therapy after experiencing a flare of skin disease. After 6 months, 95.4% of patients still maintained a cDAPSA ≤ 13 score (difference not significant when compared to the baseline). After 6 months, 96.5% of patients were still taking SB4. Eleven patients failed to maintain a state of low disease activity at the end of the study. Loss of efficacy in the above subjects was determined on subjective evaluations given by patients | |
Bruni C, [31] | Efficacy (treatment persistence and reasons for drug discontinuation) and safety (AEs) | Fifty patients (19 with PsA) experienced at least one AE (including local injection site reactions and non-severe systemic AEs). At 6 months, SB4 treatment was stopped for safety issues in 2/212 patients (1 with RA and 1 with PsA). At the 12-month of follow-up, 15 patients (8 with PsA) interrupted SB4 treatment due to the loss of efficacy or other safety concerns. The probability of persistence on treatment at 6, 12, and 18 months was 99.1%, 88.6%, and 64.6%, respectively | |
Ditto MC, [29] | Efficacy (DAS28, DAPSA) and safety (AEs) | No significant differences in disease scores after the switch were found. Eleven patients (5 with PsA) stopped the treatment after the switch due to lack of efficacy, subjective features, and AEs | |
Felis-Giemza A, [30] | Efficacy (PsARC) and treatment discontinuation due to loss of efficacy or AEs | The study enrolled 168 patients, of which 162 underwent a switch from an etanercept originator to the biosimilars. The remaining 6 patients were biologic-naïve. In almost 85% of switchers, the biosimilar was well tolerated. Twenty-four patients switched back to the originator due to AEs or loss of efficacy. Nine patients reported the subjective loss of efficacy and worsening of general health condition. Thirteen patients reported AEs, most often headache, skin lesions, itchy rash, and exacerbation of skin psoriasis or flare of pustular psoriasis | |
Glintborg B, [33] | Efficacy (DAS28) and retention rate | No clinically relevant differences were found in disease activity and flare rates 3 months before and after the switch. During the follow-up (median 401 days), 18% of switchers and 33% of non-switchers withdrew the treatment, mainly due to the loss of efficacy. Among switchers, no major safety signals emerged. Switchers were less likely to withdraw from treatment than non-switchers (adjusted HR reported no statistically significant differences) | |
Kilts U, [26] | Efficacy (DAS28) and the physical function by using the ‘Funktionsfragebogen Hannover’ (FFbH) score, which strongly correlates with the HAQ | A total of 100 patients switched twice from the etanercept originator to SB4 and then to GP2015 (109 PsA). The retention rate 6 months after the second switch was 89%. Six patients discontinued due to inefficacy. Overall, 8 patients experienced 14 AEs, including pancreatic cancer, laboratory abnormalities, infectious complications, flulike symptoms, pneumonia, gingivitis, and suspicion of bone tuberculosis. No injection site reactions were documented | |
Pescitelli L, [28] | Efficacy (PASI and DAS 28) and safety (AEs) | Enrolled patients were divided in two cohorts: the first included patients who were switched from the originator to SB4 and the second that included naïve patients who started the treatment with SB4. In the first cohort, at 24 weeks, the clinical remission was confirmed in 92% of patients with psoriasis and 64% of patients with psoriatic arthritis. No statistically significant differences in terms of DAS 28 before and after the switch have been identified, while the PASI score improved significantly (p < 0.001). In the same cohort, 4 patients experienced injection site-reaction to SB4 | |
Piaserico S, [27] | Efficacy (PASI) and safety (AEs) | The median PASI was 10.5 at baseline, 2 after the first switch, and 0.5–1 after the second switch (12-month follow-up). Three patients showed a loss of response to SB4 and were switched to another biologic, while two patients developed a flare-up while they were receiving GP2015. One patient was switched back to SB4, with a PASI decrease to 1 in 3 months, while the other patient reported a relapse of psoriasis and arthritis 2 months after switching; he was prescribed secukinumab with control of the disease | |
Tweehuysen L, [34] | Treatment discontinuation, reasons for SB4 or ETN discontinuation, and differences in disease activity measurements over 6 months. Efficacy (CRP, DAS28-CRP) and safety (AEs) | For the BIO-SPAN study, two cohorts of patients were established: the transition cohort that included patients who consented to switch to SB4 and the historical cohort that included patients being treated with originators. At 6 months, the crude treatment persistence rate for SB4 and etanercept originator was 90% and 92%, respectively. During the same period, compared to the historical cohort, patients belonging to the transition cohort had a statistically significantly higher relative risk of treatment discontinuation (adjusted HR 1.57, 95% CI 1.05–2.36) and showed smaller decreases in the CRP level and DAS28-CRP over 6 months | |
INF | Boone NW, 2018 [41] | Efficacy (DAS28-ESR) and safety (AEs) | The study enrolled 125 patients. After 9 months, 5 patients with PsA were effectively being treated with infliximab biosimilar after a median number of three, four, and four infusions, respectively. No neutralizing antibody against infliximab was observed in different indications |
Dapavo P, 2016 [39] | Efficacy (PASI and VAS) and safety (AEs) | Thirty patients switched from infliximab originator (median treatment duration of 237 weeks) to the biosimilar. No changes in the PASI and VAS scores have been identified before and after the switch. In term of safety profile, 1 patient experienced herpes zoster and no other adverse events were observed | |
Gisondi P, 2020 [47] | Efficacy (PASI) and safety (AEs) | A total of 96 patients underwent a non-medical switch. No significant difference was found in the PASI score before and after the switch. Ten patients withdrew the treatment due to the loss of efficacy or acute infusion reactions | |
Glintborg B, 2017 [42] | Efficacy (DAS28 or ΔDAS28, HAQ, CRP) and safety (AEs) | A total of 802 patients who had previously treated with infliximab originator for >6 years were enrolled. Three months after the switch, no differences in disease activity (evaluated for 94 out of 120 PsA patients) were found. In the entire cohort of enrolled patients, 132 withdrew the treatment with CT-P13 due to lack of efficacy (n = 71), AEs (n = 37), remission or cancer (n = 5 each one), death (n = 2), more than one reason (n = 3), other reasons, including pregnancy and surgery (n = 8), and unknown (n = 1) | |
Goll GL, 2019 [38] | Efficacy (ΔDAS28, DAS28, ΔPASI, PASI, ESR, CRP, overall remission status based on the main composite measures, and study drug discontinuation) and safety (drug-level, ADA, and AEs) | Of the 438 patients who completed the NOR-SWITCH, 380 continued into this 26-week extension study (20 with PsA and 31 with PsO). Patients were divided in two groups: the switch group (those who received the originator in the main trial and switched to CT-P13 during the extension study) and the maintenance group (those who have been treated always with CT-P13). At the end of the study (week 78), 61.1% of patients in the maintenance group and 67.6% of patients in the switch group were in clinical remission. A similar number of patients in both groups reported at least one AE. The most frequent AEs were infections. Lastly, although the drug concentrations were similar in both the groups during follow-up, ADA was observed in 5 patients in the maintenance group and in 4 patients in the switch group | |
Jørgensen KK, 2017 [37] | Efficacy (DAS28, PASI, time to disease worsening, study drug discontinuation, overall remission status based on the main composite measures, changes in ESR and CRP, and DLQI) and safety (AEs, drug level, and ADA) | Out of 481 enrolled patients, 240 switched to CT-P13. The results highlighted that CT-P13 is not inferior to infliximab originator; disease worsening occurred in 26% of patients in the infliximab originator group and in 30% of patients in the CT-P13 group (adjusted risk difference −4.4%, 95% CI—12.7–3.9%). AEs occurred in 70% of patients in the infliximab originator group vs. 68% of patients in the CT-P13 group (mainly infections in both groups). Drug discontinuation occurred in 4% of patients in the infliximab originator group vs. 3% of patients in the CT-P13 group. Drug levels were similar in the two groups during follow-up while ADA was observed in 11% of patients in the infliximab originator group and 13% of patients in the CT-P13 group | |
Lauret A, 2020 [48] | Immunogenicity, development of ADA, and retention rate | Patients were divided in two cohorts: cohort-1 whose patients were switched to CT-P13 (n = 265) and then to SB2 (n = 140); cohort 2 that included biologic-naive patients initiated with CT-P13 before being switched to SB2 (44 patients, of whom 29 switched to SB2). Over the 3-year observation period, the development of ADA was detected in 20 patients of cohort 1 (8.5%) vs. 11 patients of cohort 2 (25%). The risk of treatment discontinuation was significantly higher in patients with positive ADA in both cohorts | |
Morita A, 2022 [45] | Efficacy (PASI, DLQI, DAS28-CRP) and safety (AEs) | Overall, the treatment with CT-P13 was associated with an excellent efficacy profile, confirmed both in patients naïve to biologics, those who switched from the originator, and patients switched from other biologics. A total of 44 AEs and 8 serious AEs were reported during the 1-year follow-up period (the most common AE was an infusion reaction that occurred in 11 patients). Only one case of pneumonia was reported. The incidence of infusion reaction was significantly lower in patients who switched than in naïve patients (OR = 0.43, 95% CI 0.08–2.42, p = 0.012) and significantly higher in patients who switched from other biologics than in naïve patients (OR = 19.7, 95% CI 1.33–291, p = 0.009). Comorbidities were associated with infusion reactions (OR = 41.6, 95% CI 1.87–923, p = 0.018) | |
Nabi H, 2022 [36] | 1-year GP1111 treatment retention, treatment withdrawal, changes in disease activity 4 months before and after the switch | At 1 year, 83% (95% CI: 81–85%) of the originator-naïve and 92% (95% CI: 90–95%) of switchers maintained GP1111 treatment. The main reasons for withdrawal were lack of efficacy (60% of naïve patients vs. 29% of switchers) and AEs (16% vs. 23%). The risk of GP1111 withdrawal was lower among switchers with PsA compared with naïve patients with PsA (HR = 0.23, 95% CI: 0.07 to 0.75). No statistically significant differences in disease activity were found 4 months before and after the switch | |
Scherlinger M, 2018 [40] | Retention rate of CT-P13 among switchers, acceptance of the switch, reasons for switch failure, and predictive factors of switch failure | A total of 89 patients (12 with PsA) switched to CT-P13. After a median of 33 weeks, 64 (72%) patients were still treated with CT-P13. Nine patients experienced AEs (4 cases of non-serious infections, 2 cases of infusion reactions, 2 cases of post-infusion mild headaches, and 1 case of mild serum-sickness-like disease) | |
Tweehuysen L, 2018 [43] | Change in disease activity at month 6 (DAS28-CRP, CRP level, and ESR), infliximab trough levels, ADA levels, and safety (AEs) | A total of 222 patients were enrolled, of whom 192 were switched to CT-P13. At 6 months, 47 patients (24%) discontinued CT-P13 due to a perceived lack of effect, AEs, or a combination of both. The majority of reported AEs (25/32) were categorized as subjective health complaints. The intent-to-treat analysis reported no differences in the mean DAS28-CRP in RA and PsA patients from baseline to month 6 (difference of 0.0 [95% CI −0.1, 0.2]). No differences in infliximab levels were found from the baseline (2.0 lg/mL) and month 6 (1.9 lg/mL) (p = 0.45). ADA were detected in 10% of patients at baseline and 7% of patients at month 6. A total of 141 patients (73%) experienced at least one AE. Serious AEs occurred in 9 patients and included 6 planned surgeries, 1 cardiovascular event, 1 pulmonary event, and 1 malignancy | |
Valido A, 2019 [44] | Efficacy (DAS28, ESR, CRP, PtGA, and PhGA) and safety (infliximab levels, ADA, and AEs) | Sixty patients (8 with PsA) switched to CT-P13 for non-medical reasons. For PsA patients, DAS28 changed from 2.2 at baseline to 0.96 at 12 months (variation 1.4). After switching, 5 patients stopped the treatment with CT-P13, of whom 3 patients due to disease worsening. Forty-two switchers had blood samples collected before and after the switch. No significant differences in ADA and infliximab level before and after the switch were detected | |
ADA, ETA, INF | Provenzano, [46] | Retention rate | Out of 145 patients who were switched to biosimilars, 123 were stable on clinical remission or had low disease activity while on therapy with biosimilars. Twenty-two patients, of whom 5 with PsA, discontinued the treatment with biosimilars. In particular, 7 patients discontinued the biosimilar because of disease reactivation (3 months after the switch), while 15 patients discontinued the biosimilar (8 ETA, 4 ADA, and 3 INF, 8 months after the switch) because of disease reactivation, patient death, or long-standing remission. The majority of these patients were switched to another biologic drug |
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Nicoletti, M.M.; Crisci, E.; Pentella, C.; Cantone, A.; Ruggiero, D.; Anatriello, A.; Scavone, C. Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies. Biologics 2023, 3, 95-115. https://doi.org/10.3390/biologics3020006
Nicoletti MM, Crisci E, Pentella C, Cantone A, Ruggiero D, Anatriello A, Scavone C. Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies. Biologics. 2023; 3(2):95-115. https://doi.org/10.3390/biologics3020006
Chicago/Turabian StyleNicoletti, Maria Maddalena, Erminia Crisci, Ciro Pentella, Andrea Cantone, Donatella Ruggiero, Antonietta Anatriello, and Cristina Scavone. 2023. "Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies" Biologics 3, no. 2: 95-115. https://doi.org/10.3390/biologics3020006