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1 FLEXISEQ : An innovative treatment for the management of pain and stiffness in patients with osteoarthritis: Real-life data from a patient survey of members of the Feierabend Community Abstract FLEXISEQ is an innovative treatment for the pain and stiffness associated with osteoarthritis (OA), which works by physical means and contains no active pharmaceutical ingredient. The benefits of this novel approach are far-reaching; for example, FLEXISEQ is not associated with the gastrointestinal and cardiovascular adverse events that can occur with non-steroidal anti-inflammatory drugs (NSAIDs). In addition, FLEXISEQ does not interact with drugs, thus allowing it to be used in individuals in whom NSAIDs may be contraindicated due to the presence of risk factors and other medications for comorbid conditions. A survey was conducted among a community for older people to assess the effect of FLEXISEQ when used by arthritis sufferers in a daily routine setting, and to understand their views on the benefits and attributes of the product. In total, 390 subjects with OA were recruited to test the FLEXISEQ gel on an index joint. The baseline characteristics indicated that this was a fairly standard population of individuals with OA. The average age of respondents was 65 years, 85% had comorbid conditions and 83% reported having OA in more than one joint. From the enrolled population of 390 subjects, a population of 177 subjects have completed 3 weeks of treatment with FLEXISEQ. Among this group, the average baseline pain was 6.85 and the average baseline stiffness was 5.29, both measured using a 10-point Visual Analogue Scale. Three weeks of treatment resulted in a decrease of the average pain score by 2.13 (31.1%) and an improvement in the average stiffness scores of 1.52 (28.7%). Improvements of 1 point were observed by over half of respondents by the first week of treatment. After 3 weeks of treatment with FLEXISEQ, 73.4% and 57.1% of subjects reported a 1 point or 2 point improvement in pain in their index joint, respectively. No serious safety issues were reported and application site reactions were reported in just 4.0% of patients. When asked how FLEXISEQ compared with other OA treatments, 97% reported that FLEXISEQ was equal or better than other products with respect to its effects on pain, and 99% reported that FLEXISEQ was equal or better than other OA products with respect to stiffness.

2 The positive findings in this observational study reinforce those of the clinical trials with FLEXISEQ that showed that this innovative, drug-free treatment is efficacious and well tolerated for the treatment of pain and stiffness associated with OA. The benefits of FLEXISEQ are further reflected in the high patient satisfaction reported by those using the product. As FLEXISEQ improves symptoms of OA without active pharmaceutical ingredients, it represents a real breakthrough for the management of this condition, allowing it to be used with confidence in a population where comorbid conditions and concomitant medication use is widespread. Background Osteoarthritis (OA) is an inherent process of ageing in human joint cartilage, affecting most of the elderly population. The main symptoms include joint pain and stiffness; however, symptoms vary greatly from person to person, and between different affected joints. For affected individuals, OA results in significant limitations of daily living activities, and reduces quality of life. 1 In addition, the disease is associated with an extremely high economic burden, which is largely attributable to the effects of disability, comorbid disease and the expense of treatment. 2 As with other age-related diseases, as overall life expectancy increases, the prevalence of OA is anticipated to rise. OA is very prevalent in patients over 60 years of age, with prevalence of symptomatic osteoarthritis estimated at almost 1 in 10 men (9.6%) and 1 in 5 women (18%). 3 The mechanisms underlying OA are not fully understood although patients with joint disorders such as OA have been found to have reduced levels of naturally occurring synovial phospholipids that play a key role in the lubrication of articulating cartilage. 4,5 There is currently no cure for OA, but a range of non-pharmacological and pharmacological interventions can be used to ease the symptoms. Non-pharmacological approaches include exercise, weight loss and physiotherapy, while pharmacological approaches include oral pain killers mainly paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID creams and gels. Steroid injections into the affected joint may provide temporary relief for particularly painful, swollen joints, while surgery to replace the affected joint may be necessary in severe cases. As OA is a condition that can only be managed rather than cured, affected individuals will require treatment for long periods of time and therefore the long-term safety and tolerability of interventions is particularly critical. Furthermore, as OA affects mainly the elderly population who may have multiple comorbidities, risk factors and are receiving medication for comorbid conditions, it is important to consider the potential for side effects and adverse

3 drug interactions between OA medications and medications for these other conditions. Oral NSAIDs are a particular concern for OA as they are associated with well-documented adverse effects, such as gastrointestinal ulcers, serious cardiovascular events, hypertension, acute renal failure and worsening of pre-existing heart failure, particularly with long-term use. 6,7 Moreover, their use is contraindicated in many age-related comorbid conditions and also in combination with drugs used to treat these conditions. The need for effective treatments for OA that are efficacious, suitable for long-term use and can be used in combination with other medications has led to interest in developing interventions with novel mechanisms of action that are better tolerated and more suitable for long-term use. FLEXISEQ is an innovative, drug-free pain-relieving gel that is applied to the surface of the skin of joints that are painful because of OA. The gel contains lipid vesicles with a phospholipid bilayer, known as Sequessome vesicles, which are capable of passing through the skin permeability barrier. 8,9 The vesicles are not cleared by the cutaneous capillaries due to their relatively large size. Sequessome vesicles continue to penetrate while being transported with the interstitial fluid into deeper tissues below the site of dermal application. 10,11 The physical mode of action of FLEXISEQ combined with the absence of pharmaceutically active ingredients means that FLEXISEQ is classified as a medical device. 12 Data from an extensive clinical programme in over 1600 patients have demonstrated the efficacy and tolerability of this topical gel, one study showing comparable efficacy to celecoxib a routinely prescribed oral NSAID. FLEXISEQ is currently available in pharmacies in Germany. The goals of the study were to assess the effect of FLEXISEQ when used by arthritis sufferers in a daily routine setting, and to understand their views on the benefits and attributes of the product. The study was conducted by Feierabend a community for older people with members that has a goal of providing information of particular relevance (eg news, health, financial, travel) to its members. Within the organisation there is a group that focuses on evaluating the experience of new products in order to have firsthand feedback from arthritis sufferers. Survey methods Following completion of a screening questionnaire, which was designed to confirm that respondents had OA, 390 subjects were recruited to take part in the online survey. The subjects completed a baseline survey, including questions regarding their OA, symptoms, previous treatments tried, current treatments used and extent of pain and stiffness (using a Visual Analogue Scale (VAS) of 1 10). The subjects were then provided with two tubes of

4 FLEXISEQ which they were asked to apply to a reference joint as directed in the Instructions for Use. Subjects were asked to complete the survey on a weekly basis until all the gel had been used. During the survey, subjects were not requested to alter their current medication routines, although they could do so if they wished. They were asked to record all medication changes and also any perceived side effects. Results Baseline characteristics of the subjects recruited to the survey Of the 390 subjects with OA who were recruited to the survey, 101 (26.0%) were male and 289 (74.0%) were female. The average age of the respondents was years (range years).comorbid conditions were reported by 334 (85.6%) subjects with the most frequently reported condition being hypertension in 178 (45.6%) subjects. Other comorbid conditions included frequent indigestion and asthma in 61 (15.6%) and 41 (10.5%) subjects, respectively. Six (1.5%) subjects reported having a peptic ulcer or gastrointestinal bleed. Overall, 381 subjects specified the joints that were affected by OA. The majority (318; 83.5%) had OA affecting more than one joint, with the knees and wrist/hand being the most frequently reported affected joints (Table 1). Table 1: Affected joints Knee, Elbow, Shoulder, Hip, Wrist/hand, Other, Left Right Left Right Left Right Left Right Left Right 218 (57.1) 225 (59.1) 24 (6.2) 31 (8.1) 66 (17.3) 79 (20.7) 87 (22.8) 81 (21.2) 139 (36.5) 151 (39.6) 120 (31.4) Subjects reported that they were using a variety of medications and interventions for their OA with many subjects trying more than one technique or medication (Table 2). Around one third (32.3%) reported using over-the-counter topical treatments and nearly one fifth (17.4%) reported taking over-the-counter tablets. Only 26 (6.8%) subjects did not report any current treatments or interventions. Table 2: Current OA treatments and interventions Physiotherapy, 86 (22.1) Weight reduction, 107 (27.4) Fitness training, 165 (42.3) Injections, 32 (8.2) POM tablets, n (%) 38 (9.7) POM topical, 56 (14.4) OTC tablets, 68 (17.4) OTC topical, 126 (32.3) Surgery, 14 (3.25)

5 POM = prescription only medication; OTC = over the counter. For the 288 subjects currently taking medication for their OA, 69 (24.0%) reported some side effects of which stomach ache was the most frequently listed (21 subjects; 7.3%). Treatment with FLEXISEQ From the enrolled population of 390 subjects, 334 used FLEXISEQ at least once, and after 1, 2 and 3 weeks, 333, 248 and 177 subjects were still using FLEXISEQ, respectively. A variety of reasons were given for stopping treatment, including side effects (discussed later) and finishing the two tubes of FLEXISEQ gel. Although subjects were requested to use the gel on one index joint only, 172 (51.5%) reported using the gel on one or more joints. The joints that were treated are listed in Table 3. Table 3: Joints treated with FLEXISEQ Knee, n Elbow, n Wrist, n Shoulder, Ankle, n Finger, n Other, n (%) (%) (%) (%) (%) (%) 222 (66.5) 21 (6.3) 57 (17.1) 59 (17.7) 35 (10.5) 91 (27.2) 87 (26.0) Among the total population, the average baseline pain was 6.92 and the average baseline stiffness was These values were similar to the baseline values of the subjects who completed 3 weeks treatment (6.85 for pain and 5.29 for stiffness), which indicated that the 3-week completers were representative of the entire dataset and provided the opportunity to evaluate the effect of FLEXISEQ on pain and stiffness in a subset of subjects who had received 3 weeks treatment. Analysis of pain and stiffness in the index joint following 3-weeks treatment with FLEXISEQ Three weeks of treatment saw a decrease of the average pain score by 2.13 (31.1%) and an improvement in the average stiffness score of 1.52 (28.7%) (Figure 1).

6 Figure 1: Average VAS scores for pain and stiffness over 3 weeks of treatment with FLEXISEQ Responder analysis After 3 weeks of treatment with FLEXISEQ, 73.4% and 57.1% of subjects reported a 1 point or 2 point improvement in pain in their index joint, respectively, while 64.8% and 46.1% of subjects reported a 1 point or 2 point improvement in stiffness in their index joint, respectively. Although very few patients reported when they initially started to see a beneficial effect, over half (52.8%) reported an improvement of 1 point after one week of treatment. Analysis of the response according to the level of starting pain indicated that the most pronounced improvements in pain were observed in the subjects with moderate or higher pain at baseline (Table 4). Table 4: Analysis of effect according to baseline pain Starting pain Average starting pain score No subjects Av delta at 3 weeks Av delta as % of starting score

7 Safety and tolerability No serious issues associated with the use of FLEXISEQ were reported. Among the 177 subjects completing 3 weeks of treatment, 18 (10.2%) reported 22 side effects. However, the majority of side effects that were reported reflected the intended effects of the medication on pain, and should therefore not have been listed as side effects. These included improvements in pain (38.1%) and no improvements/change in pain (19.0%). Overall, among the 177 individuals who completed 3 weeks of treatment with FLEXISEQ, there were only seven patients (4.0%) who reported events that would normally be considered side effects. All of these were application site reactions consisting of localised effects and skin irritations. Subject feedback In an analysis of feedback on the product, 97% of respondents reported that FLEXISEQ was equal or better than other products with respect to its effects on pain, while 74% reported that it was slightly or much better (Table 5). Similarly, with respect to stiffness, 99% reported that FLEXISEQ was equal or better than other OA products, while 67% reported that it was slightly or much better. Overall, 94% of respondents reported that FLEXISEQ was equally or better tolerated than other products while over half of respondents reported that it was slightly or much better. A similar pattern was observed when respondents were questioned about ease of use with FLEXISEQ compared with other products, with only 8% reporting that the formulation was worse than other products. Table 5: Respondent views on FLEXISEQ compared with other OA products Pain (131/177), n (%) Stiffness (124/177), n (%) Side effects (108/177), n (%) Ease of use (125/177), n (%) Worse 4 (3) 1 (1) 6 (6) 10 (8) Equal 31 (24) 40 (32) 44 (41) 53 (42) Slightly 52 (40) 45 (36) 17 (16) 26 (21) better Much better 44 (34) 38 (31) 41 (38) 36 (29) Respondents were asked whether they would recommend FLEXISEQ to a friend, to which 69% of patients who had used it for 3 weeks responded Definitely or Probably (Table 6). Similarly, among the whole population, among the 230 individuals who responded, 66% said that they would definitely or probably recommend FLEXISEQ to a friend.

8 Table 6: Likelihood that respondents would recommend FLEXISEQ to a friend Likelihood of recommending to a friend Patients treated for 3 weeks (131/177) Total population (230/390) 0 Definitely not Probably not Not likely Maybe Probably Definitely yes Discussion The findings from this survey-based observational study indicate that FLEXISEQ gel is effective for the treatment of pain and stiffness associated with OA in a community of older people. With 3 weeks of treatment, average pain and average stiffness scores decreased by 31.1% and 28.7%, respectively. The response rates showed that around three-quarters of patients are likely to experience benefit. It is important however, to consider both the advantages and limitations of the study design. As this was a non-controlled trial, patients could continue their normal OA medication and there was no monitoring of whether individuals increased or decreased this medication or indeed started other therapies during the observational period. As such, the findings reflect how patients use these medications in the real-world setting, with natural fluctuations in usage/compliance, and the potential use of other interventions, for example over-the-counter NSAIDs. In this study, however, only 8% of the respondents with 3 weeks' data reported that they altered their medication (started taking, changed any doses or stopped taking any medicines), and as a consequence this is unlikely to have influenced the findings in this study. As the study was non-blinded, patients were aware that they were using a new active treatment and being monitored, which may have influenced their views on the product. Despite these limitations, the pain and stiffness values are broadly consistent with the extensive trial data available, which ranged from 37.8 to 49.5% reductions for pain and 24.2 to 43.8% reductions in stiffness Of note, the reductions in pain and stiffness are also comparable with the data reported for the oral NSAIDs that are routinely used by these patients. 17,18 In addition to the efficacy findings, FLEXISEQ was well tolerated with the main side effect being local and skin irritation. Again this was similar to the findings from clinical trials where the main side effects typically involved the skin and were mild to moderate in intensity. Interestingly, many patients recorded improvement in pain as a side effect even though this was the key efficacy outcome. No cardiovascular or renal adverse events were reported

9 during the observational trial, which was again consistent with the clinical trial findings and not unexpected based on the non-pharmacological mechanism of action of FLEXISEQ. The efficacy findings in this observational study and those of the clinical trials suggest that FLEXISEQ represents an effective alternative to the NSAIDs that are the mainstay treatments for OA. NSAIDs, while effective for the pain associated with OA, are associated with significant toxicities, at all doses and even with short-term use. Classic NSAIDs carry a substantial risk of upper and lower gastrointestinal events, varying from mild symptoms to gastroduodenal ulcers and related serious complications. 19 This risk increases with advancing age and concomitant treatment with many agents frequently used in elderly populations, including corticosteroids, aspirin and anticoagulants. 20 The cyclooxygenase-2 selective inhibitors have a more favourable gastrointestinal safety profile, but serious concerns about their cardiovascular toxicity, particularly in relation to increased risk of heart attacks and strokes, have led to regulatory warnings. 21 For example, a recent review among patients aged 65 years found an increase in myocardial infarction (MI) rate from 3.9 per 1000 person-years in absence of NSAIDs to 12.2 per 1000 person-years for patients receiving treatment with highly COX-2 selective NSAIDs and per 1000 person-years receiving treatment with low-to-moderate selective NSAIDs. 22 As a consequence of these toxicities and contraindications, oral NSAIDs are contraindicated or can only be used with caution in many individuals needing long-term treatment for pain. It is therefore of interest that many of the respondents in this study reported concomitant health problems for example, 45.6% of the enrolled subjects reported that they have hypertension and 41.4% of these reported taking oral prescription tablets to treat symptoms for their OA. The majority of prescription tablets are likely to be oral NSAIDs; however, the figure does not account for the subjects using the NSAIDs readily available over the counter. This is of particular note, as NSAIDs raise blood pressure in both normotensive and hypertensive individuals and also can reduce the effect of all antihypertensive drugs except calcium channel blockers. 23,24 As FLEXISEQ contains no active pharmaceutical ingredients, providing efficacy only by physical means, it is not associated with adverse drug reactions. This allows FLEXISEQ to be safely used in individuals with comorbid conditions treated with drugs that are contraindicated for use with NSAIDs. In addition, FLEXISEQ can be used concomitantly with NSAIDs, which may permit individuals to reduce their NSAID doses and thus reduce the risk of NSAID-associated adverse events. It is of interest that the majority of respondents were using a wide range of interventions to manage their OA and many of the respondents were using more than one intervention, which may suggest an overall dissatisfaction with the current options.

10 The benefits of FLEXISEQ were clearly reflected in the respondent feedback on the product with 97% and 99% of respondents reporting that the formulation was equal or better than other products with respect to its effects on pain and stiffness, respectively, and 94% reporting that FLEXISEQ was equal or better than other products with respect to side effects. Moreover around two-thirds would recommend the product to a friend. In conclusion, although this was a simple, non-controlled, observational study with its associated limitations, the findings add to the body of clinical data demonstrating that FLEXISEQ is an effective treatment option for patients with OA. The drug-free formulation means that the relief of pain and stiffness can be achieved without the risks associated with oral NSAIDs that currently represent the mainstay of OA treatment. This is an important attribute given that OA is prevalent among the elderly who frequently present with comorbid conditions and risk factors, and are often receiving drugs that should not be taken in combination with oral NSAIDs.

11 References 1. Bitton R. The economic burden of osteoarthritis. Am J Manag Care 2009 Sep;15(8 Suppl.):S Moskowitz RW. The burden of osteoarthritis: clinical and quality-of-life issues. Am J Manag Care 2009 Sep;15(8 Suppl.):S World Health Organization. Chronic rheumatic conditions, fact sheet, Available at: Accessed 04 March Sivan S, Schroeder A, Verberne G, et al. Liposomes act as effective biolubricants for friction reduction in human synovial joints. Langmuir 2010;26: Hills BA, Monds MK. Deficiency of lubricating surfactant lining the articular surfaces of replaced hips and knees. Br J Rheumatol 1998;37: Burmester G, Lanas A, Biasucci L, et al. The appropriate use of non-steroidal antiinflammatory drugs in rheumatic disease: opinions of a multidisciplinary European expert panel. Ann Rheum Dis 2011 May;70(5): doi: /ard Epub 2010 Sep Vonkeman HE, van de Laar MA. Nonsteroidal anti-inflammatory drugs: adverse effects and their prevention. Semin Arthritis Rheum 2010 Feb;39(4): Cevc G, Blume G. Lipid vesicles penetrate into intact skin owing to the transdermal osmotic gradients and hydration force. Biochim Biophys Acta 1992;1104: Cevc G, Gebauer D. Hydration-driven transport of deformable lipid vesicles through fine pores and the skin barrier. Biophys J 2003;84: Cevc G, Vierl U. Spatial distribution of cutaneous microvasculature and local drug clearance after drug application on the skin. J Control Release 2007;118: Cevc G, Vierl U. Nanotechnology and the transdermal route: a state of the art review and critical appraisal. J Control Release 2010;141: European Commission. DG Enterprise and Industry, Directorate F, Unit F3 Cosmetics and medical devices, Medical Device Guidance Document (MEDDEV) 2.1/3 rev 3 Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative. 21 September Conaghan P, Dickson JD, Bolten W, et al. A large randomised, controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel with oral

12 celecoxib for osteoarthritis knee pain. Abstract no. EULAR presented at the Annual EULAR Congress Rother M, Lipetz R, Dunmyer S. A double-blind, randomised, placebo-controlled trial to evaluate the safety and efficacy of epicutaneously applied ketoprofen in Transfersome gel for the treatment of pain associated with osteoarthritis (OA) of the knee. Abstract no. EULAR presented at the Annual EULAR Congress Conaghan PG, Dickson J, Bolten W, et al. A multicentre, randomised, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology Manuscript in press. 16. Rother M, Yeoman G, Ekman E. Double-blind, placebo-controlled trial comparing the safety and efficacy of epicutaneously applied ketoprofen in Transfersome gel with naproxen for the treatment of pain associated with osteoarthritis (OA) of the knee. Abstract no. EULAR presented at the Annual EULAR Congress McKenna F, Borenstein D, Wendt H, et al. Celecoxib versus diclofenac in the management of osteoarthritis of the knee. Scand J Rheumatol 2001;30: Bensen WG, Fiechtner JJ, McMillen JI, et al. Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial. Mayo Clin Proc 1999;74: Schoenfeld P, Kimmey MB, Scheiman J, et al. Review article: nonsteroidal antiinflammatory drug-associated gastrointestinal complications guidelines for prevention and treatment. Aliment Pharmacol Ther 1999;13: Singh G. Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. Am J Ther 2000;7: Rostom A, Muir K, Dubé C, et al. Gastrointestinal safety of cyclooxygenase-2 inhibitors: a Cochrane collaboration systematic review. Clin Gastroenterol Hepatol 2007;5: Abraham NS, El-Serag HB, Hartman C, et al. Cyclooxygenase-2 selectivity of nonsteroidal anti-inflammatory drugs and the risk of myocardial infarction and cerebrovascular accident. Aliment Pharmacol Ther 2007;25: Warner TD, Mitchell JA. COX-2 selectivity alone does not define the cardiovascular risks associated with non-steroidal anti-inflammatory drugs. Lancet 2008 Jan 19;371(9608):270 3.

13 24. White WB. Cardiovascular effects of the cyclooxygenase inhibitors. Hypertension 2007 Mar;49(3):

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