New adalimumab formulation associated with less injection site pain and improved motivation for treatment

Yoshida, Tomohiko; Otaki, Yasuhiro; Katsuyama, Naooki; Seki, Michiko; Kubota, Junko

doi:10.1080/14397595.2018.1520426

Cited by 17 publications

(10 citation statements)

References 6 publications

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“…In the current study, significantly decreased ISP was reported with FKB327 compared with CCF-RP, which may be due to the citrate buffer that is present in CCF-RP but not in FKB327, as an association between citrate buffer and ISP has been demonstrated previously [9]. Results have shown that a citrate-free formulation of the RP was associated with significantly decreased ISP [29,30]. Therefore, the results of the current study support previous findings demonstrating an association between a decreased level of ISP and citrate-free formulations.…”

Section: Multiple-dose Studiessupporting

confidence: 63%

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Alten¹,

Kellner²,

Boyce³

et al. 2020

GaBI J

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Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in safety profile, efficacy and immunogenicity. FKB327 formulation excipients differ from the citrate-containing formulation of the reference product, and injection-site pain differences have been reported. The current analysis examines pooled data to assess the amount of injection-site pain resulting from injecting FKB327 using a prefilled syringe, autoinjector, or vial/syringe versus the reference product. Methods: Data from four studies were pooled to compare injection-site pain upon subcutaneous administration of FKB327 versus the reference product. Pooled data were analysed to compare FKB327 with the reference product and to compare the autoinjector, pre-filled syringe and vial/syringe. Results: Data were analysed from 2007 assessments in 1,001 subjects. A linear mixed model of the injection-site pain visual analogue scale score across all studies showed a 12.6-point lower pain score for FKB327 versus the reference product (95% confidence interval, –14.3 to –10.8; p > 0.001). The autoinjector pain score was 4.4 points lower than the vial/syringe (95% confidence interval, –5.9 to –2.8; p > 0.001) and 1.7 points lower than the pre-filled syringe (95% confidence interval, –3.3 to –0.1; p = 0.035). No statistically significant differences were identified for gender, age, body weight, needle gauge, or injection site. Conclusion: FKB327 showed less injection-site pain compared with the reference product. No statistically significant differences were seen in injection-site reactions or related adverse events between FKB327 and the reference product or among FKB327 injection methods.

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Section: Multiple-dose Studiessupporting

confidence: 63%

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Alten¹,

Kellner²,

Boyce³

et al. 2020

GaBI J

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“…Studies have shown that in patients with subcutaneous injection stimulating pain, VAS scores can reach more than 7 points. 30 In this study, a significant proportion of patients with positive pain at the injection site experienced moderate or higher pain. In addition to acute pain, deep fascia lesions might also trigger pain sensitivity and CPSP.…”

Section: Discussionmentioning

confidence: 62%

<p>Ultrasound-Guided Transversus Abdominis Plane Block for Cesarean Delivery: Injection Site Pain as a New Complication and Dexamethasone Reduced Incidence</p>

Liu

Zhou²,

Xue

et al. 2020

JPR

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Background: Although ultrasound-guided transversus abdominis plane block (TAPB) is widely used in multimodal analgesia after cesarean delivery (CD), the complications of TAPB during analgesia after CD have rarely been reported. Methods: A total of 84 cases of CD were randomly assigned to either a ropivacaine group (R group) or ropivacaine + dexamethasone group (RD group) in this double-blind trial. The pain site and pain degree at rest and during activity at 2 h, 6 h, 10 h, 12 h, 14 h, 16 h, 20 h, and 24 h after maternal surgery were recorded. The consumption of opioids at 24h, postoperative nausea, vomiting, exhaustion, and other adverse reactions were recorded. Results: A total of 80 patients were included in the analysis of results. A total of 19 patients developed ISP, 14 in the R group and 5 in the RD group. The incidence of ISP in the R and RD groups was 35% and 12.5%, respectively. The results described above showed that combining dexamethasone with ropivacaine reduced the incidence of ISP, and the difference was statistically significant (P<0.05). Two groups of women with positive ISP had higher values of opioid consumption than women with negative ISP, but the difference was not significant. Conclusion: Dexamethasone as an adjuvant for ropivacaine can effectively relieve the ISP of ultrasound-guided TAPB after CD, and can enhance the analgesic effect of ropivacaine.

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“…In this study, we compared a 100-mg/mL, citrate-free formulation of proposed biosimilar AVT02 with recent batches of reference originator adalimumab product. The 100-mg/mL, citrate-free originator adalimumab is the most current formulation, one that augments the administration of originator adalimumab by reducing injection pain [ 10 , 20 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study

Feldman

Reznichenko²,

Pulka

et al. 2021

BioDrugs

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Background AVT02 (adalimumab) is a proposed biosimilar to Humira ® . AVT02 is produced at a 100 mg/mL concentration with a citrate-free formulation. Objectives The aim of this study was to compare the efficacy, safety and immunogenicity of AVT02 versus Humira ® in subjects with moderate to severe chronic plaque psoriasis. Methods This double-blind, randomised, parallel group, active control study of adult subjects compared (at a 1:1 ratio) AVT02 with originator adalimumab 80 mg subcutaneously in Week 1, then 40 mg every other week. At Week 16, subjects who had received originator adalimumab were re-randomised at a 1:1 ratio to continue receiving originator adalimumab, or to switch to AVT02, every other week until Week 48, with final efficacy endpoint at Week 50. Subjects who initially received AVT02 continued to receive AVT02 from Week 16 to Week 48. The primary endpoint was percentage improvement in Psoriasis Area and Severity Index (PASI) score at Week 16. Secondary efficacy endpoints included percentage improvement in PASI score at additional timepoints, change from baseline in Dermatology Life Quality Index (DLQI) score and number and percentage of subjects achieving static Physician’s Global Assessment (sPGA) responses of ‘clear’ or ‘almost clear’. Additional secondary endpoints included comparison of adverse event profiles, anti-drug antibodies and neutralising antibodies, and serum trough levels of adalimumab at steady state. Results A total of 413 subjects were randomised (205 to AVT02 and 208 to originator). The percentage improvement in PASI score at Week 16 was 91.6% for AVT02-treated subjects and 89.6% for originator adalimumab. The 90% confidence intervals for the primary endpoint were within the pre-defined equivalence margin of ±10% (90% CI − 0.76 to 5.29; 95% CI − 1.34 to 5.88), and a comparable pattern for DLQI score (11.4-point and 10.6-point improvement in AVT02-treated and originator adalimumab-treated groups, respectively) and sPGA (90.5% in both groups achieving ‘clear’ or ‘almost clear’) at Week 16 supported the assessment. Efficacy persisted through Week 50 of the study in all treatment groups, including those who switched from originator adalimumab to AVT02, for percent improvement in PASI score, quality-of-life assessment and sPGA. The safety, tolerability and immunogenicity profiles between AVT02 and originator adalimumab were similar at Week 16, and this persisted in the switched and continued groups through Week 50. Conclusion Objective and subjective measures of efficacy supported the evaluation of biosimilarity between AVT02 and originator adalimumab at Week 16 and until Week 50, in switched and continued treatment groups. AVT02 was safe and well tolerated, with a safety and immunogenicity profile similar to that observed in originator adalimumab with no clinically meaningful difference between the ...

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New adalimumab formulation associated with less injection site pain and improved motivation for treatment

Abstract: The new ADA formulation may alleviate the burden on RA patients and improve the quality of adherence to treatment, thereby influencing the RA treatment outcomes.

Cited by 17 publications

References 6 publications

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

<p>Ultrasound-Guided Transversus Abdominis Plane Block for Cesarean Delivery: Injection Site Pain as a New Complication and Dexamethasone Reduced Incidence</p>

Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study

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