Introduction

Despite the availability of diverse treatment options, COPD is still a major cause of concern due to antibiotic resistance or due to immune deficiencies in an individual. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the sudden worsening in airway function and respiratory symptoms in patients with COPD which range from self-limited diseases to episodes of respiratory failure requiring mechanical ventilation, thus adding financial burden to the patient. Cost-effective treatment strategy is required in patients with severe COPD who continue to exacerbate despite bronchodilator and antimicrobial therapies. Pidotimod, an immunostimulant, is clinically effective in the treatment of exacerbations and is associated with faster remission of symptoms by improving immune response. However, there is paucity of data on Indian patients.

Aim

The safety, efficacy and cost effectiveness of Pidotimod as an add-on drug in maintenance therapy of acute exacerbations has been assessed in adult Indian patients with COPD.

Method

Study Design

• Prospective, open label, single arm, single center study

  Patient Profile

• Adults aged between 38-73 years diagnosed with COPD
• Having >2 exacerbations that required antibiotics or >1 exacerbation requiring hospitalization in the last 12 months
• Clinically stable with no exacerbation in previous 1 month before enrolment

Treatment Strategy

• At baseline, the demographics, clinical history, smoking history was recorded and complete physical examination and laboratory assessment was conducted
• The study comprised of screening visit, enrolment and 3 follow-up visits (at the end of 2, 6 and 12 months)
• Pidotimod 800 mg twice daily for 8 days was administered as an add-on therapy and continued at 800 mg once daily till end of 2 months

Endpoints

Primary Endpoint

• Reduction in the number of COPD exacerbations

  Secondary Endpoints

• Average duration of each episode of exacerbation
• Number of episode requiring antibiotic therapy
• Average duration of antibiotic therapy
• Number of episodes requiring hospitalization
• Change in modified Medical Research Council (mMRC) score

  Endpoints

• Incidence of adverse events (AEs)
• Incidence of serious AEs (SAEs)

  Cost-analysis Endpoint

• Change in direct and indirect costs and hospital expenses

Results

• A total of 111 patients completed the study
• The mean number of acute exacerbation episodes at baseline was 2.10+0.50
• Only one patient had an AECB episode at 2 and 6 months
• None of the patient had an AECB at the end of 12 months
• The mean number of episodes of antibiotics prescribed at baseline were 2.08+0.56
• After Pidotimod treatment, only one subject was prescribed with antibiotic treatment at the end of 2 and 6 months
• There were no episodes of either exacerbations or antibiotic prescription at the end of 12 months
• Significant decrease in mMRC score was seen after treatment with Pidotimod; from baseline 2.81+0.60 to 2.47+0.67 at 12 months
• There were no hospitalizations during the follow-up visits
• Only 1 patient was taking reliever/rescue medication
• SAEs and AEs were reported by 2 and 1 patient respectively
• The AEs were pain in knees, body pain and weakness
• Significant reduction in the mean expenses at the end of 2 and 6 months was noted

Figure 1. Cost analysis

Conclusion

• Treatment with Pidotimod resulted in reduction in the overall number of exacerbations and duration of exacerbation episodes from baseline, decreased use of antibiotics and reduced hospitalizations in patients with acute exacerbation of COPD.
• Pidotimod is safe, effective and cost-effective maintenance therapy when added to standard of care in AECOPD patients.

IP Indian J Immunol Respir Med 2018;3(4):203-209.