Project description

The clinical trial with the acronym RIVALS is a multicenter phase II study aimed at evaluating the efficacy and safety of ofatumumab – a fully human anti-CD20 antibody – compared with subcutaneous immunoglobulins (SCIG) in adult patients with idiopathic inflammatory myopathies (IIM) resistant to first-line treatment.

It is a randomized, parallel, two-arm head-to-head study conducted as an open-label trial with blinded outcome assessment, without a placebo group. Two active therapeutic strategies are compared, used as add-on treatment to standard of care (SoC): patients in the experimental arm receive ofatumumab administered subcutaneously at a dose of 20 mg, and patients in the comparison arm receive 20% human immunoglobulin with hyaluronidase administered subcutaneously at a dose of 2 g/kg body weight per month.

Idiopathic inflammatory myopathies are rare, severe autoimmune diseases with a multi-organ course, which if treated incorrectly, can lead to severe disability and shortened life. The current standard of treatment based on glucocorticosteroids and classic immunosuppressive drugs often proves insufficient or is associated with numerous iatrogenic complications. Ofatumumab, so far registered for the therapy of multiple sclerosis and aimed at eliminating B lymphocytes, which play a key role in the pathogenesis of IIM, represents an innovative alternative with a favorable safety profile and a convenient form of administration.

Immunoglobulins, on the other hand, which have so far been used as second-line treatment within the drug program (IVIG), in the subcutaneous form (SCIG) represent a modern form of the only therapy with proven efficacy in randomized trials in this group of patients. The choice of exclusively subcutaneous forms of therapy aims to improve patients’ quality of life by enabling treatment at home, limiting the necessity of hospitalization, and reducing systemic costs. Proving that ofatumumab is a drug with at least comparable efficacy and safety to immunoglobulins would allow for its introduction into the second-line treatment of IIM instead of IVIG, and as a result, improve the functioning efficiency of the healthcare system in Poland at the clinical, organizational, and economic levels.

The implementation of the study is planned in five specialized academic centers in Poland: in Lodz, Gdansk, Krakow, Wroclaw, and Warsaw, and will involve approximately 40 participants.