FRI0302 SAFETY AND EFFICACY OF RITUXIMAB BIOSIMILAR IN SYSTEMIC SCLEROSIS: AN ITALIAN MULTICENTER STUDY
Authors: Corrado Campochiaro, Giacomo De Luca, Maria Grazia Lazzaroni, Silvia Laura Bosello, Maria De Santis, Adriana Cariddi, Carlo Selmi, Elisa Gremese, Paolo Airò, Marco Matucci-Cerinic, Lorenzo Dagna
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> recent data support the use of rituximab(RTX) in Systemic Sclerosis(SSc). RTX biosimilar(RTX-B) offers a more affordable option but its efficacy and safety have not yet been evaluated. <h3>Objectives</h3> To assess the safety and efficacy of RTX-B in SSc. <h3>Methods</h3> Data about SSc patients treated with RTX-B(1gr repeated after 2 weeks) and with a follow-up ≥6 months were retrospectively collected from 5 Italian centres. Both SSc patients naïve to RTX(RTX-Bn) or already treated with ≥1 course of RTX originator(RTX-O) and switched to RTX-B(RTX-Bs) were considered. A comprehensive assessment of disease features and organ involvement was available at baseline and at final follow-up for all patients. Non parametric tests were used. <h3>Results</h3> Data of 21 SSc patients(20 female, mean age 50.5±11.8 years) were collected;mean disease duration at RTX-B therapy was 7.6±4.8 yrs. Eleven patients(52%) had diffuse cutaneous SSc(dcSSc), 12(57%) were anti-topoisomeraseI+, 5 anti-RNA-polymeraseIII+ and 4 anti-centromere+. Twelve patients(57%) were RTX-Bn and 9 RTX-Bs(43%). In RTX-Bs patients, the median number of previous RTX-O courses was 3(range 1 – 8). RTX was decided because of skin progression in 11(52%), interstitial lung disease(ILD) worsening in 9(43%), arthritis in 6(29%), myocarditis and myositis in 1 patient each. All patients had been previously treated with immunosuppressants: mycophenolate mofetil(MMF) 14(67%), methotrexate(MTX) 7(33%), cyclophosphamide 6(29%), azathioprine 4(19%), tocilizumab and etanercept 1(5%) patient each. At RTX-B introduction, 14(67%) patients were on concomitant immunosuppressant: 10(48%) MMF and 4(19%) MTX; 15 patients(71%) were also on steroids(mean dose:3.1±2.1mg/day). At 6 months after RTX-B treatment, a significant reduction of the modified Rodnan skin score(mRSS), DAS28 and erythrocyte sedimentation rate(ESR) was observed in the entire cohort (p&lt;0.001,p&lt;0.028,p&lt;0.003, respectively); mRSS was significantly reduced also in RTX-Bn(p&lt;<b>0.011)</b> and RTX-Bs patients(p&lt;<b>0.046</b>)(Table 1). No significant changes were observed for lung function tests. Only 1 RTX-Bs patient experienced a transient neutropenia 3 months after the 2<sup>nd</sup> RTX-B infusion whilst also on MTX. Conclusion: in agreement with previous data published on RTX-O, also RTX-B seem efficient in improving skin and joint involvement and in stabilizing lung function, either in RTX-Bn and in RTX-Bs SSc patients. <h3>Reference:</h3> [1] JordanS,et al.AnnRheumDis.2015;74(6):1188-94. <h3>Disclosure of Interests</h3> Corrado Campochiaro Consultant for: Dr Corrado Campochiaro received consultation honoraria from Pfizer., Giacomo De Luca Consultant for: Dr Giacomo De Luca received consultation honoraria from Pfizer and SOBI., Maria Grazia Lazzaroni: None declared, Silvia Laura Bosello: None declared, Maria De Santis: None declared, adriana cariddi: None declared, Carlo Selmi Grant/research support from: AbbVie, Janssen, MSD, Novartis, Pfizer, Consultant for: AbbVie, Alfa-Sigma, Biogen, Bristol-Myrs Squibb, Celgene, Eli-Lilly, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Speakers bureau: AbbVie, Alfa-Sigma, Biogen, Bristol-Myrs Squibb, Celgene, Eli-Lilly, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Elisa Gremese Consultant for: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, and Pfizer, Speakers bureau: BMS, Speakers bureau: Roche, Speakers bureau: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, and Pfizer, Paolo Airò: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Pfizer, BMS, Chemomab, Sanipedia, Speakers bureau: Actelion, BMS; MSD, Janssen, Lorenzo Dagna Consultant for: Prof Lorenzo Dagna received consultation honoraria from Abbvie, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Novartis, Pfizer, Sanofi-Genzyme, and SOBI.