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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

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

Demonstrated:

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short-term efficacy over both hyaluronic acid (HA) and saline

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26-week sustained efficacy over saline

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Simplicity of a single injection

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good safety and tolerability profile

Most adverse events (AEs) (> 99%) were rated mild or moderate in severity and common for the general population

By combining the early benefits of a corticosteroid with the lubricating effect of 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
  • Generally well tolerated
  • Quick return to daily routine
  • May delay total knee replacement surgery
  • Convenience of a single injection

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

Monovisc’s HA offers:4–9

  • 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‡

Triamcinolone hexacetonide has been marketed for over 45 years for use in short-term symptomatic management of human joint OA.

Pain perception is subjective

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

  • It allows physicians to associate a value with their patient’s pain level.
  • It enables patients 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.

Cingal® demonstrated superiority to HA (secondary endpoint)§

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.

Proven Cingal® benefits: Both patients and evaluators perceived superior pain improvement over saline and HA (secondary endpoint)2

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.

Cingal® was generally safe and well tolerated2

Adverse events (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.

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No injection-site infections

No serious AEs related to Cingal® reported

Derived from a non-avian source

AE: adverse event; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index; NSAIDs: non-steroidal anti-inflammatory drugs; ITT: intent-to-treat; OMERACT-OARSI: Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International; PP: per‑protocol
*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 osteoarthritis (OA) in 35- to 75-year-old patients (n=369) with symptomatic OA of the knee. Patients had Grade 2 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.
§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-blind, 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 assessing pain in patients with knee OA. It is measured on a 100 mm 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.
‡‡Demonstrated statistical significance (p > 0.05).
§§The Pain VAS 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.

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 for which the use of corticosteroid is warned against.
  • 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 that 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 September 9, 2019. Available from: https://arthritis.ca/treatment/medication/medications-to-treat-inflammatory-arthritis. 4. Monovisc® 0702 pivotal clinical trial. FDA Monovisc® Summary of Safety and Effectiveness Data. 2014. 5. Anika. Data on file. Study 0703. 6. Synvisc-One® Instructions for Use. Genzyme Corporation. December 16, 2014. 7. Durolane® website. Accessed November 13, 2015. Available from: www.durolane.com. 8. Electronic Compendium of Pharmaceuticals and Specialties. NeoVisc® Product Monograph. 9. Anika. Data on file. Study 0702.