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Rheumatoid arthritis (RA) Rheumatoid arthritis (RA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Psoriatic arthritis (PsA) Psoriatic arthritis (PsA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Ulcerative colitis (UC) Ulcerative colitis (UC) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions
Efficacy

Efficacy and Safety Established in 3 Large, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies and an Open-Label Study of Patients With Moderate to Severe UC.1
  • The primary efficacy endpoint in the OCTAVE Induction 1 and 2 trials was remission at week 8, and in the OCTAVE Sustain trial, it was remission at week 521,c
  • Patients who completed one of the OCTAVE Induction studies but did not achieve clinical response or patients who completed or withdrew early due to treatment failure on XELJANZ® (tofacitinib) 5 mg BID or placebo in the maintenance study were eligible for the open-label extension study.1
  • Patients were assessed using the Mayo scale, a tool for evaluating disease activity in UC patients that is composed of 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and Physician’s Global Assessment), each with a range of 0 to 3 (higher scores indicate more severe disease)2
  1. To avoid potential bias,2 evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1
  2. Responders/response were defined as subjects with a decrease from baseline in Mayo score of ≥3 points and ≥30%, with an accompanying decrease in the subscore for rectal bleeding of >1 point or absolute subscore for rectal bleeding of 0 or 1.2
  3. Remitters/remission were defined as subjects with a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.2
 Significantly Greater Proportion of Patients Taking XELJANZ® (tofacitinib) 10 mg Achieved Treatment Endpoints vs Placebo at Week 8 Across Multiple Efficacy Parameters18-Week Efficacy
  1. To limit potential bias, evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ® (tofacitinib) or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1
  2. Remission (primary endpoint) was defined as a Mayo score ≤2 with no individual subscore >1 and rectal bleeding subscore of 0.2
  3. Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopic findings subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).2
  4. Clinical response was defined as a decrease from baseline in Mayo score of ≥3 points and ≥30%, with an accompanying decrease in the subscore for rectal bleeding of ≥1 point or absolute subscore for rectal bleeding of 0 or 1.2
  1. Remission (primary endpoint) was defined as a Mayo score ≤2 with no individual subscore >1 and rectal bleeding subscore of 0.2
  2. To limit potential bias, evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ® (tofacitinib) or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1
  3. Includes all patients, TNFi naïve and TNFi exposure.1
Onset of Symptom ImprovementXELJANZ® (tofacitinib) was shown to deliver rapid reduction in stool frequency as early as three days1
  1. The following binary endpoints based on diary data were evaluated for each day during the first 15 days of therapy: stool frequency subscore = 0, stool frequency subscore ≤ 1, reduction of ≥ 1 point from baseline in stool frequency subscore.3
  1. The following binary endpoints based on diary data were evaluated for each day during the first 15 days of therapy: rectal bleeding subscore = 0, rectal bleeding subscore ≤ 1, and reduction of ≥ 1 point from baseline in rectal bleeding subscore.3
52-Week Efficacy
  1. Remission (primary endpoint) was defined as a Mayo score ≤2 with no individual subscore >1 and rectal bleeding subscore of 0.2
  2. To limit potential bias, evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ® (tofacitinib) or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1
  3. Includes all patients, TNFi naïve and TNFi exposures.1
  1. Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopic findings subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).2
  2. To limit potential bias, evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ® (tofacitinib) or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1
  3. Includes all patients, TNFi naïve and TNFi exposures.1
  1. Sustained steroid-free remission was defined as being in remission and on no corticosteroids for at least 4 weeks prior to the visit at both week 24 and week 52 among those in remission at maintenance baseline.1
  2. Includes all patients, TNFi naïve and TNFi exposures.1
Abbreviations:BID: twice daily; SE: standard error; TNF: tumor necrosis factor; TNFi: tumor necrosis factor inhibitor; UC: ulcerative colitis
ReferencesSandborn WJ, Su C, Sands BE, et al. for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017;376(18):1723-1736.Sandborn WJ, Su C, Sands BE, et al. for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis [supplementary appendix]. N Engl J Med 2017;376(18):1-77.Hanauer S, Panaccione R, Danese S, et al. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clinical Gastroenterology and Hepatology 2019;17:139–147.Hanauer S, Panaccione R, Danese S, et al. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis [supplementary material]. Clinical Gastroenterology and Hepatology 2019;17:139–147.Sandborn WJ, Peyrin-Biroulet L, Sharara AI, et al. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clinical Gastroenterology and Hepatology 2022;20:591–601.
PP-XEL-ZAF-0083

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