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In HBeAg-negative chronic hepatitis B patients treated with peginterferon alfa-2a, HBsAg decline >10% at 24 weeks is significantly associated with SR. The combination of the PARC rule and week 24 decline in HBsAg can identify almost two-thirds of patients who are unlikely to achieve SR. Clinicaltrials.gov identifier: NCT01283074.

A pre-treatment scoring system using readily available baseline characteristics identifies HBeAg-positive Asian patients likely to experience sustained HBeAg seroconversion after treatment with peginterferon alfa-2a.

Summary What is known and objective The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head‐to‐head comparisons between these treatments do not exist. Thus, a network of multiple‐treatments meta‐analysis was performed using four clinical outcomes: ‘patients free of relapse’, ‘patients without disease progression’, ‘patients without MRI progression’ and ‘patients with adverse events’. Methods Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m2) using direct and indirect analyses. Results and discussion The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex (‘patients free of relapse’ and ‘patients without MRI progression’) and for Betaferon compared with Avonex (‘patients without disease progression’ and ‘patients without MRI progression’). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: ‘patients free of relapse’ and ‘patients without MRI progression’. Regarding ‘patients with adverse events’, no data were available for all comparisons to make fair inferences. What is new and conclusion This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head‐to‐head comparisons between treatments.

The first anticancer biosimilars have entered clinical use, with many others under clinical development. Like all biologics, biosimilars may elicit unwanted immune responses that can significantly impact clinical efficacy and safety. Head-to-head immunogenicity assessment of biosimilars and their reference biologics should, therefore, be a critical component of a biosimilar's clinical development program. Various bioanalytical platforms may be used to detect and characterize immune responses, each having relative strengths and weaknesses. To fully recognize the clinical relevance of such data, regulators must be able to interpret immunogenicity results in an assay-specific context as well as in perspective of clinical pharmacology, efficacy and safety. Herein, we discuss current challenges imposed by global regulatory requirements for immunogenicity assessment of biosimilars.