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Observational Study
. 2019 Jul;78(7):979-987.
doi: 10.1136/annrheumdis-2018-214816. Epub 2019 Apr 9.

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Muriel Elhai  1 , Marouane Boubaya  2 , Oliver Distler  3 , Vanessa Smith  4   5 , Marco Matucci-Cerinic  6 , Juan José Alegre Sancho  7 , Marie-Elise Truchetet  8 , Yolanda Braun-Moscovici  9 , Florenzo Iannone  10 , Pavel I Novikov  11 , Alain Lescoat  12 , Elise Siegert  13 , Ivan Castellví  14 , Paolo Airó  15 , Serena Vettori  16 , Ellen De Langhe  17 , Eric Hachulla  18 , Anne Erler  19 , Lidia Ananieva  20 , Martin Krusche  21 , F J López-Longo  22 , Jörg H W Distler  23 , Nicolas Hunzelmann  24 , Anna-Maria Hoffmann-Vold  25 , Valeria Riccieri  26 , Vivien M Hsu  27 , Maria R Pozzi  28 , Codrina Ancuta  29 , Edoardo Rosato  30 , Carina Mihai  31 , Masataka Kuwana  32 , Lesley Ann Saketkoo  33 , Carlo Chizzolini  34 , Roger Hesselstrand  35 , Susanne Ullman  36 , Sule Yavuz  37 , Simona Rednic  38 , Cristian Caimmi  39 , Coralie Bloch-Queyrat  40 , Yannick Allanore  41 ; for EUSTAR network
Collaborators, Affiliations
Observational Study

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Muriel Elhai et al. Ann Rheum Dis. 2019 Jul.

Abstract

Objective: To assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice.

Methods: We performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab.

Results: 254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47-5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55-1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56-3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83-9.62]; p=0.019 as compared with controls vs 3 [0.66-5.35]; p=0.012).

Conclusion: Rituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.

Keywords: lung fibrosis; rituximab; skin fibrosis; systemic sclerosis.

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Conflict of interest statement

Competing interests: OD has consultancy relationship with Actelion, Bayer, BiogenIdec, Boehringer Ingelheim, ChemomAb, espeRare foundation, Genentech/Roche, GSK, Inventiva, Italfarmaco, Lilly, medac, MedImmune, Mitsubishi Tanabe Pharma, Pharmacyclics, Novartis, Pfizer, Sanofi, Sinoxa and UCB in the area of potential treatments of scleroderma and its complications. OD has received research funding from Actelion, Bayer, Boehringer Ingelheim, Mitsubishi Tanabe Pharma and Roche in the area of potential treatments of scleroderma and its complications. In addition, OD has a patent mir-29 for the treatment of systemic sclerosis licensed. M-ET has received consulting fees, speaking fees or honoraria from Abbvie, BMS, Lilly, Medac, MSD, Pfizer, Roche and UCB. PA has received travel expenses from Roche (<2500€). SV received speaking fees by Pfizer, Abbvie, Bristol-Myers Squibb, consultant fee from Thermofischer and Boehringer-Ingelheim Italia and Educational support from Pfizer, Roche, BMS. EH has received speaker fees and/or honoraria for consultations from Roche, less than 10 000€. NH received lecture fees from Actelion Pharmaceuticals, Pfizer, Roche and grant support from Actelion and Bayer Pharmaceuticals. CM has/had consultancy relationship and/or has received honoraria from Actelion, Abbvie, Roche and Geneva Romfarm in the area of systemic sclerosis and its complications. CC has received travel grants from Roche. YA has/had consultancy relationship and/or has received grants from Actelion, Bayer, BMS, Boehringer-Ingelheim, Inventiva, Roche, Sanofi-Aventis in the area of systemic sclerosis.

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