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Study Confirms Safety and Efficacy of Adalimumab Biosimilar HS016 in IBD


A China-based study where data were collected from patients with inflammatory bowel disease (IBD) showed safety and efficacy of the adalimumab biosimilar HS016.

Digestive tract | Image Credit: sdecoret - stock.adobe.com

Image Credit: sdecoret - stock.adobe.com

A real-world study from China, published in Front Pharmacol, concluded the use of adalimumab biosimilar HS016 is as safe and effective as reference adalimumab (Humira) in patients with inflammatory bowel disease (IBD).

Existing studies compare infliximab to adalimumab, proving the benefits patients with IBD receive. Additionally, traditional treatment methods such as 5-aminosalicylic acid, glucocorticoids, and immunosuppressants have not been entirely successful among patients.

This analysis is the first to be conducted in China for patients with IBD based on the efficacy of HS016, confirming the safety, effectiveness, and similarities to the original adalimumab. The study results could aid in the expansion of biosimilar treatment options for Chinese patients diagnosed with IBD.

Biological therapy medications such as monoclonal antibodies or inhibitors, tumor necrosis factor (TNF)-α, interleukin (IL)-12/23, adhesion molecules, and Janus kinase (JAK)inhibitors are considered forms of treatment for patients with IBD. TNF-α is an important treatment in developing the inflammatory responding process as anti–(TNF)-α modifies diseases, heals the mucosal, while reducing risk of hospitalization, colectomy, and colorectal cancer in IBD patients.

(TNF)-αinhibitors bind with serum (sTNF-α) or on immune cell membranes (mTNF-α) to function as a biological agent. Anti–(TNF)-α products have become standard among all biologics, along with infliximab and the subcutaneous injection of adalimumab.

Researchers utilized therapeutic drug monitoring (TDM) to assess the safety and efficacy of HS016. TDM is a reliable tool for the management and optimization of anti–(TNF)-α agents, as well as measuring serum and anti-drug antibody concentrations. The adalimumab biosimilar HS016 acts as a biological agent with similar effects to adalimumabregarding quality, efficacy, and safety while allowing widespread accessibility with the potential of cost effectiveness.

The study included91patients with IBD (CD: n = 75; UC, n = 16), who were treated with HS016 atXijing Hospitalin China to be treated from October 2020 to April 2022. A total of 77 (CD: n = 61; UC: n = 16) patients completed the 52-week follow-up.

Of those in the CD group, 14 patients were in clinical remission at baseline and 61 had active disease. The mean age of the cohort was 30.5 years in the remission CD group, 33 years in the active CD group, and 40.5 yearsin the UC group. Most participants in all groups were male (remission CD: 71.4%; active CD: 67.2%; UC: 68.8%).Considerable factors in patients included disease duration, previous medications, disease typing, extraintestinal manifestations, complications of IBD, and previous surgical history.

Patients treated with the adalimumab biosimilar HS016 were administered a 160 mg dose at baseline, 80 mg dose at week 2, 40 mg dose every other week, and in the event of insufficient efficacy, the dose was increased to 40 mg per week based on the physicians’ judgement.

The efficacy assessment of HS016 is determined using the Harvey-Bradshaw Index (HBI) and Simplified Endoscopic Score for Crohn Disease while UC is determined by partial Mayo score (pMS). Patients with CD aimed for a score of less than or equal to 4 points, marking remission based on HBI while the pMS defines a score of less than or equal to 2 as remission.

Study results conveyed the patients with CD achieved the clinical response of 75.4% (n = 46) at 12 weeks, 73.8% (n = 45) at 26 weeks, and 50.8% (n = 31) at 52 weeks. Data of patients with CD reaching clinical remission was at 55.7% (n = 34) at 12 weeks, 65.6% (n = 40) at 26 weeks, and 45.9% (n = 28) at 52 weeks. Remission rates were maintained for 100% of patients at 12 weeks, 78.6% at 26 weeks, and 63.6% at 52 weeks (n = 14, 11, and 7, respectively). The clinical response of patients with UC achieved 37.5% (n = 6) at 12 weeks and 50% (n = 8) at 26 weeks.

Regarding safety, 3 participants experienced psoriasis-like rashes and 2 cases of fungal otitis externa. A large rash on the forehead and back developed in 1 patient afterinitial treatment. Following the 12 and 52-week mark, 2 patients presented symptoms of scattered rashes on their extremities. The researchers noted that the occurrence of adverse events was in line with previous data on the use of Humira in a similar patient population.

The authors concluded, “As research continues, we are confident that increasing biological agents will appear for IBD therapy. Additionally, biosimilars will stimulate competition in the market and have incredible potential to expand patient exposure to biologics in the context of treatment recommendations. Appropriate use of TDM will provide physicians with a more significant basis for selecting and optimizing treatment.”


Wang F, Li X, Shi Y, et al. Efficacy and safety of adalimumab biosimilar (HS016) in inflammatory bowel disease from the real-world study. Front Pharmacol. 2023;14:1259183. doi:10.3389/fphar.2023.1259183

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