Based on data from Study 1, Japanese patients who received tanezumab 2.5?mg and 5?mg showed improvements from baseline to Week 16 in WOMAC Pain subscale score, WOMAC Physical Function subscale score, and PGA-OA score. in the European Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score and WOMAC Physical Function subscale score at Week 16 (overall study and Japan-specific endpoints) as well as Patient Global Assessment (PGA)-OA score at Week 16 (overall study endpoint only). In Study 2 (“type”:”clinical-trial”,”attrs”:”text”:”NCT02709486″,”term_id”:”NCT02709486″NCT02709486), individuals received subcutaneous tanezumab 2.5?mg, 5?mg, or placebo every 8?weeks for 24?weeks. Security monitoring included adjudicated composite joint security endpoint (CJSE) including rapidly progressive osteoarthritis type 1 (RPOA1), RPOA2, main osteonecrosis, pathological fracture, or subchondral insufficiency fracture. Results For Study Rabbit Polyclonal to TUT1 1, Japanese individuals (nonsteroidal anti-inflammatory drug Table 1 Baseline characteristics for Japanese individuals enrolled in Study 1 (%)?Male21 (28.4)22 (37.3)24 (35.8)?Woman53 (71.6)37 (62.7)43 (64.2)Age, years?Mean (SD)65.7 (9.3)66.7 (8.0)63.6 (9.9)?Range40C8652C8542C88Body mass index, kg/m2?Mean (SD)26.9 (3.9)26.4 (3.7)27.1 (4.2)?Range16C3620C3719C36Duration of OAa, years?Mean4.03.64.0?Range0C190C150C28Index joint, (%)?Hip5 (6.8)7 (11.9)7 (10.4)?Knee69 (93.2)52 (88.1)60 (89.6)Kellgren-Lawrence gradeb of index GSK621 joint, (%)?0 or 1000?26 (8.1)6 (10.2)7 (10.4)?339 (52.7)39 (66.1)40 (59.7)?429 (39.2)14 (23.7)20 (29.9)WOMAC Pain subscale scorec?Mean (SD)6.7 (0.8)6.7 (1.2)6.6 (1.0)?Range5C95C105C9WOMAC Physical Function subscale scorec?Mean (SD)6.7 (0.9)6.9 GSK621 (1.1)6.6 (1.0)?Range5C95C105C10PGA-OA scored?Mean (SD)3.3 (0.5)3.5 (0.6)3.3 (0.5)?Range3C53C53C4PGA-OA level categoryd, (%)?Very good000?Good000?Fair53 (71.6)31 (52.5)48 (71.6)?Poor19 (25.7)26 (44.1)19 (28.4)?Very poor2 (2.7)2 (3.4)0Prior analgesic treatments for OA pain, (%)e?Celecoxib73 (98.6)56 (94.9)64 (95.5)?Paracetamol64 (86.5)52 (88.1)51 (76.1)?Hyaluronate sodium37 (50.0)23 (39.0)30 (44.8)?Loxoprofen sodium dihydrate34 (45.9)26 (44.1)31 (46.3)?Paracetamol/tramadol hydrochloride30 (40.5)21 (35.6)24 (35.8)?Ketoprofen17 (23.0)10 (16.9)15 (22.4)?Diclofenac sodium9 (12.2)7 (11.9)8 (11.9)?Tramadol hydrochloride8 (10.8)7 (11.9)2 (3.0) Open in a separate window nonsteroidal anti-inflammatory drug, osteoarthritis, Patient’s Global Assessment of OA, standard deviation, Western Ontario and McMaster Universities Osteoarthritis Index aDuration from 1st analysis of OA of any joint, including index joint and non-index bones bKellgren-Lawrence grade for OA severity classification is rated from 0 (no OA) to 4 (severe OA) cWOMAC Pain and Physical Function subscales are scored on an 11-point numeric rating level from 0 to 10 (higher scores indicate greater pain intensity or worse physical function) dPGA-OA is scored on a 5-point GSK621 Likert level from 1 (very good) to 5 (very poor) ePrior analgesic treatments for OA pain in??10% of patients in any treatment group In the pooled safety population from both studies, 306 Japanese patients were analyzed for safety (placebo, (%)?Male11 (32.4)31 (27.7)33 (35.5)24 (35.8)?Female23 (67.6)81 (72.3)60 (64.5)43 (64.2)Age, years?Mean (SD)64.2 (10.6)66.0 (8.8)66.5 (8.0)63.6 (9.9)?Range34C8440C8652C8542C88Body mass index, (%)? ?25?kg/m213 (38.2)40 (35.7)35 (37.6)24 (35.8)?25 to? ?30?kgm213 (38.2)48 (42.9)45 (48.4)26 (38.8)?30 to? ?35?kgm28 (23.5)20 (17.9)10 (10.8)14 (20.9)???35?kg/m204 (3.6)3 (3.2)3 (4.5)Duration of OA, years?Mean (SD)3.2 (4.3)3.5 (4.2)3.4 (3.8)4.0 (5.5)?Range0C160C190C150C27Index joint, (%)?Hip4 (11.8)8 (7.1)12 (12.9)7 (10.4)?Knee30 (88.2)104 (92.9)81 (87.1)60 (89.6)Kellgren-Lawrence gradea of index joint, (%)?0 or 10000?23 (8.8)7 (6.3)10 (10.8)7 (10.4)?318 (52.9)60 (53.6)56 (60.2)40 (59.7)?413 (38.2)45 (40.2)27 (29.0)20 (29.9)WOMAC Pain subscale scoreb?Mean (SD)6.4 (1.1)6.7 (0.9)6.7 (1.1)6.5 (1.0)?Range4C95C95C105C9WOMAC Physical Function subscale scoreb?Mean (SD)6.5 (1.0)6.7 (0.9)6.8 (1.0)6.6 (1.0)?Range5C95C95C105C10PGA-OA scorec?Mean (SD)3.3 (0.5)3.3 (0.5)3.5 (0.6)3.3 (0.5)?Range3C43C53C53C4PGA-OA level categoryc, (%)?Very good0000?Good0000?Fair23 (67.6)79 (70.5)49 GSK621 (52.7)48 (71.6)?Poor11 (32.4)31 (27.7)39 (41.9)19 (28.4)?Very poor02 (1.8)5 (5.4)0 Open in a separate window nonsteroidal anti-inflammatory drug, osteoarthritis, Patient’s Global Assessment of OA, standard deviation, Western Ontario and McMaster Universities Osteoarthritis Index aKellgren-Lawrence grade for OA severity classification is rated from 0 (no OA) to 4 (severe OA) bWOMAC Pain and Physical Function subscales are scored on an 11-point numeric rating level from 0 to 10 (higher scores indicate greater pain intensity or worse physical function) cPGA-OA is scored on a 5-point Likert level from 1 (very good) to 5 (very poor) Effectiveness: Study 1 At Week 16, Japanese individuals treated with tanezumab 2.5?mg and 5?mg showed improvements in WOMAC Pain and Physical Function subscale scores and PGA-OA scores that were numerically greater than observed in the individuals treated with NSAIDs (Table ?(Table33). Table 3 Change from baseline to Week 16 in WOMAC Pain subscale score, WOMAC Physical Function subscale score, and PGA-OA score for Japanese individuals enrolled in Study 1 confidence interval, least squares, nonsteroidal anti-inflammatory drug, Patient’s Global Assessment of Osteoarthritis, standard deviation, standard error, European Ontario and McMaster Universities Osteoarthritis Index aWOMAC Pain and Physical Function subscales are obtained on an 11-point numeric rating level from 0 to 10 (higher scores indicate greater pain intensity or worse physical function) bPGA-OA is definitely scored on a 5-point Likert level from 1 (very good) to 5 (very poor) Overall Security: Study 1 In total, 200 Japanese individuals were randomized to tanezumab 2.5?mg ((%)nonsteroidal anti-inflammatory drug, treatment-emergent adverse event aA serious TEAE was defined.
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