Adalimumab in ankylosing spondylitis: an evidence-based review of its place in therapy

Hennigan, Stephanie; Ackermann, Christoph; Kavanaugh, Arthur

doi:10.2147/ce.s7432

Cited by 2 publications

(3 citation statements)

References 41 publications

(40 reference statements)

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“…Comparison of the e cacy of biosimilar adalimumab injection with iADA injection based on ASAS 20, ASAS40, ASAS70, ASAS5/6, BASDAI50 response criteria, and global assessment of disease activity scores showed that the ndings are similar to that demonstrated in landmark studies of adalimumab. [11][12][13] The study ndings are also comparable to the results reported for other adalimumab biosimilars. Based on the primary e cacy analysis with respect to subjects achieving ASAS20 response criteria at visit 5 (week 6) and 8 (week 12), it was observed that the lower limits of the 95% CI for treatment difference was within the non-inferiority margin (i.e., 20% set for the study).…”

Section: Discussionsupporting

confidence: 84%

Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

Chandrashekara¹,

Parida²,

Sonawale

et al. 2023

Preprint

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Objectives To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. with innovator adalimumab (iADA, HUMIRA®) in subjects with active ankylosing spondylitis (AS). Methods The prospective, multicenter, randomized, double-blind, phase III study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e.,125 subjects in biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects received both the investigational products at a dose of 40 mg subcutaneously (pre-filled syringe contained 40 mg adalimumab in 0.4 ml as the active ingredient) every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, ECG, anti-adalimumab antibody (ADA) assessment, and laboratory tests. Results At 12 weeks, the ASAS 20/40/70 responses were achieved by 97.5%, 94.1%, and 68.9% patients who received biosimilar injection as compared to 98.4%, 96.7%, and 77% patients in iADA arm. Safety assessment showed that 19 (15.2%) subjects reported 33 AEs in the biosimilar adalimumab arm and 8 (11.9%) subjects reported 11 AEs in iADA arm. ADA for positive and negative subjects was statistically non-significant (P 0.3516) between the two arms. Conclusion The ASAS 20/40/70 response rates at week 12 were equivalent between patients treated with biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd and those treated with iADA. Both the drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry- India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration no: no. CTRI/2020/09/028070

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Section: Discussionsupporting

confidence: 84%

Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

Chandrashekara¹,

Parida²,

Sonawale

et al. 2023

Preprint

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“…All participants received subcutaneous injections of adalimumab (CinnoRA®, CinnaGen Co., Tehran, Iran) 40 mg/0.8 mL at the baseline and every 2 weeks during the study period. Adalimumab is an anti‐TNF medication with favorable effects in treating patients with AS 15,16 . In addition, patients in the control group (P) received a pamphlet covering information about AS and a set of illustrated exercises for managing AS.…”

Section: Methodsmentioning

confidence: 99%

“…Adalimumab is an anti-TNF medication with favorable effects in treating patients with AS. 15,16 In addition, patients in the control group (P) received a pamphlet covering information about AS and a set of illustrated exer-…”

Section: Study Interventions and Protocolsmentioning

confidence: 99%

The effects of supervision on the outcomes of exercise training in patients with ankylosing spondylitis: A single‐blind randomized controlled trial

et al. 2023

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Aim Exercise training is crucial for managing ankylosing spondylitis. We evaluated the effects of exercise with different levels of supervision on clinical outcomes in patients with ankylosing spondylitis. Methods We performed a single‐blind randomized controlled trial in a university outpatient clinic. Overall, 45 (31 men) patients with ankylosing spondylitis were randomly allocated to 3 groups. The mean (SD) for age and disease duration were 39.3 (9.3) and 8.4 (7.8) years. The primary outcome was chest expansion in cm, and the secondary outcomes were the index scores of 5 standard questionnaires. For each participant, adalimumab 40 mg/0.8 mL/2 wk was injected and a 3‐session exercise program per week for 1 month was prescribed. Controls received a pamphlet on the exercise program. Another group received the pamphlet and underwent a 2‐hour training session. The supervised group received the pamphlet, and the 2‐hour training, and completed the program by attending each exercise session in the clinic. Results Within‐group analysis showed significant improvement in chest expansion (P = 0.016) and all subjective or objective questionnaire scores (all P < 0.001) for the full‐supervised group. Between‐group analysis implied best outcomes for chest expansion (P = 0.046), Ankylosing Spondylitis Disease Activity Score (P < 0.001), Bath Disease Activity (P = 0.010), and Metrology (P = 0.002) Indices for ankylosing spondylitis. The group with 2‐hour training experienced an improvement in some indices, and the control group did not show significant changes in the outcomes. Conclusion We recommend the prescription of a supervised training program instead of in‐home exercises for patients with ankylosing spondylitis.

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Adalimumab in ankylosing spondylitis: an evidence-based review of its place in therapy

Cited by 2 publications

References 41 publications

Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

The effects of supervision on the outcomes of exercise training in patients with ankylosing spondylitis: A single‐blind randomized controlled trial

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