Table 2.

Patient Characteristics

Patient Characteristic	Outcome	First Arm	Second Arm	Comment	Sex/Age, y	Duration of Disease, mo	Location of Lesions
Patient 1	Success with placebo
Begin date, dosage		June 3, 1997, 40 mg		Completed study	M/31	40	Skin
		May 13 1998, >6.5 mg
		October 8, 1998, 0 mg
End date, dosage		January 27, 1999, 0 mg
Patient 2a	Failure with placebo (first arm) and success with dapsone (second arm)
Begin date, dosage		November 24, 1997, 40 mg every other day	July 15, 1998, 40 mg every other day	Switched to dapsone group after failure at 233 d; followed 261 d in dapsone arm	F/40	NA	Oral
End date, dosage		July 15, 1998, 40 mg every other day	February 25, 1999, 15 mg every other day
			April 1, 1999, 0 mg
Patient 3	Dropped out of dapsone group
Begin date, dosage		December 23, 1997, 20 mg		Dropped out; discontinued all treatment after drug dispensation; never showed up again; not part of per-protocol analysis	F/53	10	Oral
End date, dosage		January 19, 1998, 20 mg
Patient 4 a	Failure with placebo
Begin date, dosage		January 20, 1998, 60 mg every other day		Followed 62 d and dropped out after flare	F/42	23	Oral
End date, dosage		March 4, 1998, 60 mg every other day
Patient 5	Failure with dapsone
Begin date, dosage		February 13, 1998, 17.5 mg		Dapsone was never advanced beyond 50 mg; patient noncompliant; not part of per-protocol analysis	M/53	20	Oral and skin
End date, dosage		September15, 1998, 15 mg
Patient 6 a	Success with placebo
Begin date, dosage		February 23, 1998, 20 mg		Met definition of success at 224 d, then flared 91 d after met definition of success and was followed 294 more d	M/45	28	Oral
		July 27, 1998, 6 mg
		July 28, 1998, 0 mg
End date, dosage		September 1, 1998, 3 mg
Patient 7 a	Failure with placebo
Begin date, dosage		April 28, 1998, 40 mg every other day		Flared at d 70 and did not want to continue	F/57	>180	Oral and skin
End date, dosage		July 21, 1998, 40-20 mgb
Patient 8	Failure with placebo (first arm) and dapsone (second arm)
Begin date, dosage		September 10, 1998, 30 mg	December 3, 1998, 25 mg	Followed 84 d on placebo, then switched to dapsone group; noncompliant after 89 d receiving dapsone but unable to taper steroids; followed 187 d after crossover	M/44	7	Oral and skin
End date, dosage		December 3, 1998, 25 mg	June 18, 1999, 15 mg
Patient 9	Failure with placebo
Begin date, dosage		October 15, 1998, 35 mg		Followed 162 d and unable to taper; flared and stopped study	M/45	8	Oral and skin
End date, dosage		April 2, 1999, 60 mg
Patient 10 a	Success with dapsone
Begin date, dosage		March 12, 1999, 20 mg		Completed study at 378 d	M/51	25	Skin
		May 21, 1999, 7.5 mg
		June 4, 1999, 0 mg
End date, dosage		March 24, 2000, 0 mg
Patient 11	Success with dapsone
Begin date, dosage		April 22, 1999, 30 mg		Finished 267 d	F/37	24	Oral
		January 17, 2000, 7.5 mg
End date, dosage		June 14, 2000, 6 mg
Patient 12	Success with dapsone
Begin date, dosage		April 23, 1999, 15 mg		AE hypersensitivity; finished 109 d and tapered steroid prior to AE	M/19	25	Skin
End date, dosage		October 8, 1999, 5 mg
Patient 13	Success with placebo
Begin date, dosage		November 19, 1999, 35 mg		Finished 252 d	M/64	5	Oral
		June 5, 2000, 7 mg
End date, dosage		July 28, 2000, 5 mg
Patient 14	Failure with dapsone
Begin date, dosage		January 25, 2000, 30 mg		Failed after 143 d and not switched to dapsone group	M/39	39	Oral
End date, dosage		June 16, 2000, 30 mg
Patient 15	Failure placebo (first arm) and success dapsone (second arm)
Begin date, dosage		May 23, 2000, 20 mg	February 12, 2001, 120 mg	Flared within 30 d after reaching prednisone dosage <7.5 mg/d judged a failure, and switched to dapsone group with increase to 120 mg prednisone; followed 180 d while receiving dapsone	M/60	NA	Skin
End date, dosage		January 9, 2001, 5 mg	June 11, 2001, 7.5 mg
			July 9, 2001, 3.5 mg
Patient 16	Success with dapsone
Begin date, dosage		September 10, 2001, 60 mg		Patient had met the criteria of success; completed 301 d with taper of steroids, then flared	F/38	11	Oral
End date, dosage		August 21, 2002, 3 mg		Discontinued after hospital admission with pneumonia (unrelated to dapsone treatment); dosage was never increased to >125 mg dapsone
Patient 17	Failure with dapsone				M/43	NA	Oral and skin
Begin date, dosage		January 4, 2002, 17 mg
End date, dosage		February 23, 2002, 15 mg
Patient 18	Failure with placebo (first arm) and success with dapsone (second arm)
Begin date, dosage		October 1, 2002, 20 mg	February 11, 2003, 25 mg	Failed treatment with placebo after 126 d with inability to taper and flare; followed 293 d after switching groups	F/55	27	Oral
End date, dosage		February 11, 2003, 25 mg	December 2, 2003, 6 mg
			December 15, 2003, 5 mg
			January 9, 2004, end of study
Patient 19	Success with dapsone
Begin date, dosage		January 10, 2003, 20 mg		Completed study	F/34	3	Skin
		July 31, 2003, 7.5 mg
		September 25, 2003, 0 mg
End date, dosage		March 11, 2004, 0 mg

Abbreviations: AE, adverse event; NA, not available.

^aGlucocorticoid tapering occurred with an every-other-day schedule.

^bRefers to 40 mg alternating with 20 mg every other day.