A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone
Arthritis & Rheumatism,  Clinical Article

Kremer JM et al. – In patients with active rheumatoid arthritis (RA) in whom the response to methotrexate (MTX) has been inadequate, the addition of tofacitinib at a dosage >3 mg twice daily showed sustained efficacy and a manageable safety profile over 24 weeks.

Methods
  • In this 24–week, double–blind, phase IIb study, patients with active RA (n = 507) were randomized to receive placebo or tofacitinib (20 mg/day, 1 mg twice daily, 3 mg twice daily, 5 mg twice daily, 10 mg twice daily, or 15 mg twice daily).
  • All patients continued to receive a stable dosage of MTX.
  • The primary end point was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12.

Results
  • At week 12, ACR20 response rates for patients receiving all tofacitinib dosages ≥3 mg twice daily (52.9% for 3 mg twice daily, 50.7% for 5 mg twice daily, 58.1% for 10 mg twice daily, 56.0% for 15 mg twice daily, and 53.8% for 20 mg/day) were significantly (P ≤ 0.05) greater than those for placebo (33.3%).
  • Improvements were sustained at week 24 for the ACR20, ACR50, and ACR70 responses, scores for the Health Assessment Questionnaire disability index, the 3–variable Disease Activity Score in 28 joints using the C–reactive protein level (DAS28–CRP), and a 3–variable DAS28–CRP of <2.6.
  • The most common treatment–emergent adverse events occurring in >10% of patients in any tofacitinib group were diarrhea, upper respiratory tract infection, and headache; 21 patients (4.1%) experienced serious adverse events.
  • Sporadic increases in transaminase levels, increases in cholesterol and serum creatinine levels, and decreases in neutrophil and hemoglobin levels were observed.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Orthopedics

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Orthopedics Articles

1 New research: Arthritis medicine linked to deaths Aarhus University Health News, November 17, 2014

2 Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety BMJ, September 9, 2014    Evidence Based Medicine    Clinical Article

3 Milk intake and risk of mortality and fractures in women and men: cohort studies BMJ, November 11, 2014    Evidence Based Medicine    Clinical Article

4 Adductor pollicis muscle: A study about its use as a nutritional parameter in surgical patients Clinical Nutrition, November 21, 2014    Clinical Article

5 Hydroxychloroquine in patients with inflammatory and erosive osteoarthritis of the hands (OA TREAT): study protocol for a randomized controlled trial Full Text Trials, November 17, 2014    Free full text    Evidence Based Medicine    Clinical Article

6 Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial The Lancet, November 12, 2014    Evidence Based Medicine    Clinical Article

7 Role of vitamin D3 in treatment of lumbar disc herniation--pain and sensory aspects: study protocol for a randomized controlled trial Full Text Trials, October 15, 2014    Free full text    Evidence Based Medicine    Clinical Article

8 Calcifediol versus vitamin D 3 effects on gait speed and trunk sway in young postmenopausal women: A double-blind randomized controlled trial Osteoporosis International, November 6, 2014    Clinical Article

9 American Academy of Orthopaedic Surgeons releases new guidelines on hip fractures in older adults, ACL injuries, and infant dysplasia of the hip American Academy of Orthopaedic Surgeons News, September 12, 2014

10 Approach to pain management in chronic opioid users undergoing orthopaedic surgery Journal of the American Academy of Orthopedic Surgeons, October 7, 2014    Review Article    Clinical Article

11 Effect of physical therapy on pain and function in patients with hip osteoarthritis: A randomized clinical trial Full Text JAMA, May 21, 2014    Free full text    Evidence Based Medicine    Clinical Article

12 A randomized trial of epidural glucocorticoid injections for spinal stenosis New England Journal of Medicine, July 7, 2014    Evidence Based Medicine    Clinical Article

13 Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: A population-based cohort study Annals of Rheumatic Diseases, November 10, 2014    Evidence Based Medicine    Clinical Article

14 The incidence of hip fractures in Norway -accuracy of the national Norwegian patient registry Full Text BMC Musculoskeletal Disorders, November 18, 2014    Free full text    Evidence Based Medicine    Clinical Article

15 The role of central sensitization in shoulder pain: A systematic literature review Seminars in Arthritis and Rheumatism, November 21, 2014    Review Article

16 Risk of subsequent fractures and mortality in elderly women and men with fragility fractures with and without osteoporotic bone density: The Dubbo Osteoporosis Epidemiology Study Journal of Bone and Mineral Research, November 4, 2014    Clinical Article

17 Changes in bone mineral density at 3 years in postmenopausal women receiving anastrozole and risedronate in the IBIS-II bone substudy: An international, double-blind, randomised, placebo-controlled trial The Lancet Oncology, November 14, 2014    Clinical Article

18 The effect of adding dexmedetomidine to levobupivacaine for interscalene block for postoperative pain management after arthroscopic shoulder surgery The Clinical Journal of Pain, November 13, 2014    Clinical Article

19 Safety of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures in Europe: a meta-analysis of randomized controlled trials European Spine Journal, November 18, 2014    Evidence Based Medicine    Clinical Article

20 Self-perceived facture risk: Factors underlying womens perception of risk for osteoporotic fractures: The Risk-Stratified Osteoporosis Strategy Evaluation study (ROSE) Osteoporosis International, November 5, 2014    Clinical Article

Indexed Journals in Orthopedics: Journal of Bone and Joint Surgery, Journal of Arthroplasty, Spine, The Kneemore