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Last Updated: March 28, 2024

Claims for Patent: 6,599,873


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Summary for Patent: 6,599,873
Title: Interleukin-1 inhibitors, compositions, and methods of treatment
Abstract:Interleukin-1 inhibitors are provided. Compositions comprising an interleukin-1 inhibitor are provided. Methods of treating a patient comprising administering an interleukin-1 inhibitor are provided.
Inventor(s): Sommer; Andreas (Concord, CA), Hannum; Charles H. (Boulder, CO), Eisenburg; Stephen P. (Boulder, CO), Thompson; Robert C. (Boulder, CO), Arend; William P. (Denver, CO), Joslin; Fenneke G. (Denver, CO)
Assignee: Amgen Inc. (Thousand Oaks, CA) The Regents of the University of Colorado (Boulder, CO)
Application Number:08/468,425
Patent Claims:1. An interleukin-1 inhibitor (IL-1i), comprising a glycosylated or nonglycosylated polypeptide having interleukin-1 (IL-1) inhibitory activity and being free of other human protein, wherein said polypeptide is selected from the group consisting of: A) a polypeptide comprising all or an IL-1 inhibitory fragment of the amino acid sequence:

2. The IL-1i of claim 1, wherein the amino acid sequence of said polypeptide is at least about 95% homologous to the following amino acid sequence:

3. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 2.

4. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 2.

5. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 2.

6. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 2.

7. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 2.

8. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 2.

9. The IL-1i of claim 1, wherein the amino acid sequence of said polypeptide is at least about 90% homologous to the following amino acid sequence:

10. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 9.

11. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 9.

12. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 9.

13. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 9.

14. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 9.

15. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 9.

16. The IL-1i of claim 9, wherein the IL-1i is recombinantly made by a host cell not capable of glycosylation or a non-human host cell.

17. The IL-1i of claim 16, wherein said host cell is selected from a yeast cell, a mouse Ltk.sup.- cell, and a Chinese hamster ovary cell.

18. The IL-1i of claim 16, wherein said host cell is a prokaryotic cell.

19. The IL-1i of claim wherein said host cell is E. coli.

20. The IL-1i of claim 16, wherein said host cell is a eukaryotic cell.

21. The IL-1i of claim 20, wherein said host cell is a mammalian cell.

22. The IL-1i of claim 20, wherein said host cell is a Chinese hamster ovary cell.

23. The IL-1i of claim 9, wherein said IL-1i is glycosylated.

24. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 23.

25. The IL-1i of claim 9, wherein said IL-1i is nonglycosylated.

26. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 25.

27. The IL-1i of claim 9, wherein (U) is nothing.

28. The IL-1i of claim 9, wherein (U) is M.

29. The IL-1i of claim 1, wherein said IL-1i is a polypeptide comprising all or an IL-1 inhibitory fragment of the amino acid sequence:

30. The IL-1i of claim 21, wherein (X) is R.

31. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 30.

32. The IL-1i of claim 30, wherein said polypeptide inhibits IL-1 induced PGE.sub.2 production.

33. The IL-1i of claim 29, which comprises the following amino acid sequence:

34. The IL-1i of claim 33, wherein (X) is R.

35. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 30.

36. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 34.

37. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 34.

38. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 34.

39. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 34.

40. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 34.

41. The IL-1i of claim 34, wherein (U) is M.

42. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation. a therapeutically effective amount of the IL-1i of claim 41.

43. The IL-1i of claim 34, wherein (U) is nothing.

44. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 43.

45. The IL-1i of claim 34, wherein the IL-1i is recombinantly made by a host cell not capable of glycosylation or a non-human host cell.

46. The IL-1i of claim 45, wherein said host cell is selected from a yeast cell, a mouse Ltk.sup.- cell, and a Chinese hamster ovary cell.

47. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation a therapeutically effective amount of the IL-1i of claim 46.

48. The IL-1i of claim 46, wherein said host cell is a mouse Ltk.sup.- cell.

49. The IL-1i of claim 45, wherein said host cell is a prokaryotic cell.

50. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 49.

51. The IL-1i of claim 49, wherein said host cell is E. coli.

52. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically, effective amount of the IL-1i of claim 51.

53. The IL-1i of claim 45, wherein said host cell is a eukaryotic cell.

54. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 53.

55. The IL-1i of claim 53, wherein said host cell is a mammalian cell.

56. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 55.

57. The IL-1i of claim 53, wherein said host cell is a Chinese hamster ovary cell.

58. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 57.

59. The IL-1i of claim 34 having a purity of at least about 90%.

60. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 59.

61. The IL-1i of claim 34 having a purity of at least about 95%.

62. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 61.

63. The IL-1i of claim 34, wherein said IL-1i is glycosylated.

64. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 63.

65. The IL-1i of claim 34, wherein said IL-1i is nonglycosylated.

66. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 65.

67. The pharmaceutical composition of any of claims 42 or 64, further comprising a collagenase inhibitor.

68. The IL-1i of claim 34, wherein said IL-1i is derived from a host cell comprising a recombinant DNA molecule comprising a sequence encoding said IL-1i.

69. The IL-1i of claim 68, further comprising an N-terminal secretion leader sequence.

70. The IL-1i of claim 69, wherein the leader sequence comprises all or part of the following amino acid sequence:

71. The IL-1i of claim 34, which consists of the following amino acid sequence,

72. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 71.

73. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 71.

74. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 71.

75. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 71.

76. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 71.

77. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 71.

78. The IL-1i of claim 71, wherein (U) is M.

79. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 78.

80. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 78.

81. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 78.

82. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 78.

83. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 78.

84. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 76.

85. The IL-1i of claim 78, wherein said IL-1i is nonglycosylated.

86. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 85.

87. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 85.

88. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 85.

89. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 85.

90. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 85.

91. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 85.

92. The IL-1i of claim 85, wherein the IL-1i is recombinantly made by an E. coli host cell.

93. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 92.

94. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 92.

95. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 92.

96. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 92.

97. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 92.

98. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 92.

99. The IL-1i of claim 92 having a purity of at least about 90%.

100. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 99.

101. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 99.

102. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 99.

103. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 99.

104. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 99.

105. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 99.

106. The IL-1i of claim 92 having a purity of at least about 95%.

107. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 106.

108. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 106.

109. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 106.

110. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 106.

111. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 106.

112. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 106.

113. The IL-1i of claim 71 wherein the IL-1i is recombinantly made by a Chinese hamster ovary host cell.

114. The IL-1i of claim 71 having a purity of at least about 90%.

115. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 114.

116. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 114.

117. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 114.

118. A method of treating a patient having osteoarthritis comprising administering to the patent a therapeutically effective amount of an IL-1 inhibitor according to claim 114.

119. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 114.

120. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 114.

121. The IL-1i of claim 114, wherein said IL-1i is glycosylated.

122. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 121.

123. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 121.

124. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 121.

125. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 121.

126. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 121.

127. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative coitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 121.

128. The IL-1i of claim 71 having a purity of at least about 95%.

129. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 128.

130. A method of treating a patient having arthritis comprising administering to the patent a therapeutically effective amount of an IL-1 inhibitor according to claim 128.

131. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 128.

132. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 128.

133. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering toe patient a therapeutically effective amount of an IL-1 inhibitor according to claim 128.

134. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 128.

135. The IL-1i of claim 71, wherein the IL-1i is recombinantly made by a eukaryotic host cell.

136. The IL-1i of claim 128, wherein said IL-1i is glycosylated.

137. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 136.

138. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 136.

139. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 136.

140. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 136.

141. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 136.

142. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 136.

143. The IL-1i of claim 128, wherein the IL-1i is recombinantly made by a mammalian host cell.

144. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 143.

145. The IL-1i of claim 128, wherein the IL-1i is recombinantly made by a prokaryotic host cell.

146. An interleukin-1 inhibitor (IL-1i), comprising a glycosylated or nonglycosylated polypeptide having interleukin-1 (IL-1) inhibitory activity, wherein said polypeptide is produced by a non-human host cell comprising a recombinant DNA molecule comprising a sequence encoding said polypeptide, and wherein said polypeptide is selected from the group consisting of: A) a polypeptide comprising all or an IL-1 inhibitory fragment of the amino acid sequence:

147. The IL-1i of claim 146 wherein said polypeptide comprises an N-terminal amino acid sequence as follows:

148. The IL-1i of claim 146 wherein said polypeptide comprises the following amino acid sequence:

149. The IL-1i of claim 146 wherein said polypeptide comprises the following amino acid sequence:

150. The IL-1i of claim 146 wherein said polypeptide comprises the following amino acid sequence:

151. The IL-1i of claim 146 wherein said polypeptide comprises the following amino acid sequence:

152. The IL-1i of claim 146 wherein said polypeptide comprises the following amino acid sequence

153. The IL-1i of claim 146 wherein said polypeptide comprises the following amino acid sequence:

154. The IL-1i of claim 146, wherein the amino acid sequence of said polypeptide is at least about 95% homologous to the following amino acid sequence:

155. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 154.

156. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 154.

157. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 154.

158. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 154.

159. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 154.

160. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 154.

161. The IL-1i of claim 146, wherein the amino acid sequence of said polypeptide is at least about 90% homologous to the following amino acid sequence:

162. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 161.

163. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 161.

164. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 161.

165. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 161.

166. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 161.

167. A method of treating a patient having at least one of the Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 161.

168. The IL-1i of claim 161, wherein said host cell is selected from a yeast cell, a mouse Ltk.sup.- cell, and a Chinese hamster ovary cell.

169. The IL-1i of claim 161, wherein said host cell is a prokaryotic cell.

170. The IL-1i of claim 169, wherein said host cell is E. coli.

171. The IL1i of claim 161, wherein said host cell is a eukaryotic cell.

172. The IL-1i of claim 171, wherein said host cell is a mammalian cell.

173. The IL-1i of claim 174, wherein said host cell is a Chinese hamster ovary cell.

174. The IL-1i of claim 161, wherein said IL-1i is glycosylated.

175. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 174.

176. The IL-1i of claim 161, wherein said IL-1i is nonglycosylated.

177. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 176.

178. The IL-1i of claim 161, wherein (U) is nothing.

179. The IL-1i of claim 161, wherein (U) is M.

180. The IL-1i of claim 161, further comprising an N-terminal secretion leader sequence.

181. The IL-1i of claim 180, wherein the leader sequence comprises all or part of the following amino acid sequence:

182. The IL-1i of claim 146, wherein said IL-1i is a polypeptide comprising all or an IL-1 inhibitory fragment of the amino acid sequence:

183. The IL-1i of claim 183, wherein (X) is R.

184. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 183.

185. The IL-1i of claim 183, wherein said polypeptide inhibits IL-1 induced PGE.sub.2 production.

186. The IL-1i of claim 182, which comprises the following amino acid sequence:

187. The IL-1i of claim 186, wherein (X) is R.

188. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 187.

189. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 187.

190. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 187.

191. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 187.

192. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 187.

193. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 187.

194. The IL-1i of claim 187, wherein (U) is M.

195. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 194.

196. The IL-1i of claim 187, wherein (U) is nothing.

197. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 196.

198. The IL-1i of claim 187, wherein said host cell is selected from a yeast cell, a mouse Ltk.sup.- cell, and a Chinese hamster ovary cell.

199. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 198.

200. The IL-1i of claim 198, wherein said host cell is a mouse Ltk.sup.- cell.

201. The IL-1i of claim 187, wherein said host cell is a prokaryotic cell.

202. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 201.

203. The IL-1i of claim 201, wherein said host cell is E. coli.

204. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 203.

205. The IL-1i of claim 187, wherein said host cell is a eukaryotic cell.

206. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 205.

207. The IL-1i of claim 205, wherein said host cell is a mammalian cell.

208. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 207.

209. The IL-1i of claim 205, wherein said host cell is a Chinese hamster ovary cell.

210. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 209.

211. The IL-1i of claim 187 having a purity of at least about 90%.

212. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation. a therapeutically effective amount of the IL-1i of claim 211.

213. The IL-1i of claim 187 having a purity of at least about 95%.

214. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 213.

215. The pharmaceutical composition of any of claims 175 or 214, further comprising a collagenase inhibitor.

216. The IL-1i of claim 187, wherein said IL-1i is glycosylated.

217. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 216.

218. The IL-1i of claim 187, wherein said IL-1i is nonglycosylated.

219. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 218.

220. The IL-1i of claim 187, which consists of the following amino acid sequence:

221. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 220.

222. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 220.

223. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 220.

224. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 220.

225. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 220.

226. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 220.

227. The IL-1i of claim 187, wherein (U) is M.

228. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 227.

229. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 227.

230. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 227.

231. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 227.

232. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 227.

233. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 227.

234. The IL-1i of claim 227, wherein said IL-1i is nonglycosylated.

235. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 234.

236. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 234.

237. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 234.

238. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 234.

239. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 234.

240. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 234.

241. The IL-1i of claim 234, wherein the IL-1i is recombinantly made by an E. coli host cell.

242. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 241.

243. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 241.

244. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 241.

245. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 241.

246. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 241.

247. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 241.

248. The IL-1i of claim 241 having a purity of at least about 90%.

249. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 248.

250. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 248.

251. A method of treating a patient having rheumatoid arthritis comprising administering to the payment a therapeutically effective amount of an IL-1 inhibitor according to claim 248.

252. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 248.

253. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 248.

254. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 248.

255. The IL-1i of claim 241 having a purity of at least about 95%.

256. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 255.

257. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 255.

258. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 255.

259. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 255.

260. A method of treating a patient to reduce an adverse effect of IL-1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 255.

261. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 255.

262. The IL-1i of claim 220, wherein the IL-1i is recombinantly made by a Chinese hamster ovary cell.

263. The IL-1i of claim 220 having a purity of at least about 90%.

264. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 263.

265. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 263.

266. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 263.

267. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 263.

268. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 263.

269. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 263.

270. The IL-1i of claim 263, wherein said IL-1i is glycosylated.

271. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 270.

272. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 270.

273. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 270.

274. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 270.

275. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 270.

276. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 270.

277. The IL-1i of claim 220 having a purity of at least about 95%.

278. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 277.

279. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 277.

280. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 277.

281. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 277.

282. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 277.

283. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according lo claim 277.

284. The IL-1i of claim 277, wherein the IL-1i is recombinantly made by a eukaryotic host cell.

285. The IL-1i of claim 277, wherein said IL-1i is glycosylated.

286. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 285.

287. A method of treating a patient having arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 285.

288. A method of treating a patient having rheumatoid arthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 285.

289. A method of treating a patient having osteoarthritis comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 285.

290. A method of treating a patient to reduce an adverse effect of IL1 comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 285.

291. A method of treating a patient having at least one of the following: Crohn's disease, ulcerative colitus, glomerulonephritis, or leukemia, comprising administering to the patient a therapeutically effective amount of an IL-1 inhibitor according to claim 285.

292. The IL-1i of claim 277, wherein the IL-1i is recombinantly made by a mammalian host cell.

293. A pharmaceutical composition comprising, in a pharmaceutically acceptable preparation, a therapeutically effective amount of the IL-1i of claim 292.

294. The IL-1i of claim 277, wherein the IL-1i is recombinantly made by a prokaryotic host cell.

295. A method of any one of claims 4-6, 11-13, 36-38, 73-75, 80-82, 87-89, 94-96, 101-103, 108-110, 116-118, 123-125, 130-132, and 138-140, further comprising administering to the patient a therapeutically effective amount of a collagenase inhibitor.

296. A method of any one of claims 156-158, 163-165, 189-191, 222-224, 229-231, 236-238, 243-245, 250-252, 257-259, 265-267, 272-274, 279-281, and 287-289, further comprising administering to the patient a therapeutically effective amount of a collagenase inhibitor.

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