RUNNING
BIKING
SKIING
HIKING
KNEE PAIN

Cingal™ for healthcare professionals

Cingal (hyaluronic acid and triamcinolone hexacetonide) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). Cingal includes an ancillary steroid to provide additional short-term pain relief.1

Cingal: A powerful and unique combination for fast and sustained relief of pain from osteoarthritis of the knee in a single injection2

Demonstrated short-term efficacy over both HA and saline

Demonstrated 26-week sustained efficacy over saline

Demonstrated good safety and tolerability profile. AEs were transitory and rated mild in severity

Simplicity of a single injection

By combining the early benefits of a corticosteroid with the lubricating effect of hyaluronic acid (HA), Cingal offers:2,3

  • Fast pain relief
  • Sustained duration of benefit*

Providing pain relief to get your patients back to their active lifestyle

  • Fast relief from OA knee pain
  • Quick return to daily routine
  • May delay total knee replacement surgery
  • Convenience of a single injection

AE: adverse event

Cingal™ combines the benefits of a trusted anti-inflammatory with Monovisc® to relieve osteoarthritis knee pain.

The anti-inflammatory (triamcinolone hexacetonide) offers:4

  • Fast pain relief generally beginning 24 hours after administration
  • Approximately 5X the potency of hydrocortisone
  • Practically no sodium retention

Monovisc’s HA offers:5–10

  • Effective OA pain relief for up to 6 months
  • Generally well-tolerated, next-generation, non-avian HA
  • More HA per syringe than any other single injection
WOMAC: Western Ontario and McMaster Universities Osteoarthritis index
NSAIDs: non-steroidal anti-inflammatory drugs
*Demonstrated long-term pain relief through 26 weeks.
†A 6-month prospective, multicentre, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of a single injection of Monovisc for the treatment of knee pain from OA in 35- to 75-year-old patients (n=369) with symptomatic OA of the knee. Patients had Grade II or III OA with baseline index knee WOMACTM Pain Subscale of 200–400 mm (< 150 mm for contralateral knee) and a washout period for all NSAIDs, corticosteroids and analgesics prior to study initiation. All patients received Monovisc or a saline solution (placebo) as a single 4 mL injection. Efficacy was assessed at weeks 2, 4, 8, 12, 20 and 26 following injection. The primary endpoint was the proportion of treatment success in the Monovisc (n=184) and the placebo (n=185) groups, defined as patients who achieved ≥ 40% improvement in WOMAC Pain Score and ≥ 15 mm improvement from baseline at Week 12.
‡Comparative clinical significance has not been established.

Pain perception is subjective

The VAS is a validated tool that helps objectively measure the intensity of certain sensations and feelings, such as pain.

  • It allows the physician to associate a value to their patient’s pain level
  • It enables the patient to position their current level of pain on the scale

It is key to assess each patient’s pain relief and functional requirement expectations individually.

Consider a single injection of Cingal, for all new patients suffering from OA knee pain.

VAS: visual analog scale
mm: millimeter

Cingal™ demonstrated superiority to HA*

WOMAC Pain Score differences between Cingal™ and HA from baseline at Weeks 1 and 3†,‡,§

Cingal delivered a 59% (-34.6 mm) and 68% (-40.1 mm) improvement relative to baseline, at Weeks 1 and 3, respectively (ITT population; secondary endpoint)

 

  • Fast
    • Cingal offered significant quick pain relief relative to HA at Weeks 1 and 3.
  • Long-lasting
    • Cingal was superior to saline in providing significant pain reduction through 12 weeks post-treatment.
    • Cingal demonstrated strong long-term pain and symptom relief similar to HA from Week 6 through Week 26.
ITT: Intent-to-treat
OMERACT-OARSI: Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International
*The primary endpoint was the change from WOMAC baseline in knee pain through 12 weeks between Cingal vs. saline. Secondary endpoints included the change from WOMAC baseline in knee pain at Weeks 1 and 3 between Cingal and Monovisc, and the change from WOMAC baseline in knee pain through 26 weeks between Cingal and saline.
†A randomized, double-blinded, multicentre, placebo-controlled study (with an active comparator arm) to evaluate the safety and effectiveness of a single injection of Cingal in patients with symptomatic OA of the knee. A total of 368 patients were enrolled and randomized in a 2:2:1 ratio to Cingal, Monovisc, or saline injection. The combined average age (in all study arms) was 58.3 years. The outcome measures included the WOMAC pain, stiffness, physical function, and total scores; OMERACT-OARSI responder index; and investigator and patient global assessments. The primary endpoint was the change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) through 12 weeks post treatment comparing the Cingal group to the saline control group.
‡Baseline refers to the assessments performed prior to the study injection after the screening visit.
§The WOMAC Pain Score is a health status questionnaire assessesing pain in patients with knee OA. It is measured on a 100 mm Visual Analog Scale (VAS) and ranges from no pain to extreme pain. For each question, the possible range of scores is 0–100. The total WOMAC Pain Score is created by summing all questions. Higher WOMAC scores indicate worse pain.

Proven Cingal™ benefits: Both patients and evaluators perceived superior pain improvement over saline and HA2

Change in the global assessments as measured by the WOMAC Pain Subscale (100 mm VAS) from baseline through 26 weeks (ITT population)*

  • Results
    • Patient- and physician-assessed measurements showed consistency in evaluating knee pain as measured by the WOMAC Pain Subscale (100 mm VAS).
    • Patients reported a significant pain reduction at Weeks 3, 12, and 26 and physicians at Weeks 1, 12, and 26.
    • Results across all measurements in the PP population showed uniformity with the ITT population.
PP: per-protocol
*A randomized, double-blinded, multicentre, placebo-controlled study (with an active comparator arm) study to evaluate the safety and effectiveness of a single injection of Cingal in patients with symptomatic OA of the knee. A total of 368 patients were enrolled and randomized in a 2:2:1 ratio to Cingal, Monovisc, or saline injection. The combined average age (in all study arms) was 58.3 years. The outcome measures collected included the WOMAC pain, stiffness, physical function, and total scores; OMERACT-OARSI responder index; and investigator and patient global assessments. The primary endpoint was the change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) through 12 weeks post treatment comparing the Cingal group to the saline control group.
†The Pain VAS (Visual Analog Scale) rates the patient’s subjective level of pain on a scale of 0 to 100 mm. A patient marks a point on the line that matches the amount of pain felt.

Cingal™ was generally safe and well tolerated2

  • No injection site infections
  • No serious AEs related to Cingal reported
  • Derived from a non-avian source

AEs were distributed proportionally to study randomization, with no statistical differences related to study arm.

Most common AEs (> 5% of total AEs) regardless of relatedness to treatment:

  • Headache (15.7%)
  • Arthralgia (12.9%)
  • Spinal pain (8.3%)
  • Back pain (6.0%)
  • Nasopharyngitis or common cold (5.1%)

The majority of AEs were transitory and rated mild (71.7%) in severity.

Contraindications:

  • Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations and/or to triamcinolone hexacetonide preparations.
  • The safety and effectiveness of the use of Cingal in pregnant women, nursing mothers, and in pediatric patients (≤ 21 years of age) has not been tested.

Relevant warnings and precautions:

  • Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation as hyaluronan can precipitate in their presence.
  • Cingal should be used with great caution in patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned.
  • The safety and effectiveness of the use of Cingal in joints other than the knee have not been demonstrated.
  • The effectiveness of Cingal has not been established for more than one course of treatment.
  • Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject Cingal for the indicated use.

For more information:

Please consult the Cingal Product Licence for important information relating to adverse reactions and dosing information, which have not been discussed in this piece.

The Product Licence is also available upon request by calling 1-888-550-6060 or by emailing medinfo@pendopharm.com.

References:

1. Cingal Package Insert, Pendopharm, February 2016. 2. Data on File. Clinical study report: Cingal 13-01. Anika Therapeutics, Inc. January 2015. 3. The Arthritis Society. Arthritis medications: A reference guide. Accessed on March 23, 2016. https://arthritis.ca/getmedia/dccf0bdc-7ff0-4b3c-aa0c-fd2b36729fff/Arthritis-Medications-A-Reference-Guide-2015.pdf 4. electronic Medicines Compendium (eMC). Triamcinolone hexacetonide 20 mg/ml suspension for injection. Accessed on April 1, 2016. https://www.medicines.org.uk/emc/medicine/28913 5. Monovisc 0702 pivotal clinical trial. FDA Monovisc Summary of Safety and Effectiveness Data. 2014. 6. Anika, Data on File, Study 0703. 7. Synvisc-One® Instructions for Use, Genzyme Corporation, December 16, 2014. 8. Durolane® website. Accessed November 13, 2015. www.durolane.com. 9. Electronic Compendium of Pharmaceuticals and Specialties. NeoVisc® Product Monograph, 10. Anika, Data on File, Study 0702.

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Cingal™, Monovisc® and Orthovisc® may not be suitable for everyone. Talk to your doctor if you have questions regarding these products, or for more information on pain associated with osteoarthritis of the knee. CingalTM, Monovisc®, and Orthovisc® are trademarks of Anika Therapeutics Inc., used under licence by Pharmascience Inc. Pendopharm, Division of Pharmascience Inc. Product Licences are pertinent to use in Canada. Product Licences herein are not approved for use in the U.S.