The efficacy, safety and carry-over effect of diacerein in the treatment of painful knee osteoarthritis: a randomised, double-blind, NSAID-controlled study

SummaryObjectiveTo evaluate the efficacy, safety and carry-over effect of diacerein, in comparison to piroxicam, in the treatment of Thai patients with symptomatic knee osteoarthritis (OA).DesignThis was a double-blind, randomised, piroxicam-controlled, parallel-group study. A 7-day non-steroidal anti-inflammatory drug washout period was followed by a 16-week treatment period with either diacerein 100mg/day or piroxicam 20mg/day, and an 8-week treatment-free observation period. The primary efficacy criterion was pain on Western Ontario and McMaster University Osteoarthritis (WOMAC) A. The secondary criteria included WOMAC B, C and total WOMAC, paracetamol intake, Short Form-36 questionnaire and global judgements on efficacy and tolerability by patients and investigators.ResultsOf 171 randomised patients, 150 completed the study and 161 were analysed in the intent-to-treat population (diacerein: 82, piroxicam: 79). Pain (WOMAC A) decreased to a similar extent in both groups at Week 16 (diacerein: −69.7%±31.5%; piroxicam: −74.1±26.2%; P=n.s.). On treatment discontinuation, pain increased in the piroxicam group at Weeks 20 (−47%±47.8%) and 24 (−26.8%±60.6%) while improvements persisted in the diacerein group at Weeks 20 (−66.9%±35.9%) and 24 (−69.5%±33.7%), with a significant difference in favour of diacerein at Weeks 20 and 24, demonstrating the carry-over effects of the drug. The incidence of adverse events was similar in both groups but more patients from the piroxicam group dropped out of the study due to these events.ConclusionsDiacerein was as effective as piroxicam in reducing pain and improving function but, unlike piroxicam, displayed a carry-over effect and a better safety profile

Effect of patient education on medication adherence of patients with rheumatoid arthritis: a randomized controlled trial

Nichapa Taibanguay, Sumapa Chaiamnuay, Paijit Asavatanabodee, Pongthorn Narongroeknawin Division of Rheumatology, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand Purpose: There is a general understanding that patient educational interventions for enhancing medication adherence are important. However, their success at improving adherence is debatable. This study aimed to assess the influence of different modes of patient education on medication adherence in patients with rheumatoid arthritis (RA).Materials and methods: One hundred and twenty RA patients with non-adherence, defined as pill count ≤80% or medication-taking behavior questionnaire for Thai patient ≤23, were randomized by block randomization and assigned in a 1:1 allocation ratio to two study arms: multi-component intervention group or single intervention group. The multi-component intervention group received 30-minute directed counseling and a disease information pamphlet. The single intervention group received only a disease information pamphlet. The primary outcomes were an improvement in an adherence rate measured by pill count after 12 weeks. The Thai Clinical Trial Registry number is TCTR20171207003.Results: After 12 weeks, the pill count adherence rate increased significantly from baseline in both study groups. In the multi-component intervention group, adherence rate increased from 92.21±14.05 to 97.59±10.07 (P=0.002) and in the single intervention group, it increased from 88.60±19.66 to 92.42±14.27 (P=0.044). However, the mean difference between the multi-component intervention group and the single intervention group was not significant (5.38±12.90 vs 3.18±14.23, P=0.531). Clinical outcomes, including disease activity score 28, EuroQoL-5D, EuroQol visual analog scale, pain score, and physician global assessment were unchanged from baseline in both groups.Conclusion: Patient education significantly improved adherence. However, there were no differences between single education intervention and multi-component education intervention in improving medication adherence. Provision of a disease information pamphlet with or without directed counseling can equally enhance medication adherence of patients with RA. Keywords: adherence, rheumatoid arthritis, education, disease pamphle

Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial.

Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; OPTION Investigators. Collaborators (76)Tate G, Maldonado-Cocco JA, Scali J, Taylor A, Hanrahan P, Nash P, Smith M, Smolen J, Koeller M, Smolen J, Eberl G, Dunky A, Zamani O, Simon JC, Scheinberg MA, Yaneva D, Oparanov B, Karastatev D, Atkins C, Beaulieu A, Bell M, Haraoui B, Marin L, Thorne JC, Zummer M, Khraishi M, McKendry RJ, Pandith V, McCarthy T, Lau CS, Li E, Mok CC, Kahan A, Wendling D, Bardin T, Nguyen M, Claudepierre P, Berenbaum F, Puechal X, Alten R, Fiehn C, Heilig B, Hellmich B, Lange U, Lorenz HM, Rubbert-Roth A, Wendler J, Czirijak L, Hodinka L, Szekanecz Z, Molad Y, Nahir M, Rosner I, Rubinow A, Abu Shakra M, Elkayam O, Marcolongo R, Bagnato G, Triolo G, Trotta F, de Vita S, Ramos-Remus C, Lugo GE, Abud-Mendoza C, Pineca C, de la Torre IG, Pacheco C, Leong KH, Koh DR, Rovensky J, Dudler J, Villiger P, Lothrenoo W, Asavatanabodee P, Nilganuwong S, Totemchokchaiyakarn K. SourceDivision of Rheumatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. [email protected] Abstract BACKGROUND: Interleukin 6 is involved in the pathogenesis of rheumatoid arthritis via its broad effects on immune and inflammatory responses. Our aim was to assess the therapeutic effects of blocking interleukin 6 by inhibition of the interleukin-6 receptor with tocilizumab in patients with rheumatoid arthritis. METHODS: In this double-blind, randomised, placebo-controlled, parallel group phase III study, 623 patients with moderate to severe active rheumatoid arthritis were randomly assigned with an interactive voice response system, stratified by site with a randomisation list provided by the study sponsor, to receive tocilizumab 8 mg/kg (n=205), tocilizumab 4 mg/kg (214), or placebo (204) intravenously every 4 weeks, with methotrexate at stable pre-study doses (10-25 mg/week). Rescue therapy with tocilizumab 8 mg/kg was offered at week 16 to patients with less than 20% improvement in both swollen and tender joint counts. The primary endpoint was the proportion of patients with 20% improvement in signs and symptoms of rheumatoid arthritis according to American College of Rheumatology criteria (ACR20 response) at week 24. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00106548. FINDINGS: The intention-to-treat analysis population consisted of 622 patients: one patient in the 4 mg/kg group did not receive study treatment and was thus excluded. At 24 weeks, ACR20 responses were seen in more patients receiving tocilizumab than in those receiving placebo (120 [59%] patients in the 8 mg/kg group, 102 [48%] in the 4 mg/kg group, 54 [26%] in the placebo group; odds ratio 4.0 [95% CI 2.6-6.1], p<0.0001 for 8 mg/kg vs placebo; and 2.6 [1.7-3.9], p<0.0001 for 4 mg/kg vs placebo). More people receiving tocilizumab than those receiving placebo had at least one adverse event (143 [69%] in the 8 mg/kg group; 151 [71%] in the 4 mg/kg group; 129 [63%] in the placebo group). The most common serious adverse events were serious infections or infestations, reported by six patients in the 8 mg/kg group, three in the 4 mg/kg group, and two in the placebo group. INTERPRETATION: Tocilizumab could be an effective therapeutic approach in patients with moderate to severe active rheumatoid arthritis. FUNDING: F Hoffmann-La Roche, Chugai Pharmaceutical

Psoriasis : State of the art 2013 Part II :Therapeutics

The treatment of psoriasis is mainly based on anti-inflammatory and/or anti-hyperproliferative agents. The topical steroids appeared in the fifties and were the first therapeutic breakthrough for psoriasis, followed by methotrexate and phototherapy in the sixties, photochemotherapy (PUVA) in the seventies and acitretin and cyclosporine in the eighties. The targeted biologic therapies represent a whole new era of therapeutic possibilities with a highly beneficial safety record. The choice of treatment depends on a large series of factors, including the type and extend of the psoriasis, the patient's preferences, co-medications, comorbidities and drug tolerance. This overview presents the currently available topical and systemic agents for treating psoriasis, including topical corticosteroids, vitamin D derivatives, UV-light based therapies, methotrexate, cyclosporine, acitretin, and the biologic agents such as the TNF antagonists etanercept, adalimumab and infliximab, as well as the anti-p40 IL12/23 agent ustekinumab. Newer, very promising, agents aiming the Th17 pathway are under development for psoriasis