Extrapolation from Rheumatoid Arthritis Studies

If a biosimilar is highly similar to a reference medicine and has comparable safety and efficacy in one therapeutic indication, safety and efficacy data may be extrapolated to other indications approved for the reference medicine. This means that fewer clinical trials or no trials at all need to be carried out with the biosimilar in certain indications.

Extrapolation of data to other indications is always supported by scientific evidence generated in robust comparability studies (quality, non-clinical and clinical). For Hulio®, studies on Rheumatoid arthritis (RA) patients was used to extrapolate for other indications.1

Hulio® has been indicated in rheumatologic therapeutic areas such as RA, psoriatic arthritis, ankylosing spondylitis, juvenile Idiopathic arthritis. The recommended dose of Hulio® for adult patients with RA is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Hulio®.2

Pharmacokinetic Study

A randomized, double-blind, parallel-group, single injection study was done to assess the clinical pharmacokinetics.3

180 healthy subjects, aged 18-65 years, were randomized stratified by bodyweight, to receive a single subcutaneous injection of 40mg/0.8ml of Hulio®.3

Pharmacokinetics, local tolerability, immunogenicity and adverse events were assessed prior to and up to 64 days after treatment.3

The 90% confidence intervals (CI) for the results for average blood adalimumab level over time and maximum adalimumab concentration were within the range 0.80-1.25, indicating bioequivalence.3

ACR Score Response

ARABESC phase III clinical trial: Around 75% of patients achieved ACR 20 score at the end of week 244

ARABESC Open-label extension: Long-term results from the extension study show patients on Hulio® do similarly well, even when switching. These results indicate that switching patients from biologic to biosimilar adalimumab, or vice versa, maintains the clinical status of the patients.5

Clinical Studies on Rheumatoid Arthritis

ARABESC phase III clinical trial: A randomized, double-blind, multi-centre (105 sites in 12 countries), and 24-week study. It included 728 adult patients with moderate-to-severe active RA for at least 3 months, and taking MTX for at least 3 months: mean age 55.3 years; mean DAS28-CRP score 6.1; mean MTX dose 15.7mg/wk. Patients were randomised to receive Hulio® 40mg/0.8ml every other week plus methotrexate.4,5

ARABESC Open-label extension: 645 participants in ARABESC continued in an open label extension (ARABESC-OLE). This study is ongoing with interim assessment results available at Week 54. Patients were randomized 2:1 to stay with their original treatment or switch to the alternate treatment.6

The primary efficacy endpoint was the ACR20 response rate at Week 24 (defined as a 20% improvement in tender joint count and swollen joint count, and in at least 3 of the other 5 core elements).

and Risks

One of the major benefits of Hulio® is that it has shown considerable improvement in the symptoms of RA when the initial treatment with other drugs have failed.2

The risk associated with Hulio® involves adverse reactions such as infections (nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.5

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Report side effects

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events.

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