P-100 - Patient Reported Burden of Disease in Postherpetic Neuralgia Pain: Learnings from In-depth Patient Interviews, Sub-study of RELIEF-PHN-1

Abstract Title: Patient Reported Burden of Disease in Postherpetic Neuralgia Pain: Learnings from In-depth Patient Interviews, Sub-study of RELIEF-PHN-1


Background: Postherpetic Neuralgia (PHN) is a chronic debilitating neuropathic pain (NP) complication of the acute neuritis associated with Varicella-zoster skin rash. PNH develops in up to 20% of the approximately 1 million patients who suffer each year with shingles in US and refers to pain persisting beyond three months from the initial onset of the rash. LX9211, a potent, small molecule inhibitor of Adapter protein-2 Associated protein Kinase 1 (AAK1), is a novel, non-opioid target for the treatment of NP. LX9211 has been shown to be effective in managing Diabetic Peripheral Neuropathic Pain (DPNP).



RELIEF-PHN-1 was a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of LX9211 for the treatment of NP associated with PHN in 79 adults (≥18 years of age) with prior herpes zoster skin rash and moderate to severe PHN pain persisting for ≥3 months after healing of the herpes zoster skin rash. The primary outcome was change from baseline in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale.



Purpose/Objectives: A sub-study of RELIEF-PHN-1 employed in-depth patient telephone interviews conducted by trained qualitative research professionals. The interview had specific objectives of characterizing patient-reported disease burden at baseline and defining unmet patient needs in management of NP associated with PHN. The patient interview was conducted within 2 weeks of completing, or permanently withdrawing from, the double-blind treatment phase of the trial. All randomized patients were invited to participate in this voluntary sub-study.


Methods: Nineteen telephone interviews were conducted with English-speaking participants from 10 US clinical trial sites. Data were analyzed using a thematic qualitative data analysis approach. Dominant trends in each interview were identified and compared across interviews to describe the themes of pain quality and severity and the relative importance of NP to daily living as described by interviewed participants. Descriptive statistics pertaining to demographic and clinical information were computed and summarized.


Results: Of the 19 patients interviewed, 9 (47%) were female, with a mean age of 67 years. On average, participants had been experiencing symptoms associated with PHN for 6 years. Eight descriptions of symptoms emerged from interview analyses. “Tingling/Pins and needles” (84%), “Sensitivity to touch or pressure” (74%), and “Burning” (68%) were described with greatest frequencies. Of these symptoms “Burning” (26%), “Itching” (21%), and “Tingling/Pins and needles” (16%) were reported as the top three “Most Bothersome” symptoms associated with NP.

Participants reported that NP had many significant impacts on their lives. The most frequently impacted aspects included “Mood/emotions” (90%), “Sleep” (84%), and “Social or Recreational activities.” Over 44% of patients were “not at all satisfied” with prior treatments for NP; only 6% reported being “very satisfied.” NP was at least “moderately difficult” to manage for 78% of patients, while 37% reported it “very difficult.”

Conclusions/Implications for future research and/or clinical care: This sub-study elucidates the self-described experiences of patients with NP symptoms associated with PHN by characterizing their pain types, frequencies and the most burdensome impacts on quality of life. The disease burden of PHN as perceived by patients appears to be highly significant and inadequately treated. This data highlights a pressing need for improved therapies and innovations in NP management for patients with PHN.

References: NA