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7 Articles in this Series
Introduction
Addressing Arthralgia in Children
An ACR/ARHP Preview
Axial Spondylitis: Mimics, Progression, the Need for MRI, and New Management Recommendations
How Rheumatic Diseases Can Hurt Sexual Health
Tanezumab for Hip and Knee OA; Cosentyx for Ankylosing Spondylitis; and Upadacitinib for RA
Treating Chronic Musculoskeletal Pain in Older Adults
Uncovered Inflammatory Pathways of Osteoarthritis Call for New Targets

Tanezumab for Hip and Knee OA; Cosentyx for Ankylosing Spondylitis; and Upadacitinib for RA

The following study updates for the treatment of common rheumatic disease were announced at the 2018 ACR/ARHP annual meeting in Chicago.

 

Tanezumab Improved Pain in Hip and Knee Osteoarthritis; May Also Curb cLBP

Pfizer (New York, NY) and Eli Lilly (Indianapolis, IN) announced study results evaluating the efficacy and safety of subcutaneous administration of tanezumab in patients with osteoarthritis (OA) pain treated for 16 weeks. The study demonstrated that, among patients with moderate-to-severe OA pain of the knee or hip, both dosing regimens (2.5 mg alone and 2.5 mg followed by 5 mg) of tanezumab led to a statistically significant improvement in pain, physical function, and a patient’s global assessment of their OA (PGA-OA) when compared to placebo.

The randomized, double-blind, placebo-controlled, multicenter, parallel-group trial included patients who were enrolled with moderate-to-severe OA pain who had experienced inadequate pain relief with other treatment options for OA pain or were unable to take other pain medications. Just under 700 (n = 698) patients were randomized to three treatment groups in a 1:1:1 ratio to receive two injections over a 16-week treatment period; injections were given once every eight weeks and 696 patients received the treatment. One group received two doses of placebo, while the second group received two doses of tanezumab 2.5 mg, while the third group received one dose of tanezumab 2.5 mg followed by one dose of tanezumab 5 mg eight weeks later.

Data measured based on change from baseline to Week 16 using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function subscales and PGA-OA scores. Average baseline scores were as follows: WOMAC Pain and Physical Function subscales of approximately 7.1 to 7.4, and PGA-OA scores of approximately 3.4 to 3.5.

The tanezumab 2.5mg group and the tanezumab 2.5/5mg group reduced pain levels on the WOMAC scale  (-3.2 and -3.4, respectively) and the Physical Function scale (-3.2 and -3.5, respectively) compared to placebo (-2.6), as well as the PGA-OA scale (-0.87 and -0.90, respectively) compared to placebo (-0.65). Tanezumab was generally well tolerated, with 0.4% and 1.3% of patients in the tanezumab 2.5 mg and 2.5/5 mg groups, respectively, discontinuing treatment due to adverse events.

The overall global clinical development program evaluating the efficacy and safety of tanezumab includes six studies including approximately 7,000 patients with OA pain, chronic low back pain (cLBP), and cancer pain due to bone metastases. Tanezumab is part of an investigational class of pain medications known as nerve growth factor (NGF) inhibitors, and, if approved, could be a first-in-class, non-opioid treatment for these conditions.

Additional results of the program are anticipated in Q1 of 2019.

Source: Pfizer. Press Release: Complete Results From First Study In Ongoing Phase 3 Program For Tanezumab Demonstrated Significant Improvement In Pain And Function In Osteoarthritis Patients. October 23, 2018.

Source: 123RF

Cosentyx Led to Long-Term Positive Responses for Ankylosing Spondylitis

From a MEASURE 2 study, Cosentyx (secukinumab), developed by Novartis (Basel, Switzerland), delivered high (73.3%) sustained Assessment of Spondyloarthritis International Society response criteria (ASAS) of ankylosing spondylitis (AS) patients treated with Cosentyx 150 mg at Year 4.

Data presented from 106 patients treated with Cosentyx 150 mg—or those initially treated with placebo who switched to Cosentyx 150 mg for four years—both showed 73.3% achieved at least a 20% improvement in AS symptoms at four years, as measured by the ASAS20. Additionally, more than half (60.5%) achieved an ASAS40 response at Week 208. The safety profile was consistent with that observed in previous studies. Upper respiratory tract infection and nasopharyngitis were the most frequently reported adverse events, with exposure-adjusted incidence rates (EAIR; per 100 patient-years) of 23.7 and 10.2, respectively.

According to the company release, Cosentyx is the first and only IL-17A antagonist to show sustained ASAS response rates, a measure of improvements in signs and symptoms of ankylosing spondylitis. More than 160,000 patients have been prescribed Cosentyx across all indications worldwide thus far.

Source:  Novartis. Press Release: Novartis presents new Cosentyx data demonstrating long-term response and safety in ankylosing spondylitis. October 22, 2018.

 

Upadacitinib Demonstrated Numerous QOL Improvements for Patients with Rheumatoid Arthritis, including Physical Function

AbbVie (North Chicago, IL) announced new patient-reported outcome data from its ongoing Phase 3 SELECT-MONOTHERAPY trial evaluating upadacitinib (15 mg and 30 mg, once-daily). The  investigational medication, a JAK1-selective inhibitor, is meant to be indicated as a monotherapy treatment for patients with moderate to severe rheumatoid arthritis who have not adequately responded to treatment with methotrexate.

Improvements in physical function, quality of life (QOL), pain and morning joint stiffness were reported after 14 weeks. Specific outcomes from the SELECT-MONOTHERAPY included:

  • Improvements in physical function, from the Health Assessment Questionnaire-Disability Index (HAQ-DI), were observed as early as two weeks after initial treatment with upadacitinib across both doses compared to eight weeks for patients receiving methotrexate. At Week 14, 65% of patients receiving 15 mg and 69% of patients receiving 30 mg of upadacitinib reported improvements in physical function compared to 45% of patients receiving methotrexate (P < 0.001).
  • At Week 14, 65% of patients receiving 15 mg and 73% of patients receiving 30 mg of upadacitinib reported improvements in health-related QOL compared to 48% of patients receiving methotrexate (P < 0.001).
  • Patients reported reductions in pain, from the Patient's Assessment of Pain (based on AS), as early as two weeks after initial treatment with both doses of upadacitinib compared to four weeks for patients receiving methotrexate. At Week 14, 64% of patients receiving 15 mg and 75% of patients receiving 30 mg of upadacitinib reported a reduction in pain compared with 46% of patients receiving methotrexate (P < 0.001).
  • Patients receiving upadacitinib reported reductions in the severity of morning stiffness as early as two weeks after initial treatment with both doses of upadacitinib compared to four weeks for patients receiving methotrexate. At Week 14, 27% of patients receiving 15 mg and 28% of patients receiving 30 mg of upadacitinib reported reductions in the severity of morning joint stiffness compared to 18% of patients receiving methotrexate (P < 0.001).

Vibeke Strand, MD, lead investigator and adjunct clinical professor in the Division of Immunology/Rheumatology at Stanford University, stated in the company release that, “These results are especially important because many patients cannot tolerate or do not respond to treatment with methotrexate and additional effective monotherapy options are needed for these patients.”

Source: AbbVie. Press Release: AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data. October 23, 2018.

 

 

Next summary: Treating Chronic Musculoskeletal Pain in Older Adults
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