FRI0179 Comparison of tocilizumab as monotherapy or in combination with non-biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) and an inadequate response to anti-TNF agents:
Authors: A. Östör, J.A. Román Ivorra, J. Wollenhaupt, C. Mpofu, C. Bernasconi, J. Sibilia, V. Bykerk
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Monotherapy with a biological can offer an alternative treatment approach in RA patients (pts) for whom methotrexate (MTX) is not appropriate. In ACT-SURE, a phase 3b, 24-wk, prospective, open-label study in adult pts who had moderate to severe active RA and an inadequate response (IR) to current biological or non-biological DMARDs, tocilizumab (TCZ) monotherapy has shown safety and efficacy similar to those of TCZ+DMARD combination.<sup>1</sup> However, it is unknown whether biological monotherapy is appropriate for TNF-IR pts, who often have more refractory disease. <h3>Objectives</h3> To analyse safety and efficacy measures in pts who were TNF-IR and received TCZ monotherapy or TCZ+DMARDs in the ACT-SURE study. <h3>Methods</h3> In ACT-SURE, pts at academic/non-academic centres and in private practice settings who were DMARD-IR or TNF-IR received TCZ 8 mg/kg every 4 wks, alone or in combination with 1 or more DMARDs at the investigator's discretion. Analyses are presented in TNF-IR pts who received TCZ as monotherapy vs TNF-IR pts who received TCZ+DMARDs. <h3>Results</h3> Of 1,681 evaluable pts in the study, 706 were TNF-IR. Of these, 173 pts received TCZ monotherapy and 532 received TCZ+DMARD. 63% of the monotherapy pts and 30% of the TCZ+DMARD pts were IR to ≥3 TNF inhibitors. In pts on TCZ+DMARD, the most commonly used DMARD was MTX (78%; median weekly dose 17.5 mg), followed by leflunomide (12%), hydroxychloroquine (11%) and sulphasalazine (10%). Baseline DAS28 was similar in both groups (6.3, 6.0). Safety in monotherapy/add-on DMARDs was: withdrawal, 16%/17%; adverse event (AE), 82%/81%; serious AE, 10%/9%; AE leading to withdrawal, 7%/6%; infection, 39%/40%; serious infection, 3%/2%; AE during infusion; 6%/7%; neutrophil decrease &lt;1,000/mm<sup>3</sup>at least once, 1%/4%; ALT shift to &gt;1.5× upper limit of normal (ULN) at any time point, 11%/15%; AST shift to &gt;1.5× ULN at any time point, 2%/6%. At wk 24, efficacy end points were comparable between groups (Table). <h3>Conclusions</h3> In a setting close to real life, TCZ monotherapy was highly efficacious at wk 24 in a refractory TNF-IR population and comparable to TCZ+DMARDs. The safety profile was similar for both groups. The results suggest that TCZ monotherapy offers clinical benefit in pts who cannot tolerate MTX or in whom MTX is not appropriate. <h3>References</h3> Sibilia J et al. Ann Rheum Dis 2011;70(suppl 3):466. <h3>Disclosure of Interest</h3> A. Östör Consultant for: Roche, Chugai, Schering-Plough/MSD, Abbott, Wyeth/Pfizer, BMS, GSK, MerckSorono and UCB, J. Román Ivorra Consultant for: Pfizer, UMC, Actelion, J. Wollenhaupt Consultant for: Roche, Chugai, Speakers Bureau: Roche, Chugai, C. Mpofu Employee of: Roche, C. Bernasconi Consultant for: F. Hoffmann-La Roche Ltd, J. Sibilia Speakers Bureau: Roche, Chugai, V. Bykerk Grant/Research support from: Amgen, Pfizer, UCB, BMS, Roche, Abbott, Consultant for: Pfizer, BMS, UCB, Boehringer Ingelheim, Genentech