Background/Purpose: There is evidence for a critical role of B cells in the pathogenesis of pSS. Both open labelled and small controlled studies suggested the efficacy of Rituximab (RTX) in specific subgroups of pSS (early or systemic).We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of RTX in a large group of patients with active recent and/or systemic pSS.

Methods: 122 Patients were assigned to receive either RTX infusions (1g) or placebo (P) at weeks 0 and 2. They were followed up for 24 weeks. All patients fulfilled the new American-European Consensus Group criteria for pSS, had an active disease as assessed by mean values of the 2 highest visual analog scales (VAS) ≥50 evaluating dryness, pain, fatigue and global, and had either a recent (less than 10 years since first clinical sign) and a biologically active pSS [Auto antibodies (SSA or RF) or cryoglobulinaemia, or hypergammaglobulinaemia, or high level of beta 2-microglobulinemia or hypo-complementaemia] or at least one extra-glandular manifestation. The primary end point was an improvement of at least a 30 mm on 2 of 4 VAS between weeks 0 and 24. Secondary end points included delta of improvement of all VAS separately, the ESSDAI score, the number of swollen joints, the basal salivary flow rate, results of the Schirmer test, the schirmer score, biological and extra glandular improvement, evaluated from week 0 to week 24.

Results: 24 of 122 patients (19.5%) had a recent pSS, 31 (25.4%) had systemic pSS and 67 (54.9%) had both. 33 (28%) had pulmonary manifestations, 63 (53%) an articular involvement and 33 (28%) a parotidomegaly. 113 patients were evaluated at week 24. For primary end point, 11/53 (20.7%) patients receiving placebo and 13/60 (21.7%) treated with RTX had a favourable overall response (P = 0.9). Similarly, the 30 points improvement for each VAS separately did not reach significance, although the delta of improvement of sicca and fatigue VAS were statistically improved in RTX group (P<0.05). Delta improvement between W24 and W0 was significant for the salivary flow rate (p:0.009) but not for other objectives variables (Schirmer, focus score, Chisholm score). Concerning systemic manifestations, the ESSDAI score (total and each domain) was not significantly improved in the RTX group. For synovitis, only 2/24 patients of the P group and 4/25 of the RTX group were improved. The difference between RTX and P group at W24 did not differ in terms of primary end point or ESSDAI in the recent and systemic subgroups evaluated separately. Tolerance was similar in both groups excepted for reaction to infusion, more frequent in the RTX group.

Conclusion: In this randomized, double blind, placebo controlled study, the efficacy of RTX, was not sufficient enough to allow its prescription in both recent and systemic pSS. Studies in specific unfrequent manifestations (thrombopenia, neurological disorders) or using more specific measurement tools (parotid ultrasound) are warranted.

---

« Back to 2012 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/tolerance-and-efficacy-of-rituximab-in-primary-sjogren-syndrome-final-results-of-a-randomized-controlled-trial/