Gout Flares : an Excruciatingly Painful Arthritis
PKM-01
Gout is a rheumatologic condition known for its chronic manifestations and its acute disabling attacks (the ‘flares’) characterized by agonizing pain in the lower limb joints.
A flare typically lasts up to 7-10 days, leaving the patients drained, in fear of a relapse.
The disease begins with an increase of uric acid in the blood, leading to urate crystals formation in the joints, triggering the first attack. As the disease progresses over the years, the attacks become more frequent, from 1 up to 5-6 flares per year, longer and more painful. Gout patients describe this unbearable, poorly controlled pain as a “thousand needle poking”, “hurting worse than a bone fracture” and “a pain that no one cares about and that no one will really understand”.
1,2
A frequent disease with numerous comorbidities, making patients difficult to treat
Gout is a frequent disease affecting 4% of the US adult population (more than 10 million patients), 1-2% in Europe and growing worldwide. This disease particularly affects elderly populations with a prevalence increasing every decade of life to reach nearly 11%-13% in people over 80.
Moreover, patients frequently have multiple chronic comorbidities including hypertension, Chronic Kidney Disease (CKD), obesity, diabetes and cardiovascular diseases.
4
3
Existing Gout Flare Treatments: a Persistent Challenge for Physicians
The currently recommended treatments to reduce the inflammatory response and to relieve pain during a gout flare remain largely unchanged, both in the US and the EU. These include oral Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), oral Colchicine and oral, parenteral or intra-articular glucocorticoids.
All of these treatments have demonstrated a significant lack of efficacy with only 33% to 50% of patients experiencing pain relief ≥50% after 1-3 days, combined with major safety issues as 30% to 50% of gout patients have at least one strong contraindication.
Given that gout patients are often under several disease-specific concurrent medications due to their comorbidities, the management of gout flares for these difficult-to-treat patients remains a true challenge for physicians.
6
5
A Strong Unmet Need Calling for a New Paradigm of Action
There is a clear unmet medical need for a more effective drug product against acute pain, providing a rapid onset of action and a favorable safety profile in patients suffering from gout.
This innovative treatment should be tailored to address the “difficult-to-treat” gout patients, having contraindications or being intolerant to existing treatments.
1 - Seow et al., Clinical Nursing Research, 2020
2 - Singh et al., Arthritis research and therapies, 2014
3 - Chen-Xu et al., Arthritis and Rheumatology, 2019
4 - Zhu et al., American Journal of Medicine, 2012
5 - Khanna et al., Seminars in Arthritism and Rheumatism, 2014
6 - Keenan et al., American Journal of Medicine, 2011