Clinical Course and Corticosteroid Excretion of Patients with Rheumatoid Arthritis During Long-term Treatment with Corticotropin

Savage, Oswald; Davis, Peter S.; Chapman, Leslie; Popert, A. J.; Robertson, J. D.; Copeman, W. S. C.

doi:10.1136/bmj.2.5056.1257

Cited by 23 publications

(11 citation statements)

References 4 publications

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“…Hydrocortisone appears to give a lower incidence. The impression that corticotrophin results in a lower incidence of ulcer is confirmed by a perusal of the published reports (Savage et al, 1957;West, 1957). The difference between cortisone and prednisolone and prednisone is probably not significant, provided that the difference in potency is remembered.…”

Section: Resultsmentioning

confidence: 87%

Discussion on the Complications of Steroid Therapy

Jp¹,

Jh²,

Ev³

1958

Proceedings of the Royal Society of Medicine

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Section: Resultsmentioning

confidence: 87%

Discussion on the Complications of Steroid Therapy

Jp¹,

Jh²,

Ev³

1958

Proceedings of the Royal Society of Medicine

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“…We identified 6 studies [38][39][40][41][42][43] that evaluated the benefits of corticotropin for the treatment of rheumatoid arthritis (Table 3). The only RCT 43 responded to an initial 12-week run-in period of corticotropin.…”

Section: Rheumatoid Arthritismentioning

confidence: 99%

“…Other composite measures of response (eg, American College of Rheumatology 20/50/70 criteria, 63 defined as improvement of 20%, 50%, or 70% in both the number of tender and swollen joints and 3 of 5 additional criteria, including patient global assessment, physician global assessment, functional ability measure, visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein level) were not substantially different 12 weeks after randomization. The remaining 5 studies [38][39][40][41][42] were cohort studies. Four of those studies 38,[40][41][42] enrolled between 8 and 49 participants who received variable dosages of corticotropin and evaluated several clinical outcomes over periods ranging from 12 weeks to 2.5 years.…”

Section: Rheumatoid Arthritismentioning

confidence: 99%

“…The remaining 5 studies [38][39][40][41][42] were cohort studies. Four of those studies 38,[40][41][42] enrolled between 8 and 49 participants who received variable dosages of corticotropin and evaluated several clinical outcomes over periods ranging from 12 weeks to 2.5 years. In all 4 studies, 38,[40][41][42] corticotropin was associated with improvements in certain symptoms or severity of illness criteria.…”

Section: Rheumatoid Arthritismentioning

confidence: 99%

“…Four of those studies 38,[40][41][42] enrolled between 8 and 49 participants who received variable dosages of corticotropin and evaluated several clinical outcomes over periods ranging from 12 weeks to 2.5 years. In all 4 studies, 38,[40][41][42] corticotropin was associated with improvements in certain symptoms or severity of illness criteria. The other cohort study 39 of 110 participants characterized treatmentassociated adverse events (AEs) only.…”

Section: Rheumatoid Arthritismentioning

confidence: 99%

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Characterization of the Clinical Evidence Supporting Repository Corticotropin Injection for FDA-Approved Indications

et al. 2022

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IMPORTANCE Repository corticotropin injection is an expensive medication that was approved in 1952 for the treatment of many inflammatory conditions. The clinical evidence supporting the use of repository corticotropin (hereinafter referred to as corticotropin) has been weak, perhaps because its approval predated the modern review standards of the US Food and Drug Administration (FDA).OBJECTIVE To characterize the clinical evidence supporting the use of corticotropin for its FDA-approved indications.EVIDENCE REVIEW Studies were identified via electronic searches of Ovid MEDLINE, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), and the Cochrane Central Register of Controlled Trials (CENTRAL) from database inception to May 12, 2021 (the MEDLINE search was updated on June 8, 2021). Bibliographies of retrieved articles were also reviewed through ClinicalTrials.gov, FDA documents, and the manufacturer's website. Search terms included HP Acthar, ACTH gel, repository corticotropin, and terms for specific diseases, such as multiple sclerosis, nephrotic syndrome, rheumatoid arthritis, and West syndrome (or spasms, infantile). The review included randomized clinical trials (RCTs), nonrandomized and single-arm clinical trials, and prospective cohort studies that compared corticotropin with an active comparator, placebo, or no treatment. Data were extracted by 1 reviewer and verified by a second. Disagreements were resolved through discussion. Studies were qualitatively synthesized by indication to summarize important design features and results.FINDINGS Of 1059 records screened, 203 full-text articles were assessed for eligibility. A total of 41 studies involving 2235 participants met inclusion criteria; of those, 11 involved infantile spasms, 10 involved multiple sclerosis (MS), 11 involved rheumatological conditions, 7 involved nephrotic syndrome, 1 involved ocular conditions, and 1 involved sarcoidosis. Overall, 19 studies either included a single arm or exclusively compared different corticotropin dosing strategies. The evidence was most robust for the treatment of infantile spasms and MS. The largest number of studies comparing corticotropin with an active agent (n = 4) or placebo (n = 5) pertained to MS, with almost all studies finding that corticotropin performed better than placebo but no different than corticosteroids. For the treatment of infantile spasms, 8 controlled studies were identified (6 were randomized); of those, only 1 small RCT found corticotropin to be significantly superior to corticosteroids. Studies of patients with other conditions (n = 20) frequently lacked a control group (n = 12), were placebo-controlled (n = 5), or exclusively examined different corticotropin dosing strategies (n = 2). Placebo-controlled RCTs of rheumatoid arthritis, ankylosing spondylitis, optic neuritis, systemic lupus erythematosus, and nephrotic syndrome were generally small and did not consistently demonstrate that corticotropin was superior to placebo. Blinded RCTs showed a similar or greater number...

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