Effectiveness of transdermal delivery of corticosteroids in improving arthritis pain and functional disability

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SCIENCE
Effectiveness of transdermal delivery of corticosteroids in improving arthritis pain and functional disability
Key Take-Away: 

Transdermal delivery of betamethasone valerate shows a considerable safety and efficacy in arthritis and osteoarthritis patients.

Arthritis is marked by joint pain and inflammation. The most common form of arthritis is osteoarthritis (OA) which can be described as a degenerative mesenchymal disease, affecting approximately 10% of the world’s population over 60 years.

ABSTRACT: 
Background: 

Arthritis is marked by joint pain and inflammation. The most common form of arthritis is osteoarthritis (OA) which can be described as a degenerative mesenchymal disease, affecting approximately 10% of the world’s population over 60 years. Pain, stiffness, and functional limitation are the common symptoms subsequently leading to loss of autonomy and reduced quality of life. The drugs used for treating OA include non-steroidal anti-inflammatory drugs (NSAIDs) for pain management, bisphosphonates to decrease pain and improve functionality by preserving the structural integrity of subchondral bone, pulsed electromagnetic field therapy, and viscosupplementation, with hyaluronic acid alone or in combination with bisphosphonates or NSAIDs, to improve pain and functional activity. It is true that viscosupplementation with hyaluronic acid improves articular cartilage degeneration and decreases osteophyte formation. Topical corticosteroids are also known to ease pain and improve joint functionality.

Transdermal delivery of betamethasone valerate for treatment of arthritis

For arthritis, corticosteroids can be administered by iontophoresis which is a non-invasive technique that allows transdermal drug delivery. Betamethasone valerate (BMV) is a synthetic, moderately active corticosteroid without mineralocorticoid properties, which binds the intracellular cytoplasmic glucocorticoid receptor and translocates it to the nucleus to function as a ligand-activated transcription factor. Eight sessions of dexamethasone iontophoresis have been used for treating juvenile idiopathic arthritis affecting the temporomandibular joint. Resolution of pain took place in 73% patients, who had pain at the baseline.

Rationale behind the research
There is lack of data regarding the clinical efficacy of transdermal delivery of corticosteroids for OA management.

Objective

To relate the effectiveness of transdermal BMV and Diclofenac sodium cream in patients affected by arthritis and OA, to determine the best therapeutic option to treat pain, redness, edema, and functional disability.

Methods: 

 

Study outcomes

  • Pain and functional disability assessment: VAS (0–100 mm; 0 mm = minimum pain; 100 mm = maximum pain) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scores were used to evaluate the efficacy of BMV medicated plaster on pain and functional disability at 10-day follow-up. WOMAC is based on five items related to pain (subscore 0– 20; 0 = minimum pain; 20 = maximum pain), two to stiffness (subscore 0–8; 0 = minimum stiffness; 8 = maximum stiffness), and 17 to functional limitation (subscore 0–68; 0 = minimum functional limitation; 68 = maximum functional limitation).
  • Redness and edema assessment: Redness was assessed by visual clinical inspection (subscore 0–3; 0 = absence of redness, 1 = slight redness, 2 = moderate redness, and 3 = intense redness). Edema was assessed by the “fovea sign” method. The fovea sign is positive when there is exquisite tenderness compared with the contralateral side and is scored as follows: subscore 0–3, 0 = absence of edema, 1 = 2 mm edema following depression of the skin, 2 = 4 mm edema following depression of the skin, and 3 = 5 mm edema following depression of the skin
  • C-reactive protein: The venous blood of all fasting subjects was drawn in the morning, and C-reactive protein (CRP) levels were detected by immunoturbidimetric method, using an automated analyzer.

Time Points: Baseline and after 10 days

Results: 

 

Study Outcomes

  • Pain and functional disability assessment: A significant reduction in VAS and WOMAC scores from baseline was seen in patients treated with BMV medicated plaster (55.44 ± 1.28% and 52.4 ± 2.31%), when compared with diclofenac sodium cream (13.89 ± 0.8% and 12.35 ± 1.26%). A more significant reduction in WOMAC functional limitation and stiffness scores from baseline was observed in patients treated with BMV medicated plaster (44.79 ± 2.33% and 50.03 ± 3.08%), when compared with diclofenac sodium cream (9.62 ± 0.79% and 14.94 ± 2.26%).

Figure 1: Percentage variation in VAS pain in BMV medicated plaster and Diclofenac Sodium cream group

Figure 2: Percentage variation in WOMAC pain in BMV medicated plaster and Diclofenac Sodium cream group

  • Redness and edema assessment: Redness and edema scores in patients treated with BMV medicated plaster were significantly reduced when compared with diclofenac sodium cream (all p<0.01).
  • C-reactive protein: A greater reduction in CRP levels from baseline was also observed in patients treated with BMV medicated plaster (46.54 ± 3.52 %) when compared with diclofenac sodium cream (14.42 ± 1.25 %; p<0.01).
Conclusion: 

The present study demonstrated that BMV medicated plaster is well tolerated and shows greater effectiveness in alleviating pain and functional disability and improving CRP levels, redness, and edema when compared with diclofenac sodium cream, in arthritis and OA patients. The improvement in CRP levels supports tissue recovery and functional restoration, proving the therapeutic efficacy of BMV medicated plaster and further supporting its use as a local pharmacological therapy for arthritis pain and functional disability.

This study was the first to evaluate the clinical efficacy and safety of a BMV medicated plaster for treatment of symptomatic joint arthritis and OA. Scientists are more interested in exploring transdermal drug delivery systems as this approach is novel and a valid therapeutic alternative to oral and more invasive strategies. Transdermal drug delivery offers better patient compliance, improved control over input kinetics, and a lower incidence of gastrointestinal-related side effects. Also, it evades the first-pass hepatic metabolism and plasma bioavailability fluctuations which are usually seen with oral administration.

Drug Deliv. and Transl. Res. (2017) 7:156–161
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