ACR Congress Review 2019

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from baseline in DAS28-4(CRP) versus placebo was observed in PF-06650833 60 mg, 200 mg, and 400 mg QD groups at Week 12 (P
Safety, efficacy and PROs with a tofacitinib modified-release formulation in RA Results of the open-label phase of the ORAL Shift study were presented by Cohen and colleagues. This Phase 3b/4 study compared the efficacy and safety of tofacitinib modified-release 11 mg QD with and without MTX in patients with RA who had achieved LDA with tofacitinib and MTX. Patients with moderate-to-severe RA and an inadequate response to MTX received open-label tofacitinib modifiedrelease 11 mg QD with MTX (tofacitinib + MTX) for 24 weeks. Patients achieving LDA (CDAI≤10) at week 24 entered the 24-week double-blind MTX withdrawal phase and were randomised 1:1 to receive tofacitinib modified release 11 mg QD with placebo (tofacitinib monotherapy) or continue tofacitinib + MTX. In the open label phase, DAS28-4(ESR) improved with mean changes from baseline of ‐1.96 and -2.67 at Week 12 and Week 24, respectively. Improvements from baseline were observed for all other efficacy outcomes and PROs at these timepoints. <strong>ACR</strong>20/50/70 and HAQ-DI response rates, and LDA and remission rates, improved from Week 12 to Week 24. AEs, SAEs, and discontinuations due to AEs were reported by 52.2%, 2.9%, and 5.9% of patients, respectively; no deaths were reported. AEs of special interest each occurred in ≤1% of patients. The authors concluded that efficacy and safety in the open label phase appeared consistent with that of tofacitinib immediate-release 5 mg BID and with the double-blind phase of ORAL Shift [1412*]. Strand and colleagues presented SF-36 data from double-blind phase of the ORAL Shift study. A total of 530 patients achieved LDA at Week 24 and were treated in the double-blind phase (tofacitinib monotherapy: n=264; tofacitinib + MTX: n=266). Mean changes from baseline to Week 24 showed improvements in SF-36 PCS, MCS, and all domain scores. LSM changes from Week 24 to 36 and 48 in SF-36 PCS, MCS, and all domain scores (except Role Physical and Bodily Pain at Week 36) were similar in both treatment arms. These findings reinforce that patients receiving tofacitinib modified release 11 mg QD plus MTX who achieve LDA, may withdraw MTX up to Week 48 without significant worsening of PROs [1377]. Tofacitinib efficacy in RA patients with early versus established disease Takeuchi and colleagues presented findings from a post-hoc analysis of ORAL Strategy evaluating the efficacy and safety of tofacitinib monotherapy, tofacitinib plus MTX and adalimumab plus MTX, stratified by baseline RA duration. A total of 241 patients had early RA (≤2 years duration) and 905 patients had established RA (>2 years duration). <strong>ACR</strong>50 and ΔDAS28-4(ESR) were generally similar for tofacitinib monotherapy and tofacitinib plus MTX up to Month 12 in early RA but were significantly greater with tofacitinib plus MTX in established RA (P
Page 1 and 2: Enhancing knowledge of the clinical
Page 3 and 4: Highlights from ACR 2019 During the
Page 5 and 6: In summary, individually, high base
Page 7 and 8: treatment with MTX. A total of 1629
Page 9 and 10: Individual and composite measures o
Page 11: Upadacitinib in axial spondylarthri
Page 15 and 16: Impact of BMI on tofacitinib safety
Page 17 and 18: Patient-reported outcomes with JAK
Page 19 and 20: Update on JAK inhibitor safety data
Page 21 and 22: In the first presentation, the anal
Page 23 and 24: References Bergman M, Tanaka Y, Cit
Page 25 and 26: Kremer J, Van den Bosch F, Rubbert-

ACR Congress Review 2019

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