Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis

Background/objective: The objective of this study was to investigate the safety and efficacy of subcutaneous (SC) and intravenous (IV) tanezumab administration in osteoarthritis (OA) patients. Materials and methods: Study 1027 (NCT01089725), a placebo-controlled trial, evaluated the efficacy of SC tanezumab (ie, 2.5, 5, and 10 mg) and the therapeutic equivalence of 10 mg tanezumab given subcutaneously versus intravenously every 8 weeks in the symptomatic treatment of OA. Coprimary endpoints were: change from baseline in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) Pain and Physical Function indices, and Patient\u27s Global Assessment (PGA) of OA. Study 1043 (NCT00994890) was a long-term, noncontrolled safety study of tanezumab (ie, 2.5, 5, and 10 mg) subcutaneously administered every 8 weeks. Both studies were discontinued prematurely due to a US Food and Drug Administration partial clinical hold. Results: Due to the clinical hold, Study 1027 was underpowered, and no statistical analyses were performed. Mean (standard error [SE]) change from baseline to week 8 in WOMAC Pain in tanezumab groups ranged from -3.59 (0.26) to -3.89 (0.32), versus -2.74 (0.25) with placebo. Mean (SE) change from baseline to week 8 in WOMAC Physical Function ranged from -3.13 (0.25) to -3.51 (0.28) with tanezumab and was -2.26 (0.24) with placebo. PGA mean (SE) change from baseline to week 8 ranged from -0.90 (0.11) to -1.08 (0.12) with tanezumab and was -0.78 (0.10) with placebo. Similar effectiveness was associated with tanezumab in Study 1043. Few patients in either study (1.4%-5.2%) discontinued due to adverse events. Five patients required total joint replacements in Study 1027 (placebo, n=2 [2.8%]; tanezumab 2.5 mg, n=3 [4.1%]) and 34 patients in Study 1043 (tanezumab 2.5 mg, n=11 [4.8%]; tanezumab 5 mg, n=8 [3.6%]; tanezumab 10 mg, n=15 [6.6%]). Conclusion: Preliminary results show similar efficacy and safety for both SC and IV administration of tanezumab based on the direct comparisons reported here and indirect comparisons with published results, confirming pharmacokinetic/pharmacodynamic modeling predictions

Ganglions of the proximal interphalangeal joint.

Ganglions of the proximal interphalangeal joint are uncommon. Six patients (nine ganglions) were treated surgically. The lesions presented on the ulnar aspect of the extensor mechanism between the lateral band and the central slip and communicated with the joint by means of a stalk. Mild degenerative joint disease was noted in each case. Surgical excision provided relief of symptoms, and no patient has experienced any recurrence to date

Experience, organisations and bodies at Vatican II. proceedings of the Bologna Conference, december 1996

The volume presented here gathers some of the contributions of the 1996 meeting in Bologna. In addition to essays of a more methodological approach, important work is presented on the bishoprics, the sources and on the bodies of the council. Bringing the studies together reveales how they complement each other. This, in turn, not only identifies gaps in our documentation which might be filled with further effort but also indicates new paths for further research. Futhermore, these essays demonstrate the variegated seriousness with which the many participants in this international undertaking have interpreted the work of the historian vis-à-vis Vatican II. Therefore, it was possible for the Bologna study to explore the roles of groups and episcopal conferences whose institutional shape and whose self-awareness must be traced back to that fundamental experience represented by the Council. It has been possible to examine the role of leading figures and to give private sources their due. Through them it is possible to understand better not only the dynamics of the events but also the degree of self-awareness with which they were lived through. Finally, other articles, which are partial results of studies in progress, reconstruct how the discussions went in some of the Council commissions